Recon: Pfizer to pursue COVID-19 booster, shot for Delta; Philip Morris strikes £1B deal for Vectura
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Citing Delta variant, Pfizer will pursue booster and a new vaccine (NYTimes) (STAT) (Reuters)
- Fully vaccinated people don't need Covid boosters, US health agencies say (NBC)
- Calls mount on FDA to formally endorse Covid vaccines as Delta surges (Politico)
- FDA’s expansive Alzheimer’s drug approval surprised even top agency officials (STAT)
- 15 more US states reach settlement in OxyContin maker Purdue bankruptcy (Reuters) (FT) (NPR)
- St. Jude Medical to pay $27M to settle allegations over heart devices (Reuters) (DoJ)
- In a sweeping executive order, Biden endorses importing drugs from Canada and orders a bigger drug pricing plan by late August (STAT) (The Hill)
- Pelosi threatens to slide drug pricing reform into Biden's budget bill (Endpoints)
- Drugmakers’ Spending on Stock, Dividends and Executive Pay Exceeds Research, Democrats Say (KHN) (STAT)
- Question open on need for COVID booster shot, data awaited, WHO says (Reuters)
- IMF board approves $650B aimed at struggling countries to pay for medical care, vaccines (The Hill)
- Philip Morris International makes £1bn offer for UK pharma firm Vectura (The Guardian) (FT)
- Britain bets on biotech as billions set to boost life sciences sector (Fierce)
- New Fujifilm CEO focuses on drug ingredients unit after Avigan stumbles (Reuters)
- EMA finds no evidence linking viral vector in Zynteglo to blood cancer (EMA)
- Public Health England says Pfizer, AstraZeneca vaccines effective in high-risk groups (Reuters)
- EU finds potential link between mild heart inflammation and mRNA COVID shots (Reuters) (EMA)
- EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome (EMA)
- How effective are coronavirus vaccines against the Delta variant? (FT)
- A new study finds genetic variations in Covid patients that could point to better drug treatments. (NYTimes)
- U.K. regulator accepts Humanigen's COVID drug for speedy review, as analysts spell out reasons to be hopeful for FDA nod (Fierce)
- Moroccan government drops $500M into new Recipharm fill-finish plant in big boost for African manufacturing (Endpoints)
- Livzon's COVID-19 vaccine appears safe, triggers antibodies (Reuters)
- Vietnam licenses firm to import 5 mln doses of Sinopharm vaccine (Reuters)
- N.Korea rejected AstraZeneca's COVID-19 vaccine over side effects, says think-tank (Reuters)
- 1,600 Vaccine Doses Ruined at Chugai Due to Flawed Temperature Control (PharmaJapan)
- Gap between Sputnik V COVID-19 shots can be up to 180 days - Russia's RDIF (Reuters)
- Procurement hurdles could delay launch of Johnson and Johnson’s shot in India (Economic Times)
- India's Hetero seeks emergency use nod for Merck's COVID-19 drug (Reuters)
- Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy (Reuters)
- Argentina announces COVID-19 vaccine supply deal with Moderna (Reuters)
- FDA extends shelf life for glaucoma drug discontinued by Pfizer, but patients remain concerned (STAT)
- GlaxoSmithKline to close Memphis consumer health plant, putting 150 jobs on the chopping block (Fierce)
- With plans for a massive plant in China, small Chicago biotech Sparx could be the talk of the town in Yangzhou (Fierce)
- NICE rejects gene therapy for children with neurodegenerative disorder (Pharmafile)
- SPAC downpour continues (LifeSciVC)
- AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis (PMLive)
- Gene therapy for sickle cell disease: progress and competition (BioPharmaDive)
- Biohaven beats expectations with fast sales of migraine drug (BioPharmaDive)
- Ovid shuffles C-suite, lays off staff in wake of PhIII Angelman syndrome fail (Endpoints)
- Agenus to move California operations to new biomanufacturing cluster in Vacaville (Endpoints)
- Muna raises $73M to go after Alzheimer's, Parkinson's and MS (Fierce)
- With LentiGlobin cleared by FDA, bluebird lifts EU marketing hold on gene therapy using the same delivery mechanism (Endpoints)
- Often-passed plant in Colorado has a new owner, who's already operating nearby (Endpoints)
- IVD Regulation 'Correction' Published In EU Official Journal (MedtechInsight)
- Alpha Tau hops aboard the SPAC train with $367M deal to take its tumor-blasting tech public (Fierce)
- Natural Cycles snags FDA clearance to use wearable temperature data in its fertility algorithm (mobihealthnews)
- Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers (FDA)
- EU Parliament Wants Two-Tier Database To Monitor Drug Supplies (Pink Sheet)
- Stryker inks $15M settlement to resolve Conformis patent dispute (MedtechDive)
- A VALID Argument: Proposed Legislation Would Reshape Regulation of Diagnostics (FDA Law Blog)
- Fed. Circ. Appears Split On Novartis' MS Drug Patent (Law360)
- Judge Blasts J&J Unit For 'Tactical' Silence In Drug IP Fight (Law360)
- IP Forecast: Daiichi Sankyo Unit Takes Drug Rival To A Jury (Law360)
- Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charges Related to the Fraudulent Misbranding of Its Microcool Surgical Gowns (FDA)
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.
