News

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

AstraZeneca's three patents protecting Crestor (rosuvastatin) have been ruled invalid by the Federal Court of Australia.

Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash.

The Rostov-on-Don Medicines Quality Control Laboratory is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation.

Franz B. Humer, chairman of the board of directors of the Roche Group, will not stand for re-election to the Board in 2014.

SAFC added 20 raw materials to its PharmaGrade portfolio and announced an expansion of its Irvine, Scotland manufacturing plant.

Room-temperature sterilization using nitrogen dioxide gas benefits parenteral drugs.

Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

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

QbD paradigm advances process understanding in development and manufacturing.

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.

Belgium drug developer Ablynx and UK-based Spirogen have entered into a research collaboration to discover and develop novel anticancer drug conjugates combining Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBDs), and the company's associated linker technology, with nanobodies generated using Ablynx's proprietary technology platform.

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.