Recon: Pharma's rep down again; Roche ponies up $3B for Shape's RNA editing tech

ReconRecon | 24 August 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Six U.S. states do not join $26B opioid settlements with distributors, J&J (Reuters)
  • ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan (KHN)
  • Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 (CNBC)
  • American Medical Association calls for public, private sectors to mandate vaccines (The Hill)
  • Pfizer, BioNTech look ahead to pediatric data after FDA approval of Comirnaty (Biocentury)
  • Will breaking apart Google’s health bets give them a better shot at success? (STAT)
In Focus: International
  • Samsung plots $205B investment, massive hiring spree to ramp up CDMO, biosimilars and more (Fierce)
  • Pfizer, Moderna get EU nod for boosting mRNA COVID-19 vaccine output (Reuters)
  • Israel lowers age of eligibility for COVID-19 vaccine booster to 30 - Health Ministry (Reuters)
  • Israel's COVID-19 vaccine boosters show signs of taming Delta (Reuters)
  • UK vaccine advisers to call for targeted booster programme (FT)
  • EC approves AbbVie's upadacitinib as first JAK inhibitor for atopic dermatitis (Endpoints)
  • India approves further trials for first homegrown mRNA COVID-19 shot (Reuters)
  • Britain reports 174 COVID deaths, highest since March 12 (Reuters)
Coronavirus Pandemic
  • Delta cases show 300 times higher viral load - S.Korea study (Reuters)
  • Will three-dose Covid vaccine give Cadila Healthcare a booster shot? (Economic Times)
  • U.S. review of COVID origins due Tuesday, but public must wait for unclassified version (Reuters) (NPR)
Pharma & Biotech
  • Pharma's reputation drops again. Could it foreshadow a return to the bottom? (Fierce)
  • Roche tees up $3B+ for Shape's RNA editing platform, with the bold promise of 'one-time' cures for Alzheimer's, Parkinson's (Endpoints)
  • Pfizer deal a spark for M&A, or just fuel for an empty pipeline? Analysts try to read the tea leaves (Fierce)
  • Investors to take Inovalon private in $7.3B deal (MedCity News)
  • Vertex, looking to broaden its gene editing abilities, asks a young biotech for help (Biopharma Dive)
  • Avera Health, Sema4 join forces on precision cancer care (Outsourcing Pharma)
  • FDA OKs New Drug for CKD-Related Pruritus (MPT)
  • J&J, Bayer's Xarelto scores FDA nod in post-surgery artery disease as partners try to catch up with Eliquis (Fierce)
  • Bimzelx® receives EC approval for plaque psoriasis treatment (EPR)
  • Regeneron earns mid-stage win for higher dose of Eylea, hoping to refresh its sales pitch (Endpoints)
  • Novartis' CAR-T fails to help a vulnerable group of NHL patients — quashing hope of moving up lines of treatment (Endpoints)
  • Theravance’s Janssen Biotech-partnered ulcerative colitis drug flops in Phase 2 (MedCity News)
  • Despite A Third Failure, Merck KGaA And GSK Won’t Give Up On Bintrafusp Yet (Scrip)
  • The FDA wants more data. Stealth is filing for approval anyway (Fierce)
  • BlueWillow shares early look at data on nasal anthrax vaccine (Fierce)
  • Orphazyme rises on positive trial of arimoclomol in Niemann-Pick disease type C (Pharmaletter)
  • Former Blueprint and Peloton vets team up to take on big players in growing hunt for a new type of small molecule (Endpoints)
  • Biotage moves to support scale up of lipid production for COVID-19 vaccines (BioPharma Reporter)
  • AllStripes Raises $50 Million to Advance Global Rare Disease Research (Rare Daily)
  • Lonza to establish drug product manufacturing capacity at Chinese facility (BioPharma Reporter)
  • Biohaven points up Nurtec dual-migraine approval with growing stable of celebrity users (Fierce)
  • Elizabeth Holmes will be on trial. But the evidence will expose a bigger collision between tech culture and health care (STAT)
  • Medtronic starts FY22 with electives boost, but delta hits in summer months (MedTech Dive)
  • EU builds out MDR, IVDR guidance ahead of flurry of implementing acts (MedTech Dive)
  • Class I Recall of Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
Government, Regulatory & Legal
  • Purdue Pharma judge says Sacklers face 'substantial risk' of liability (Reuters)
  • Purdue Pharma Narrows Protection for Sacklers During Trial (Bloomberg)
  • FibroGen Gets 1 Anemia Patent Revived On Appeal (Law 360)
  • They Still Live in the Shadow of Theranos’s Elizabeth Holmes (NYT)
  • PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs (FDA Law Blog)
  • Patent Thickets And Legislative Logjams (Pink Sheet)
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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