9 June 2021

Summary

  • NHS delays GP data scheme following backlash – Financial Times 
  • Covid-19: Problems at biggest vaccine maker leave world short on Covid shots – Bloomberg 
  • How to make the most of the Alzheimer’s drug approval – Financial Times 
  • Covid-19: Pfizer to launch final study of Covid shot in kids under 12 – Bloomberg 
  • Amazon pharmacy to offer six-month prescriptions starting at $6 – Bloomberg
  • Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD – FiercePharma 
  • Bayer’s billion-dollar Parkinson’s disease bets land in the clinic – FierceBiotech 
  • Covid-19: San Francisco may be first major US city to hit herd immunity, experts say – The Guardian 
  • European Commission unveils EU IVDR implementation plan – BioWorld 
  • Boehringer Ingelheim taps into Lifebit’s AI for global disease surveillance – FierceMedTech
Madhumita Murgia of the Financial Times reports that the NHS has pushed back its plans to pool the full medical histories of 55m patients in England into a single database after extensive pressure from campaigners, politicians and patients. NHS Digital, which runs the health service’s IT systems, confirmed plans for the database, which will be made available to academic and commercial third parties for research and planning purposes, will be delayed by two months to 1 September. 
Financial Times >>
Chris Kay and P R Sanjai of Bloomberg report that the world’s largest vaccine maker, the Serum Institute of India, has been dogged by setbacks that have hampered its ability to fill orders. Covax has pledged to send shots to some 92 countries, but has so far received only 30m of the minimum 200m doses it ordered from Serum. Serum’s travails have now become a key illustration of how the effort to inoculate against Covid has failed the developing world, and a cautionary tale for becoming over-reliant on one manufacturer amid a global crisis.
Bloomberg >>
The Financial Times writes that the US Food and Drug Administration (FDA) permitted Biogen to market aducanumab, the first drug designed to treat Alzheimer’s disease, in the face of scientific doubts about its clinical effectiveness. Biogen also set a list price of $56,000 a year, which industry critics say would bring Biogen billions in profits without significantly benefiting patients. Now that the FDA has made its decision, governments must ensure the approval gives a boost to the unsuccessful process of developing effective treatments for dementia. 
Financial Times >>
Riley Griffin of Bloomberg reports that Pfizer and BioNTech’s vaccine will be tested in children less than 12 years old in a late-stage study seeking to extend Covid-19 protection. The vaccine partners announced plans to kick-start the trial which will enrol as many as 4,500 participants at more than 90 sites spanning the US, Finland, Poland and Spain. Expanding the vaccine to more populations promises to further reduce the spread of the pandemic that has already begun waning in Western countries where shots are used widely. 
Bloomberg >>
Spencer Soper of Bloomberg reports that Amazon is offering six-month prescriptions starting at $6 for medications for common ailments. Most insurance companies don’t cover six-month prescriptions, so the offering targets both the uninsured and those who are insured but still pay cash due to high out-of-pocket prescription costs associated with their plans. Amazon has been trying to make headway in the $360bn US prescription drug market since acquiring online pharmacy PillPack in 2018.
Bloomberg >>
  Angus Liu of FiercePharma reports that the entire JAK inhibitor family of medicines is feeling the ripple effects from a safety signal flagged for Pfizer’s Xeljanz. Now, the first marketed drug in the class is encountering increased scrutiny from the US Food and Drug Administration (FDA). The FDA has pushed back a decision for Incyte’s application for Jakafi in steroid-refractory chronic graft-versus-host disease by three months. The delay came after Incyte submitted additional data in response to a recent request by the agency.
FiercePharma >>
Annalee Armstrong of FierceBiotech reports that Bayer’s Parkinson’s disease stem cell therapy has officially landed in the clinic while another treatment for the neurodegenerative movement disorder is seeking patients. The first dose of DA01 was given out in a phase 1 test through its biotech subsidiary, BlueRock Therapeutics. Bayer has also kicked off a gene therapy trial in Parkinson’s disease, this time through Asklepios BioPharmaceutical, an adeno-associated virus gene therapy unit also known as AskBio, in a phase 1b.
FierceBiotech >>
Erin McCormick of The Guardian reports that San Francisco may have become the first major American city to hit herd immunity to the coronavirus, experts say. San Francisco is still recording a small number of coronavirus cases, about 13.7 per day, but they don’t appear to be gaining enough of a foothold in the population to trigger wider outbreaks. “That is what herd immunity looks like,” Dr George Rutherford, professor of epidemiology at University of California, said. “You’re going to have single cases, but they’re not going to propagate out.”
The Guardian >>
Ana Mylero of BioWorld reports that the European Commission unveiled its new joint implementation and preparedness plan for the EU’s In Vitro Diagnostic Regulation (IVDR). It sets forth priority actions, noting “the implementation of the IVDR has proven to be a very challenging task,” exacerbated in the response to the Covid-19 pandemic “despite the efforts undertaken by all” to transition. The document lists a set of priority actions to be carried out by member states and the EC and monitored at the level of the Medical Device Coordination Group. 
BioWorld >>
Conor Hale of FierceMedTech reports that Boehringer Ingelheim plans meet new hazards on the horizon in an ambitious project with artificial intelligence developer Lifebit, which aims to use natural language processing to help chart a course through the world’s data and track outbreaks of infectious diseases. Using AI programs to digest international scientific publications along with real-world data from open sources, the companies hope to establish the prevalence of any particular disease and discover whether it has begun to spread across national borders.
FierceMedTech >>

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