In this week’s news, EDQM wants feedback on new texts, US FDA temporarily halts inspections and UK rejigs device regulations and more.
EDQM seeks feedback on 48 draft European Pharmacopoeia texts
The European Directorate for the Quality of Medicine (EDQM) wants drug and CDMO sector feedback on 48 revised pharmacopeia texts.
The EDQM asked for input on the draft texts this week, explaining that they cover things like the use of edotreotide, gozetotide and oxodotreotide for radiopharmaceutical preparations, and nuclear medicine procedure positron emission tomography.
Once finalized and adopted the texts will become legally binding standards. See press statement.
MHRA rejigs device guidelines to reflect end of Brexit transition period
The UK MHRA has revised guidelines on medical devices to remove measures introduced to ease industry practices during the Brexit transition period.
The original texts featured advice about the need to register devices on the market in Great Britain before the end of 2021, depending on their risk classification.
The MHRA said it has updated the documents to reflect the current situation.
US FDA halts plant inspections citing Omicron
The US FDA has temporarily halted drug and CDMO facility inspections, citing the spread of the Omicron COVID-19 variant as the basis for its decision.
In a statement the agency said it had “implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.”
The agency will continue “mission-critical” inspections through to 19 January but will postpone other inspections for the time being.
Also in the news
The New York Times took a look at what it describes as 30 years of Government mishandling of vaccine development in the US. The article touches on the role of several prominent CDMOs.
The Irish Times reported that Amgen plans to invest to add capacity at its manufacturing and development site in Dublin, Ireland.
US politicians are due to vote on whether to appoint Dr Robert Califf as US FDA Commissioner. Read more at RAPS.
And Spark Therapeutics has detailed plans to invest $575M in a gene therapy innovation centre on Drexel University’s campus in Philadelphia.
Endpoints looked at Novartis’ increased focus on siRNA based therapies, citing its recent deal with Alnylam.
Some developments of note in the contracting sector:
Merck KGaA has said it will buy Exelead, a biopharmaceutical contract development and manufacturing organization (CDMO), for $780 million in cash. Exelead specializes in complex injectable formulations, including those used in mRNA based vaccines.
Healthcare investment group Altaris Capital Partners has bought drug device product specialist Meridian Medical Technologies from Pfizer and Johnson Matthey Health, a contract producer of complex active pharmaceutical ingredients.
Piramal Pharma has invested in fellow Indian CDMO in Yapan Bio, buying a 27.8% equity stake in the company. The firm said the investment adds to its large molecule drug production capabilities. See press release.
In related news, Piramal has announced plans for a high-throughput screening facility to will augment its drug discovery services site in Ahmedabad, India.
FUJIFILM Diosynth Biotechnologies plans to expand its BioProcess Innovation Center (BIC) in Research Triangle Park (RTP). See press release for details.
Vibalogics has finished the first phase of construction of a live virus and viral-vector facility in Massachusetts. See statement.