Recon: FDA warns of risks linked to compounded ketamine; Pfizer slated to settle EpiPen antitrust litigation for $50 million
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders (FDA)
- Operation Warp Speed: The Untold Story of the COVID-19 Vaccine (Vanity Fair)
- FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue (BioSpace) (Endpoints)
- House Democrats demand answers on year-long Adderall shortage (The Hill)
- Pfizer to pay $50 mln to settle drug wholesalers' EpiPen antitrust claims (Reuters)
- Eli Lilly touts PhIII mirikizumab win in Crohn’s despite woes in other conditions (Endpoints)
- Medicare may plan to negotiate drug prices, but some states are taking their own steps to lower costs (STAT)
In Focus: International
- EU orders Illumina to divest cancer diagnostics firm Grail (STAT)
- MHRA pledges two-week review for low-risk clinical trials (Pharmaphorum)
- UK Regulator Attempts To Demystify Upcoming Drug Approval Rules (Pink Sheet)
- UK Offers 14-Day Approvals For Lowest-Risk Phase III/IV Trials (Pink Sheet)
- Scotland Fast Tracks HTA For AbbVie’s Aquipta While England Switches To Lengthier Process (Pink Sheet)
Pharma & Biotech
- Life sciences deals on track to hit lowest point since 2017 (STAT)
- Biotech Dealmaking Spree Sparks Torrent of Shareholder Lawsuits (Bloomberg Law)
- CRO claims there was no misconduct in Lyme vaccine trial it ran for Pfizer (STAT)
- Better Therapeutics data on apps’ benefit with GLP-1s, Orexo hits a snag (STAT)
- Cell and gene therapies could be a safer bet than other drugs (STAT)
- With Ozempic, Wall Street moves on from a whole other class of medicines (STAT)
- Novo Nordisk warns online offers of fake Ozempic, Wegovy are rising (Reuters)
- Lilly's bowel disease drug succeeds in late-stage study (Reuters)
- DaVita sees limited impact from Ozempic's kidney trial success (Reuters)
- #EuroBio23: The downturn, taking risks and the ‘biotech mafia’ (Endpoints)
- Astria nabs preclinical OX40 atopic dermatitis drug for $15M upfront, prices $64M offering (Endpoints)
- BioNTech sends $70M to another ADC partner to go up against Daiichi Sankyo in HER3 (Endpoints)
- AbbVie and Incyte report PhIIb vitiligo data on oral JAKs analysts call ‘undifferentiated’ (Endpoints)
- FDA lifts hold on PepGen's myotonic dystrophy drug; Takeda teams with cancer nonprofit (Endpoints)
- Fujifilm Irvine workforce cuts; Gates Foundation invests in Africa-made vaccines; Sharp acquires BSM (Endpoints)
- Getinge inks $320M Healthmark takeover to bolster US sterile reprocessing capabilities (MedTech Dive)
Medtech
- Key takeaways from AdvaMed, the world’s largest medical device conference (STAT)
- Blood tests needed for widespread Alzheimer's diagnosis on the way (Reuters)
- J&J’s Abiomed hit with FDA warning letter over Impella heart pump (MedTech Dive)
- Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market (MedTech Dive)
- How Medtronic, Zimmer Biomet and Smith & Nephew are thinking about acquisitions, spinoffs (MedTech Dive)
- Haemonetics inks $253M OpSens buyout, adding cardiology guidewires to portfolio (MedTech Dive)
Government, Regulatory & Legal
- Over 7 million Americans have gotten updated COVID vacines (Reuters)
- Shutdown Threat Forced US FDA To Cancel Some Travel (Pink Sheet)
- Philips $479 Million CPAP Machine Settlement Gets Initial Nod (Bloomberg)
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.
