Industry News

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.

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

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.

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

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

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

FDA publishes the final Q3D Elemental Impurities guidance.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

Pharma scientists announced for AAPS executive council and section leadership positions.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

The new, still unnamed biosciences arm of Emergent BioSolutions will be a separate public company with a focus on novel therapeutics in immuno-oncology.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

  The provisions in the Trans-Pacific Partnership (TPP) dealing with patent exclusivity periods are diametrically opposed to the main goals originally outlined in the Biologics Price Competition and Innovation Act of 2009 in the Patient Care Protection and Affordable Care Act, the Biosimilars Council wrote in an open letter to President Obama on July 27, 2015.

Drug development is South Korea is being driven by the government’s R&D strategy under its Pharma 2020 Vision.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.