News

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

President Obama unveils his “Precision Medicine Initiative”.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

AstraZeneca will team up with various organizations to employ CRISPR technology for precise gene editing in recombinant cell lines.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

The new facility will feature new research and development capabilities.

The new facility will feature dry powder cell-culture media capabilities.

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

Following a proposal by the World Health Organization, Australia will abandon a previously proposed update in biosimilar nomenclature.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.