Industry News

The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The agency launched a secure online portal for orphan drug designation applications.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

Legislators have requested that FDA do more to prevent drug shortages.

Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.

The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.

The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.

The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.

The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

National Institutes of Health (NIH) researchers combine two microscope technologies to create sharper, faster images.

The Amgen Foundation and Harvard University will develop LabXchange, a free online science education platform that will provide digital instruction and virtual lab experiences.

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Internationalization and regulatory reform are driving growth and investment China.

The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.