Recon: FDA warns of risks linked to compounded ketamine; Pfizer slated to settle EpiPen antitrust litigation for $50 million

• 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)

• 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)

• 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)

• 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)

• 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)