Court Report

As per the court report published on patentdocs.net.

Sepracor Inc. and University of Massachusetts v. Pharmaceutical Associates, Inc.
3:08-cv-04718; filed September 19. 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough........,
View the complaint here.

Bayer Schering Pharma AG et al. v. Sandoz, Inc. et al.
1:08-cv-08112; filed September 18, 2008 in the Southern District of New York

Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone as an antiandrogen," issued October 29, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture ......
View the complaint here.

View the details here.

Actavis to market BSV's anti-infective generic formulation in Europe, SA & Turkey

Bharat Serums and Vaccines Limited (BSV), one of the top ten Indian biopharmaceutical companies, has entered into an exclusive licensing , manufacturing and supply agreement with Actavis for marketing one of BSV's anti-infective generic formulations.

The details can be read here.

Eli Lilly Sues Teva Again Over Gemzar ANDA

Eli Lilly & Co. has filed another infringement complaint against Teva Pharmaceuticals USA Inc. in the U.S. District Court for the Southern District of Indiana, over efforts to make a generic version of Lilly's cancer treatment Gemzar.

The details can be read here.

Debiopharm seeks European approval for Decapeptyl for prostate cancer

Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announces the filing of an application with the European Agencies for the approval of its new 6-month formulation of Decapeptyl (triptorelin pamoate 22.5 mg), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer.

The details can be read here.

Orchid ties-up with Merck to develop anti-infective drugs

Orchid Chemicals and Pharmaceuticals and Merck & Co, Inc have entered into research collaboration and license agreement focused on the discovery, development and commercialization of novel agents for the treatment of bacterial and fungal infections.

The details can be read here.

ImClone begins patient enrolment in phase-2 study of breast cancer drug

ImClone Systems Incorporated, a global leader in the development and commercialization of novel antibodies to treat cancer, announced that its disease-directed randomized phase-2 clinical trial of IMC-A12, ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in women with advanced breast cancer has commenced patient enrolment.

The details can be read here.

Morphotek, Pivotal Biosciences enter monoclonal antibodies development pact

Morphotek, Inc, a subsidiary of Eisai Corporation of North America, and Pivotal BioSciences, Inc, a privately held Los Angeles-based biotechnology company developing oncology products, have entered into an agreement in which Morphotek will access Pivotal BioSciences' LEC platform technology, developed by Dr Alan Epstein, for the development of therapeutic monoclonal antibodies.

The detailc can be read here.

Sagent Pharma acquires Infusive Technologies

Sagent Pharmaceuticals, Inc, a privately-held specialty pharmaceutical company, announced the acquisition of Infusive Technologies' proprietary, patented, multi-chamber, sequential dose syringe technology.

The details can be read here.

New Life for Old Antibiotics – Senate Passes Bill Creating New Exclusivity Provisions; House Passage is Expected Very Soon

According to a blog post on fdalawblog...
Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.” Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics.

The details can be read here.

New drug promising in HCV infection: SciClone

SciClone Pharmaceuticals, Inc announced promising results from its proof-of-concept phase-2 clinical trial using its proprietary, immunomodulatory compound SCV-07 as a sole agent administered to patients chronically infected with the hepatitis C virus (HCV).

The details can be read here.

ProStrakan's cancer pain drug gets UK MHRA marketing nod

ProStrakan Group plc, the international specialty pharmaceutical company, announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a marketing authorisation for Abstral (for breakthrough cancer pain).

The details can be read here.

Roche completes acquisition of Arius

Roche announced that it has completed the acquisition of cent per cent of the issued and outstanding shares and warrants of Arius Research. On September 19th, the Ontario Superior Court, Canada, approved the plan of arrangement previously approved by the security holders and announced ....

The details can be read here.

Indevus and FDA Agree on Path Forward for Nebido

Indevus Pharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for NEBIDO(R) in the first quarter of calendar 2009. ...

The details can be read here.

Merck KGaA’s Kuvan Recommended for European Approval

Merck KGaA and its Merck Serono division announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for Kuvan® (sapropterin dihydrochloride) as an oral treatment for hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.

The details can be read here.

Zypadhera Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Maintenance Treatment of Schizophrenia

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced today.

The details can be read here.

SCOLR Pharma's ANDA for 12-Hour CDT-Based Pseudoephedrine Accepted for Review by U.S. FDA

SCOLR Pharma, Inc. announcedtoday that the United States Food and Drug Administration ("FDA") has accepted for review the Company's Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on the Company's patented Controlled Delivery Technology (CDT(R)) platform.

The details can be read here.

Cipla Mocks Roche’s Patent for Valganciclovir

This post is published on http://patentcircle.blogspot.com/2008/09/cipla-mocks-roches-patent-for.html.

Mumbai-generic major Cipla has yet again made a mockery of Indian patent law by launching a generic version of Roche patented anti-infection drug Valganciclovir. This is the second instance of Cipla mocking Indian patent after it deliberately launched generic copy of Roche patented anti-cancer drug Erlotinib. Though we are not sure how much impact this will make on availability of drugs to Indian patients but surely it will deteriorate India’s image in global IP scenario. What is more...

I invite comments on this post for further discussion.

Related links: http://www.business-standard.com/india/storypage.php?autono=335321
http://spicyipindia.blogspot.com/2008/09/cipla-takes-on-roche-again-valcyte-vs.html

Joseph J. Farnan: Failure to Disclose Does Not Always Equate to Inequitable Conduct

Resolving a charge of inequitable conduct requires a close reading of an often conflicting factual record for clues that evince an intent to deceive. In a post-trial opinion released yesterday, District Judge Joseph J. Farnan Jr. acknowledged that.....

The whole story can be read here.

Suven gets DCGI nod for phase-I trial of SUVN-502 for Alzheimer's disease

Suven Life Sciences Ltd, a drug discovery and development company has received permission from Drug Controller General of India (DCGI) to conduct phase-I clinical trials of SUVN-502, a potent, safe, highly selective, brain penetrant and orally active antagonist at a non-peripheral, CNS receptor site 5-HT6, intended for the symptomatic treatment of Alzheimer's disease and other disorders of memory and cognition like attention deficient hyperactivity, Parkinson, Schizophrenia.

The details can be read here.

Glenmark receives US FDA approval for Betamethasone cream

Glenmark Generics Limited's (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (US FDA) for Betamethasone dipropionate cream, 0.05 per cent (augmented) and will soon commence marketing and distribution of this product in the US market.

The details can be read here.

Aurobindo Pharma receives US FDA approval for didanosine capsules

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market didanosine delayed release (Enteric-Coated) capsules........

The whole story can be read here.

Dr Reddy's Laboratories launches Combihale

Dr Reddy's Laboratories Ltd has entered the inhaler segment in India with the launch of 'Combihale' - a combination of a steroid and a long acting bronchodilator. It is used in the treatment of asthma and is available in two combinations, Combihale FF (Formoterol + Fluticasone) and Combihale FB (Formoterol + Budesonide)........

The details can be read here.

CHMP Issues 7 Positive Opinions

1. Committee for Medicinal Products for Human Uses Summary of Positive Opinions for Vildagliptin/Metformin Hydrochloride Novartis

2. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Zypadhera

3. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Xiliarx

4. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Irbesartan KRKA

5. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Zomarist

6. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Azarga

7. Committee for Medicinal Products for Human Use Summary of Positive Opinion for Kuvan

The details can be read here.

Debiopharm Moves Towards a New 6-Month Formulation of Decapeptyl to Further Help Prostate Cancer Patients

Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announces the filing of an application with the European Agencies for the approval of its new 6-month formulation of Decapeptyl(R) (triptorelin pamoate 22.5 mg), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Once approved, Decapeptyl(R) 6-month formulation will be marketed by Debiopharm's partners, such as Ipsen in most European Union countries.

The details can be read here.

3SBio Inc. Files for SFDA Approval of High-dose (36,000 IU) EPIAO

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 a 36,000 IU dosage formulation of EPIAO for the treatment of anemia associated with chemotherapy in cancer patients. If approved, high-dose EPIAO would be the only dosage form of this kind available in China.

The details can be read here.

UCB Withdraws EU Marketing Authorisation Application for Lacosamide in Diabetic Neuropathic Pain

UCB announced today that it is withdrawing the European Marketing Authorisation Application with the European Medicines Agency (EMEA) for Vimpat® (lacosamide) in the treatment of diabetic neuropathic pain.

The details can be read here.

Boston Scientific Announces FDA Approval of TAXUS Express2 Atom Stent System, First Drug-Eluting Stent For Small Vessels

Boston Scientific Corporation today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System. The TAXUS Express Atom Stent is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels.

The details can be read here.

Teva, Kowa sign pact to establish generic pharma firm, Teva-Kowa Pharma in Japan

Teva Pharmaceutical Industries Ltd. and Kowa Company, Ltd. announced that they have signed a definitive agreement to establish a leading generic pharmaceutical company in Japan.

The details can be read here.

Biocon 7th largest biotech employer, Med Ad News report

Biocon is ranked as the seventh largest employer amongst the top global biotechnology companies, according to a report released by Med Ad News. The report takes into consideration drug based firms, as these companies provide the best numbers to track the progress of the sector.

The details can be read here.

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action.

The details can be read here.

Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema

Dyax Corp. announced today the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE).

The details can be read here.

PPD Confirms Takeda's NDA Submission of Alogliptin and Actos to U.S. Food and Drug Administration

PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application to the U.S. Food and Drug Administration for marketing approval of alogliptin (SYR-322) and ACTOS(R) (pioglitazone HCl) in a single tablet for the treatment of type 2 diabetes.

The details can be read here.

Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ProAir(R) HFA (albuterol sulfate) Inhalation Aerosol for use in patients as young as 4 years of age. Previously, ProAir HFA had been indicated for use in patients aged 12 and older.

The details can be read here.

US Court Denies Teva's Motion for Summary Judgment in Pulmicort Respules Patent Litigation

AstraZeneca today announced that the US District Court for the District of New Jersey has denied Teva's Motion for Summary Judgment of no infringement in the PULMICORT RESPULES(R) (budesonide inhalation suspension) patent litigation.

The details can be read here.

FDA MedWatch - Tarceva (erlotinib) - Cases of Hepatic Failure and Hepatorenal Syndrome, Including Fatalities, Have Been Reported During Use of Tarceva

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment......

The details can be read here.

FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma

ARCA biopharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for the company's lead product candidate, bucindolol, an investigational and pharmacologically unique beta-blocker and mild vasodilator developed for the treatment of chronic heart failure. If approved by the FDA, bucindolol could become the first genetically targeted cardiovascular therapy.

The details can be read here.

FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 Years Old

Sanofi-aventis announced today the U.S. Food and Drug Administration (FDA) has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2-5 years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

The details can be read here.

FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 Years Old

Sanofi-aventis announced today the U.S. Food and Drug Administration (FDA) has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2-5 years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

The details can be read here.

Gemin X Announces Key U.S. Patent Issued for Obatoclax

Gemin X, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced that the United States Patent & Trademark Office issued to Gemin X a patent protecting the composition of matter of obatoclax through 2025 - U.S. Patent No. 7,425,553. One of Gemin X's lead pipeline programs, obatoclax is an oncology treatment based on programmed cell death, or apoptosis, and has the potential to be a first-in-class pan Bcl-2 inhibitor. Obatoclax is currently in Phase 2 clinical trials for the treatment of elderly acute myeloid leukemia and the treatment of small cell lung cancer.

The details can be read here.

Ambrilia develops novel one-month formulation of goserelin

Ambrilia Biopharma Inc announced that it has succeeded in manufacturing a final one-month formulation of goserelin intended for the treatment of prostate cancer and several gynaecological indications. The company has already developed a proprietary, novel three-month formulation of goserelin for which a phase-I/II clinical programme in prostate cancer patients was initiated in July 2008.

The details can be read here.

KeyNeurotek Pharma Receives OD Designation of its lead compound KN38-7271 for the treatment of moderate and severe closed traumatic brain injury

KeyNeurotek Pharmaceuticals AG, a biotechnology company focused on the development and marketing of drugs against autoimmune diseases and degenerative disorders of the central nervous system (CNS), today announced that the Committee for Orphan Medicinal Products (COMP) of the London-based European Medicines Agency (EMEA) has approved KN38-7271 as an Orphan Medicinal Product for the orphan indication moderate and severe closed traumatic brain injury (TBI).

The details can be read here.

Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression

Labopharm Inc. today announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for DDS-04A, that provides an effective alternative in the treatment of major depression.

The details can be read here.

Basilea's Toctino (alitretinoin) Receives Marketing Authorization in Denmark

September 22, 2008 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Danish Medicines Agency (DKMA)

The details can be read here.

AstraZeneca Receives Six Months Pediatric Exclusivity for Casodex (bicalutamide) from the FDA

AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009.

The details can be read here.

Teva Introduces Nicardipine HCl Injection in the United States; First Alternative to Cardene I.V.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the introduction of Nicardipine Hydrochloride Injection, 2.5 mg/mL, which is AP-rated to EKR Therapeutics' hypertension treatment Cardene(R) I.V. Teva's product is the first alternative to the brand product, which had annual sales of approximately $181 million in the United States for the twelve months ended June 30, 2008, according to IMS sales data.

The details can be read here.

Ariad Announces Court Rulings Regarding NF-(kappa)B Patent Lawsuit with Amgen

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that the United States District Court for the District of Delaware granted Amgen's (Nasdaq: AMGN) motion for summary judgment of non-infringement of seven claims of U.S. Patent No. 6,410,516 (the '516 patent) based on activities related to Enbrel(R) (etanercept). The court found that administration of Enbrel falls outside the scope of the asserted claims based on the court's interpretation of these claims to exclude extracellular methods of reducing NF-(kappa)B activity.

The details can be read here.

Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Parcopa ODT

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 Carbidopa and Levodopa Orally Disintegrating Tablets (ODT), 10 mg/100 mg, 25 mg/100 mg and 25 mg/250 mg.

The details can be read here.

Continuous treatment with Abbott's Humira achieves superior long-term efficacy

More psoriasis patients achieve efficacy when they receive continuous treatment with Humira (adalimumab) compared to patients who interrupt their therapy, according to data presented at the European Academy of Dermatology and Venereology (EADV) Congress in Paris.

The details can be read here.

Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040

Enobia Pharma, an emerging biotech company focused on developing novel therapeutics for serious bone disorders, announced that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for ENB-0040, its enzyme replacement therapy (ERT) for hypophosphatasia, a rare, life-threatening genetic bone disease. In August 2008, Enobia dosed the first patient in a Phase I clinical trial of ENB-0040.

The whole story can be read here.

Cangene Files in Europe for HepaGam B (Human Hepatitis B Immunoglobulin) Solution for Infusion or Injection

Cangene Corporation today announces that it has submitted a Marketing Authorization Application ("MAA") for HepaGam B (Human Hepatitis B Immunoglobulin) Solution for Infusion or Injection to the European Medicines Agency ("EMEA"). The indications included in the MAA are immunoprophylaxis of hepatitis B and prevention of hepatitis B virus recurrence after liver transplantation in patients who are positive for hepatitis B surface antigen.

The details can be read here.

FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults

GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView(TM) (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumors in children and adults. AdreView provides high quality images that allow physicians to detect tumors, both at the time of initial diagnosis and at later examinations when relapse or recurrence is suspected.

The details can be read here.

Maxygen and Astellas Announce Global Agreement to Develop New Therapies for Autoimmune Diseases and Transplantation

Sep 19, 2008 - Maxygen, Inc. (Nasdaq:MAXY) and Astellas Pharma Inc. today announced a global agreement under which Astellas will receive worldwide rights to commercialize MAXY-4 lead candidates for all autoimmune diseases and transplant rejection.

The details can be read here.

Roxane Laboratories, Inc. Announces the Launch of Protriptyline HCl Tablets, USP

Roxane Laboratories, Inc. announced today the approval of their Abbreviated New Drug Application for Protriptyline HCl Tablets, USP, 5mg and 10mg. The product is available in bottles of 100 tablets for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

Lupin acquires majority stake in SA based Pharma Dynamics

Mumbai based Lupin Limited has completed the acquisition of a majority stake in Pharma Dynamics (PD) in South Africa. PD is amongst the fastest growing generic companies and commands a premium image with the medical profession with a clear leadership in the cardiovascular segment.

The details can be read here.

Dr Reddy to enter US specialty business through its subsidiary Promius Pharma

Dr Reddy's Laboratories has set up a wholly owned subsidiary Promlus Pharma in US to undertake specialty business. The subsidiary will initially focus on the branded dermatology market and it is based on a platform of strategic licensing initiatives and internal product development activities.

The whole story can be read here.

EMEA Recommends Orphan Drug Designation for AX200 in the Treatment of Spinal Cord Injury

Sept. 18, 2008 –SYGNIS Pharma AG today announced that it has received a positive recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) for AX200 in the treatment of spinal cord injury.

The details can be read here.

FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application

Roche today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the Biologics License Application (BLA) for ACTEMRA (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The details can be read here.

Ranbaxy Laboratories, Ltd., Retains Former New York City Mayor Rudy Giuliani to Lead Team in Resolution of Issues Raised by U. S. FDA

Ranbaxy Laboratories Ltd., today announced that they have retained the services of former New York City Mayor Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues related to the recent United States Food and Drug Administration letters and Import Advisory.

The details can be read here.

Trastuzumab improves treatment outcome in breast cancer: Study

The GBG 26 - TBP study of the German Breast Group addressed the question of whether the treatment of women with HER2-positive metastatic breast cancer with trastuzumab is effective beyond progression (Trastuzumab Beyond Progression TBP).

The details can be read here.

Aurobindo Pharma gets US FDA approval for Abacavir sulfate tabs

Aurobindo Pharma Limited has received the tentative approval to manufacture and market Abacavir sulfate tablets 60mg from the US Food & Drug Administration (US FDA).

The details can be read here.

Ranbaxy, Statement on FDA Letters

In response to a U.S. Food and Drug Administration press release announcing warning letters and an Import Alert for Drugs issued to Ranbaxy Laboratories Ltd. regarding drug products produced in two Ranbaxy plants in India, the company issued the following statement:

"Ranbaxy is very disappointed in the action taken by the U.S. FDA. The company has responded to each concern the FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that the FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues."

According to the FDA announcement, the warning letters and Import Alert do not apply to Ranbaxy's other facilities, including its three manufacturing facilities in the U.S.: Ohm Laboratories' facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the U.S. healthcare system, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.

Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure

Daiichi Sankyo, Inc. today announced the filing of a supplemental New Drug Application (sNDA) with the United States Food and Drug Administration (FDA) for the combination treatment AZOR(R) (amlodipine and olmesartan medoxomil) as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goal.

The whole story can be read here.

China Biologic Receives SFDA Approval for Clinical Trial of Human Coagulation Factor VIII

China Biologic Products, Inc. ("China Biologic" or the "Company"), one of the leading plasma-based pharmaceutical companies in the People's Republic of China ("PRC"), today announced that the Company received approval from the PRC State Food and Drug Administration (the "SFDA") to commence clinical trial of its new Human Coagulation Factor VIII product ("FVIII"), a coagulation treatment for hemophilia and mass hemorrhaging.

The details can be read here.

Covidien Launches TussiCaps Extended-Release Capsules

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced the U.S. availability of TussiCaps(R) (hydrocodone polistirex/chlorpheniramine polistirex) extended-release capsules, the first and only hydrocodone antitussive oral capsule to provide powerful cough suppression for up to 12 hours.

The details can be read here.

Barr Receives Approval for Generic Version of Razadyne ER Capsules

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne(R) ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg.

The details can be read here.

Teva wins EU approval for biosimilar Neupogen

European authorities have approved Teva Pharmaceutical Industries' biosimilar version of Neupogen, Amgen's best-selling treatment for neutropenia, the Israeli generic drugmaker said on Tuesday.

The details can be read here.

USFDA bans 30 drugs manufactured by Ranbaxy

The United States Food and Drug Administration (USFDA) has banned over 30 generic medicines manufactured by Ranbaxy Laboratories after two of its manufacturing plants were found to have not followed the good manufacturing practices prescribed by the US authorities. The authority however clarified that there is no evidence to doubt the quality of the products that have been shipped by Ranbaxy.

The details can be read here.

Bayer HealthCare acquires Direvo Biotech for Euro 210 mn

Bayer HealthCare AG acquires the German biotech company Direvo Biotech AG, Cologne for a total consideration of Euro 210 million. With the acquisition of the biotech company specialized in protein engineering, Bayer strengthens the research competence in biologicals of its pharmaceutical division Bayer Schering Pharma.

The details can be read here.

Patent office begins hearing post-grant opposition in Pegasys case

The Indian Patent Office has begun hearing on the validity of a patent granted to Roche for Pegasys (pegylated interferon alfa 2a), a drug used to treat hepatitis C. Assistant controller of patents at the Chennai Patent Office heard the post-grant opposition filed by Sankalp Rehabilitation Trust against the patent.

The details can be read here.

GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.

The details can be read here.

Bayer’s Xarelto Approved in Canada

September 16, 2008 – Health Canada has granted Bayer HealthCare marketing authorization for the anticoagulant Xarelto® (rivaroxaban), taken as one tablet, once-daily, for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery.

The details can be read here.

USPTO Grants Formatech Novel Drug Formulation Patent

Sep 16, 2008 - Formatech, Inc. today announced the issuance of U.S. patent 7,345,093, entitled "Methods for Enhancing Solubility of Compounds" which covers novel formulation methods to enhance the solubility of hydrophobic compounds.

The details can be read here.

Aegis Therapeutics Awarded Patent for its ProTek Room Temperature Stable Human Growth Hormone Formulations Suitable for Metered Nasal Spray Delivery

Aegis Therapeutics LLC announced today that it has been awarded U.S. Patent 7,425,542, entitled, “Stabilizing alkylglycoside compositions and methods thereof.” The patent provides broad protection for stabilized human growth hormone (hGH) formulations.

The details can be read here.

Boston Scientific Announces Court Decision

Boston Scientific Corporation announced today a decision by the United States District Court in Delaware. The case involves a patent owned by Johnson & Johnson and Boston Scientific's NIR(R) stent product. In the decision, the Judge granted Johnson & Johnson's motion for entry of final judgment and denied Boston Scientific's motion for a new trial. In 2000, a jury awarded Johnson & Johnson $324 million in damages based on Boston Scientific's sale of the NIR stent. The Court also awarded pre-judgment interest at prime rate based on after-tax damages.

The details can be read here.

Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

The details can be read here.

King Pharma starts $1.6 bn bid for Alpharma

King Pharmaceuticals, Inc announced that it commenced a tender offer, through a wholly-owned subsidiary, to acquire all of the outstanding shares of Class A Common Stock of Alpharma Inc for $37 per share in cash.

The details can be read here.

Novartis receives FDA priority review for Coartem, potentially the first artemisinin-based combination treatment (ACT) for malaria in the US

Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review for Coartem® (artemether 20 mg/lumefantrine 120 mg), the leading artemisinin-based combination treatment (ACT) for malaria worldwide. Recommended by the World Health Organization (WHO) and widely used in Africa, Coartem could become the first ACT approved for use by the FDA.

The details can be read here.

Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer

Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) registration of DAVANAT(R), a new chemical entity, for the treatment of advanced colorectal cancer.

The details can be read here.

Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia

Sept. 15, 2008-H. Lundbeck A/S announced today that the U.S. Food and Drug Administration (FDA) has completed the initial check for completeness and accepted the New Drug Application on Serdolect® for the treatment of schizophrenia for review. This is the first NDA submitted in the US by Lundbeck, and it follows the launch of Serdolect® in Europe, South and Central America, Asia, and the Middle East.

The details can be read here.

Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain

Cephalon, Inc. announced today receipt of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.

The details can be read here.

FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter

Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA) Approvable Letter.

The details can be read here.

FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States

Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills.

The details can be read here.

Keppra XR Approved in the U.S.

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR(TM) (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial onset seizures who are 16 years of age and older. Keppra XR(TM) is expected to be available in U.S. pharmacies at the end of September 2008.

The details can be read here.

ProStrakan Receives US FDA Approval for Sancuso

ProStrakan Group plc, the international specialty pharmaceutical company, today announces that it has received approval from the US Food and Drug Administration (FDA) for Sancuso®, ProStrakan’s novel, patent protected transdermal patch for the prevention of chemotherapy-induced nausea and vomiting (CINV).

The details can be read here.

Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax

Joseph F. Finn, Jr., C.P.A. ("Finn"), Assignee of the assets of Spherics, Inc. ("Spherics") for the benefit of creditors, announced today that all oral drug delivery intellectual property will be sold at a sealed bid auction on October 10, 2008.

Topamax(R) produces adverse effects on cognitive functions at rates of over 40% in subjects with epilepsy. These effects manifest as confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language and word-finding difficulties. Using computerized Neuropsychological Test Battery (CNTB) modules, measuring attention/concentration, verbal and visual memory, and working memory, as well as two paper and pencil processing speed tests: Symbol Digit Modalities Test (SDMT) and verbal associative fluency test (FAS), the novel extended release Topiramate formulation (SRx-502) was shown to be associated with both significantly reduced cognitive impairment and fewer reduced adverse events.

Teva Announces Appellate Court Reverses Generic Risperdal Exclusivity Decision

Sept. 14, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that following a hearing on September 12, 2008, the U.S. Court of Appeals for the District of Columbia has vacated an April 2008 ruling, which granted Teva 180-day exclusivity for its Risperidone Tablets, AB-rated to Janssen's Risperdal(R) Tablets. As a result of this decision, the U.S. Food and Drug Administration is no longer enjoined from approving subsequent Abbreviated New Drug Applications (ANDA).

The details can be read here.

Byetta shows an edge over Januvia: Study

Amylin Pharmaceuticals, Inc and Eli Lilly and Company announced results from a randomized, double-blind, cross-over, four-week head-to-head study demonstrating that Byetta (exenatide) injection, a GLP-1 receptor agonist, provided significantly lower glucose levels in the post-meal setting when compared to Januvia (sitagliptin), a DPP-4 inhibitor.

http://www.pharmabiz.com/article/detnews.asp?articleid=46026

CV Therapeutics Announces License Agreement for Ranexa in Europe With Menarini Group

CV Therapeutics, Inc. announced today that it has entered into an agreement granting exclusive rights to Ranexa(R) (ranolazine prolonged release tablets) in Europe and other countries to the Menarini Group. Menarini, with its significant pan-European presence, makes the most physician calls for cardiovascular products and has the fourth largest pharmaceutical sales team for delivering medical information to physicians in Europe.

The details can be read here.

FDA Approves Fougera's Clotrimazole Cream USP 1%

Fougera, a division of Nycomed US Inc., today announced the FDA has approved its Clotrimazole Cream USP 1%. The generic formulation compares to Taro's Referenced Listed Drug (RLD) and is available in three sizes: 15g tubes (NDC # 0168-0133-15), 30g tubes (NDC # 0168-0133-30) and 45g tubes (NDC # 0168-0133-46).

The details can be read here.

Novartis meningitis B vaccine may also protect six months olds

New data show the investigational Novartis meningitis B vaccine may be the first to also protect infants six months and older against multiple strains of potentially deadly meningococcal B bacteria. This second successful study of the vaccine in infants supports its potential to provide broad serogroup B strain coverage for both younger and older babies.

The details can be read here.

Glenmark files IND application with US FDA for GBR 500 molecule phase-I trials

Glenmark Pharmaceuticals Ltd. (India) has filed its molecule GBR 500 for phase-I trials with the US FDA. The filing of this crucial IND (Investigational New Drug Application) signifies the successful completion of a substantial number of pre-clinical studies for its humanized biologic molecule. GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (Alpha2 ?eta1) integrin.

The details can be read here.

FDA MedWatch- Rituzan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan

Sept. 11, 2008--Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study.

The details can be read here.

Merck KGaA Submits New License Application for Erbitux in Firstline Non-Small Cell Lung Cancer in Europe

Merck KGaA announced today that its Merck Serono division has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the firstline treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC).

The details can be read here.

Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Laonian Kechuan Tablets

Tianyin Pharmaceutical, Co., Inc., , a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced that the Company has received approval from the Chinese State Food and Drug Administration (SFDA) to produce Laonian Kechuan Tablets in the dosage form of 0.25 gram/tablet (SFDA approval number Z20083360). The Company plans to launch Laonian Kechuan Tablets in the domestic market and begin recording revenue in November 2008.

The details can be read here.

Trubion Pharmaceuticals Wins Patent Opposition - Genentech / Biogen Idec European Patent Revoked

Trubion Pharmaceuticals, Inc. , today announced that the Opposition Division (OD) of the European Patent Office (EPO) has revoked Genentech and Biogen Idec's European Patent 1176981, in its entirety. This patent was generally directed to the use of an anti-CD20 antibody for the treatment of rheumatoid arthritis (RA). The revocation was the result of an opposition proceeding brought by Trubion and several other parties.

The details can be read here.

MonoSol Rx Granted Strategic US Patent for Thin Film Manufacturing Process

MonoSol Rx, a drug delivery company specializing in quick dissolving thin film pharmaceutical products, today announced that it has been granted U.S. patent No. 7,425,292 from the United States Patent and Trademark Office (USPTO).

The details can be read here.

Vectura, Sandoz partner for asthma/COPD products

Vectura Group plc , the inhalation product development company, announces that Sandoz, the generics division of Novartis, is the exclusive licensee in certain territories for Vectura's combination asthma/COPD products, VR315 and VR632.

The details can be read here.

Wyeth starts shipping haemophilia A drug Xyntha

Wyeth Pharmaceuticals, a division of Wyeth announced that product shipments have begun for Xyntha Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, a new recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with haemophilia A, a rare, inherited blood-clotting disorder.

The details can be read here.

Elan, Biogen Idec start natalizumab trial in cancer

Elan Corporation, plc and Biogen Idec have initiated the first clinical trial of Tysabri (natalizumab) in oncology. The first dose of Tysabri was already administered in the trial.

The details can be read here.

VioQuest Pharmaceuticals Receives 510(k) Response from FDA for Xyfid

Sep 10, 2008 - VioQuest Pharmaceuticals (OTCBB: VOQP) today announced that it has received a determination from the U.S. Food and Drug Administration (FDA) that Xyfid(TM) (1% uracil topical) is a drug rather than a device and would be regulated with the Center for Drug Evaluation and Research (CDER) as opposed to the Center for Devices and Radiologic Health (CDRH).

The details can be read here.

Schering-Plough Announces European Launch of Bridion (Sugammadex)

Schering-Plough Corporation today announced that the European launch of BRIDION(R) (sugammadex) injection has begun with its introduction this week in Sweden, and that the product is expected to be available soon in the United Kingdom and Germany, with several other European markets to follow by the end of the year and in early 2009.

The details can be read here.

Allele Biotech Received Broader US Patent in RNAi

The US Patent and Trademark Office today issued patent 7,422,896 entitled "Compositions for DNA mediated gene silencing" to Allele Biotech. In addition to what was covered in an earlier patent, 7,294,504, issued to Allele Biotech last November, the current patent described more ways of using RNA polymerase III and its promoters to express siRNA or shRNA in human or other mammalian systems.

The details can be read here.

Celator's blood cancer drug gets orphan drug status

Celator Pharmaceuticals announced that the US Food & Drug Administration (FDA) has granted orphan drug designation to CPX-351 (Cytarabine: Daunorubicin) Liposome injection for the treatment of Acute Myeloid Leukaemia (AML).

The details can be read here.

Biocon presents human clinical data on oral insulin

Biocon Limited has announced the results of an ascending dose study with oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome. The study involved dosing type-2 diabetes subjects with single doses of 0 mg (placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a mixed 600 kcal breakfast. The outcome measurements were the safety and tolerability of IN-105, as well as the pharmacokinetics and pharmaco-dynamics of IN-105. The results showed that IN-105 was safe and well tolerated by patients.

The details can be read here.

FDA Issues Warning Letter for Forest Laboratories' Bystolic Tablets

The FDA posted on its web site a warning letter to Forest Laboratories, Inc. about a journal ad for its hypertension treatment Bystolic (nebivolol) Tablets.

The details can be read here.

RAD001 Granted Priority Review in the US Based on Potential to Fill Unmet Medical Need in Patients with Advanced Kidney Cancer

Novartis announced today that RAD001 (everolimus) has been granted priority review by the US Food and Drug Administration (FDA). The designation is based on the drug's potential to become the first therapy to demonstrate significant benefit in patients with advanced kidney cancer after failure of standard treatment.

The details can be read here.

Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial

Sep 9, 2008 - Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug application (NDA) and the European marketing authorization application (MAA).
The details can be read here.

Salix Commences Patent Infringement Litigation against Novel Laboratories

Sept. 8, 2008 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that Salix Pharmaceuticals, Inc. has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of the patent protecting OSMOPREP(R) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets. Salix has an exclusive license to the patent protecting OSMOPREP(R) from CDC III, LLC (CDC) for commercialization of OSMOPREP(R) in the United States.

The details can be read here.

Ortho Biotech Files sNDA for Doxil for the Treatment of Advanced Breast Cancer

Ortho Biotech Products, L.P. today announced that the Company has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the combination of DOXIL(R) (doxorubicin HCl liposome injection) and Taxotere(R) (docetaxel)* for the treatment of women with advanced breast cancer who have received prior anthracycline treatment.

The details can be read here.

Akorn, Inc. Announces First Lyophilized Product Approval For Decatur, IL: IC-Green for Injection, USP

Sep 8, 2008 - Akorn, Inc. (NASDAQ: AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted supplemental NDA approval for IC-Green(TM) for Injection, USP. This approval is Akorn's first lyophilized product approval for manufacture in its Decatur, IL production facility.

The details can be read here.

Velcade (Black Triangle Drug) (bortezomib) Approved For Previously Untreated Multiple Myeloma

Janssen-Cilag / Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced the European Commission's approval of VELCADE in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma (MM) who are not eligible for high-dose chemotherapy with bone marrow transplant.

The details can be read here.

Basilea's Toctino (alitretinoin) Receives First National Marketing Authorization in the UK

September 8, 2008 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

The details can be read here.

Novo Nordisk Launches a Next Generation of FlexPen

Novo Nordisk announced the launch of a next generation of FlexPen® at the European Association for the Study of Diabetes (EASD) Annual Meeting. The new insulin injection device builds upon the high standards set by the current version of FlexPen®, with new features providing improved safety, convenience and ease of use for people with diabetes. FlexPen® is already the most widely used prefilled insulin device in the world(1), benefiting millions of people with diabetes worldwide.
The details can be read here.

New Low-Dose Oral Contraceptive Yaz Launched in Europe

Bayer Schering Pharma´s YAZ® will be available across Europe as of September 2008. YAZ® is the first oral contraceptive containing 3 mg of the unique progestin drospirenone combined with 0.02 mg of ethinyl estradiol in a new dosing regimen of 24 days of active hormone tablets followed by 4 days of hormone-free tablets.

The details can be read here.

eGenomics Awarded First U.S. Patent Covering Rapid DNA Sequencing Technology Platform to Control Hospital-Acquired Infections

eGenomics, Inc., a leader in the development of state of the art genomic and informational systems for infectious disease control, announced today that the United States Patent and Trademark Office (USPTO) recently issued U.S. Patent no. 7,449,808, for key elements of its proprietary warning system for hospital infection control.

The details can be read here.

Perrigo Acquires Exclusive Sales and Distribution Rights to Allergy Drug Levocetirizine from Synthon

Perrigo Company announced today that it has acquired the exclusive U.S. rights to sell and distribute Levocetirizine tablets, the generic version of UCB's Xyzal(R) tablets, from Synthon Pharmaceuticals, Inc. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.

The details can be read here.

Inhaled Treprostinil New Drug Application Filed by FDA

United Therapeutics Corporation and its wholly-owned subsidiary Lung Rx, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for inhaled treprostinil for the treatment of pulmonary arterial hypertension. The NDA will be subject to a standard review period of 10 months, with a targeted user fee deadline of April 30, 2009.

The details can be read here.

Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge

September 3, 2008 -- Sandoz has received US Food and Drug Administration approval for its Omnitrope® Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

The details can be read here.

USPTO Office Action in the Reexamination of U.S. Patent No. 6,545,040

Forest Laboratories, Inc. announced today that an Office Action in the Reexamination of U.S. Patent No. 6,545,040 ("the '040 patent") was received from the U.S. Patent and Trademark Office ("USPTO") by Janssen Pharmaceutica N.V., the patent holder of the '040 patent.

The details can be read here.

Teva Introduces Nicardipine Hydrochloride Injection

September 3, 2008 – Teva Health Systems is pleased to announce the introduction and availability of the first generic Nicardipine Hydrochloride Injection. This product is AP rated to Cardene®* I.V. Nicardipine HCl Injection is available as 2.5 mg/mL-25 mg, in single dose amber glass vials.

The details can be read here.

Biovail Announces Filing of ANDA for Fenofibrate Tablets

Sep 3, 2008 - Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

The details can be read here.