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

• 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)

• 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)

• 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)

• 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)

• Congress Cites KHN Investigation in Probe of National Academies (KHN)
• Lupin Will Pay $150M To End Glumetza Antitrust Suit (Law360)