News

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

Latin America's diverse growing market seeks regulatory harmonization.

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

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.

The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.

Strengthening government control or striving for compliance with international standards?

Draft guidance combines and supersedes previous guidance documents.

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

In the context of international trade, the need to develop global quality standards for medicines is increasing.

Sound policies are needed to govern the substitution of interchangeable biologics.

Conference and exhibits provide a meeting place for professionals to exchange ideas.

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

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.

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.

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

Rigaku Raman Technologies announced an updated version of the FirstGuard handheld Raman analyzer at Pittcon 2013.

Metrohm and FOSS have entered into a strategic alliance in which Metrohm will become the sole global distributor of FOSS NIR instruments for the pharmaceutical sector.