Recon: Biotech's 'coolers of cash;' Slipping pharma halo?

ReconRecon | 07 July 2021 |  By 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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