Our top picks from this week’s news stories…
CDMOs set for California gold rush thanks to new drug manufacturing law
California will need CDMO partner to help it make generic drugs under new law designed to reduce prices.
Earlier this month California legislators passed a bill designed to force pharmaceutical firms to cut prices by supplementing the drug supply chain with state-sponsored drugs, thereby increasing competition.
The Bill requires the California Health and Human Services Agency (“CHHSA”) to form agreements “resulting in the production or distribution of generic prescription drugs” to be made available to both public and private purchasers.
These partnerships will involve manufacturing contracts with CDMOs and purchasing agreements for the procurement of generic prescription drugs.
The CHHSA will need to prioritize generic drugs that would have the greatest impact on lowering costs, increasing competition and addressing shortages. The agency must also include high-cost products according to the Bill.
Read the FDA Law Blog’s take here.
US politicians consider continuous manufacturing proposal
The US Congress has discussed a plan to let FDA partner with universities to encourage adoption of continuous manufacturing.
US Congressman Frank Pallone, Jr. shared details of the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 this week, explaining it would let the FDA team with academics to improve drug quality, reduce drug shortages, and make pharmaceutical production.
He wrote “My bill will help expand continuous manufacturing technology in the United States, so we can avoid future drug shortages and other supply chain interruptions, while bringing jobs back to the United States.”
Pallone cited Rutgers University as a likely partner for the FDA, adding that the institution is playing a leading role in the advancement of continuous manufacturing technology.
US FDA launched digital centre for device firms
The FDA has set up a digital health centre of excellence to help medical device developers.
The centre will provide developers with access to a pool of partner organisations with expertise in pre- and postmarket issues, clinical care and evolving developments in digital health.
It will also provide resources for developers of software as a medical device (SaMD).
Also in the news
The world will not have an effective coronavirus vaccine until 2024 according to the director of India’s Serum Institute. See more at WIONews.
Peter Marks, director of the US FDA Centre for Biologics Evaluation and Research (CBER), says production of SARS-CoV-2 vaccines could be accelerated with manufacturing techs used to make other jabs. See more at the Pink Sheet.
Also, the Pink Sheet reports the US FDA has reviewed its virtual facility review process after assessing 500 biomanufacturing facilities.
Pharmaceutical Online looked at the implications of new guidance on reducing nitrosamine impurities in drugs.
Some developments of note in the CDMO space:
Germany’s Vetter has opened a training centre. The facility will provide courses in a range of pharmaceutical manufacturing skills, including 3D manufacturing and facility automation.
RNAi drug developer Alnylam Pharmaceuticals has hired Sharp as its packaging contractor. Under the deal, Sharp Belgium’s Hamont-Achel site will package products for European markets.
Thermo Fisher Scientific has partnered with AstraZeneca and the University of Nebraska Medical Center to develop solutions for unmet needs in clinical biomarker discovery.
BioNTech will buy Novartis’ manufacturing facility in Marburg, Germany to up capacity for its SARS-CoV-2 vaccine development programme.