A roundup of regulatory news from across the global pharmaceutical industry.

QbD paradigm advances process understanding in development and manufacturing.

Brazil's major vaccine producer innovates with stem-cell research.

Has Europe's Innovative Medicines Initiative been successful in alleviating concerns regarding the region?s levels of pharmaceutical innovation?

Capsugel’s acquisition of Encap Drug Delivery expands its lipid expertise and adds an FDA-inspected commercial manufacturing facility.

INTERPHEX 2013 to be held April 23–25, 2013, at the Javits Center in New York will highlight pharmaceutical regulation QA/QC, product development, facility, process design, manufacturing, packaging, and supply chain programs.

Mandatory cuts threaten to slow research and patient access to new therapies, Burrill & Company says.

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

The European Commission has granted H. Lundbeck A/S marketing authorization for Selincro (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence.

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.