News

Cobra Biologics installs a new single-use bioreactor to expand its antibody GMP production capacity.

Thomas Engineering names David Decker as the new director of European operations.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

ISPE will discuss FDA’s recent draft guidance on breakthrough therapies at its 2013 Annual Meeting.

PharmaCell will become the European CMO for Dendreon for the commercial production of its cellular immunotherapy product Provenge.

Gentium receives marketing authorization for Defitelio (R) for the treatment of severe hepatic veno-occlusive disease.

Ganymed Pharmaceuticals receives orphan drug designation from FDA and EMA for IMAB362 for the treatment of pancreatic cancer.

CDER recommends reclassifying opioid products as Schedule II.

IDT Biologika and Oncotec Pharma Produktion to expand vaccine and oncology capacity.

SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

CPhI recognizes innovation in formulation, process development, and packaging.

IBEF and Pharmexcil report the country?s plans for growth and its commitment to lowering the cost of medicines globally.

Recent news and developments from CPhI of excipient producers, CDMOs, and CMOs are highlighted.

Fine-chemical producers and contract API manufacturers expand capacity and expand service offerings.

Excipients market will be shaped by greater supply-chain concerns, quality-by-design programs,and overall drug-safety issues.

Overall growth in the market for pharmaceutical contract research and manufacturing is strong although growth in established markets erodes at the expense of emerging markets.

PharmTech spoke with Dow about innovations in polymers to address poor solubility.

Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.

Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.

Amarin cuts staff in half after an FDA committee rejects its product label expansion.

Pliva?s new Oral Solid Forms Facility will increase Pliva's production capacities for tablets and capsules.

Pharmaceutical Technology speaks with PolyOne, a provider of specialized polymer materials, services and solutions about the company?s product, Versaflex HC, for infusion therapy stoppers and septums.

Brian Scanlan, CEO and president of Cambridge Major Laboratories, discusses the rationale behind the company's merger with AAIPharma Services.

Winners for the 2013 CPhI Pharma Awards, which recognize pharmaceutical innovation, will be awarded on later today, Tuesday Oct. 22.

The Aenova Group will merge with Haupt Pharma, a company specializing in contract development and manufacturing.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

Capsule design was developed for patients who have difficulty swallowing.

Novozymes Biopharma will collaborate with Almac to provide a combined service for drug development applications.

Abbott?s third-quarter 2013 global sales increased slightly but were affected by a disruption in the International Nutrition business.