Recon: Roche in talks with FDA on Alzheimer's candidate; Pfizer bets $1B on Arvinas' protein degrader
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Roche in talks with FDA on Alzheimer's candidate, says CEO (Reuters)
- States reach $26 billion deal with three wholesalers and J&J to end opioid lawsuits (STAT) (NYTimes)
- Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer (Endpoints) (FDA)
- Pfizer bets $1B cash on the original protein degraders as technology nears prime time (Endpoints)
- J&J Settles Pfizer's Antitrust Suit Over Remicade Biosimilar (Law360)
- Biogen launches staunch defence of contentious Alzheimer’s treatment (FT) (STAT)
- A controversial Alzheimer’s drug has already yielded $2 million in sales. (NYTimes)
- Two doses of Pfizer, AstraZeneca shots effective against Delta variant: study (Reuters)
- Mexico in talks to produce Italy's GRAd-COV2 COVID-19 vaccine (Reuters)
- EU has shipped tiny percentage of planned COVID-19 shot donations – document (Reuters)
- WHO DG's remarks on expanding COVID-19 vaccine manufacturing (WHO)
- Africa demands local production of COVID vaccines (Reuters)
- GSK picks insider to run consumer health business after spin-off (FT)
- EU lists rare nerve disorder as side-effect of J&J COVID-19 vaccine (Reuters) (EMA)
- As part of movement to boost African presence, Grifols to build IV bag facility in Nigeria (Endpoints)
- CDC investigating deaths of immunized nursing home residents: report (The Hill)
- CDC advisory group meets to review data on extra shots for immune-compromised (NBC)
- ‘The race is on’: CureVac seeks answers to vaccine disappointment (FT)
- China rejects WHO plan for study of COVID-19 origin (Reuters)
- More than 90% of adult Beijing residents fully vaccinated against COVID-19 (Reuters)
- Vietnam in talks with U.S. for local production of COVID-19 mRNA vaccine (Reuters)
- Cigna paying members to use biosimilars draws providers ire (Modern Healthcare)
- Bluebird, with little fanfare, is first to bring a second gene therapy to market (BioPharmaDive)
- Seres Therapeutics’ microbiome therapy for ulcerative colitis falls short in Phase 2 trial (STAT)
- Ex-Merck chief Ken Frazier takes a leading role in a $600M 'health assurances' venture fund (Endpoints)
- Inside Biogen's scramble to sell Aduhelm: Project 'Javelin' and pressure to ID as many patients as possible (Endpoints)
- When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval (Pink Sheet)
- MSD, Bayer’s heart failure med Verquvo gains EU approval (PharmaTimes)
- NICE recommends Incyte’s Pemazyre for rare bile duct cancer (PharmaTimes)
- Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment (Pink Sheet)
- Building off Pfizer investment, microbiome-focused Vedanta expands new fundraise to launch 2 studies (Endpoints)
- After slicing and dicing TCRs for 8 years, Swedish biotech reloads to angle for a spot in crowded cell therapy space (Endpoints)
- Hemab, still playing coy, gets its first major fundraise for hemophilia bispecifics (Endpoints)
- Prepping for yet more pricey rare disease drugs, UK launches £340M 'Innovative Medicines Fund' (Endpoints)
- From cellist to synthetic cell-ist: Jeffrey Kim scores $23M to reimagine blood tests, cell therapy (Endpoints)
- Happify to release prescription app to treat depression under loosened FDA rules (STAT)
- FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain (MedtechDive)
- Recall Of Device For Critically Ill Newborns High-Risk Class I, FDA Says (MedtechInsight)
- Intuitive's Q2 robot placements accelerate amid procedure recovery (MedtechDive)
- Boston Scientific heart implant linked to steep drop-off in AFib-related stroke risk: study (Fierce)
- ‘Light at the end of the COVID-19 tunnel’ as J&J’s medtech companies rebound to $7B in second-quarter sales (Fierce)
- Abbott returns to pre-pandemic growth, clocking 11% sales bump from 2019 sans COVID testing revenues (Fierce)
- FDA Reporting and Consumer Protection Issues Certified to Connecticut Supreme Court (Drug & Device Law)
- Daiichi Sankyo Unit Seeks $178M From Novartis As Trial Ends (Law360)
- Illumina 'Wasting Court Time' With Deal Overtures, FTC Says (Law360)
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