Recon: Biden admin eyes COVID booster shots at six months; AstraZeneca reports positive Phase 3 for Wilson disease drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Biden Administration Likely to Approve Covid-19 Boosters at Six Months (WSJ)
- Pfizer seeks U.S. approval for COVID vaccine booster (Reuters)
- Pfizer and BioNTech say a third shot boosts antibodies against the virus. (NYTimes)
- Biden Falls Short on Pledge for U.S. to Be the World’s Vaccine ‘Arsenal,’ Experts Say (NYTimes)
- Lilly puts more money into protein degradation (BioPharmaDive) (PMLive)
- Pharma’s Appetite for Biotech Deals Bodes Well (WSJ)
- Purdue Pharma bankruptcy judge to rule Friday on opioid settlement (Reuters)
- FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma (FDA)
- EU says COVID boosters may have higher legal risks without EMA approval (Reuters)
- AstraZeneca drug for rare disease shows promise in flushing copper build-up (Reuters)
- China Livzon Pharma affiliate's COVID-19 vaccine candidate enters phase III trial (Reuters)
- WHO begins shipping Chinese vaccines despite some misgivings (Reuters)
- Brazil's Eurofarma to make Pfizer COVID-19 shots for Latin America (Reuters)
- Breakthrough Covid Cases: Uncommon and Often Mild, but Not Always (NYTimes)
- Pediatric Covid hospitalizations surge to highest on record in U.S. as doctors brace for more (CNBC)
- Heart Problem More Common After Covid-19 Than After Vaccination, Study Finds (NYTimes) (NEJM)
- FDA greenlights first smartphone-based home COVID-19 test (Fierce)
- Cipla reopens South African manufacturing site after violent protests (Endpoints)
- Sanofi, GSK and Seqirus prep for near-record flu shot sales as COVID's delta variant cooks up 'recipe for disaster' (Fierce)
- Playing a surprisingly hot hand, BeyondSpring nails a $200M China deal in wake of a pivotal success (Endpoints)
- Kevin Judice plays DiCE, pivoting from a $60M raise straight to the big S-1 filing (Endpoints)
- Cassava Stock Plummets On Claims Of 'Data Manipulation' In Alzheimer's Testing (Investor's Business Daily)
- Albert Bourla picks a new dealmaker to lead the hunt for more drugs to swell Pfizer’s pipeline (Endpoints)
- Amneal touts results from Phase III trial in Parkinson's; NovaRock partners on cancer drug (Endpoints)
- Malaysia, Singapore Join Hands On Review Of Generic Drugs (Pink Sheet)
- Cara, Vifor receive FDA nod for pruritus treatment (PharmaTimes)
- FDA blasts Toyobo for subpar particulate investigation and data integrity breaches (Fierce)
- mRNA vaccines for infectious diseases: principles, delivery and clinical translation (Nature)
- Ascendis wins approval for once-weekly growth hormone drug as Pfizer, Opko Health keep up the pressure (Endpoints)
- FDA faults Japanese manufacturer with data breach, contaminated injectables (Endpoints)
- ADC Therapeutics sells off royalty share for lead antibody-drug conjugate in $325M deal (Endpoints)
- Shortly after her first work anniversary, an oncolytic player abruptly terminates its CMO and eliminates the job (Endpoints)
- After pandemic delay and a South Korean deal, Boston-area biotech raises Series B with sights on IPO (Endpoints)
- Apple, Bose and Others Pump Up the Volume on Hearing Aid Options, Filling Void Left by FDA (KHN)
- Breast Reconstruction Mesh, Endovascular Grafts In Focus At Fall FDA Meetings (MedtechInsight)
- FDA doles out Class I rating to recall of replacement part for BD's Alaris infusion pump (Fierce)
- BD locks down FDA approval for automated molecular diagnostics platform, with initial test for HPV (Fierce)
- Abbott predicted to quickly take share from Boston Scientific's Watchman: survey (MedtechDive)
- FDA clears battery-free suction pump for surgical wound closures (Fierce)
- Senator To Philips CEO: Fork Over Info On Class I Recall Of Sleep, Ventilator Devices – Pronto (MedtechInsight)
- Once A Cheerleader For Latest VALID Act For Diagnostics, Pew Now Has Some Reservations (MedtechInsight)
- The Theranos scandal cast a pall over self-testing. The pandemic is giving the industry another shot (STAT)
- Dozens of potential jurors in Elizabeth Holmes trial cut for potential bias (CNBC)
- Takeda Can't Duck Generic-Drug Delay Suit At 2nd Circ. (Law360)
- 6th Circ. Revives Suit Over J&J Unit's Pelvic Mesh (Law360)
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