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