Abbott to acquire business of Solvay Pharma for US$ 6.6 Bn

Abbott has entered a definitive agreement with the Solvay Group for acquisition of Solvay's pharmaceuticals business for EUR 4.5 billion ($6.6 billion) in cash, providing Abbott with a large and complementary portfolio of pharmaceutical products and a significant presence in key global emerging markets.

The details can be read here.

CHMP recommends for approval of GSK's H1N1 vaccine 'Pandemrix'

GlaxoSmithKline (GSK) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK's candidate pandemic (H1N1) adjuvanted vaccine Pandemrix. The indication for the vaccine is for protection against pandemic H1N1 2009 influenza.

The details can be read here.

Boehringer announces phase-III clinical trials of diabetes drug linagliptin

Following the release of linagliptin phase-II data earlier this year, Boehringer Ingelheim has now announced the conclusion of the linagliptin pivotal phase-III clinical trials. The company confirmed that first results from the phase-III clinical trials programme consistently support the favourable efficacy and safety profile already observed in earlier linagliptin investigational studies, such as the phase-II data which had shown significant results in haemoglobin A1c (HbA1c)-lowering (-0,73 percent, 5 mg dose) and a safety profile comparable to placebo.


The details can be read here.

Lupin acquires US rights for Antara from Oscient Pharma for US$ 38.61 mn

Lupin Ltd, a fifth largest Indian Pharma company with net sales of Rs 3,775 crore, has acquired US rights for Antara (Fenofibrate capsules 43 mg, and 130 mg) for a total consideration of US$ 38.61 crore from Oscient Pharmaceuticals under the procedures of the US Bankruptcy Court. Antara recorded net sales of US$ 70 million for the year 2008.

The details can be read here.

DBT launches new vaccine programme for developing vaccines for cholera, malaria

Department of Biotechnology (DBT) has launched a new initiative called 'vaccine grand challenge programme' to accelerate the development of candidate vaccines for which leads are available and to take them through clinical studies and commercialization.

The details can be read here.

Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric

Sep 28, 2009 - Sciele Pharma, Inc., a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients.

The details can be read here.

Wyeth Receives Positive Opinion from European Regulators for its 13-valent Pneumococcal Candidate Vaccine for Infants and Young Children

Wyeth Pharmaceuticals, a division of Wyeth announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's pneumococcal conjugate vaccine, Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent Adsorbed]).

the details can be read here.

Actavis (IS) - Actavis launches Topiramate on day one in four European markets

29 September 2009 -- Actavis Group, the international generic pharmaceuticals company, today announced the launch of the antiepileptic drug Topiramate in the UK, Germany, France and Switzerland. The product was launched on day one as the originator's patent expired on 25 September. Actavis was first to market in all four countries.

The details can be read here.

Precision BioSciences Announces U.S. Patent Office Reexamination of Cellectis Patents Involved in Litigation

Sep 29, 2009 - Precision BioSciences, Inc. today announced that the United States Patent and Trademark Office (PTO) has granted Precision's requests for inter partes reexamination of U.S. Patent Nos. 6,610,545 (the ˜545 patent) and 7,309,605 (the ˜605 patent), which Cellectis SA has asserted against Precision in litigation.

The details can be read here.

US Court of Appeals Affirms Summary Judgment Decision in Seroquel Patent Litigation

Sept. 25, 2009--AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving SEROQUEL (quetiapine fumarate) tablets. In July 2008, AstraZeneca announced that the US District Court for the District of New Jersey granted the company's Motion for Summary Judgment of No Inequitable Conduct in litigation involving Teva Pharmaceutical Industries Ltd. and Sandoz, Inc.

The details can be read here.

The whole judgement can be read here.

MediZine Named in Intellectual Property Lawsuit Filed by Marketing Technology Solutions

Marketing Technology Solutions, Inc. ("MTS"), owner and operator of the health website QualityHealth.com, has today filed a lawsuit alleging that MediZine, LLC infringed MTS's intellectual property rights and misappropriated trade secrets and other confidential information by utilizing MTS-copyrighted online lead generation software in support of RemedyLife.com, a health website owned and operated by MediZine.

The details can be read here.

Natalizumab - FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML)

FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.

The details can be read here.

FDA Advisory Committee Hears Presentations and Public Comment on EXALGO Extended-Release Tablets

)--Sep 23, 2009 - Covidien, a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGOTM (hydromorphone HCl extended release) tablets, an opioid formulation.

The details can be read here.

PARI's Altera Delivers Gilead's Cayston, Approved by European Commission to Treat Cystic Fibrosis

PARI Pharma's Altera, which uses eFlow Technology, is the first drug-specific nebuliser for cystic fibrosis and has been specifically developed to deliver Gilead Sciences' Cayston. Cayston, aztreonam lysine 75 mg powder and solvent for nebuliser solution, is a new antibiotic that received conditional marketing approval from the European Commission as a suppressive therapy for cystic fibrosis patients, 18 years and older, who have chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) infection.

The details can be read here.

Simcere Pharmaceutical Group Invested Company Obtains Production License for H1N1 Flu Vaccine

Simcere Pharmaceutical Group a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd ("Jiangsu Yanshen"), in which Simcere holds a 37.5% stake, was awarded a new drug certificate and production license from China's State Food and Drug Administration (SFDA) on September 18 for Jiangsu Yanshen's H1N1 vaccine.

The details can be read here.

2.25 MM CYPHER Sirolimus-eluting Coronary Stent Approved by FDA

Sep 21, 2009 - Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a new, smaller version of the CYPHER® Sirolimus-eluting Coronary Stent, the world's most studied drug-eluting stent that has been used to treat nearly 4 million people worldwide.

The details can be read here.

Walgreens to Compound Tamiflu Oral Suspension for Children in Response to Supply Shortage

Sep 23, 2009 - Less than a month after launching the largest flu prevention initiative in the company's 108-year history, Walgreens (NYSE: WAG)(NASDAQ: WAG) is taking proactive measures to ensure its nearly 7,000 pharmacies can provide the suspension - or liquid - form of seasonal flu-fighting drug Tamiflu this season.

The details can be read here.

U.S. District Court Upholds Validity of Lilly's Evista Patents Through 2014

The U.S. District Court for the Southern District of Indiana today upheld Eli Lilly and Company's method-of-use patents on Evista (raloxifene HCl tablets). In the case of Eli Lilly and Company v. Teva Pharmaceuticals Industries Ltd., the court ruled in favor of Lilly on all accounts for these method-of-use patents, including the patent doctrines of obviousness, enablement, and inequitable conduct. These patents provide protection for Evista through March of 2014.

The details can be read here.

Perrigo Acquires ANDA for Generic Version Duac Gel From KV Pharmaceutical

Perrigo Company today announced that it has purchased the ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel from KV Pharmaceutical for $14 million in cash at closing and a $2 million milestone payment upon the completion of a successful technical transfer.

The details can be read here.

US patent grant extends VivaGel coverage to 2024

22 September 2009 – Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced that it has received notification of the grant in the US of a key patent specifically relating to the use of SPL7013 to protect against sexually transmitted infections (STIs).

The details can be read here.

Impax Laboratories Confirms Patent Challenge Relating to ORACEA Delayed-Release Capsules, 40mg

Sep 21, 2009 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Galderma Laboratories, L.P. in connection with its ORACEA® (doxycycline) delayed-release capsules, 40 mg.

The details can be read here.

Madras University develops herbal drug for swine flu

The Centre for Herbal Sciences (CHS) at the University of Madras, along with Ramoni Research Foundation (RRF), Chennai has invented a new herbal drug for curing the pandemic swine flu. The drug, developed from Siddha and Ayurveda preparations, is named as 'Ayusrem'.


The details can be read here.

AstraZeneca and Nektar Sign Worldwide Agreement for Nektar Drug Development Programmes NKTR-118 and NKTR-119 -to Address Opioid-Induced Constipation

AstraZeneca and Nektar Therapeutics announced today that they have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product being evaluated for the treatment of opioid-induced constipation, and the NKTR-119 programme, an early stage programme that is intended to deliver products for the treatment of pain without constipation side effects.

The details can be read here.

Genzyme's Synvisc-One injection gives relief in knee pain for 6-8 months without side effects

Synvisc-One has started to cement its place in the treatment protocol for osteoarthritis of knee amongst the orthopaedicians. Manufactured and marketed by Genzyme, Synvisc-One is the only US FDA approved single injection regimen that provides up to six months of relief from osteoarthritic (OA) knee pain.

The details can be read here.

King Announces Commercial Availability of EMBEDA (morphine sulfate and naltrexone hydrochloride)

King Pharmaceuticals , Inc. today announced a true milestone as it marks the first commercial availability for EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

The details can be read here.

Developing countries express concern over WIPO's hidden agenda of pushing patent harmonization

Even as the World Intellectual Property Organisation's (WIPO) two-day Global Symposium of IP Authorities is underway in Geneva, the developing countries are expressing concern on the larger agenda of the organisation, controlled by US, EU and Japan, on pushing a patent harmonization agenda.

The details can be read here.

Merck Serono gets Japanese nod for easypod

Merck Serono, a division of Merck KgaA Darmstadt, Germany, announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency (PMDA), have granted a marketing authorization for easypod in Japan. Easypod was developed for exclusive use with cartridges of Saizen (somatropin), Merck Serono's human recombinant growth hormone for the treatment of growth hormone deficiency.

The details can be read here.

FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE (bortezomib) for Injection

Sep 18, 2009 - Millennium: The Takeda Oncology Company today announced that the U.S. FDA has granted priority review to the Company's supplemental new drug application (sNDA) for VELCADE.

The details can be read here.

Tarceva Application for Approval of Additional Indication of Pancreatic Cancer

September 18, 2009 - Chugai Pharmaceutical Co., Ltd. announced today that the company filed an application with the Japanese Ministry of Health, Labour and Welfare for the approval of an additional indication of pancreatic cancer for the antineoplastic agent / epidermal growth factor receptor tyrosine kinase inhibitor, "TARCEVA® Tablet 25 mg and 100 mg" [generic name: erlotinib hydrochloride].

The details can be read here.

Panvax H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration

18/09/2009 -CSL Biotherapies, a subsidiary of CSL Limited, Australia's leading biopharmaceutical company, can today confirm that its vaccine against the pandemic (H1N1) 200 influenza or 'swine flu' has been approved registration for use in people aged 10 years and over.

The details can be read here.

APP Pharmaceuticals Receives Approval for Deferoxamine Mesylate for Injection, USP

Sep 17, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the reference-listed drug Desferal®, which is marketed by the innovator Novartis.

The details can be read here.

Dr Reddy's in talks with Glaxo for stake sale

UK-based pharma giant GlaxoSmithKline (GSK) is in talks to pick up a 5% stake in Hyderabad-based Dr Reddy’s Laboratories (DRL) in order to strengthen its association with the Indian firm with whom it had signed a marketing alliance four months ago.

The details can be read here.

Matrix gets tentative US FDA approval for HIV/AIDS drugs

Matrix Laboratories, a Hyderabad-based subsidiary of Mylan Inc. has received tentative approval from the US FDA under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg.


The details can be read here.

Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri) Submission

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri ).

The details can be read here.

YM Biosciences Reports Nimotuzumab Approved For Marketing In Mexico

Sept. 17 -- YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported that nimotuzumab has been approved for marketing in Mexico.

The details can be read here.

Novartis receives FDA approval for Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure

September 17, 2009 - The US FDA has approved Valturna® (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure.

The details can be read here.

U.S. PTO Issues a Notice of Allowance in OSI Pharmaceuticals' Reissue Application on Tarceva Composition of Matter Patent

Sep 17, 2009 - OSI Pharmaceuticals, Inc. announced today that the U.S. Patent & Trademark Office has issued a “Notice of Allowance” in OSI's reissue application for U.S. Patent No.5,747,498 (the ˜498) composition of matter patent for Tarceva® (erlotinib).

The details can be read here.

APP Pharmaceuticals Receives Approval for Deferoxamine Mesylate for Injection, USP

Sep 17, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. FDA to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths.

The details can be read here.

FOPE urges PM to amend Section 36AC of D&C Act to save genuine drug manufacturers

The Federation of Pharma Entrepreneurs (FOPE), a federation of around 700 drug manufacturing units in the tax-free zones of Himachal Pradesh and Uttarakhand, has urged Prime Minister Dr Manmohan Singh to amend Section 36AC of the recently notified Drugs & Cosmetics Act to exclude licensed manufacturers from its provisions and also to amend 36AC(b) to make a distinction between offences relating to adulterate/spurious drugs and other offences of minor nature like substandard drugs.

The details can be read here.

U.S. FDA Licenses Sanofi Pasteur's Pandemic Influenza Vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of its Influenza A (H1N1) 2009 Monovalent Vaccine.

The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Sanofi Pasteur provides the only influenza vaccine licensed in the U.S. for populations as young as 6 months of age and older.


The details can be read here.

FDA Approves Vaccines for 2009 H1N1 Influenza Virus

Sept. 15,2009--The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

The details can be read here.

US FDA accepts for filing Mylan's ANDA for generic Copaxone

Mylan Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for glatiramer acetate injection (20 mg/mL), a generic version of Teva's Copaxone, a product indicated for the treatment of multiple sclerosis.


The details can be read here.

Abbott's once-daily dosing of Kaletra tablet gets European nod

Abbott announced has received marketing authorization from the European Commission for once-daily dosing of the Kaletra (lopinavir/ritonavir) tablet, the company's leading HIV protease inhibitor (PI), in adult patients new to HIV therapy.

The details can be read here.

FDA and EMEA Grant Orphan Drug Designation for Antisense Pharma's Investigational Drug Trabedersen in Pancreatic Carcinoma

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received orphan drug designation from both the European Medicines Agency EMEA and the US Food and Drug Administration FDA for its investigational drug trabedersen in the treatment of pancreatic carcinoma.

The details can be read here.

European Union Commission Approves Expanded Use of Isentress (raltegravir), from MSD, in Adult Patients with HIV-1 Infection

Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients.

The details can be read here.

New Treatment Zolinza Reduces Visible Impact Of Advanced Form Of Skin Lymphoma

Merck Frosst has announced today the approval in Canada of a first of its class in cancer treatment, (Pr)ZOLINZA(TM) (vorinostat capsules) for advanced CTCL (cutaneous T-cell lymphoma), a rare form of non-Hodgkins lymphoma which affects mainly the skin.


The details can be read here.

Abbott Announces Approval in China for Next-Generation Xience V Drug Eluting Stent

Abbott announced today that the Chinese State Food and Drug Administration (SFDA) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD) - the leading cause of death in China.

The details can be read here.

AMRI Files New Patent Infringement Lawsuits against Dr. Reddy's Laboratories and Sandoz

Sep 15, 2009 - AMRI announced today that it has filed two new patent infringement lawsuits in U.S. District Court in New Jersey against Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. and Sandoz, Inc. for infringement of AMRI's U.S. Patent Number 7,390,906. The recently issued patent relates to the manufacturing process for the active ingredient in sanofi-aventis's Allegra® and Allegra®D drug products.

The details can be read here.

Appeals Court Affirms Patent Infringement Rulings Against Roche's peg-EPO Product

Amgen today announced that the Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's decision that Roche's peg-EPO product, Mircera, infringes four Amgen patents ('868, '698, '933 and '422) relating to recombinant erythropoietin (EPO) and processes for making it.

The details can be read here.

The judgement can be read here.

Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA

Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz's premarket approval (PMA) application for Belotero Balance.

The details can be read here.

Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections

September 11, 2009 - Theravance, Inc. and Astellas Pharma US, Inc. announced today that the U.S. FDA has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.

The details can be read here.

Synthon announces European approvals for Raloxifene

10 September 2009--Synthon is announcing that it has successfully completed multiple decentralized procedures (DCP) for Raloxifene. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Synthon's Raloxifene 60 mg tablets are a fully generic and bioequivalent version of the brand product Evista®.

The details can be read here.

US FDA okays ISTA Pharma's Bepreve to treat ocular itching

ISTA Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.


The details can be read here.

IPA calls for amendment to D&C Act to exclude IPR issues from Sec 17

Indian Pharmaceutical Alliance (IPA) has called for more clarity in the definitions of counterfeit and spurious drugs and necessary amendment to the Drugs and Cosmetics Act accordingly, if the country wants to deal tougher with the instances like recent seizure of fake drugs with 'made in India' labels in Nigeria but produced and exported from China.

The details can be read here.

Biocon, Amylin Pharma ink pact to develop and market novel peptide hybrid for diabetes

Biocon Limited and Amylin Pharmaceuticals Inc have entered into an exclusive agreement to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes.

The details can be read here.

Generex Announces USFDA Approval Of Use Of Company’s Flagship Buccal Insulin Product, Generex Oral-Lyn under Treatment IND Program

Generex Biotechnology Corporation the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn™ under the FDA’s Treatment Investigational New Drug (IND) program.

the details can be read here.

FDA Issues Complete Response Letter For Trabectedin Combined With Doxil

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. FDA regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer.

The details can be read here.

Warner Chilcott Files New Lawsuit for Infringement of Loestrin 24 FE and Femcon FE Patents

Warner Chilcott plc announced today that one of its subsidiaries has filed two lawsuits against Lupin Limited and its wholly owned subsidiary Lupin Pharmaceuticals, Inc. in the District Court for the District of Delaware for infringement of Warner Chilcott's U.S. Patent Nos. 5,552,394 (the "'394 Patent") and 6,667,050 (the "'050 Patent"), which cover oral contraceptives LOESTRIN 24 FE and FEMCON FE, respectively.

The details can be read here.

Synthon announces European approvals for Raloxifene

10 September 2009--Synthon is announcing that it has successfully completed multiple decentralized procedures (DCP) for Raloxifene. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Synthon's Raloxifene 60 mg tablets are a fully generic and bioequivalent version of the brand product Evista®.

The details can be read here.

Par Pharmaceutical Receives Final Approval To Market Generic Starlix

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets. Nateglinide is a generic version of Novartis' Starlix .

The details can be read here.

Adamis Pharmaceuticals Pre-Filled Epinephrine Syringe Categorized as a Generic by Leading Drug Database Providers

Sep 10, 2009 - Adamis Pharmaceuticals Corporation announced on July 23 that its wholly owned subsidiary, Adamis Labs launched and shipped the first orders of the company's Epinephrine Injection, USP, 1:1000 (0.3mg prefilled single dose syringe) (“PFS”).

The details can be read here.

Announcement of the filing of once daily aclidinium bromide for COPD in Europe in early 2010

Almirall, S.A. today announced its intention to file a Marketing Authorization Application with the European Medicines Agency (EMEA) for its once-daily long acting muscarinic antagonist Eklira® (aclidinium bromide) in early 2010, for the maintenance bronchodilator treatment and symptom control of COPD.

The details can be read here.

ChemGenex Submits New Drug Application for OMAPRO (Omacetaxine Mepesuccinate) to U.S. FDA

ChemGenex Pharmaceuticals Limited announced today the completion of its New Drug Application (NDA) submission to the U.S. FDA for OMAPRO™ (omacetaxine mepesuccinate).

The details can be read here.

MediGene AG Receives Marketing Authorization for Veregen in Germany

September 09, 2009. MediGene AG announces that it has received German marketing authorization for Veregen® for the treatment of genital warts from the Federal Institute for Drugs and Medical Devices

The details can be read here.

Venus Remedies gets Indian patent for Potentox

Venus Remedies, a mid-cap Rs 260 crore plus Chandigarh based pharma company, has received first ever injectable FDC product patent for Potentox, a research product of the company, from the Indian Patent Office, Government of India.

The details can be read here.

Chugai to boost Tamiflu drugs supply for Japan

Chugai Pharmaceutical Co, Ltd (Chugai) announced the supply plan up to March 2010, of the anti-influenza drug Tamiflu capsule 75 and Tamiflu dry syrup 3% imported from F. Hoffmann-La Roche Ltd for production and marketing in Japan.

The details can be read here.

FDA Grants Protalix Orphan Drug Designation for prGCD

Sep 8, 2009 - Protalix BioTherapeutics, Inc., announced today that it has received notice from the U.S. FDA that the FDA's Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company's proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

The details can be read here.

Salix Receives FDA Marketing Approval for METOZOLV ODT

Sep 8, 2009 - Salix Pharmaceuticals, Ltd. today announced the U.S. FDA has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets.

The details can be read here.

Genova files patent for new prostate cancer treatment

GENova Biotherapeutics, Inc., is pleased to announce that it has filed a patent for a novel peptide that disrupts the advance of prostate cancer and thus has blockbuster potential as a new anti-cancer drug.

The details can be read here.

Meda Introduces Edluar, the First and Only Sublingual Tablet That Contains the Most Prescribed Sleep Medication, Zolpidem Tartrate

Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep.

The details can be read here.

Aurobindo receives US FDA and Swissmedic approvals

Aurobindo Pharma has received US FDA final approval for Risperidone oral solution 1mg/ml. The product is generic equivalent to Risperidal oral solution 1mg/ml of Ortho-McNeil Janssen. It is indicated in the treatment of schizophrenia and falls under the neurological segment.

The details can be read here.

Archimedes Announces US Filing of NasalFent for the treatment of Breakthrough Cancer Pain

7 September 2009 - Archimedes Pharma, the pan-European specialty pharmaceutical company, today announced that it has filed a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for its lead development product, NasalFent, an innovative and highly differentiated fentanyl nasal spray for the rapid relief of breakthrough cancer pain.

The details can be read here.

REGURIN XL (trospium chloride) Once Daily Tablets Now Available in the UK for the Treatment of Overactive Bladder

Regurin XL (trospium chloride), a once-daily, prolonged-release capsule to treat patients with overactive bladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid, significant and consistent improvements in the symptoms of OAB1 and has a reduced potential for central nervous system (CNS) side effects(2-7).

The details can be read here.

Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and Actos

Pharmaceutical Company Limited today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS (pioglitazone HCl).

The details can be read here.

FDA Approves ZEVALIN Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma

Sep 4, 2009 - Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (FDA) for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.

The details can be read here.

Cornerstone Therapeutics Receives Approval to Acquire Commercial Rights to the Antibiotic Factive

Cornerstone Therapeutics Inc, a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that it has received the approval of the United States Bankruptcy Court for the District of Massachusetts for its acquisition of the commercial rights to the antibiotic Factive (gemifloxacin mesylate) in North America and certain countries in Europe from Oscient Pharmaceuticals Corporation (OSCIQ.PK) and expects to promptly close the transaction.

The details can be read here.

Sinovac Obtains Production License for H1N1 Vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

The details can be read here.

Orion and Hospira,Inc. sue Sandoz companies in the U.S. to enforce their U.S. Patents covering the proprietary drug Precedex

Sept. 4, 2009--Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce Orion's U.S. Patent No.4,910,214 and Orion's and Hospira's commonly owned U.S. Patent No. 6,716,867 against Sandoz International Gmbh and Sandoz Inc.

The details can be read here.

The Medicines Company Receives Paragraph IV Notifications

The Medicines Company today announced that it has received Paragraph IV Certification notice letters from Teva Parenteral Medicines, Inc. (TPM) and Pliva Hrvatska, d.o.o. (Pliva) notifying the Company that TPM and Pliva have submitted ANDAs to the U.S. FDA for approval to market generic versions of Angiomax. The Certification notice letters relate to U.S. patent No. 7,582,727, the recently issued product patent.

The details can be read here.

Ranbaxy Launches Authorized Generic Version of Rocaltrol

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), Gurgaon, India, announced an agreement with Validus Pharmaceuticals LLC (Validus) to market and distribute an authorized generic version of Rocaltrol (calcitriol) in both softgel capsules and an oral liquid formulation. Overall market sales for calcitriol softgel capsules and oral liquid were $70 million.

The details can be read here.

Shantha Biotech bags US$340 mn contract from UN Agency for pentavalent vaccine

The Hyderabad-based Shantha Biotechnics, recently acquired by the Sanofi-Pasteur - the vaccines division of sanofi-aventis Group, has bagged US$ 340 million worth contract from the United Nations Agency to supply its pentavalent vaccine Shan5 for the period 2010-2012.

The details can be read here.

Ranbaxy enters pact with Validus Pharma to market & distribute generic Rocaltrol

Ranbaxy Pharmaceuticals Inc., a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL), Gurgaon, India, announced an agreement with Validus Pharmaceuticals LLC (Validus) to market and distribute an authorized generic version of Rocaltrol (calcitriol) in both softgel capsules and an oral liquid formulation.

The details can be read here.

Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application

Sep 3, 2009 - Bristol-Myers Squibb Company announced today that the U.S. FDA has accepted, for filing and review, the company's submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.

The details can be read here.

Acura Pharmaceuticals and King Pharmaceuticals Provide Update on Acurox NDA

Sep 3, 2009 - Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. FDA on September 2, 2009 to discuss the FDA's June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox® (oxycodone HCl and niacin) Tablets CII (NDA).

The details can be read here.

MabThera Approved In Europe For Use In Patients With Previously-Treated Chronic Lymphocytic Leukaemia

Sept. 3, 2009--Roche announced today that the European Commission has approved MabThera (rituximab) for use in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), the most common form of the disease in adults.

The details can be read here.

Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

The details can be read here.

Vical Receives Broad U.S. Patent for Vaxfectin-Formulated DNA Vaccines for Influenza; Coverage Includes All Seasonal and Pandemic Strains

Vical Incorporated announced today the issuance of U.S. Patent No. 7,582,613 covering Vaxfectin(R)-formulated DNA vaccines for influenza. The patent provides broad coverage for any circulating or potential influenza viruses, including both seasonal and pandemic strains.

The details can be read here.

NGO asks govt to further amend Patent Act to avoid frivolous patent filings

The National Working Group on Patent Law (NWGPL), an NGO working on patent issues in the country has asked the government to further amend the Amended Patent Act 1970 to avoid frivolous and questionable patent claims being filed by the industry and are being granted by the Patent Offices.


The details can be read here.

FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma

Sep 2, 2009 - Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL).

The details can be read here.

Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine

Meda Pharmaceuticals Inc. today announced that the US FDA has approved ASTEPRO (azelastine HCl) Nasal Spray 0.15%, for the treatment of the symptoms of seasonal and perennial allergic rhinitis (SAR and PAR). New ASTEPRO Nasal Spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies.

The details can be read here.

The Medicines Company Announces New Patent Issuance for Angiomax

The Medicines Company today announced that the United States Patent and Trademark Office (PTO) issued a new U.S. patent No. 7,582,727 ('727 patent). The '727 patent relates to a more consistent and improved Angiomax drug product.

The details can be read here.

Pfizer Pays a Record Amount to Settle Federal and State Fraud Investigations Into Illegal Off-Label Marketing Practices

Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

The details can be read here.

Pharma industry upset over DCGI decision to include old drugs in List of New Drugs

The pharmaceutical industry in the country is upset over the way several drugs which have been in the market for decades are being licensed as new drug by the Drug Controller General of India (DCGI).

The details can be read here.

Strides Arcolab gets govt order to supply oseltamivir caps

Strides Arcolab, a Rs 1000 crore plus Bangalore based phrama company, has received order from the Ministry of Health, Government of India for supply of 7.40 lakh doses of oseltamivir capsules - the generic equivalent of Tamiflu - Roche's innovator product, drug prescribed to treat influenza - A (H1N1).

The details can be read here.

POZEN Announces FDA Acceptance of NDA For VIMOVO

POZEN Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for VIMOVO™ (enteric-coated naproxen / immediate release esomeprazole magnesium, formerly know as PN 400).

the details can be read here.

UCB's Cimzia (certolizumab pegol) approved by Health Canada for adult patients suffering from moderate to severe rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia(TM), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(TM) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered. Cimzia(TM) is available in Canada as of today.

The details can be read here.

Hospira Receives FDA Approval for Six New Presentations of Heparin

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that the U.S. FDA has approved the company's applications for six new presentations of therapeutic heparin in single- and multiple-dose vials.

The details can be read here.

Claritin 12-Hour Gets Allergy Sufferers Through Their Busy Day

Schering-Plough Corporation today announced the introduction of CLARITIN 12-Hour, the only 12-hour allergy medicine found in the allergy aisle. New CLARITIN 12-Hour lasts all day and provides effective, non-drowsy relief from the worst indoor and outdoor allergy symptoms.

The details can be read here.

Daiichi Sankyo and Ranbaxy Leverage New Business Model with Launch of Evista in Romania

Daiichi Sankyo Company Limited and Ranbaxy Laboratories Limited announced today that Terapia S.A., a subsidiary of Ranbaxy in Romania, will market the osteoporosis medication, Evista® in Romania.

The details can be read here.

Watson Pharmaceuticals Receives FDA Approval for Generic PLAN B for Over-the-Counter Use

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the USFDA on its ANDA for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

The details can be read here.