News

FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions.

Prefilled-syringe line features automation and novel disinfection techniques.

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

The process-driven system reduces total cost of ownership.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products

Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology.

Dr. Reddy's Laboratories has announced plans to relocate its North America headquarters and establish a R&D facility in Princeton, New Jersey.

FDA Releases Guidance on Self-Selections Studies

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.

Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.

USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China.

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

The Access to Medicines Index shows that pharmaceutical companies are increasing drug development for the developing world and using more tiered pricing mechanisms to lower pricing.

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

The outlook of the European biotech sector may not be as bleak as apparently believed despite the current economic climate, but compared with their US rivals, biotech companies are still struggling to attract investors and secure funding.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

Draft guidance combines and supersedes previous guidance documents.

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013

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

Shire has announced plans to acquire dry eye specialist SARcode Bioscience with the aim of expanding its ophthalmics portfolio. Under the terms of the agreement, Shire will pay $160 million upfront and SARcode shareholders will receive additional undisclosed payments upon achievement of certain clinical, regulatory and/or commercial milestones.

FDA's Commissioner discusses pharmacy compounding, EMA updates guidance

Merck's Januvia [sitagliptin] was named 2013 Brand of the Year by Pharmaceutical Executive magazine.

A Massachusetts-based compound pharmacy is voluntarily recalling all sterile compound products dispensed since Jan. 1, 2013 due to possible filament contamination.

AstraZeneca announced further downsizing in response to an expected period of declining revenues in the face of patent expirations. The company will eliminate 2300 positions in sales and general administration.

The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.