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  4. Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

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Recon
31 July 2020
by Michael Mezher

Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US to pay $2.1B to Sanofi, GSK, in COVID-19 vaccine deal (Reuters) (Politico) (NYTimes) (Press)
  • Trump planning for US rollout of coronavirus vaccine falling short, officials warn (Reuters)
  • Large US COVID-19 vaccine trials will exclude pregnant women for now (Reuters)
  • Merck plans large trials of antiviral COVID-19 drug in September (Reuters)
  • China-backed hackers 'targeted COVID-19 vaccine firm Moderna' (Reuters)
  • Moderna board member resigns to avoid conflict of interest during vaccine trial (CNBC) (STAT)
  • NIH investing $248.7 million in seven companies to scale up COVID-19 testing (Reuters)
  • Ginkgo, Mammoth among winners of NIH’s ‘Shark Tank’ for Covid-19 tests (STAT)
  • Gilead Raises 2020 Profit Outlook on Remdesivir Demand (WSJ) (CNBC)
  • AbbVie's Humira powers profit beat as COVID-19 weighs on Botox sales (Reuters) (Press)
In Focus: International
  • Impact of coronavirus will be felt for decades to come, WHO says (Reuters)
  • Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan (Reuters) (Press)
  • Gilead hopes to meet global remdesivir demand by October (FT)
  • Seasonal flu reports hit record lows amid global social distancing (NBC)
  • Takeda Announces FY2020 Q1 Results (Press)
  • Global regulatory workshop on COVID-19 real-world evidence and observational studies (EMA)
  • Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials (EMA)
Coronavirus Pandemic
  • AstraZeneca signals it won't wait for US data to seek clearance of coronavirus vaccine (BioPharmaDive)
  • CytoDyn CEO claims Covid-19 drug success while describing data suggesting study failure (STAT)
  • House Democrats find Trump officials overpaid for ventilators by as much as $500 million (The Hill)
  • COVID-19 Hospital Data System That Bypasses CDC Plagued By Delays, Inaccuracies (NPR)
  • Trump testing czar says 56 percent of COVID-19 results coming back within three days (The Hill)
  • Trump urges recovered COVID-19 patients to donate plasma (The Hill)
  • Early coronavirus drug trials tested vaccines mostly on White people; next phase aims for diversity (CNBC)
  • Children May Carry Coronavirus at High Levels, Study Finds (NYTimes)
  • Aboard the Diamond Princess, a Case Study in Aerosol Transmission (NYTimes)
  • Coronavirus (COVID-19) Update: Daily Roundup July 30, 2020 (FDA)
  • Brazil Issues Guidance For Clinical Trials Conducted During Pandemic (Pink Sheet)
Pharma & Biotech
  • Trump’s ‘radical’, ‘horrible’ executive orders on drug pricing earn a C-suite backlash this week — with one threat to do more overseas (Endpoints)
  • Roche's Tecentriq triplet nabs melanoma OK, but BMS' Opdivo-Yervoy still reigns supreme (Fierce) (Endpoints)
  • BioNTech and Regeneron launch new melanoma collab; Harbour BioMed finds incubation partner (Endpoints)
  • AlloVir rides IPO boom on first market day, soars after bagging $276 million (Endpoints)
  • Tetraphase deal done, La Jolla Pharmaceutical taps Larry Edwards as CEO; Longtime Eli Lilly exec Michael Overdorf heads to Annexon as CBO (Endpoints)
  • FDA expands Stelara indication to cover paediatric plaque psoriasis (Pharmafile)
  • NICE backs Bavencio combo for kidney cancer (PharmaTimes)
  • EU regulators approve Novartis' breast cancer combo (PharmaTimes)
  • EU Pilot Facilitates Multilingual Packaging To Improve Medicines Availability (Pink Sheet)
Medtech
  • Eargo raises $71M for its 'invisible,' direct-to-consumer hearing aid (Fierce)
  • Teleflex reports rapid rebound in UroLift sales, driving Q2 beat (MedtechDive)
  • Hologic blows away earnings expectations on COVID-19 testing surge (MedtechDive)
  • Baxter takes $180M revenue hit in thick of COVID-19 (MedtechDive)
  • Medtechs’ View Of UK Brexit Deal: More Certainty, But Still No Detail (MedtechInsight)
Government & Regulatory
  • Sanofi And GSK Face DOJ Probes Over Zantac Cancer Risk (Law360)
  • Biogen Can't Block Mylan MS Drug Launch During IP Appeal (Law360) (Endpoints)
  • Juul Seeks FDA Approval To Market E-Cigarettes (Law360)
  • Humira Buyers Take AbbVie Antitrust Challenge To 7th Circ. (Law360)
  • Justices Told Horizon's IP Loss 'Casts A Pall' On 32K Patents (Law360)
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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