Industry News

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

SpacePharma will give US researchers access to microgravity solutions to advance R&D projects.

ISPE announced the results of its 2016–2017 International Board of Directors election.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act.

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.