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May 2, 2023
by Michael Mezher

Recon: Pfizer tops expectations on strong demand for COVID products; FDA halts Sun Pharma’s dermatological drug trials

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer leans on COVID products to top estimates (Reuters)
  • Patients Lose Access to Free Medicines Amid Spat Between Drugmakers, Health Plans (WSJ)
  • Largest International Operation Against Darknet Trafficking of Fentanyl and Opioids Results in Record Arrests and Seizures (DoJ)
  • J&J, building on CAR-T success, strikes another cell therapy deal (BioPharmaDive)
  • Gilead, US square off in billion-dollar HIV drug patent trial (Reuters)
  • US FDA halts India's Sun Pharma trials on dermatological drug (Reuters) (Fierce)
  • AmerisourceBergen raises profit forecast on demand for pricier specialty drugs (Reuters)
  • US judge declares mistrial in Apple-Masimo smartwatch trade secrets fight (Reuters) (STAT)
  • Bipartisan bill seeks to curb drug shortages with more info to FDA on spikes in demand (Endpoints)
In Focus: International
  • EU states push for law to limit dependency on drug ingredients from China (FT)
  • EU Plans To Trial Antimicrobial Voucher Scheme For 15 Years (Pink Sheet)
  • WHO says risk 'moderate' after laboratory in Sudan seized by fighters (Reuters)
  • Italian hearing aid maker Amplifon expects higher 2023 earnings (Reuters)
Pharma & Biotech
  • Ovid partners with Waksal startup to develop drugs for rare brain disorders (BioPharmaDive)
  • Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars (Pink Sheet)
  • Pfizer culls some Arena-acquired programs as it looks toward new launches (Endpoints)
  • Biogen prices new ALS drug at more than $14K per dose (Endpoints)
  • ‘Leaps of Faith:’ ICER Meeting Suggests Reimbursement Hurdles For NASH Drugs (Pink Sheet)
  • Incyte misses quarterly estimates on weak sales of key drugs (Reuters)
  • Immatics spikes on a round of promising — but still early — autologous cell therapy data for solid tumors (Endpoints)
  • Travere misses primary endpoint in PhIII for rare kidney disease but the company is still considering a 'path forward' (Endpoints)
  • What to know about the upcoming readout of Eli Lilly’s experimental Alzheimer’s therapy (STAT)
  • Thermo Fisher to make another round of layoffs in San Diego (Endpoints)
  • More than two dozen attorneys general push Medicare to cover new Alzheimer's treatments (Endpoints)
  • Bristol Myers' CAR-T Breyanzi hits endpoints in two lymphoma studies (Endpoints)
Medtech
  • Stryker lifts profit forecast on robust demand for devices (Reuters)
  • Zimmer Biomet raises annual forecasts on knees and hips unit strength (Reuters) (MedtechDive)
  • Zimmer Biomet picks up 3D-printed orthopedic implant maker Ossis (Fierce)
  • Hologic, after overcoming chip shortage, starts considering larger M&A deals (MedtechDive)
  • English, Canadian and US HTA Bodies Team Up On Unpublished Clinical Data Transparency Drive (MedtechInsight)
  • Finetuning The Art Of Leveraging Past Notified Body Assessments Of Technical Documentation (MedtechInsight)
  • Therapy Chatbots And Medtech Laws: Why AI App Developers Must Tread Carefully (MedtechInsight)
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.
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