Industry News

Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.

Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.

The recommended drugs include two orphan medicines and three biosimilars.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.