Recon: Biotech's 'coolers of cash;' Slipping pharma halo?
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position (Pink Sheet) (Biocentury)
- The Delta Variant Is The Dominant Coronavirus Strain In The U.S. (NPR) (Reuters)
- COVID-19 cases up in nearly half of US states: analysis (The Hill)
- Maryland says 100 percent of COVID-19 deaths last month were among unvaccinated (The Hill)
- Ex-Surgeon General: People ‘Are Dying’ Because FDA Hasn’t Fully Approved A Covid-19 Vaccine (Forbes)
- Biden’s new Covid vaccine push focuses on workers, students, doctor’s offices to stifle delta variant (NYT) (CNBC) (MPT)
- Funding Boom Time Continues For UK Life Sciences (Pink Sheet)
- UK MHRA Awards Bluebird’s LentiGlobin An Innovation Passport (Pink Sheet)
- German COVID-19 cases rise again after two months of decline (Reuters)
- China Reins In Cancer Drug Trials, Stressing Patient Needs and Benefits (Pink Sheet)
- WHO urges countries 'not to lose gains' by prematurely lifting COVID-19 measures (Reuters)
- Sydney locked down for another week as Delta COVID-19 variant spreads (Reuters)
- Prenatal test developed with Chinese military stores gene data (Reuters)
- The world is worried about the Delta virus variant. Studies show vaccines are effective against it. (NYT)
- Mass-testing reduced Liverpool COVID-19 cases by a fifth, study finds (Reuters)
- Doctors Without Borders urges Roche to cut price of drug now recommended for Covid-19 (STAT)
- Developer says Russia's CoviVac COVID-19 vaccine effective against Delta variant (Reuters)
- Vaccines may curb new virus mutations; teens use soft drinks to fake positive COVID-19 tests (Reuters)
- Biotechs hit 3Q with coolers full of cash (Biocentury)
- Is pharma's halo slipping? Industry image continues to slide in latest Harris Poll (Fierce)
- Keytruda gains expanded US approval in skin cancer (PharmaTimes)
- United States Pharmacopeia acquires Pharmatech Associates, Inc. to expand services that help ensure the quality of medicines (USP)
- The top 10 pipeline blowups, setbacks and snafus for H1 2021 (Endpoints)
- Moderna's first seasonal flu vaccine slides into clinic as pharma giants crowd into mRNA (Fierce)
- Sanofi looks to emerging target for multiple myeloma (Biocentury)
- Live malaria vaccine shows promise (Nature Reviews Drug Discovery)
- Startup boasting 'gobstopper-style' vaccine delivery draws big partnerships — and backing from Adjuvant Capital (Endpoints)
- Understanding your cleanroom fungi is key, says expert (EPR)
- Otsuka Signs Three-Year Collaboration with Holmusk to Enhance Digital Health and Data Analytics for Global Behavioral Health Programs (PR Newswire)
- BioCryst & Celgene Suffer English Funding Setback For Rare Disease Drugs (Pink Sheet)
- Novartis takes Leqvio in-house to get submission back on track (Pharmaletter)
- Eureka Therapeutics out-licenses multiple myeloma candidate to Sanofi (Pharmaletter)
- FDA’s Mismanaged Aduhelm Review: What Went Wrong (Pink Sheet)
- ‘Some hope is better than having no hope’ (NYT The Daily)
- Aduhelm’s accelerated approval offers a promising roadmap for rare neurological diseases (STAT)
- Possible FDA Advisory Committee Meeting for Xeljanz, Rinvoq, and Other Janus Kinase Inhibitors (Drug Injury)
- The failure of a cancer drug study leaves Cel-Sci on the brink of collapse (STAT)
- Interview with Phlow CEO: How soon will essential drug manufacturing come to the US? (Endpoints)
- UK supercomputer Cambridge-1 to hunt for medical breakthroughs (Guardian)
- Improving the response to cancer immunotherapy by reactivating the 'guardian of the genome' (Fierce)
- VitriVax bags funding for thermostable, single-dose vaccine R&D (Fierce)
- Bob Nelsen is building a Really Big Neuroscience Company (Endpoints)
- Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations (PubMed)
- MIT team employs synthetic biology to create 'circuits' that could detect signs of disease (Fierce)
- Pharmalittle: Another lawmaker calls for probe of FDA approval of Alzheimer’s drug; Roche urged to lower price of Covid-19 therapy (STAT)
- Digital health companies smash another funding record, raising $14.7B in first half of the year (MedCity News)
- Startup using VR for surgical training raises $27M (MedCity News)
- Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum (MedTech Dive)
- Engineering an Early Warning System for Implant Failure (MD+DI)
- CytoSorbents to Conduct Pivotal Trial for Removal of Ticagrelor in a Cardiopulmonary Bypass Circuit (MD+DI)
- Uro Medical Launches its Guardian Against Overactive Bladder (MD+DI)
- Duke University, HumanFirst partner to assess digital clinical measuring tools (Outsourcing Pharma)
- GE Healthcare, Sophia Genetics tag-team cancer care with patient-treatment matching tools (Fierce)
- Fed. Circ. Judge Unsure IP At Heart Of $1.1B Juno Win Is Valid (Law360)
- M.D. Tennessee Excludes IVC Post-Sale Evidence (Drug and Device Law)
- European CVC CRISPR Patent Revoked Because of Invalid Priority Claim (Patent Docs)
- The Prospects for an IP Waiver Under the TRIPS Agreement (Harvard Law Blog)
- Can a CRL Be Final Agency Action: One Step Closer to Finding Out (FDA Law Blog)
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