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)
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.
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