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.