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