Recon: Pfizer, BioNTech combination COVID-Flu combo vaccine enters Phase 1 trial; Leaked UK-India trade deal raises concerns over drug access
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer, BioNTech start COVID-flu combination vaccine study (Reuters)
- FDA is temporarily exercising enforcement discretion with respect to certain Clozapine REMS program requirements (FDA) (MedPage Today)
- The eagles have landed: GSL halts successful UTI trials early, preps FDA submission (Fierce)
- Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says (Pink Sheet)
- FDA warning letters detail issues for manufacturing sites in the US and India (Endpoints)
- For months Biden has touted his win over pharma in the election lead-up. Will it help? (Endpoints)
- New JAMA study digs into the rise of stacking FDA’s expedited programs and designations for new drugs (Endpoints)
- Updated: Eli Lilly blames Biden's IRA for cancer drug discontinuation as the new pharma playbook takes shape (Endpoints)
- New U.S. cancer drug prices rise 53% in five years -report (Reuters)
- European Expedited Programs & Harnessing HTA (Pink Sheet)
- A leaked version of a U.K.-India free trade deal sparks alarm over access to medicines (STAT)
- Swiss drugs regulator looking into bubbles in COVID booster vials (Reuters)
- UK Blood Cancer Patient Group Wants More Price Flexibility (Pink Sheet)
- New Pack Coding Requirements Imminent In Australia (Pink Sheet)
- Uganda says Ebola outbreak death toll rises to 48 (Reuters)
- ‘Concerning’ Malaria Surge After Asian Mosquito Invades African City (MedPage Today)
- Africa CDC hoping to send team back to Ethiopia's Tigray region after peace deal (Reuters)
- GSK touts record Shingrix sales as Zantac cases go to trial (Endpoints)
- Cost watchdog ICER backs multimillion-dollar price tags for BioMarin, CSL hemophilia gene therapies (Fierce)
- Novo Nordisk drops two programs as it plots Wegovy comeback (Endpoints)
- Eli Lilly plans to make tirzepatide next big thing as pharma experiences 'unprecedented' demand for the drug (Endpoints) (Fierce)
- Moderna slashes billions from its sales forecast after a quarter of ‘pain points’ (Fierce)
- Gilead, Arcus slim phase 3 TIGIT trial to take on king Keytruda (Fierce)
- Avanair, Strides are laying off US employees as Sanofi eyes early retirements in Korea: report (Fierce)
- CSL stacks up $4.5B in chips — with a $200M ante — to wager on the next-gen mRNA wave (Endpoints)
- Regeneron Pulls the Plug on Osteoarthritis and Cat Allergy Therapies (Biospace)
- J.P. Morgan’s new life sciences private equity arm will be hottest ticket at firm’s upcoming conference (Fierce)
- More biotechs hit the wall as Rubius lays off 82% of staff and Tricida seeks a sale (Fierce)
- Exscientia wants to bring its AI/ML approach into the world of biologics. It's starting with antibodies (Endpoints)
- What causes hot flashes? Astellas ramps up educational campaign ahead of FDA decision (Endpoints)
- After pulling IPO plans, Artiva partners with Affimed to speed up NK cell therapy combo (Endpoints)
- 'Considerable' monkeypox transmission happens before symptoms, study suggests (Reuters)
- Pulse Oximeters Need to Work Better for Dark Skinned Patients, FDA Panel Says (MedPage Today) (NYT) (MedTech Dive) (Reuters)
- Covid Test Makers Must Alter Labels for Repeat Testing, FDA Says (Bloomberg)
- First EU Guidance On Authorized Representative Role And Responsibilities (MedTech Insight)
- BSI Receives Expert Panel Opinion For Non-Novel Device (MedTech Insight)
- OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price (MedTech Dive)
- Still awaiting US approval, Medtronic’s auto-adjusting insulin pump lands Canadian nod (Fierce)
- Teva to pay up to $4.2 billion in U.S. to settle opioid claims (Reuters)
- Lilly, Teva Clash on Time Left in Trial on Rival Migraine Drug (Bloomberg)
- Moderna Must Face Patent Claims Over US Government Vaccine Sales (Bloomberg)
- Moderna Loses AstraZeneca’s Support in IL-2 Program, must Defend Arbutus Suit (Biospace)
- Walgreens And CVS Agree To Opioid Settlements, But States Waiting To See Details (Pink Sheet)
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