Industry News

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.