rf-fullcolor.png

 

July 24, 2020
by Michael Mezher

Recon: EU looks to pay less than $40 per COVID-19 vaccine; Taro to pay upwards of $200M to settle price-fixing suit

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump will sign executive orders on lowering drug prices on Friday: White House (Reuters)
  • Trump drops plan to eliminate government drug rebates (Politico)
  • US Clears Way for Drugmakers to Share COVID Antibody Capacity (Reuters)
  • Taro Pharmaceuticals to pay more than $200 million to settle US price-fixing probe (Reuters) (DOJ)
  • AstraZeneca's lung disease treatment gets FDA nod (Reuters) (Endpoints)
  • Ruling threatens to upend patents on Moderna’s Covid-19 vaccine (STAT) (Endpoints)
  • Another four biotechs make Wall Street debut, raising $772M+ as IPO tidal wave crests (Endpoints)
  • NIH to start ‘flurry’ of large studies of potential Covid-19 treatments (STAT)
  • Trump’s end run around CDC brings threat of fewer drugs for hospitals (Politico)
  • Senate GOP punts coronavirus package to next week (The Hill)
In Focus: International
  • Rich country vaccine rush threatens supply security (Financial Times)
  • EU eyes COVID-19 vaccines at less than $40, shuns WHO-led alliance – sources (Reuters)
  • Don't expect first COVID-19 vaccinations until early 2021: WHO's Ryan (Reuters)
  • WHO scientist sees regulators cooperating to speed COVID-19 vaccine approval (Reuters)
  • EU prolongs duty-free import of face masks, medical gear (Reuters)
  • Roche says military planes load up COVID-19 test gear as demand soars (Reuters)
  • Roche cites COVID-19 and biosimilars in Q2 decline (PMLive)
  • China Says It Will Have Covid-19 Vaccine Ready This Year (WSJ)
  • Lonza sees no delays for COVID-19 vaccine project, citing Trump backing (Reuters)
  • India sees record 49,000 new coronavirus cases, drug shortages in places (Reuters)
Coronavirus Pandemic
  • A Guide to Coronavirus Vaccines in the Works (WSJ)
  • New study finds hydroxychloroquine ineffective at treating COVID-19 (The Hill) (NEJM)
  • Trump admin's $21M gambit for Pepcid as a COVID remedy fizzles (AP)
  • Chinese COVID-19 vaccine candidate shows promise in animal tests (Reuters)
  • Cipla gets India approval to sell COVID-19 drug favipiravir (Reuters)
  • On eve of first big coronavirus vaccine study, trial leaders brace for 'unprecedented' task (BioPharmaDive)
  • UK's home testing dogged by delays, undermining push to reduce virus transmission (Reuters)
  • Novavax, Fujifilm lock up supply for late-stage COVID-19 vaccine trial (Fierce)
  • RedHill Biopharma advances phase 2/3 COVID-19 programme (PMLive)
  • Coronavirus (COVID-19) Update: Daily Roundup July 23, 2020 (FDA)
Pharma & Biotech
  • Pharma deal values plummet 56% as COVID-19 disrupts resources: report (Fierce)
  • Clinical trials rebound after COVID-19 crash, but can enrollment gains continue? (Science)
  • EQRx, gearing up for a price war with big pharma, buys two cancer drugs (BioPharmaDive)
  • BioMarin submits EU marketing application for vosoritide (PharmaTimes)
  • Thermo Fisher rakes in $1.3B in coronavirus-related revenue (BioPharmaDive)
  • EMA Takes A Dive Into Patient-Level Data (Pink Sheet)
  • UK Pharma Exports To Fall 22% In No-Deal Brexit (Pink Sheet)
  • Eli Lilly asks for a $24 million tax break for diabetes care facility expansion in Indianapolis (Pharmafile)
  • As China Volume Purchase Builds, Novartis Scrambles To Launch New Products (Scrip)
  • Turning cancer into a curable disease: Immunotherapy expert John Connolly picks up the reins as the new CSO of Sean Parker’s cancer institute (Endpoints)
  • UCB touts another psoriasis win, this time over Cosentyx, as they look to break into packed market (Endpoints)
  • Jeff Capello out the door as Michael McDonnell takes over Biogen's CFO post; Ron Bruehlman named interim CFO at IQVIA (Endpoints)
  • Christoph Westphal bags a $170M Fund V, slated to help breed some new biotechs at Longwood (Endpoints)
Medtech
  • Abbott receives FDA approval for neurostimulator-controlling iPhone app, for personalizing therapies for pain, Parkinson's disease (Fierce)
  • Edwards Lifesciences Q2 results are better than expected (MassDevice)
  • AngioDynamics lands 510(k) for ‘smart’ implantable port (MassDevice)
  • A test you can breathe in: Scientists are developing synthetic biosensors to monitor lung disease (STAT)
  • COVID-19 diagnostics emerging as prime investment target, SVB analysis shows (MedtechDive)
  • Quest says small labs ripe for acquisition as coronavirus pandemic sets stage for industry consolidation (CNBC)
  • Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus (FDA)
Government & Regulatory
  • FDA Sends New CBD Guidance To White House Budget Office (Law360)
  • Juul Quietly Revamped Its E-Cigarette, Risking the FDA’s Rebuke (Bloomberg)
  • Wire-Wearing Novartis Whistle-Blower Gets $109 Million Award (Bloomberg Law)
  • FBI crackdown on China’s R&D espionage intensifies with new arrests and one fugitive in San Francisco (Endpoints)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.