Regulatory Focus™ > News Articles > 2021 > 7 > Recon: Roche in talks with FDA on Alzheimer's candidate; Pfizer bets $1B on Arvinas' protein degrade

Recon: Roche in talks with FDA on Alzheimer's candidate; Pfizer bets $1B on Arvinas' protein degrader

Posted 22 July 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  •  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)
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.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.