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Regulatory Focus™ > News Articles > 2020 > 8 > Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

Posted 05 August 2020 | By Michael Mezher 

Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate (Reuters) (FT)
  • US government begins two trials testing Eli Lilly’s coronavirus antibody drug (CNBC)
  • Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma (WSJ) (Reuters)
  • Novavax’s Covid-19 vaccine shows promising immune response, early data show (STAT) (NYTimes)
  • Kodak Loan Disclosure and Stock Surge Under SEC Investigation (WSJ) (Business Insider)
  • Bausch Health to pay $45M to settle US charges over Valeant-era accounting (BioPharmaDive)
  • BARDA faces pressure to force Moderna to disclose cost details from its Covid-19 contract (STAT)
  • Moderna is pricing coronavirus vaccine at $32 to $37 per dose for some customers (CNBC)
  • Mallinckrodt May File for Bankruptcy, Undercutting Opioid Settlement (WSJ)
  • The FDA is finalizing its long-awaited rules for CBD (STAT)
In Focus: International
  • Moderna says discussing supply deals with countries for COVID-19 vaccine (Reuters)
  • COVID opens new doors for China's gene giant (Reuters)
  • Pfizer, BioNTech in deal with Canada to supply COVID vaccine hopeful (Reuters)
  • BioNTech, Fosun launch another COVID-19 vaccine trial (Reuters)
  • Switzerland nears deal to get Moderna COVID vaccine, official says (Reuters)
  • UK NICE Recommends Against Common Drugs For Chronic Primary Pain (Pink Sheet)
  • Astellas’ Q1 Sales Falter 8% on Deal Terminations, COVID-19 (PharmaJapan)
  • Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status (Big Molecule Watch)
Coronavirus Pandemic
  • As Trump Praises Plasma, Researchers Struggle to Finish Critical Studies (NYTimes)
  • The COVID Drug Wars That Pitted Doctor vs. Doctor (NYTimes)
  • Scientists Uncover Biological Signatures of the Worst Covid-19 Cases (NYTimes)
  • FDA’s Shifting Standards for Chinese Face Masks Fuel Confusion (WSJ)
  • Senate Democrats propose 'Force to Fight COVID-19' in next coronavirus relief package (NBC)
  • State attorneys general urge U.S. to let other firms make Gilead COVID-19 drug (Reuters) (STAT)
  • After 'Severe' Delays, 6 States Band Together To Buy Coronavirus Tests (NPR)
  • Scientists are testing pricey rare-disease drugs as Covid-19 treatments. What if one works? (STAT)
  • India's Lupin to sell generic COVID-19 drug favipiravir (Reuters)
  • Zydus Cadila's COVID-19 vaccine candidate found safe in early-stage human trial (Reuters)
  • UK agrees joint investment with Valneva to boost vaccine production (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020 (FDA)
Pharma & Biotech
  • FDA rejects a peanut allergy treatment, sinking a small biotech's shares (BioPharmaDive)
  • Flu shot makers plan to supply record numbers of vaccine doses amid Covid-19 pandemic (CNBC)
  • US FDA Picks Up The Pace Of Complete Response Letters Over June And July (Pink Sheet)
  • Merck enters agreement with Hanmi for investigational NASH drug (PMLive)
  • AbbVie exits Voyager alliance for Alzheimer’s/Parkinson’s gene therapies (PMLive)
  • RA, Novartis back GentiBio's seed round, plans to launch development of EngTreg therapies (Endpoints)
  • Novartis says CAR-T cancer therapy works in second lymphoma type (BioPharmaDive)
  • Stem cell player ViaCyte expands collaboration with Gore to develop subcutaneous diabetes treatment (Endpoints)
  • Less than 3 months after launch, the AveXis crew’s Taysha raises $95M Series B. Is an IPO next? (Endpoints)
  • Myovant lands a fresh $200M loan as FDA marketing decision looms; Amarin goes it alone in Europe (Endpoints)
  • CF Foundation, Longwood team on new incubator for companies with cutting-edge CF treatments (Endpoints)
  • Versant debuts Ridgeline's startup #4, armed with $30M and alternative TCR cell therapies for solid tumors (Endpoints)
  • Opioid Use Disorder: Treatment with Injectable and Implantable Buprenorphine (GAO)
  • Haven was supposed to reimagine health care. An exodus of talent has gutted it (STAT)
Medtech
  • Roche gets FDA okay for transplant patients Epstein-Barr virus test (Reuters)
  • Rapid diagnostic for gonorrhea wins $19 million federal prize competition to combat antibiotic resistance (NIH)
  • Apple and UCLA kick off a three-year depression study (CNBC)
  • Medtronic’s rechargeable neurostimulator implant nets FDA approval for bladder and bowel control (Fierce)
  • Earnings season highlights how health tech companies fared in the first full quarter of the pandemic (STAT)
Government & Regulatory
  • Klobuchar Asks GAO To Examine Prescription Drug Rebate Traps (Forbes)
  • CMS Cuts in Drug Payment to Hospitals for 340B Drugs – Post Script (FDA Law Blog)
  • Free COVID-19 Tests Are Not Kickbacks, HHS Watchdog Says (Law360)
  • How Biologics Cos. Disparage Biosimilars And How To Stop It (Law360)
  • States Defend FDA's Abortion Pill Restrictions At 4th Circ. (Law360)
  • VC Funding For Pharma Declines After Patent Rule Changes (Law360)
  • Bayer Says Essure Settlement Deal In The Works (Law360)
  • Mylan Fights To Invalidate Novartis Blood Transfusion IP (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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