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Recon: J&J says second shot boosts protection against moderate to severe COVID; AZ to invest $360M in Irish manufacturing site

Posted 21 September 2021 | By Michael Mezher 

Recon: J&J says second shot boosts protection against moderate to severe COVID; AZ to invest $360M in Irish manufacturing site

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • J&J says second shot boosts protection for moderate-severe COVID-19 to 94% (Reuters) (STAT)
  • US lawmakers accuse patent office of weakening challenges and allowing drug prices to rise (STAT)
  • Biosimilar drugs gain ground in U.S., but concerns linger about when patients can switch (STAT)
  • Amgen scores Otezla patent win, protecting its blockbuster from Sandoz and Zydus generics until 2028 (Fierce)
In Focus: International
  • French company Carmat announces first implant of its artificial heart in a woman (Reuters)
  • India govt won't buy Pfizer, Moderna vaccines amid local output -sources (Reuters)
  • India plans to resume vaccine exports starting next month. (NYTimes) (BBC)
  • AstraZeneca to invest $360 mln in Irish drug manufacturing site (Reuters)
  • AstraZeneca Breast Cancer Drug Found to Reduce Risk of Dying (WSJ)
  • Citing competitive concerns, European Commission seeks to intervene in Illumina’s $8 billion acquisition of Grail (STAT) (Law360)
Coronavirus Pandemic
  • EU says people vaccinated with AstraZeneca shots should be able to travel to U.S. (Reuters)
  • Biden to get COVID-19 booster on camera once fully approved (The Hill)
  • Becerra takes a back seat while others steer Covid response (Politico)
Pharma & Biotech                                                                                                     
  • Exclusives: Eli Lilly out to crash the megablockbuster PD-(L)1 party with 'disruptive' pricing; reveals cancer biotech buyout (Endpoints)
  • Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular (Pink Sheet)
  • Opioid prescriptions fell over past decade while drug overdose deaths climbed: AMA report (The Hill)
  • FDA hands accelerated nod to Seagen, Genmab's solo ADC in cervical cancer, but combo studies look even more promising (Endpoints)
  • Verrica hits another bump in the road with CMO related letter from FDA (Endpoints)
  • When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds (Endpoints)
  • After selling to Genentech, the old Jecure team is back at an RNA-focused startup — and more enthusiastic than ever (Endpoints)
  • Diving deeper into inherited retinal disorders, Novartis gobbles up another bite-sized optogenetics biotech (Endpoints)
  • Good ad or bad ad? FDA quiz reminds docs about its Bad Ad program to police problematic advertising (Fierce)
  • Aerie fires CEO after lead program flop, comments about primary endpoints being 'not required' (Endpoints)
  • Takeda snaps up the Japanese rights to an old Shire cast-off; Boehringer Ingelheim acquires Abexxa Biologics (Endpoints)
  • The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments (FDA Law Blog)
  • Medtronic recalls brain aneurysm-blocking implant due to potential breakages during placement (Fierce)
  • Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market (MedtechDive)
  • Boston Scientific to spend $269M for remaining stake of Devoro in latest deal (MedtechDive)
  • Illumina Ventures sets sights on European genomics startups with new $325M fund (Fierce)
  • Johnson & Johnson, Mauna Kea launch study of lung cancer biopsy guidance tool (Fierce)
  • Apple taps Biogen, UCLA to explore adding mental health tracking to iPhone: report (Fierce)
Government, Regulatory & Legal
  • Congress Cites KHN Investigation in Probe of National Academies (KHN)
  • Lupin Will Pay $150M To End Glumetza Antitrust Suit (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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