News

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

Collaboration provides pharmaceutical industry customers with access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development, from preclinical to commercial manufacturing scale.

FDA issues list of 2013 guidance documents.

INTERPOL and 29 of the world’s largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs.

America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report.

Product sold online in Malaysia and Indonesia infringes on the company’s trademark.

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

While the number of patent filings at the European Patent Office in 2012 increased by 5.2% over 2011, pharmaceutical-based patents remained flat, and biotechnology patents dropped slightly.

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.

Incremental innovation advances medicines by expanding therapeutic classes, increasing the number of available dosing options, discovering new physiological interactions of known medicines, and improving other properties of existing medicines

Ilaris (canakinumab), a selective, fully human, monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), has been approved in the EU for symptomatic pain relief in patients suffering from gouty arthritis whose condition cannot be managed with current treatments.

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.

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.

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.