News

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization.

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).

Affymax Inc. and Takeda Pharmaceutical Company Limited have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.

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.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

A Q&A with Michael Lacey, plant manager at the National Institute for Bioprocessing Research and Training.

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.

The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.

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

Sanofi is investing EUR 44 million ($58.7 million) in Genzyme?s biotechnology campus in Waterford, Ireland.

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.

Mylan has entered into a definitive agreement with Biocon Limited for an exclusive collaboration on the development and commercialization of generic versions of three insulin analog products.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

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.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

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).

Heated magnetic nanoparticles consisting of a liposome nanocontainer with superparamagnetic iron oxide nanoparticles are among the recent advances in nano-based drug delivery.

Pharma companies intensify R&D efforts to address treatments for neglected tropical diseases in the developing world.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

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.

GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%.

The latest news from the pharmaceutical regulatory community.

Quality assurance of biological products is central to India's good distribution practices guidelines.