Recon: FDA approves Otsuka subsidiary’s bile duct cancer drug Lytgobi; AstraZeneca buys LogicBio for $67M to grow genomics pipeline

• Otsuka’s Taiho Oncology bags approval for bile duct cancer med Lytgobi, teeing up showdown with BridgeBio and Incyte (Fierce) (Endpoints) (Pharma Letter)
• Advocates, experts cry foul over Amylyx's new ALS drug, citing issues with price, PhIII commitment (Endpoints) (Reuters) (BioPharma Dive)
• Allogene Frustrated By FDA’s Delayed CAR-T Trial Review (Scrip)
• 5 FDA decisions to watch in the fourth quarter (Biopharma Dive)
• Mesoblast keeps hope of cell therapy approval alive in latest response to FDA (Fierce)
• Updated: Alnylam reinforces APOLLO-B patisiran data before heading to the FDA (Endpoints)
• Biogen/Eisai’s Lecanemab Suggests A New Model For Accelerated Approval In The US (Pink Sheet)
• White House’s open-access research directive scrambles long-entrenched models, raising key question (STAT)
• Fentanyl Test Strips Highlight Rift in Nation’s Struggle to Combat Drug Deaths (NYT)

• EMA makes new recommendations for Imbruvica, medicines with terlipressin over respiratory and cardiovascular risks (Endpoints)
• Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings (Pink Sheet)
• European pharma group wants to create PRV-like system to spur antibiotics R&D (Endpoints)
• Stakeholders Must ‘Fully Engage’ If WHO’s Medicines Access Platform Is To Succeed (Pink Sheet)
• China Drug Price Negotiations: Another Race To The Bottom? (Pink Sheet)
• Moderna refused China request to reveal vaccine technology, Financial Times reports (Reuters)
• Swedish geneticist wins Nobel medicine prize for decoding ancient DNA (Reuters) (Washington Post)
• New model says Type 1 diabetes cases worldwide could double by 2040 (Washington Post)

• AstraZeneca Acquires LogicBio for $67 Million to Bolster Genomics Pipeline (Biospace) (Fierce) (Endpoints) (Reuters)
• Myovant Turns Down Acquisition Offer from Largest Stakeholder (Biospace) (Endpoints)
• Amylyx Falls as Controversial ALS Drug Hit by Pricing Doubts (Bloomberg)
• Amylyx and ALS Researchers Look to Build on Relyvrio Momentum (Biospace)
• Not so Clene break: Biotech’s shares slump 34% on phase 2 ALS flop despite plans to continue testing (Fierce)
• Fierce Biotech Summit: Gene editing execs reflect on promises and challenges as CRISPR celebrates 10-year anniversary (Fierce)
• Intercept's NASH drug fails late-stage trial, shares tumble (Reuters)
• Scandion posts phase 2 trial flop just one month after the departure of 2 top execs (Fierce) (Endpoints)
• Zealand rival to Takeda bowel disease drug hits goal in phase 3 (Fierce)
• #AAO22: In bid for first FDA nod in geographic atrophy, Apellis claims another first in eye disease field (Endpoints)
• NC and Texas Biopharma Hubs Grow as Companies Look Beyond Boston & California and (Biospace)

• European AI Act could have ‘significant impact’ on manufacturers, medtech group warns (MedTech Dive)
• European Regulatory Roundup, August 2022: Stakeholders Start Taking Radical Decisions (MedTech Insight)
• Joint Mission: FDA And VA Partner On Device Development Initiative (MedTech Insight) (MedTech Dive)
• Industry View: EU Plans To Extend Product Liability Rules Bad News For Medtech (MedTech Insight)
• Roche Diagnostics taps North American head Sause to be next CEO (Fierce)
• Philips shareholders officially appoint Jakobs as CEO, president (MedTech Dive)
• Veterans Affairs, FDA partner to accelerate medical device development (MedTech Dive)
• GE Healthcare nabs FDA clearance for deep-learning MRA imaging software (Fierce)
• To prevent unnecessary biopsies, scientists train an AI model to predict breast cancer risk from MRI scans (STAT)

• U.S. Supreme Court turns away Biogen bid to reinstate MS drug patent (Reuters) (Bloomberg)
• Justices Ask DOJ to Weigh In on Teva’s Drug Labeling Fight (Bloomberg)
• Merck celebrates another win in Januvia patent battle against Viatris (Endpoints)
• Supreme Court Turns Down State’s Fight Over Drug Enforcement Order (Bloomberg)
• Teva settles price-fixing claims with Georgia for a ‘modest’ $3.3M (Fierce)