Recon: Philips in talks with FDA after ventilator findings; Washington state seeks billions from opioid distributors
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Dems’ plan to limit drug price inflation faces test in Senate (Politico)
- Landmark opioid trial of 3 major pharmacy chains nears its end (Reuters)
- McKesson, drug distributors face $95 billion opioid trial in Washington state (Reuters) (AP)
- Philips in talks with FDA after new ventilator findings – statement (Reuters)
- FDA Approves Treatment for Rare Blood Disease (FDA)
- Johnson & Johnson to Split Consumer From Pharmaceutical, Medical-Device Businesses, Creating Two Companies (WSJ) (MedtechDive) (NYTimes)
- Regeneron’s COVID-19 antibody cocktail approved in Europe (PMLive)
- India's Dr. Reddy's open to making Pfizer COVID pill after Merck deal (Reuters)
- AstraZeneca to take profits from Covid vaccine sales (FT) (NYTimes)
- First-in-class medicine recommended for treatment of rare blood vessel inflammation (EMA)
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 (EMA)
- 8 lingering questions about the new Covid pills from Merck and Pfizer (STAT)
- Appeals Court Extends Block on Biden’s Vaccine Mandate for Employers (NYTimes)
- States rush ahead of feds on boosters (The Hill)
- UK firm to trial T-cell Covid vaccine that could give longer immunity (The Guardian)
- Why Don’t We Have a Covid Vaccine for Pets? (NYTimes)
- After triggering a global valsartan recall 3 years ago, Chinese drug manufacturer overcomes FDA warning letter (Fierce)
- How The US FDA’s Inspectional Approach Is Shifting For The Post-Pandemic Era (Pink Sheet)
- When FDA rattles its sabre, drug makers and universities start reporting overdue trial results (STAT)
- CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System (Pink Sheet)
- Novartis touts more late-stage data for inclisiran, the once-centerpiece heart drug spurned by the FDA (Endpoints)
- Spurned by FDA on another immunotherapy, Agenus holds up early data for CTLA-4 drug across tumor types (Endpoints)
- NICE ‘no’ for BioMarin’s Vimizin (PharmaTimes)
- Eli Lilly and Boehringer Ingelheim set their sights on acute heart failure with new Jardiance data (Endpoints)
- ‘It’s a transformation’: Researchers are taking DeepMind’s groundbreaking protein folding software to places few predicted (Endpoints)
- Eyeing an accelerated BLA, PhaseBio says its monoclonal antibody reversed the dangerous effects of AstraZeneca's blood thinner (Endpoints)
- A couple months ahead of its PDUFA date, Bristol Myers rolls out long-term data for mavacamten (Endpoints)
- Bristol Myers and Janssen race toward PhIII with a next-gen blood thinner (Endpoints)
- J&J looks to toss its SGLT2 hat in the ring for two types of heart failure (Endpoints)
- Merck looks to ditch the needles with its next-gen oral PCSK9 inhibitor for high cholesterol (Endpoints)
- NICE recommends cenobamate for treatment of adult epilepsy patients in UK (PharmaTimes)
- Lundbeck cuts 300 jobs to fuel Vyepti growth as CGRP migraine competition heats up (Fierce)
- C2N's amyloid blood test for Alzheimer's risk matches up to PET scans in study (Fierce)
- BD's $2B annual M&A war chest, connected care devices at heart of growth plan (MedtechDive)
- FDA panel finds need for surveillance of devices from Endologix, Medtronic and others (MedtechDive)
- Olympus launches VC fund with $50M to back new surgical devices, diagnostics (Fierce)
- Abbott's retrievable, leadless pacemaker clears trial hurdle as FDA continues review (Fierce)
- FDA grants de novo clearance to ALung’s ‘respiratory dialysis’ machine (Fierce)
- U.S. FTC okays changes to Bristol Meyers Squibb divestiture agreement (Reuters)
- Merck Faces Design Claims Alleging Shingles Shot Caused Shingles (Bloomberg)
- Amgen Backs Juno's Fed. Circ. Bid To Revive $1.1B Judgment (Law360)
- As Ginkgo looks to clear its name, the feds have come sniffing around on the heels of short sell report (Endpoints)
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