News

The project seeks to index the properties of various proteins in solution and create a home for data on the performance of product excipients with their active substances.

The results from an international study on nivolumumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

US Compounding, Inc. issues voluntary recall of all sterile products.

A drug price hike like that of the one seen in the highly publicized case of Turing Pharmaceuticals' Daraprim is prompting a public outcry and is demonizing the industry for those who see Martin Shkreli as representative of all pharmaceutical executives. But capping drug price increases may affect actual patient costs less than imagined, and may have a bigger impact on pharmacy benefit managers and insurance companies.

Hillary Clinton unveiled a new plan on Sept. 22 during a community forum in Des Moines, Iowa to tackle high drug prices. The plan reveal was a follow-up to a tweet from the presidential candidate a day prior, on Sept.

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

The protective suit was recently honored by Fast Company’s 2015 Innovation by Design Awards.

Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Daiichi Sankyo signed an exclusive licensing agreement with clinical-stage biopharmaceutical company Translational Sciences to develop and commercialize its novel thrombus (blood clot) dissolving agent, TS23.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.