rf-fullcolor.png

 

November 7, 2023
by Jason Scott

Recon: Senate confirms Monica Bertagnolli as NIH director; Sen. Sanders pushes for hearing with top pharma executives

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Bertagnolli confirmed as new head of National Institutes of Health (Washington Post) (The Hill)
  • Ozempic side effects 'well-known,' Novo Nordisk argues (Reuters)
  • Judge trims US lawsuit accusing Cencora of fueling opioid epidemic (Reuters)
  • HHS secretaries Becerra, Azar face off on lowering drug prices (STAT)
  • FDA Abortion Pill Actions See Fresh Challenge From Red States (Bloomberg Law)
  • US orders Puerto Rico drug distribution company to pay $12 million in opioid case (Associated Press)
  • Sen. Bernie Sanders moves toward another hearing with pharma CEOs (STAT)
  • Drug shortages and the supply chain are a matter of national security, experts say (STAT)
  • Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDA (STAT)
In Focus: International
  • UK’s ‘Pioneering’ Medicines Repurposing Program Delivers First License (Pink Sheet)
  • EFPIA: One Fifth Of Future Products ‘Unviable’ Under EU’s Plans To Modulate Regulatory Data Protection (Pink Sheet)
  • EMA Consults On Guidance On Vaccine Trials In Immunocompromised Individuals (Pink Sheet)
  • Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines (STAT)
  • The doping of Sanofi's financial communications in the PNF's sights (La Lettre)
  • Intellectual Property Negotiations Belong at WTO, European Countries Tell Pandemic Accord Negotiations (Health Policy Watch)
Pharma & Biotech
  • Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule (BioSpace)
  • Astellas shows enough data for eye treatment to support expanded use, but still lags competitor (STAT)
  • FDA cites cancer links in seeking to withdraw approval of antibiotic used in pigs (STAT)
  • Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug (STAT)
  • Your morning biotech news roundup (STAT)
  • Johnson & Johnson to submit application to start trials for surgical robot (Reuters)
  • Biogen-Sage Therapeutics postpartum depression pill priced at $15,900 (Reuters)
  • Novo Nordisk to present new data from weight-loss, diabetes trials (Reuters)
  • mRNA’s next trick? Reprogramming off-the-shelf cell therapies for cancer and autoimmune diseases (Endpoints)
  • Lilly backs OrsoBio's $60M Series A for PhII trials in obesity and NASH (Endpoints)
  • Novartis slots PhI cardiovascular candidate into pipeline, paying Korean partner $80M upfront (Endpoints)
  • WuXi XDC eyes $470.5M IPO to fuel manufacturing expansions at home and abroad (Fierce)
  • Imbria touts PhII success in hypertrophic cardiomyopathy, adding fuel to overall efficacy profile (Endpoints)
  • MarketingRx roundup: Sanofi, Regeneron renew Dupixent asthma effort; Bausch Health battles seasonal affective disorder (Endpoints
  • Gilead, Arcus’ PhII gastroesophageal cancer data argue for TIGIT antibody drug class potential (Endpoints)
 
Medtech
  • Remote patient monitoring helped manage hypertension better, but at a higher cost (STAT)
  • A fertility clinic failure destroyed my chance at motherhood (STAT)
  • The PATCH Act’s approach to securing medical devices actually gives malicious actors a blueprint (STAT)
  • Zimmer Biomet’s Ivan Tornos sets priorities for first year as CEO (MedTech Dive)
  • Diabetes tech firms focusing on Type 2 patients (MedTech Dive)
Government, Regulatory & Legal
  • California Low-Cost Insulin Faces Delays After Price-Cap Veto (Bloomberg Law)
  • FTC’s Lina Khan makes a stop at Y Combinator, how telehealth helps rural America (STAT)
  • Government looks to tinker with new caps on Medicare Advantage broker payments (STAT)
  • US FTC disputes listing for more than 100 patents in FDA Orange Book (Reuters)
  • US CDC to expand surveillance of traveler samples for respiratory viruses (Reuters)
  • Pfizer gathers Covid campaign 'icons' Martha Stewart, John Legend, Travis Kelce and more for latest booster push (Endpoints)
 
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
 

Related topics

×

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.