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May 5, 2020
by Michael Mezher

Recon: Alexion to buy Portola for $1.4B; Pfizer, BioNTech begin clinical trial for coronavirus vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Alexion bets on Portola's bleeding antidote with $1.41 billion deal (Reuters) (Endpoints)
  • Pfizer Begins Human Trials of Possible Coronavirus Vaccine (NYTimes) (Reuters)
  • Antibiotic pipeline in peril from coronavirus and incentives system (Axios)
  • Lawmakers question Jaguar Health on price hike of drug that may help treat COVID-19 patients (Reuters)
  • Akebia’s experimental pill meets anemia, heart-safety goals in 2 late-stage trials (STAT) (Endpoints)
  • Models Project Sharp Rise in Deaths as States Reopen (NYTimes) (Politico) (Reuters)
  • Pharma startups forced to sit on their hands as clinical trials halt (Axios)
  • Amgen Wins Ruling on Patents for Kyprolis Cancer Drug (Bloomberg)
  • Teva And Celltrion Healthcare Announce Launch Of TRUXIMA Injection (Reuters) (Big Molecule Watch)
In Focus: International
  • World leaders pledge €7.4bn to research Covid-19 vaccine (The Guardian)
  • Heartburn Pill in Short Supply After Word of Covid-19 Trial (Bloomberg)
  • Exclusive: Bangladesh's Beximco to begin producing COVID-19 drug remdesivir – COO (Reuters)
  • WHO says it will engage US to make remdesivir coronavirus treatment more widely available (CNBC)
  • WHO cautions against untested COVID-19 traditional remedies (Reuters)
  • This Drug May Cause Birth Defects. Japan’s Pushing It for Coronavirus. (NYTimes)
  • Japan sending Fujifilm’s flu drug favipiravir to over 40 countries for Covid-19 trials (CNBC)
  • Coronavirus lessons for the fight against ‘superbugs’ (Financial Times)
  • Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19 (TGA)
Coronavirus Pandemic
  • U.S. starts study to find COVID-19 infection rate in children (Reuters)
  • Neutralizing antibody; new virus details to aid vaccine research (Reuters) (Reuters)
  • A Coronavirus Vaccine Project Takes a Page From Gene Therapy (NYTimes)
  • How a 96-hour project helped Trump's team reverse its testing debacle (Politico)
  • Coronavirus testing numbers are ticking up (Politico)
  • Most COVID-19 patients get antibodies but immunity unclear: UK official (Reuters)
  • Call to overhaul plasma rules to speed up potential virus therapy (Financial Times)
  • HHS Waits for FDA OK as It Buys 10 Million ‘Reusable’ N95s (Bloomberg)
  • With Crispr, a Possible Quick Test for the Coronavirus (NYTimes) (STAT)
  • Were researchers wrong to move the goalposts on remdesivir? In the end, it may not have mattered (STAT)
  • With new estimate, ICER sets terms of debate on pricing Gilead's COVID-19 drug (BioPharmaDive)
  • 7 states team up to buy $5B in medical equipment, supplies for COVID-19 (MedtechDive)
  • New Zealand records no new coronavirus cases for a second day (Reuters)
  • UK overtakes Italy with Europe's highest official coronavirus death toll (Reuters)
  • Italy's coronavirus death toll far higher than reported: stats office (Reuters)
  • UK to recommend sweeping changes to workplaces after lockdown: report (Reuters)
  • Hydroxychloroquine Update, May 4 (In The Pipeline)
  • Coronavirus (COVID-19) Update: Daily Roundup May 4, 2020 (FDA)
Pharma & Biotech
  • Orphan drugs improve health — but aren’t priced cost-effectively, study finds (STAT)
  • BioMarin pens gene therapy pact with little-known Swiss biotech (Fierce)
  • How biopharma companies can keep ‘feeding the beast’ in the time of coronavirus (STAT)
  • CytoDyn CEO made $12M from his stock sale, and his explanation raises more questions (STAT)
  • Dealmaking spiked to record levels in April as Covid-19 triggered a fever of partnering. But what happens to collaborations in a new world seen through Zoom? (Endpoints)
  • Billions for biotech: Oberland boosts biotech fund-raising past the $5B mark in a matter of weeks (Endpoints)
  • Battling low expectations and goliath rivals, Regeneron/Sanofi add positive Libtayo data in pursuit of blockbuster status (Endpoints)
  • Praxis Precision Medicines launches with $100M and bold sights on long-evasive neurological disorders (Endpoints)
  • Two years after U2 disappointment, TG Therapeutics wins back investors with PFS win — setting the stage for NDA (Endpoints)
  • Adverum soars on early gene therapy data; BerGenBio raises €45.4M on the heels of Covid-19 move (Endpoints)
  • A UCSD center that's been facilitating Covid-19 clinical research gets $55M from NIH to boost translational work (Endpoints)
Medtech
  • Oncology systems maker Varian ekes out sales gain amid procedure delays (MedtechDive)
  • Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients (MedtechDive)
Government & Regulatory
  • US Supreme Court hears case on overseas anti-AIDS funding restrictions (Reuters)
  • J&J settles with West Virginia over allegations on mesh, hips (MedtechDive)
  • Good Pharmacovigilance Practice Symposium 2020 (MHRA)
  • Coronavirus: new website for reporting medicines side-effects and equipment incidents (MHRA)
  • Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak (MHRA)
  • 3M Wins Its First NY Injunction Over COVID-19 Price-Gouging (Law360)
  • Gov't Tells Justices Retroactive IPRs Aren't Theft (Law360)
  • USPTO Unveils Virus Patent Platform, EPO Extends Deadlines (Law360)
  • Pricing in the Time of Price Gouging: Trying to Find a Safe Harbor (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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