In this week’s news

The FDA slowest to release review data, Plans to beef up EMA, DSCSA prep impacted by COVID-19 on machine learning guidelines for medical devices sector and more.

Plans to make EMA better able to fight pandemics

European politicians have agreed to beef up the EMAs ability to cope with future health crises and drug shortages.

The plan – available here includes measures to empower the agency, undertake a region-wide response to future crises and disease outbreaks, assess the risk of shortages of critical drugs and co-ordinate clinical trials.

In a press statement Nicolás González Casares, rapporteur for the Parliament’s health committee said: 

“With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues.”

EMA launches drug repurposing pilot

The EMA has started a project to support the repurposing of approved drugs by not-for-profit organizations and academia. The aim is to generate data to support the use of medicines in new indications. See press release for details.

US FDA plans virtual meeting on GDUFA

The US FDA will hold a virtual public meeting on November 16 to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. 

Drug companies, CDMOs and others are invited to take part. See details.

COVID-19 impacting DSCSA prep says survey

COVID-19 has further hindered industry efforts to align with Drug Supply Chain Security Act (DSCSA) according to a new survey.

The report – available here suggests not all firms are up to speed with the serialization systems they will need to comply with the  Drug Supply Chain Security Act (DSCSA) by the November 2023 deadline.

The authors wrote “There continues to be uneven readiness that has likely been exacerbated by the difficulties of conducting business during the pandemic and the prioritization of COVID-19 response”.

Also in the news

Reuters reported that up to 50 million doses of Johnson & Johnson’s COVID-19 vaccine are sitting in Emergent BioSolutions’ plant in Baltimore.

STAT looked at US President Joe Biden’s decision to halt efforts to force companies to reduce prices.

The EMA and Health Canada release drug review data faster than the US FDA according to a new transparency study

BioCentury looked at how Janet Woodcock, currently acting commissioner, has changed operations at the US FDA during her three and a half decades at the agency. Helping drug firms understand what reviewers are looking for is cited as a major impact.

Pharma Manufacturing reported that a growing number of US biopharmaceutical companies are outsourcing work overseas.

CDMO trends

Some developments of note in the contracting sector:

CDMO ten23 health has acquired Swissfillon AG to expand its portfolio of manufacturing services.

Renaissance Lakewood is expanding its facility in Ocean County, NJ.

Catalent has opened a facility in San Diego, in response to increased demand for integrated development, clinical packaging, and distribution solutions on the US West Coast. 

WuXi Biologics has completed a remote GMP inspection by Health Canada for its drug substance facility (called MFG2) in Wuxi city. See press release.

MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, has launched new technology and expanded capacity to advance ADC therapies. See media statement.