GSK’s revenue drops by 18% in Q1 as performance pressures mount (PMLive)
Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with a Revision of ICH Q9 Among the Focal Points (IPQ)
Pfizer weighs sale of Philly-area campus—where 2,000 once worked—as company mulls when and how to bring employees back (Fierce)
Sanofi is expanding at light speed abroad, but it's leaving behind a Pennsylvania plant and its 75 employees (Endpoints)
The biotech craze hits the Nordics, driving a record-high $62M Series A for a Copenhagen-based ADC player (Endpoints)
Galera claims positive update in pancreatic cancer but doesn't report p-values; Amgen launches Canadian fund in tandem with CCRM (Endpoints)
Forge Biologics bags $120M round as it looks to scale AAV manufacturing for Krabbe disease treatment (Endpoints)
Cara touts subgroup in failed atopic dermatitis trial, but stock craters (Endpoints)
Lonza adds on small molecule facility at Visp site, adding new weight to its expansion plans on the back of a big year (Endpoints)
A new gene therapy player debuts in LA with 2 startup VCs at its back, AbbVie on board with a $90M cash upfront and big plans to upend the field (Endpoints)
BeiGene's late stage trial shows promising numbers; Amgen to study sotorasib dosage after FDA recommendation (Endpoints)
How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products (FDA)
Medtech
EU Must Have Courage To Take The Sensible Decision On IVDR Deadline, Says German Industry (MedtechInsight)
EU MDR Guidances: Can Stakeholders Be Punished For Not Applying Them? (MedtechInsight)
Smith & Nephew returns to growth as US hip sales surge (MedtechDive)
CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices (MedtechDive)
LabCorp, still riding the COVID-19 testing wave, exceeds its own expectations with $4.2B Q1 revenue (Fierce)
FDA says it will ban menthol cigarettes and all flavored cigars within a year (Politico)
House Introduces Bill, BIOSIM Act, Designed To Lower Drug Costs (Big Molecule Watch)
Law Firms Representing Purdue Pharma Agree to Relinquish $1 Million in Settlement with U.S. Trustee Program (DOJ)
Justices' Restitution Order May Allow FTC-Surescripts Deal (Law360)
Opioid Ad Blitz Targeted Not Just Docs But Insurers: J&J Rep (Law360)
GSK Says Amgen Patent Decision Will 'Devastate' Innovation (Law360)
Dr. Reddy's Says Amarin Delaying Heart Drug Competition (Law360)
Pfizer Tells Court Allele Wrong On Hatch-Waxman Safe Harbor (Law360)
Pharma Cos. Can Expect Harsh Antitrust Scrutiny From Biden (Law360)
Long-Running MRI Patent Row Settles Days Before Ill. Trial (Law360)
Baylor, Gensetix Agree To Drop Cancer Patent Fight For Good (Law360)
J&J, Imerys Beat $117M Talc Verdicts Over Flawed Testimony (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.
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