News

Merck's investigational integrin inhibitor cilengitide did not meet its primary endpoint in the CENTRIC Phase III trial evaluating if the agent could prolong overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy).

The Breakthrough Prize in Life Sciences Foundation, dedicated to celebrating scientists and generating excitement about the pursuit of science as a career announced the initial recipients of the foundation?s awards.

Scripps Research Institute Team Shows How DNA Sequences Long Considered ?Junk? Are Involved in Gene Regulation

FDA approved Roche?s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer.

A GBI Research report says the opioid market will be driven by development of new products and post-marketing studies designed to reduce abuse risk.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Biopharmaceuticals-the major source of new medicines and a key knowledge industry for the future-faces another rough year from empowered payers as it makes its slow passage to a renewed product base. This is the main finding from Pharmaceutical Executive magazine's annual survey of trends and issues facing the biopharma world in the year ahead.

Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program.

Merck has agreed in principle to pay $688 million to settle two federal securities class-action lawsuits involving the company's anticholesterol drugs Vytorin and Zocor, thereby avoiding trial.

SGS has added a 12-bed, Biosafety Level 2-Q compliant, quarantine facility for viral challenge studies to its clinical pharmacology unit in Antwerp, Belgium.

The biopharmaceutical company lycera has announced a collaboration agreement with Merck, Sharpe & Dohme (MSD) that will focus on developing and commercializing small-molecule therapies for treating a range of autoimmune diseases.

Eli Lilly and Co. announced that it will discontinue its Phase III rheumatoid arthritis program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, because of lack of efficacy.

An international consortium of pharmaceutical companies, academia, research organisations and other related entities have launched a new platform to help enhance drug discovery in Europe.

Group sales were down, but R&D progress points to future growth.

Biogen Idec has agreed to acquire full Tysabri rights from Elan, and will use its existing cash reserves to make a payment of $3.25 billion to Elan upon the closing of the transaction and make future contingent payments to Elan.

Biotest Pharmaceuticals Corporation announced that Bivigam [immune globulin intravenous (human), 10% liquid] is now available in the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the US. Bivigam is a sugar-free, glycine stabilized intravenous immune globulin that has been approved by the FDA in December 2012 for the treatment of patients with primary humoral immunodeficiency (PI).

FDA has released a list of more than 50 guidance documents planned for 2013.

FDA has released a list of more than 50 guidance documents planned for 2013.

Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company?s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana.

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a CRO based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialization of the product.

Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

Following its recent acquisition, Actavis (formerly Watson Pharmaceuticals) unveiled its long-term growth strategy during its investor meeting in New York.

According to the Federal Trade Commission, the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased between 2011 and 2012.

FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved FluBlok for people 18–49 years old.