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June 16, 2020
by Michael Mezher

Recon: UK study finds dexamethasone could improve COVID-19 survival; Supreme Court declines to hear generic price fixing challenge

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US narrows list of promising COVID-19 vaccine candidates to about seven (Reuters)
  • Supreme Court deals a series of blows to generic drug companies (STAT) (Reuters) (Law360)
  • Supreme Court Passes on Eli Lilly Patent Infringement Win (Bloomberg)
  • Trump critical of FDA decision to revoke emergency use of drug he has promoted for COVID-19 (Reuters)
  • A YouTube ‘hit job’ about a Catalyst Pharma rival is posted amid its battle with the FDA (STAT)
  • Proteus files for bankruptcy, reveals it has held acquisition talks with Otsuka (STAT) (CNBC)
  • Trump admin pledges Covid-19 vaccines will be free for ‘vulnerable’ Americans (STAT) (CNBC)
  • Royalty Pharma IPO Expanded to Raise Almost $2.2 Billion (Bloomberg) (Financial Times)
  • German vaccine developer CureVac plans US listing: report (Reuters)
  • Jazz Pharma’s $1B bet pays off with accelerated lung cancer approval (Endpoints) (FDA)
  • Eli Lilly Says FDA Approves its New Rapid-Acting Insulin Lyumjev (Reuters) (Press)
In Focus: International
  • First drug proves able to improve survival from COVID-19 (AP) (STAT) (Politico) (NYTimes) (Reuters)
  • Coronavirus Vaccine Makers Are Hunting for Vital Equipment: Glass Vials (WSJ)
  • Spain is likely to join European deal to buy COVID-19 vaccine from AstraZeneca (Reuters)
  • UK funds human trials of potential COVID-19 vaccine from Imperial (Reuters)
  • France gives its drugs industry a shot in the arm to tackle pandemic (Reuters)
  • Sanofi to invest 610 millions euros at two French vaccines sites (Reuters)
  • Sinopharm touts 100% antibody response for COVID-19 vaccine, already giving to workers (Fierce)
  • NICE backs Rozlytrek for subset of NSCLC patients (PharmaTimes)
  • Japan Stiffens Foreign Investment Rules for Certain Drug, Medical Device Manufacturers (PharmaJapan)
  • Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (EMA)
Coronavirus Pandemic
  • AstraZeneca CEO Soriot says fast-tracked COVID-19 shot will protect for just one year (Fierce)
  • China's new virus outbreak needs further testing after 'hypothesis' on cause: WHO (Reuters)
  • Coronavirus Breaches Chinese Capital, Rattling Officials (NYTimes)
  • EU member states agree specs for coronavirus app interoperability (Reuters)
  • All of Us Research Program launches COVID-19 research initiatives (NIH)
  • Shares of Martin Shkreli’s Former Company Surge on Limited Coronavirus-Drug Study (WSJ)
  • A tech investor’s rude awakening on clinical trials sparks an effort to make them faster for Covid-19 (STAT)
  • Coronavirus (COVID-19) Update: Daily Roundup June 15, 2020 (FDA)
Pharma & Biotech
  • Upcoming market catalysts in Q3 2020 (Nature)
  • Gilead sees better days ahead for CAR-T therapy Yescarta with Amsterdam manufacturing hub online (Fierce)
  • Magenta's technology attracts another gene therapy developer (BioPharmaDive)
  • Takeda spins out a pipeline of ‘interesting but still difficult’ psych drugs in $2B deal as it wraps up a post-merger R&D shakeout (Endpoints)
  • Adding billions in value, Eli Lilly succeeds where Pfizer failed, halting breast cancer recurrence (Endpoints)
  • A failure at Eli Lilly, the comeback drug teplizumab shows off more upbeat diabetes data in the run-up to an FDA filing (Endpoints)
  • Billions on the table, GSK’s Hal Barron antes $120M cash to partner with a specialist in synthetic lethality (Endpoints)
  • Eyeing a hot IPO market, 4DMT tops up its cash reserves and preps a leap into the clinic with bespoke gene therapy vectors (Endpoints)
  • Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA (Pink Sheet)
  • US FDA Sees Slow But Steady Progress In Adoption Of Continuous Manufacturing (Pink Sheet)
  • MHLW to Propose Two-Third Sampling Rate for Wholesaler Survey for Off-Year Drug Re-Pricing; Go/No-Go Debate to Continue (PharmaJapan)
  • 4 Life Sciences Companies Launch IPOs Totaling $588M (Law360)
Medtech
  • FDA Doubles Test Review Staff, Is Prioritizing EUA Reviews For Home-Use And High-Batch Tests (MedtechInsight)
  • Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias (MedtechDive)
  • Myriad prostate cancer test wins coverage from Aetna (MedtechDive)
Government & Regulatory
  • It's not just Charles Lieber: NIH's ongoing investigation has swept up 54 scientists who violated rules about foreign ties (Endpoints)
  • Proposed delayed commencement of certain medical device regulatory changes (TGA)
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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