Breast Cancer Drug Trial Results in ‘Unheard-Of’ Survival (NYTimes)
Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel (Reuters) (STAT)
Sanofi's Dupixent gets U.S. approval to treat eczema in young children (Reuters)
Eli Lilly’s new diabetes drug continues to show promise as an obesity treatment (CNBC)
White House to cut funding for Covid testing to purchase vaccines for fall (NBC)
Opinion: Prices for New Drugs Are Rising 20 Percent a Year. Congress Needs to Act. (NYTimes)
Two new versions of Omicron are gaining ground in the U.S., according to C.D.C. estimates. (NYTimes)
In Focus: International
EMA adopts first list of critical medicines for COVID-19 (EMA) (List)
One More EU MDR Notified Body In The Pipeline And Then A Gap (MedtechInsight)
More than 1,000 monkeypox cases reported to WHO – briefing (Reuters)
Innovation Passport awarded Alnylam and its hypertension therapy (PharmaTimes)
Novavax says COVID vaccine for U.S. to be manufactured by India's Serum (Reuters)
Takeda teams with GSK, other drugmakers to track supplier emissions (Nikkei)
Pharma & Biotech
DBV patches up prospects with phase 3 win in infants with peanut allergies (Fierce)
Opinion: FDA user fee legislation needs to mitigate the pharmaceutical industry’s carbon pollution (STAT)
After late-study endpoint switch, Aldeyra hails success of phase 3 dry eye disease trial (Fierce)
Astellas joins Pfizer in emerging North Carolina hub, unveiling new $100M gene therapy manufacturing site (Endpoints)
With eyes on first allogeneic CAR-T approval, Precision touts 100% response in 'small niche' population (Endpoints)
For Rigel, a surprising placebo response spurs a PhIII fail, stock beating. But it's been here before (Endpoints)
India Proposes OTC List But Clarity On Pricing, Switching Pathway Awaited (Pink Sheet)
RA Capital backs a Philly biotech's $118M crossover as it aims to break into the hypertension space (Endpoints)
New survey suggests many Black cancer patients aren't made aware of clinical trials (Endpoints)
EQT's investment arm and Mubadala ink $3B deal for medical freight and storage company (Endpoints)
German startup jumps into the hot radiopharma space with a former Ipsen compound as lead program (Endpoints)
Medtech
FDA mulls pilot program on alternative sterilization for medical devices (MedtechDive) (MedtechInsight)
As monkeypox cases rise, BD pairs up with Spain-based CerTest for diagnostic (Fierce)
FDA slaps Class I label on Medtronic latest heart pump recall (Fierce)
GE Healthcare’s recall of ventilator batteries gets Class I label from FDA over device shutdown risk (MedtechDive)
Expected Spread Of US OTC Diagnostics Could Change Consumers’ Health Care Behaviors (MedtechInsight)
Government, Regulatory & Legal
FTC opens investigation into largest PBMs' anticompetitive practices (Endpoints) (STAT)
Bristol Myers settles anti-generic HIV drug scheme allegations for almost $11M (Endpoints)
Georgia senator urges majority leader Chuck Schumer to follow through on insulin cap legislation (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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.