Recon: Pfizer, BioNTech omicron-targeted shot delayed; UCB, Novartis back SpliceBio’s AAV delivery tech

• Pfizer and BioNTech Omicron-targeted vaccine delayed - BioNTech CEO (Reuters)
• Sage, Biogen score on phase 3 depression trial, but we still don’t know about durability (Fierce) (STAT) (Reuters)
• Court sides with Teva over Emergent in generic Narcan suit (Endpoints)
• Generic Manufacturers Face Uphill Climb After Federal Circuit’s ‘Skinny Label’ Decision (The Pink Sheet) (Pharmaceutical Technology)
• Biden Readies $30 Billion Request for New Covid-19 Funding (Bloomberg)
• Mirati’s ‘very big’ KRAS drug gets December decision date, further extending Lumakras’ first-mover status (Fierce)(STAT)
• Tramadol IV Opioid Gets Negative Vote From US FDA Advisory Panel (The Pink Sheet)
• The new lightning rod in the fight over high drug prices (STAT)
• Benefits of Lilly's diabetes candidate tirzepatide aren't better than other diabetes drugs, says watchdog ICER (Endpoints)
• A middle-aged woman is the third patient to be potentially cured of HIV, scientists report (Washington Post) (Reuters) (NYT)
• US Vaccines Sent Overseas Turned Away Amid Logistics Trouble (Bloomberg)

• Moderna turns to Asia, plots 1,000+ new hires as it ponders $35B+ Covid-19 vaccine windfall (Endpoints)
• Some genes are too large to fit into AAV vectors. UCB, Novartis back $57M idea to deliver them in parts instead (Endpoints) (Fierce)
• Illumina continues to battle EU regulators over premature $8B Grail buy (MedTech Dive)
• The Key To Big Pharma Deals: How Korea's ABL Reached $1bn Sanofi Agreement (Scrip)
• Vaccines could lower risk of ‘long covid,’ UK health agency says (Washington Post)
• Merck gets ahead of the Curve, inking oncology and neurology drug discovery deal with emerging British biotech (Fierce)
• Industry wants new European pharma makeover to increase the continent's attractiveness for R&D (Endpoints)
• Biotech pipeline is outpaced by antibacterial resistance, new BIO report says (Fierce)

• BioNTech to ship mRNA vaccine factory kits to Africa (Reuters) (STAT)
• BioNTech says it won't challenge vaccine copying in Africa (Reuters)
• Short AstraZeneca shelf life complicates COVID vaccine rollout to world's poorest (Reuters)

• Padcev gets a shot at another indication — for invasive bladder cancer — thanks to initial data readout (Endpoints)
• AstraZeneca/Merck come out of ASCO GU with a big win over J&J in battle over prostate cancer franchises (Endpoints)
• Wegovy Manufacturing Delays Highlight Challenges Of Managing Aging Facility Risks (The Pink Sheet)
• After a year as Merck KGaA healthcare CEO, Guenter reflects on I-O bispecific flop, spots new multiple sclerosis strategy (Fierce)
• Catalent expands deep-freeze operations in Chinese free trade zone (Endpoints)
• Some newly public biotech companies are trading below cash. Is it as bad as it looks? (STAT)
• Hunting deals on all fronts, Merck enlists drug discovery biotech on search for protein modulators (Endpoints)
• Gilead comes back around on Hookipa HIV partnership, signing away $15M upfront and more down the line (Fierce)
• Biotech startup launches with $155 million to develop pill for chronic hives (STAT)
• A new startup sets course against a constellation of rare diseases with a first shot repurposing the SIRP pathway (Endpoints)

• Guidance Sets Out How Notified Bodies Must Assess Highest Risk IVDs Under New Regulation (MedTech Insight)
• Industry Looks To Califf’s Leadership As It Negotiates User Fee Deal, Fights Pandemic (MedTech Insight)
• Diagnostics M&A expected to be strong in 2022 after dealmaking took off last year (MedTech Dive)
• Electronics giant Casio scores first FDA clearance in decades for dermatology camera system (Fierce)
• Companion Spine nets $55M to carry ex-Medtronic implants to US market (Fierce)

• SeaSpine, NuVasive Fail in Bids to Trim Surgeon’s Patent Suits (Bloomberg)
• Roche Unit, AstraZeneca’s Alexion Settle Ultomiris Patent Suit (Bloomberg)