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Purdue Pharma can protect Sackler owners in opioid bankruptcy (Reuters)
FDA issues draft guidance for clinical research into psychedelics (Endpoints)
Jazz sues FDA, HHS over rival narcolepsy drug approval (Endpoints)
How the Shortage of a $15 Cancer Drug Is Upending Treatment (NYTimes)
The next big advance in cancer treatment could be a vaccine (AP)
A Pill Form of Ozempic Is on the Horizon (NYTimes)
STAT-Harris Poll: Nearly half of U.S. adults would spend $100 a month for Ozempic, other weight-loss drugs (STAT)
In Focus: International
Novo Nordisk says obesity pill leads to 15% weight loss; availability 'to be determined' (Reuters)
Zealand, Boehringer tout higher weight-loss drug efficacy in update (Reuters)
Galderma raises $1 bln through private placement before IPO (Reuters)
iNova to buy Mundipharma's consumer healthcare brands for $540 mln (Reuters)
EU poised to reject Amylyx’s ALS drug, as the company vows an appeal (STAT)
COVID-19 vaccine scheme for poorest has $2.6bn left to spend as pandemic recedes (Reuters)
Indonesia police probe drug regulators over cough syrup (Reuters)
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage (GOV.UK)
Pharma & Biotech
Biotech begins human trials of drug designed by artificial intelligence (FT)
After steering Lundbeck through buyouts, layoffs and big approval, Deborah Dunsire will step down (Endpoints)
WHO outlines 40 research priorities on antimicrobial resistance (WHO)
5 FDA decisions to watch in the third quarter (BioPharmaDive)
In approving Sarepta's DMD gene therapy, FDA's Peter Marks overruled reviewers' rejection (Fierce)
Looking to expand Pyrukynd label, Agios treks toward PhIII in sickle cell disease (Endpoints)
Shareholders elect director’s romantic partner to Biogen’s board (STAT)
Lonza, Vertex to build a new cell therapy manufacturing facility for the biotech’s type 1 diabetes therapies (Endpoints)
Erytech’s merger with Pherecydes reaches the finish line after contentious few months (Fierce)
Shionogi takes antibiotic maker under its wing in $100M cash buyout (Endpoints)
Avalo fails asthma PhII with lead candidate, shares crater (Endpoints)
Invivyd, FDA agree on steps to emergency approval for COVID monoclonal antibody (Fierce)
FibroGen reports third PhIII failure in two months, this time in idiopathic pulmonary fibrosis (Endpoints)
The secret to designing protein drugs with AI? Generate believes it's cryo-EM at unprecedented scale (Endpoints)
MoonLake's PhII data on skin disease set it up against Cosentyx, UCB and others in IL-17 field (Endpoints)
Medtech
ADA: Abbott pushes for widespread CGM use in Type 2 diabetes with WeightWatchers, ADA collabs (Fierce)
Medtronic links 780G insulin pump to benefits in kids as it works to grow sales (MedtechDive) (Fierce)
ADA: Gelesis study data position stomach-filling capsule as alternative to GLP-1s for weight loss (Fierce)
Conformis stock soars on buyout deal from fellow implant maker restor3d (Fierce)
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage (FDA)
Rare FDA Move Shows Stance On Remote Monitoring Devices (Law360)
Government, Regulatory & Legal
Biden directs HHS to boost contraception access, a year after Dobbs decision (STAT)
McKinsey Nears Opioid MDL Deal With Tribes, Insurance Plans (Law360)
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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.