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April 29, 2021
by Michael Mezher

Recon: Global spending on COVID vaccines to exceed $150B through 2025; BMS misses in Q1 as cancer drugs underperform

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna boosting COVID-19 vaccine capacity, targets up to 3 billion shots in 2022 (Reuters)
  • BMS Q1 earnings miss expectations as cancer drugs underperform (Reuters) (Press) (Endpoints)
  • US trade negotiator discusses COVID-19 IP waiver with Moderna CEO (Reuters)
  • With Amy Abernethy out, Vid Desai takes over as FDA’s acting CIO (Endpoints)
  • Gene therapy deaths push back Astellas-Audentes' approval by at least two years (Endpoints)
  • Gene therapy trial is derailed after getting hit by the latest serious adverse event in the field — shares crash (Endpoints)
  • Americans paid two to four times as much for some drugs as in three other countries (STAT) (GAO)
  • In biggest speech yet, Biden pitches a new health agency to help ‘end cancer as we know it’ (STAT)
  • Biden called for drug pricing reform this year. But it’s an empty call (STAT)
In Focus: International
  • EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen (EMA)
  • BioNTech expects vaccine trial results for babies by September (Reuters)
  • British regulator cites 41 more blood clot reports following AstraZeneca shots (Reuters)
  • World to spend $157 billion on COVID-19 vaccines through 2025 -report (Reuters)
  • Germany says new EU COVID vaccine contracts have clear rules on delivery shortfalls (Reuters)
  • Spain's Reig Jofre new plant to produce J&J vaccine by end-Q2 (Reuters)
  • Spain's Rovi will double its capacity to bottle Moderna's COVID-19 vaccines (Reuters)
  • Takeda Accused of Favoring Japanese Patients for Cancer Drug (Bloomberg)
  • Illumina sues Brussels over probe into $8bn cancer deal for Grail (FT)
  • India urges China to clear bottlenecks on key pharma raw-material (Economic Times)
Coronavirus Pandemic
  • Russia, China sow disinformation to undermine trust in Western vaccines: EU (Reuters)
  • Australia says two deaths not likely to be linked to COVID-19 vaccine (Reuters)
  • Moderna says COVID-19 vaccine can be stored at refrigerator temperatures for 3 months (The Hill)
  • Help wanted: Lonza seeks workers to lift Moderna vaccine output (Reuters)
Pharma & Biotech
  • Top Drugs Losing Patent Exclusivity in 2021 (Patent Docs)
  • FDA pandemic delays strike again with Israeli microcap the latest to receive a CRL based on inspection setbacks (Endpoints)
  • Triple combo cystic fibrosis therapy Kaftrio scores EU label expansion (PharmaTimes)
  • GSK’s revenue drops by 18% in Q1 as performance pressures mount (PMLive)
  • Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with a Revision of ICH Q9 Among the Focal Points (IPQ)
  • Pfizer weighs sale of Philly-area campus—where 2,000 once worked—as company mulls when and how to bring employees back (Fierce)
  • Sanofi is expanding at light speed abroad, but it's leaving behind a Pennsylvania plant and its 75 employees (Endpoints)
  • The biotech craze hits the Nordics, driving a record-high $62M Series A for a Copenhagen-based ADC player (Endpoints)
  • Galera claims positive update in pancreatic cancer but doesn't report p-values; Amgen launches Canadian fund in tandem with CCRM (Endpoints)
  • Forge Biologics bags $120M round as it looks to scale AAV manufacturing for Krabbe disease treatment (Endpoints)
  • Cara touts subgroup in failed atopic dermatitis trial, but stock craters (Endpoints)
  • Lonza adds on small molecule facility at Visp site, adding new weight to its expansion plans on the back of a big year (Endpoints)
  • A new gene therapy player debuts in LA with 2 startup VCs at its back, AbbVie on board with a $90M cash upfront and big plans to upend the field (Endpoints)
  • BeiGene's late stage trial shows promising numbers; Amgen to study sotorasib dosage after FDA recommendation (Endpoints)
  • How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products (FDA)
Medtech
  • EU Must Have Courage To Take The Sensible Decision On IVDR Deadline, Says German Industry (MedtechInsight)
  • EU MDR Guidances: Can Stakeholders Be Punished For Not Applying Them? (MedtechInsight)
  • Smith & Nephew returns to growth as US hip sales surge (MedtechDive)
  • CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices (MedtechDive)
  • LabCorp, still riding the COVID-19 testing wave, exceeds its own expectations with $4.2B Q1 revenue (Fierce)
  • Baxter Reports First-Quarter 2021 Results (Press)
Government, Regulatory & Legal
  • FDA says it will ban menthol cigarettes and all flavored cigars within a year (Politico)
  • House Introduces Bill, BIOSIM Act, Designed To Lower Drug Costs (Big Molecule Watch)
  • Law Firms Representing Purdue Pharma Agree to Relinquish $1 Million in Settlement with U.S. Trustee Program (DOJ)
  • Justices' Restitution Order May Allow FTC-Surescripts Deal (Law360)
  • Opioid Ad Blitz Targeted Not Just Docs But Insurers: J&J Rep (Law360)
  • GSK Says Amgen Patent Decision Will 'Devastate' Innovation (Law360)
  • Dr. Reddy's Says Amarin Delaying Heart Drug Competition (Law360)
  • Pfizer Tells Court Allele Wrong On Hatch-Waxman Safe Harbor (Law360)
  • Pharma Cos. Can Expect Harsh Antitrust Scrutiny From Biden (Law360)
  • Long-Running MRI Patent Row Settles Days Before Ill. Trial (Law360)
  • Baylor, Gensetix Agree To Drop Cancer Patent Fight For Good (Law360)
  • J&J, Imerys Beat $117M Talc Verdicts Over Flawed Testimony (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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