Avesthagen gets licence to manufacture bioactives for ayurvedic drugs

Avesthagen Limited, India's leading life sciences company that focuses on pharma and population genetics leading to predictive, preventive, personalized healthcare has been granted a licence to manufacture bioactives for ayurvedic drugs by the Drugs Licensing Authority, under the Department of Ayush, Ministry of Health & Family Welfare, Government of India. This licence will help Avesthagen to tap into the huge Indian ayurvedic market and the growing global market of ayruvedic products.

The details can be read here.

ScinoPharm gets US patent for novel crystal forms of Irinotecan Hydrochloride

ScinoPharm, an active pharmaceutical ingredient (API) specialist, has been granted US Patent No. 7,435,818 entitled "Novel Crystal Forms of Irinotecan Hydrochloride." The new patent provides for novel crystalline forms of irinotecan hydrochloride and processes for their preparation as well as pharmaceutical compositions containing the new forms and methods of treating metastatic carcinoma of the colon or rectum using these new forms.

The details can be read here.

Sun Pharma acquires Chattem Chemicals from Elcat

Sun Pharmaceutical Industries Ltd announced that its fully-owned US subsidiary, Sun Pharmaceutical Industries, Inc, has acquired cent per cent ownership of Chattem Chemicals, Inc (Chattem) from Elcat, Inc. The terms of the transaction were not disclosed.

The details can be read here.

Johnson & Johnson to acquire Omrix

Johnson & Johnson and Omrix Biopharmaceuticals, Inc, a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer. Omrix is expected to operate as a stand-alone entity reporting through Ethicon, Inc, a Johnson & Johnson company and leading provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.

The details can be read here.

Basilea Pharmaceutica Ltd. (CH) - FDA issues Complete Response Letter for ceftobiprole

November 26, 2008 - Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) issued to the sponsor, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), a Complete Response Letter for ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections.

The details can be read here.

Pfizer's Novel HIV/AIDS Treatment Selzentry Becomes the Latest Fully Approved Antiretrovial for Treatment-Experienced HIV Patients

Nov 25, 2008 - The U.S. FDA has granted SELZENTRY (maraviroc) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.

The details can be read here.

Québec is the First Province to Cover New, Topical Once-Daily Rosacea Medication

Québec leads the way by being the first province to list MetroGel(R) 1% (metronidazole topical gel, 1%) on its provincial formulary for the treatment of rosacea - a facial skin disease thataffects an estimated two million Canadians(1). MetroGel is the most commonly prescribed topical medication for rosacea(2). The new 1% formulation provides a convenient once-daily dosing for individuals who suffer from this skin condition.

The details can be read here.

California Court's Decision Could Be Deathblow to Pharma Innovation

Legal history was made earlier this month when an intermediate appeals court in San Francisco became the first appellate court in the nation to let a civil case go forward against a product manufacturer by a consumer who used the generic equivalent of that product.

The details can be read here.

Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharmaceuticals

Cephalon, Inc. and Eurand, Inc. today announced that they have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. and its subsidiary, Mylan, Inc., and Barr Pharmaceuticals, Inc. and its subsidiary, Barr Laboratories, Inc., for infringement of Eurand's U.S. Patent Number 7,387,793.

The details can be read here.

Barr Confirms Patent Challenge of Amrix Extended-Release Capsules, 15mg & 30mg

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.

the details can be read here.

King Pharma to acquire Alpharma for around $1.6 bn

King Pharmaceuticals, Inc and Alpharma Inc announced that the two companies have signed a definitive merger agreement under which King will acquire all of the outstanding shares of Class A Common Stock of Alpharma for $37.00 per share in cash for a total equity value of approximately $1.6 billion. The Boards of Directors of both companies have unanimously approved the transaction.

The details can be read here.

DOR BioPharma's orBec Receives Orphan Drug Designation in Australia for the Treatment of GI GVHD

November 25, 2008 - DOR BioPharma, Inc, a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that the TGA of Australia has designated orBec as an Orphan Drug for the treatment of patients with gastrointestinal Graft-Versus-Host-Disease following allogeneic hematopoietic cell transplantation.

the details can be read here.

U.S. FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Diffuse Large B-Cell Lymphoma

Allos Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that the U.S. FDA granted orphan drug designation to the Company's novel antifolate, pralatrexate, for the treatment of patients with diffuse large B-cell lymphoma.

The details can be read here.

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. FDA recommended that the FDA approve febuxostatfor the treatment of hyperuricemia in patients with gout.

The details can be read here.

AstraZeneca Provides Update on Agreement With Abraxis Biosciences for Co-Promotion of Abraxane in the US

On 19 November 2008, AstraZeneca entered into an agreement with Abraxis BioScience, LLC, under which, subject to the satisfaction of terms and conditions thereof, Abraxis would re-acquire exclusive rights to market ABRAXANE in the United States.

The details can be read here.

US Patent Granted on Antibodies Against GM-CSF to Treat Inflammatory Disorders

MorphoSys AG and the University of Melbourne announced today that the USPTO has confirmed that it will issue U.S. Patent No. 7,455,836, covering key uses of antibodies against GM-CSF.

The details can be read here.

ScinoPharm Granted US Patent for Novel Crystal Forms

ScinoPharm, an active pharmaceutical ingredient specialist, announced it has been granted US Patent No. 7,435,818 entitled "Novel Crystal Forms of Irinotecan Hydrochloride." The new patent provides for novel crystalline forms of irinotecan hydrochloride and processes for their preparation as well as pharmaceutical compositions containing the new forms and methods of treating metastatic carcinoma of the colon or rectum using these new forms.

The details can be read here.

Teva Announces Agreement on Generic Pulmicort Respules Patent Challenge

Nov 25, 2008 - Teva Pharmaceutical Industries Ltd. today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva's U.S. generic version of AstraZeneca's Pulmicort (Budesonide) Respules including all claims for patent infringement and damages.

The details can be read here.
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Watson Enters Into Agreement to Acquire Products Related to Teva's Proposed Acquisition of Barr

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced a definitive agreement to acquire a portfolio of generic pharmaceutical products that are being divested as a result of the proposed merger between Teva Pharmaceutical Industries, Ltd. and Barr Pharmaceuticals, Inc. The closing of the product acquisition is contingent upon the consummation of Teva's merger with Barr.

The details can be read here.

USPTO Confirms Validity of Bystolic Patent

Forest Laboratories, Inc. announced today that the USPTO has closed prosecution on the merits of the reexamination proceedings for the patent for Bystolic i.e. US6,545,040 and confirmed the validity of all of the previously granted claims.

The details can be read here.

Solvay gets North American rights to Depomed's pain drug gabapentin

Depomed, Inc announced a product license agreement under which Solvay Pharmaceuticals will have exclusive rights for DM-1796 (formerly Gabapentin GR) for the treatment of pain in the United States, Canada, Mexico and Puerto Rico.

The details can be read here.

Biovitrum's and Syntonix's Novel Factor IXFc for Hemophilia B has Received Orphan Drug Designation From the FDA

Biovitrum AB and Syntonix Pharmaceuticals, Inc., today announced that the company's FIXFc compound for the control and prevention of hemorrhagic episodes in patients with hemophilia B has received an orphan-drug designation from the US FDA.

The details can be read here.

Genzyme Seeks U.S. Approval for Clolar to Treat Adult AML

Nov 24, 2008 - Genzyme Corporation announced today that it has filed a supplemental New Drug Application with the U.S. Food and Drug Administration for the use of Clolar (clofarabine) to treat adult patients with acute myeloid leukemia (AML).

The details can be read here.

FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months

Nov 24, 2008 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it received notification that the U.S. FDA will not be able to complete its review of the company's New Drug Application for Silenor (doxepin) by the Prescription Drug User Fee Act (PDUFA) date of December 1, 2008.

The details can be read here.

Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA

Labopharm Inc. today announced that its NDA for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. FDA. The action date under the Prescription Drug User Fee Act (PDUFA) is July 18, 2009.

The details can be read here.

Biovail Announces U.S. Availability of Xenazine Tablets

Nov 24, 2008 - Biovail Corporation today announced that Xenazine tablets, an orphan drug recently approved by the U.S. FDA for the treatment of chorea associated with Huntington's disease (HD), is now available throughout the United States.

The details can be read here.

Synthon successfully completes European decentralized procedures for generic Pramipexole

24 November 2008 - Synthon announces that it has successfully completed multiple decentralized procedures (DCP) for its latest product Pramipexole. Regulatory clearance has been obtained for Synthon's product in thirteen European countries. Synthon' s product is a generic version of the anti-Parkinson agent Pramipexole.

The details can be read here.

Dr. Reddy's Launches Authorized Generic Version of Imitrex Tablets

Nov 24, 2008 - Dr. Reddy's Laboratories today announced that it has launched the authorized generic version of GlaxoSmithKline's Imitrex (sumatriptan succinate) tablets 25mg, 50mg, and 100mg in the United States. Dr. Reddy's is the first company to launch an authorized generic version of Imitrex tablets in the US market.

The details can be read here.

Pfizer withdraws application for non-prescription status of Viagra in EU

Pfizer announced that it has withdrawn its application to switch the legal status of the 50 mg tablet strength of Viagra from 'prescription only' to 'non-prescription' in the European Union (EU).

the details can be read here.

GSK's eltrombopag gets US FDA approval

GlaxoSmithKline (GSK) announced that the United States FDA granted accelerated approval for Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

The details can be read here.

Kolkata Patent Office Issued Arzoxifene Polymorph Patent to Eli Lilly

In an article published on patent circle:

Lately Kolkata Patent Office issued an Indian Patent No. 225209 to Eli Lilly & Co. for crystalline non-solvated anhydrous Arzoxifene. The ‘209 patent titled “A crystalline non-solvated anhydrous form 6-hydroxy-3-(4-[2-piperdin-1-yl) ethoxy] phenoxy)-2-(4-methoxyphenyl) benzo [b] thiophene hydrochloride” is published in Official Journal of the Patent Office (Issue no. 45/2008 dated 07/11/2008).

The details cna be read here.

Archemix to merge with NitroMed

NitroMed, Inc and Archemix Corp, a privately-held biopharmaceutical company working to develop aptamer-based therapeutics, announced that they have entered into a definitive merger agreement under which Archemix will merge with NitroMed in an all-stock transaction.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter

Caraco Pharmaceutical Laboratories, Ltd. announced today that it will be filing its response to the FDA warning letter on November 24, 2008 as planned. In the warning letter, received on October 31, 2008, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008.
The details can be read here.

Rasilez HCT Receives Recommendation for European Approval as a Single-Pill Combination to Treat High Blood Pressure

November 21, 2008 _ Rasilez HCT® (aliskiren and hydrochlorothiazide) received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization as a new treatment for high blood pressure.

the details can be read here.

Nplate (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

Amgen today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate(TM) (romiplostim) in the European Union (EU).

The details can be read here.

CHMP Recommends Approval of New Indication for Enbrel as Treatment for Severe Psoriasis in Paediatric Patients

The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel(R) (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis.

The details can be read here.

Zevtera (ceftobiprole medocaril), the Novel anti-MRSA Broad-spectrum Antibiotic, Receives a Positive Opinion from the CHMP

November 21, 2008 - Basilea Pharmaceutica Ltd. announces that Zevtera (ceftobiprole medocaril), the first-in-class anti-MRSA broad-spectrum cephalosporin, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of complicated skin and soft tissue infections.

The details can be read here.

Valdoxan, the First Melatonergic Antidepressant, Receives EU CHMPPositive Opinion for Major Depressive Disorder

The first melatonergic antidepressant - Valdoxan/Thymanax (agomelatine) - has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD).

The details can be read here.

Ligand Collaborator GlaxoSmithKline Receives FDA Approval for Promacta

Ligand Pharmaceuticals Incorporated announced today that the U.S. FDA has granted accelerated approval of GlaxoSmithKline's PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. PROMACTA is the first oral thrombopoietin receptor agonist therapy for the treatment of adult patients with chronic ITP.

The details can be read here.

FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain

Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.

The details can be read here.

Glenmark gets USFDA approval for Ranitidine tablets

US subsidiary of Glenmark Generics Ltd has received ANDA approval from the U.S. FDA for Ranitidine 150 mg and 300 mg tablets and will soon commence marketing and distribution of these products in the U.S. market.

The details can be read here.

Arcutis Pharmaceuticals Announces FDA Approval of Acanya Gel for the Treatment of Acne

Nov 20, 2008 - Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced today that the United States Food and Drug Administration (FDA) has approved the new drug application (NDA) of Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) for the once-daily treatment of acne vulgaris in patients 12 years and older..

The details can be read here.

European Medicines Agency Recommends the Suspension of the Marketing Authorisation of Ionsys (fentanyl hydrochloride)

Nov. 20, 2008-The European Medicines Agency has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed.

The details can be read here.

Teva Provides Update on Generic Pulmicort Respules Launch

Nov 20, 2008 - Teva Pharmaceutical Industries Ltd. announces that further to its press release dated November 19, 2008, the United States District Court for the District of New Jersey has granted AstraZeneca's request for a temporary order restraining further sales of Teva's generic version of AstraZeneca's Pulmicort (Budesonide) Respules® pending the Court's decision on AstraZeneca's motion for a preliminary injunction.

The details can be read here.

CHMP Confirms Original Opinion on Santhera's SNT-MC17/Idebenone for Treatment of Friedreich's Ataxia

Nov. 19, 2008-Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announced today that the European Medicines Agency (EMEA) has informally advised that it would maintain its negative opinion on the Company's Marketing Authorization Application (MAA) for SNT-MC17/idebenone in Friedreich's Ataxia.

The details can be read here.

Generex Awarded New Pain Relief Patents

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has received two new patents, one in Mexico (issued by the Mexican Institute of Industrial Property), the other in New Zealand (issued by the Intellectual Property Office of New Zealand).

The details can be read here.

Par Pharmaceutical Begins Shipment of Budesonide Inhalation Suspension Immediately

Par Pharmaceutical Companies, Inc. today announced that it has entered into a supply and distribution agreement with AstraZeneca in the U.S. to market budesonide inhalation suspension, which is a generic form of AstraZeneca's Pulmicort Respules(R) indicated for the maintenance treatment of asthma. Par began shipping 0.25 mg/2 ml and 0.5 mg/2 ml to the trade today.

The details can be read here.

AstraZeneca Enters Agreement for Authorized Generic Pulmicort Respules

Nov. 19, 2008- AstraZeneca today announced that it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of budesonide inhalation suspension in the United States in response to the launch ‘at risk’ of a generic version of this product by Teva. Currently, the authorized generic product will be distributed in the 0.25 mg/2 mL and 0.5 mg/2 mL dosage strengths. Par Pharmaceutical began shipping the product today.

The details can be read here.

AMRI Announces Agreement with Teva Pharmaceuticals and Barr Laboratories to Settle Litigation in Allegra and Allegra D-12 U.S. Patent Dispute

Nov 19, 2008 - Albany Molecular Research, Inc. and its wholly owned subsidiary, AMR Technology, Inc., announced that a settlement regarding U.S. patent infringement litigation involving ALLEGRA and ALLEGRA D-12 has been reached among them, Aventis Pharmaceuticals, Inc., sanofi-aventis U.S. LLC, Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. The settlement agreement and related licensing arrangements are subject to review by the Federal Trade Commission and U.S. state Attorneys General.

The details can be read here.

The Relevance of In re Bilski to the Patentability of the Metabolite Claim

A very nice article is published on the patentability of metabolite claims and the effect of In re Bilski to the same by Kevin E. Noonan on patentdocs.org.

The complete details can be read here.

FDA Extends Metozolv ODT Review Date

Salix Pharmaceuticals, Ltd. today announced that the U.S. FDA has informed Wilmington Pharmaceuticals that the Prescription Drug User Fee Act action date for the New Drug Application for METOZOLV (metoclopramide) Orally Disintegrating Tablets has been extended three months to provide time for a full review of the submission.

the details can be read here.

Arpida Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting on iclaprim

Arpida announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 20, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting.

The details can be read here.

Novagali Pharma S.A. Withdraws Its Marketing Authorisation Application for Vekacia (ciclosporin)

Nov. 18, 2008-The European Medicines Agency (EMEA) has been formally notified by Novagali Pharma S.A. of its decision to withdraw its application for a centralised marketing authorisation for the medicine Vekacia (ciclosporin) 0.05% eye drops. Vekacia was expected to be used for the treatment of vernal keratoconjunctivitis. Vekacia was designated as an orphan medicine on 6 April 2006.

The details can be read here.

Catalent Introduces the Secure-Vial Technology for Innovative and Cost Effective Delivery of Injectable Pharmaceuticals

Catalent Pharma Solutions, one of the leading providers of advanced technologies and outsourced services to the global pharmaceutical, biotechnology and consumer health industry, announces the introduction of the SECURE-VIAL™ technology, a new patent-pending delivery system for injectable drug products. Catalent is launching the SECURE-VIAL™ technology to the scientific community this week at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS).

the details can be read here.

Oncolytics Biotech Inc. Announces Issuance of 30th U.S. Patent

Oncolytics Biotech Inc. today announced that it has been granted its 30th U.S. Patent, # 7,452,723, entitled "Methods for Preventing Reovirus Recognition for the Treatment of Cellular Proliferative Disorders." The allowed claims relate to kits comprised of reovirus and an immune suppressive agent that are designed to prevent reovirus recognition by the immune system.

The details can be read here.

Salix Announces Issuance of U.S. Patent for Rifaximin

Salix Pharmaceuticals, Ltd. today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 7,452,857. This patent provides protection until August 2019.

The details can be read here.

Jury Awards $16.5 Million in Fentanyl Death Case

A jury in Chicago has found two Johnson & Johnson subsidiaries liable in the death of a Cicero, Ill., woman who died while using a Duragesic(R) patch, and ordered the companies to pay her family $16,560,000.

The details can be read here.

Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem Pulvules Capsules

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg.

The details can be read here.

Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

University of Kansas Center for Research, Inc. v. United States of America2:08-cv-02565; filed November 12, 2008 in the District Court of Kansas

Correction of inventorship of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), directed to formulations or methods for formulating the drug Velcade®, to add inventors from University of Kansas.

All filed cases and details of the cases can be read here.

Innocoll Receives Fast Track Designation for Gentamicin Surgical Implant

Innocoll, Inc., a privately-held biopharmaceutical company, announced that the FDA has designated Gentamicin SURGICAL Implant as a Fast Track development program.

the details can be read here.

AMAG Pharma gets class 1 US FDA response for ferumoxytol

AMAG Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has designated the company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, class 1 response.

The details can be read here.

Progenics Announces Wyeth Has Received Relistor Approval in Australia

17, 2008 - Progenics Pharmaceuticals, Inc., today announced the Therapeutic Goods Administration division of the Australian Government has approved the registration of RELISTOR(methylnaltrexone bromide 12mg/0.6ml solution for injection) for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient.

The details can be read here.

Jubilant subsidiary Clinsys acquires TrialStat ClinicalAnalytics

Jubilant Organosys Ltd announced that its subsidiary Clinsys Clinical Research, Inc, New Jersey, a global contract research organization (CRO), has acquired TrialStat ClinicalAnalytics from TrialStat for a purchase consideration of CAD 750,000.

The details can be read here.

FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder

Eisai Corporation of North America announced today that the U.S. FDA approved BANZEL (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. One of the most severe forms of childhood epilepsy, LGS is characterized by multiple and frequent seizures.

The details can be read here.

Gilead Sciences Announces Notification of ANDA Filing for Truvada

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application to the U.S. FDA requesting permission to manufacture and market a generic version of Truvada (emtricitabine and tenofovir disoproxil fumarate).

The details can be read here.

Mylan Receives Tentative FDA Approval for the Generic Version of the Antidepressant Effexor XR

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base).

The details can be read here.

Bayer named best pharma company in Brazil

Bayer is recognized as Brazil's best chemical and pharmaceutical company. This was the result of a survey of 12,000 consumers conducted by Época Negocios Magazine, one of the country's leading business news magazines. Respondents were asked to rank over 200 local and international companies on several criteria, including trust, quality, social and environmental responsibility, as well as innovation. Bayer finished first on all criteria in both the pharmaceutical and chemical branch.

The details can be read here.

Indian drug exporters run into trouble as EU tightens patent laws

Some Indian drug exporters have run into a serious trouble of getting their products confiscated or ending up paying huge damages after the European Union countries have started implementing local patent rules very rigidly. Indian authorities, hence, have advised exporters to make sure that patented products are not shipped through European ports.

The details can be read here.

Bioseek licenses two anti-inflammatory peptides from Amylin Pharma

BioSeek, Inc, a pioneer in the application of predictive human biology to drug discovery, announced that it has exclusively licensed two novel anti-inflammatory peptides from Amylin Pharmaceuticals, Inc. The two novel peptides were identified as candidates for development by BioSeek as a result of an ongoing joint research collaboration initiated between the two companies in 2007.

The details can be read here.

FDA MedWatch- Bisphosphonates-Update To The Early Communication Issued Regarding Atrial Fibrillation With Bisphosphonates

Nov. 12, 2008-On October 1, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased risk for atrial fibrillation in patients treated with a bisphosphonate drug (http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm). An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine described increased rates of serious atrial fibrillation in two different studies of women ages 65 to 89 years old with osteoporosis treated with the bisphosphonates, Reclast and Fosamax.

The details can be read here.

Watson Announces the NDA for a 6-Month Formulation of Trelstar Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that its NDA for a 6-month formulation of TRELSTAR (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist, has been accepted for filing by the U.S. FDA.

The details can be read here.

Stem Cell Sciences Reinforces its International Patent Position in Stem Cell Technologies

November 14, 2008 /PRNewswire-FirstCall/ --Stem Cell Sciences plc announces that European patent no. 0695361 covering its IRES technology was upheld by the European Patent Office in Munich on 12th November 2008.

The details can be read here.

U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products

November 14, 2008 -- The United States is seeking a permanent injunction to bar Actavis Totowa LLC, and Actavis Inc. and two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act, the Justice Department announced today.

The details can be read here.

Azur Pharma, Elan sign pact to develop once-daily clozapine formulations

Azur Pharma Limited announced that it has entered into an agreement to develop and commercialise once-daily formulations of clozapine using Elan Corporation plc's proprietary drug delivery technologies, including its NanoCrystal technology.

The details can be read here.

Almirall to market Pfizer's Astucor in Spain

Almirall, the international pharmaceutical company based in Spain, has signed a co-marketing agreement with Pfizer by which Pfizer grants Almirall commercialisation rights in Spain of a new medicine that combines amlodipine and atorvastatin under the trademark Astucor.

The details can be read here.

Wanbury launches Cdense for osteoporosis & gynaecology related calcium deficiency

Wanbury Ltd, one of the fastest growing pharma companies in the domestic market, has entered into the osteoporosis & gynaecology related calcium deficiency market with the launch of Cdense - Calcium Orotate, a mineral transporter. Cdense will be available in tablet form of 740 mg dosage.

The details can be read here.

Wockhardt launches Midazolam in US market

Wockhardt has launched Midazolam injection in the United States after receiving approval from the US FDA for marketing the preservative-free version injections containing 1 mg/ml and 5mg/ml Midazolam, which is used for treating acute insomnia and anxiety.

The details can be read here.

Shreya Life Sciences launches first buccal insulin spray in India

The Mumbai-based Shreya Life Sciences Pvt Ltd, in collaboration with the US-based Generex Biotechnology Corporation, has announced launch of world's first buccal insulin spray under the brand name of Oral-Recosulin in India.

The details can be read here.

AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA

Nov 13, 2008 - AMAG Pharmaceuticals, Inc. today announced that the U.S. FDA has designated the Company's resubmission to the October 2008 Complete Response letter for its NDA for ferumoxytol as a complete, Class 1 response.

The details can be read here.

Seroquel XR And Seroquel Approved In Europe For New Indications For The Treatment Of Bipolar Disorder

Nov. 13, 2008-AstraZeneca today announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been licensed for moderate to severe manic episodes in bipolar disorder.

The details can be read here.

Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives approval by Swissmedic

November 13, 2008 - Basilea Pharmaceutica Ltd. announces that ceftobiprole (Zevtera), the anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Swissmedic for the treatment of complicated skin and soft tissue infections including diabetic foot infections.

the details can be read here.

FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia

PREMARIN (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. FDA for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals.

The details can be read here.

Public Statement On Exubera (Insulin Human) Withdrawal Of The Marketing Authorisation In The European Union

10 November 2008: On 24 January 2006 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Exubera, human insulin, 1 mg and 3 mg inhalation powder for inhalation use, which had been approved for the treatment of type II diabetes mellitus.

The marketing authorisation holder (MAH) responsible for Exubera was Pfizer Limited. The European Commission was notified by letter dated 26 June 2008 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Exubera for commercial reasons.

The details can be read here.

Patents Issued for Inotek Pharmaceuticals' Lead Clinical Compounds in Glaucoma and Contrast-Induced Nephropathy

Nov 13, 2008 - Inotek Pharmaceuticals Corporation announced today that the United States Patent and Trademark Office has issued two new patents covering the Company's two lead clinical compounds. US Patent number 7,423,144 relates to INO-8875, in clinical development as a novel treatment for glaucoma and US Patent number 7,432,369 relates to INO-4885, in clinical development for the prevention of contrast-induced nephropathy.

The details can be read here.

Orion Sues Sun Pharma Global, Inc. in the U.S. to Enforce Orion's U.S. Patent No. 5,446,194 Covering its Proprietary Drug Comtan

Nov. 12, 2008--Orion Corporation filed a patent infringement lawsuit in the United States to enforce its U.S. Patent No. 5,446, against Sun Pharma, who seeks to market a generic version of Orion Corporation's proprietary drug, Comtan in the US. Comtan contains entacapone and is a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis.

The details can be read here.

USPTO To Increase PCT Transmittal and Search Fees

The U.S. Patent and Trademark Office has finalized fee increases it proposed earlier this year for international patent applications filed under the Patent Cooperation Treaty, hiking the charges for prior art searches and the PTO is reducing transmittal fees.

The detials can be read here.

The whole notice can be read at following reference.
Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations

TNFerade Receives FDA Fast Track Designation for Treatment of Pancreatic Cancer

Nov 11, 2008 - GenVec, Inc. announced today that TNFerade has been granted Fast Track product designation by the U.S. FDA for its proposed use in the treatment of locally advanced pancreatic cancer.

The details can be read here.

Bayer's Xarelto shows encouraging results in patients with acute coronary syndrome

Findings from the ATLAS ACS TIMI 46 study - a phase-II study of the novel oral anticoagulant Xarelto (rivaroxaban) - were presented as a late-breaking clinical trial at the American Heart Association's Scientific Sessions 2008 in New Orleans by C Michael Gibson, director of the TIMI Data Coordinating Center, Harvard Medical School, Boston, Massachusetts, USA. Results from this phase-II study support moving rivaroxaban into a pivotal phase-III trial for the secondary prevention of acute coronary syndrome (ACS) later this year.

The details can be read here.

ArQule, Daiichi-Sankyo sign R&D partnership for cancer compounds

ArQule, Inc and Daiichi Sankyo Co, Ltd announced that they have entered into two agreements that form the basis of a strategic relationship for the development and discovery of novel oncology therapeutics.

The details can be read here.

EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags

Nov 11, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. FDA for double concentration Cardene I.V. (nicardipine hydrochloride) premixed injection.

The details can be read here.

FDA Approves 30-Minute Onset of Action for FocalinXR

The USFDA has approved a 30-minute onset of action for Focalin XR (dexmethylphenidate HCl) ER capsules for the treatment of Attention Deficit/Hyperactivity Disorder, bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.

The details can be read here.

Intellect Neurosciences, Inc. Validates Pivotal European Patent for Alzheimer's Monoclonal Antibody Platform

November 11, 2008 -- a biopharmaceutical company focused on development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), announced today that it has completed validation of its European patent related to antibodies and methods of treatment for Alzheimer's disease in Germany, France, United Kingdom and the Netherlands.

The details can be read here.

Indian pharma cos fail to compete with foreign players in securing product patents for innovations

Indian pharmaceutical companies and individuals together could grab just above 15 per cent of the total product patents granted to pharmaceutical inventions and innovations in the past three years from January 1, 2005, ever since the country moved into the product patent regime from process patents.

The details can be read here.

SCOLR Pharma's ibuprofen ER phase III trial meets endpoints

SCOLR Pharma, Inc reported favourable top-line results from its pivotal phase-III trial to evaluate the safety and efficacy of its 12 hour CDT 600 mg. extended-release (ER) ibuprofen for the over-the-counter market.

The details can be read here.

Study confirms erlotinib delays lung cancer progression

Roche announced that the SATURN (SequentiAl Tarceva in UnResectable NSCLC) study met its primary endpoint of progression free survival. The study showed that Tarceva (erlotinib), when given in first line maintenance - immediately following initial treatment with platinum-based chemotherapy - significantly extended the time patients with advanced non-small cell lung cancer (NSCLC) lived without their cancer getting worse.

The details can be read here.

Glenmark launches fifth pain management product in US

Glenmark Generics Inc, has launched its morphine sulfate oral concentrate solution product in the US market through a licensing agreement with a US-based pharmaceutical development company.

The details can be read here.

GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for RLS

Nov 10, 2008 - GlaxoSmithKline and XenoPort, Inc. announced today that the NDA for Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) has been withdrawn.

The details can be read here.

FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin

Discovery Laboratories, Inc., today announced that the USFDA has accepted for review Discovery Labs' Complete Response for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome in premature infants.

The details can be read here.

3SBio Inc. Files for SFDA Approval of NuLeusin

3SBio Inc. , a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has filed with the Chinese State Food and Drug Administration (SFDA) for approval of NuLeusin for the treatment of late stage metastatic renal cell carcinoma. If approved, NuLeusin is expected to be the only treatment of this kind available in China.

The details can be read here.

Impax sued again over ULTRAM ANDA

(November 06, 2008) -- While Impax Laboratories Inc. continues to try to bring a generic version of the painkiller Ultram to market, the drug’s marketer, Ortho-McNeil-Janssen Pharmaceuticals Inc., has filed another infringement suit against the company.

The details can be read here.

HemaQuest gets orphan drug status for blood disorders drug

HemaQuest Pharmaceuticals announced that the US Food and Drug Administration (FDA) has awarded the company orphan drug designations for sickle cell anaemia and beta thalassemia for HQK-1001, which is an orally administered therapeutic under clinical development for these two indications.

The details can be read here.

FDA Approves Ranexa for First Line Anti Anginal Use

CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease.

The details can be read here.

Winston Laboratories, Inc. Announces Licensing Agreement with sanofi-aventis Canada Inc. in Canada

Nov 7, 2008 - Winston Laboratories, Inc., a wholly owned subsidiary of Getting Ready Corporation (OTC: GTRY.OB), announced that on October 30, 2008 it entered into a licensing agreement with sanofi-aventis Canada Inc. for the Canadian rights to Winston's proprietary transient receptor potential vanilloid (TRPV-1) modulator in formulations for topical application.

The details can be read here.

Teva Provides Update on Generic Prevacid Litigation

Nov 7, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a March 31, 2008 decision by the District Court, which had found TAP Pharmaceutical Products Inc.'s U.S. Patent No. 4,628,098 valid and enforceable. As a result of today's decision, Teva expects to market its generic version of TAP's Prevacid(R) (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg no later than November 10, 2009, when the patent is otherwise set to expire.

The details can be read here.

Daiichi Sankyo completes Ranbaxy acquisition

MUMBAI: Japanese drugmaker Daaichi Sankyo Company has completed the acquisition of Ranbaxy Laboratories, with the final transfer of the promoters’ stake. As a result of this acquisition of shares, the Singh family has ceased to be the promoters of the co mpany and Daiichi Sankyo has become the promoter of the company with effect from November 7.

Daiichi now holds 63.92 per cent stake in Ranbaxy, the companies said in a statement to the Bombay Stock Exchange on Friday.

Supreme court of Canada upholds clopidogrel patent

The Supreme Court of Canada has rejected an attempt by a Toronto-based generic drug maker to prevent brand-name pharmaceutical companies from patenting specific parts of previously patented medicines.

The court ruled unanimously against Apotex Inc. and in favour of France's Sanofi-Synthelabo over a challenge involving the blood-thinner clopidogrel bisulphate. The compound is marketed as Plavix, one of the world's top-selling drugs.

The whole judgement can be read here.

US FDA recalls mislabelled ReliOn insulin syringes

The US Food and Drug Administration announced that the agency is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabelling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycaemia, serious health consequences, and even death.

The details can be read here.

Glenmark Generics launches Perindopril tablets in UK

Glenmark Generics Limited has announced that its European subsidiary has launched its first product in Western Europe via initiation of sales of Perindopril tablets in the United Kingdom.Perindopril Erbumine, an ACE inhibitor indicated for symptomatic heart failure is being manufactured at the Glenmark Generics' plant in Goa, India.

The details can be read here.

Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal

SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL(R) (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In an Approvable Letter received on April 6, 2006, the FDA requested additional data with respect to chemistry, manufacturing, and controls.

The details can be read here.

FDA Approves Ranexa for First Line Anti Anginal Use

CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.

The details can be read here.

Benitec Limited (ASX:BLT) Double-Stranded Patent Granted in Singapore

Benitec Limited today announced that a key patent focused on producing Double-Stranded Nucleic Acid constructs for therapeutic and related applications of RNA interference (RNAi) had been granted in Singapore.

The details can be read here.

Santarus Prevails on Claims Disputed by Par Pharmaceutical at Markman Hearing

Nov 5, 2008 - Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, today announced that Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware has ruled in favor of Santarus and the University of Missouri following the Markman hearing held November 5, 2008. "Markman" hearings, also known as claim construction hearings, are held to resolve any disputes concerning the meaning of asserted patent claims prior to trial.
The details can be read here.

Par Pharmaceutical Begins Shipment of Sumatriptan Injection

Par Pharmaceutical Companies, Inc. today announced that it will begin shipping generic versions of Imitrex(R) Injection (sumatriptan succinate injection) 4mg and 6mg starter kits and 4mg and 6mg prefilled syringe cartridges to the trade immediately. In addition, Par anticipates launching the 6mg vials early next year.

The details can be read here.

NicOx says naproxcinod has an edge over naproxen for hypertension

NicOx SA announced positive top-line results from a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study), which compared the 24-hour blood pressure profile of escalating doses of naproxcinod and naproxen in osteoarthritis (OA) patients with controlled hypertension.

The details can be read here.

US FDA clears Salix's mesalamine pills for ulcerative colitis

Salix Pharmaceuticals, Ltd. announced that the US Food and Drug Administration (FDA) has granted marketing approval for Apriso (mesalamine) extended-release capsules 0.375 g.

The details can be read here.

Antares Announces Additional Regulatory Approvals in Europe and Australia for Its Needle-Free Injection Device

Nov 5, 2008 - Antares Pharma, Inc. today announced that it's license partner, Ferring Pharmaceuticals has received additional regulatory approvals in Europe and Australia for use of Antares' needle-free injection devices with it's human growth hormone (hGH), Zomacton.

The details can be read here.

Keppra XR Offers Convenient Dosing For People With Partial Onset Seizures

UCB announced today that Keppra XR(TM) offers convenient dosing for people with epilepsy. Keppra XR(TM) was approved by the U.S. Food and Drug Administration (FDA) in September 2008 for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older.

The details can be read here.

Through the Eye of a Needle - Labcyte Awarded U. S. Patent Describing the Acoustic Transfer of Droplets into Small Openings

Nov 5, 2008 - Labcyte Inc., the pioneer in 'touchless' acoustic transfer of liquids, announces the issuance of U.S. Patent 7,405,395 which exploits the unique advantages of using sound to move liquids. This patent describes the acoustic transfer of fluid droplets into openings less than 300 microns in diameter. "We have exquisite capabilities for directing a droplet exactly to where we want it," said Chief Technical Officer, Richard Ellson. "We can easily direct a droplet of almost any liquid into an extremely small opening or lay it onto a complex surface such as a stent. We have been able to position droplets with better than 10 micron accuracy.

The details can be read here.

Aldagen receives orphan drug status for ALD-101

Aldagen, Inc announced that it has received orphan drug designation for ALD-101 from the US Food and Drug Administration (FDA). The designation was granted for the use of ALD-101 to improve patient outcomes by decreasing time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.

The details can be read here.

Stride Arcolab gets US FDA nod for pamidronate injection

Stride Arcolab has received US FDA approval for pamidronate disodium injection, 3mg/ml and 9mg/ml for single use vials. The product is licensed to Akorn-Strides, LLC, which is a joint venture that was formed in 2004 by Akorn Inc and Strides.

The details can be read here.

Sanvar (Debio 8609) for Esophageal Variceal Bleeding

Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that Debiovision Inc., its Canadian affiliate, filed its Complete Response to the approvable letter received from the United States (U.S.) Food and Drug Administration (FDA) for Sanvar(R), or Debio 8609 (vapreotide acetate). The immediate release formulation of Sanvar(R), a somatostatin analogue, is used in the treatment of acute esophageal variceal bleeding (EVB).

The details can be read here.

FDA Approves Additional Indication for Norditropin for Small for Gestational Age (SGA) in Children

Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years.

The details can be read here.

Sanusco, the First and Only Patch for Preventing Nausea and Vomiting in Chemotherapy Patients, Now Available

ProStrakan Group plc today announced that SANCUSO(R) (Granisetron Transdermal System) is now available by prescription for patients with chemotherapy-induced nausea and vomiting (CINV) in the United States. Sancuso was approved by the U.S. Food and Drug Administration (F.D.A.) in September 2008 as the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.

The details can be read here.

Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra and Launches Immediately

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra(R).

The details can be read here.

US FDA approves new indication for Hospira's Precedex

Hospira, Inc, a global specialty pharmaceutical and medication delivery company, announced that the US Food and Drug Administration (FDA) approved a new indication for Precedex (Dexmedetomidine Hydrochloride Injection), the company's innovative drug for in-hospital sedation. This approval allows for use of Precedex in non-intubated patients requiring sedation prior to and/or during surgical and other procedures.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter

On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. received a warning letter from the FDA. The letter was issued as a follow up to the last FDA inspection of the Company's manufacturing facility in Detroit, Michigan which was initiated in May 2008. As previously disclosed, a Form 483 notice was issued in June 2008 following this inspection.

The details can be read here.

Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer

November 3, 2008 -- Genentech, Inc. today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

The details can be read here.

Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Cephalon, Inc., (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA(R) (bendamustine hydrochloride) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The details can be read here.

UCB (BE) - Fesoterodine approved in the U.S.

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The details can be read here.

Daiichi Sankyo Acquires Merck Serono's Cardio-Metabolism Sales Force and Products in Turkey

DAIICHI SANKYO ILAÇ TICARET Ltd. Sti., the Turkish subsidiary of Japan's second-largest pharmaceutical company, has obtained 20 members of the cardio-metabolism sales force at Merck ILAÇ Ltd, a subsidiary of Merck Serono in Turkey. The agreement also includes the transfer of marketing-authorization for Concor, an anti-hypertensive medication, and Glucophage, a diabetes agent.

The details can be read here.

Mologen AG receives patent for cell based gene therapy

November 3, 2008 - The Berlin biotech company MOLOGEN AG announced today that the Russian patent office is going to issue the patent for cell based gene therapy against cancer.

The details can be read here.

Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo in the United States

Nov. 3, 2008-Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Wockhardt Limited (Wockhardt) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States.

The details can be read here.

Barr Announces Approval of Generic Camptosar Injection, 20 mg/mL

Barr Pharmaceuticals, Inc. today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pfizer Inc.'s Camptosar(R) (irinotecan hydrochloride) Injection, 20 mg/mL, packaged in 40 mg/2 mL and 100 mg/5 mL vials. The Company plans to launch its product in the fourth quarter of 2008. Barr's U.S. generic injectable portfolio now totals nine products.

The details can be read here.