Recon: Philips in talks with FDA after ventilator findings; Washington state seeks billions from opioid distributors

• 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)