Recon: FDA Approves Lilly’s Emgality as First Drug to Treat Cluster Headaches

• FDA approves Lilly's migraine drug as first ever cluster headache treatment (Reuters) (Endpoints) (FDA) (Press)
• Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world? (Washington Post) (Endpoints)
• Welcome to the Age of One-Shot Miracle Cures That Can Cost Millions (Bloomberg)
• Ned Sharpless weighs in on gene therapy pricing debate, suggesting 'the messaging got lost' (Endpoints)
• Controversial US bill would lift Supreme Court ban on patenting human genes (Science)
• Foreign Threats to NIH Research: Senate Finance Committee Digs In (Focus) (STAT)
• House Appropriators Target Areas for FDA Improvement (Focus) (Pink Sheet-$)
• The Trump administration will end fetal tissue research by government scientists (STAT)
• BMS R&D Chief to Leave After Celgene Acquisition (WSJ) (STAT) (Fierce) (Endpoints) (Press)
• Trump’s Mexico Tariffs To Hit Medical Device Makers Hard (Forbes)
• FDA 'open for business' in considering real-world evidence, Sharpless says (BioPharmaDive)
• FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials (BioPharmaDive)
• Nearly every US state is now suing OxyContin maker Purdue Pharma (CNBC) (Law360-$)

• UK patients form a buyer’s club to get a cheaper version of a Vertex cystic fibrosis drug (STAT) (The Guardian)
• China’s Churning Out Revolutionary Cancer Drugs Much Cheaper Than the US (Bloomberg)
• Pharma groups combine to promote drug discovery with AI (Financial Times)
• China is leapfrogging the US in using AI in medicine. These five companies are leading the way (STAT)
• Spreading its wings in China with global ambition, EpimAb snags $74M Series B for bispecific work (Endpoints)
• InflaRx shares fall on failure of lead drug to improve debilitating skin disease (STAT) (Endpoints)
• Britain's health service is not for sale, says defacto deputy PM (Reuters)
• Trump backtracks on ‘NHS on the table’ comments (PMLive)
• Roche Diagnostics among beneficiaries as NHS fast-tracks more tech (PMLive)
• An Urgent Mystery: Who's Attacking Ebola Responders In Congo — And Why? (NPR)
• Fight the fakes: how to beat the $200bn medicine counterfeiters (The Guardian)

• Why Doesn’t FDA Publicly Disclose All NDAs and BLAs? Researchers Discuss (Focus) (STAT)
• Podcast: This Drug Could End HIV. Why Hasn’t It? (NYTimes)
• Creating eggs and sperm from stem cells: the next big thing in assisted reproduction? (STAT)
• ASCO or AdCo? Advertising splashes all over meeting, but attendees mostly blasé (Fierce)
• Move aside, Humira. Merck's Keytruda will capture industry's top sales spot in 2024: report (Fierce)
• CMC Review Update: Evenity Sequence Variants, Sunosi Split-Tablet Risks, Mayzent Particle Size (Pink Sheet-$)
• Profits in the 2019 Fortune 500: Manufacturers vs. Managed Care vs. Pharmacies, PBMs, and Wholesalers (Drug Channels)
• After two years, diabetes patients see gains with startup’s digital coaching — and some drop-off (STAT)
• Eli Lilly's Olumiant lead jumps ship to a Ramaswamy 'vant' (Fierce)
• As rivals crowd in, can Novartis' Xolair remain a blockbuster? New sinusitis data could help (Fierce)
• Biden Cancer Initiative pairs up with IBM, Syapse to improve access to clinical trial information (MedCity)
• Columbia University teams up with Deerfield for $130M R&D alliance (Fierce) (Endpoints)
• Lung Therapeutics raises $36M to trial pleural effusion drug (Fierce) (Endpoints)

• Alnylam Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration (FDA) for Givosiran for the Treatment of Acute Hepatic Porphyria (Press)
• Enzyvant Announces FDA Acceptance of Biologics License Application (BLA) and Priority Review Status for RVT-802, a Novel Investigational Tissue-Based Regenerative Therapy for Pediatric Congenital Athymia (Press)
• Mid-stage data on Allena's hyperoxaluria drug fuel optimism ahead of pivotal readout (Endpoints)
• Roche's Xofluza scores trial win in flu prevention, providing sales hope as Tamiflu craters (Fierce)
• CStone received approval to initiate clinical development in China of CS1001 and BLU-554 (CS3008) in combination therapy for HCC (Press)
• Prevail Therapeutics Announces IND Active for Phase 1/2 Trial of its Gene Therapy PR001 to Treat Parkinson’s Disease Patients with GBA1 Mutations (Press)
• Vaccitech Universal Flu Vaccine Passes Phase 2b Clinical Development Milestones (Press)
• Sierra Announces FDA Regulatory Clarity for Momelotinib & Design of the MOMENTUM Phase 3 Clinical Trial (Press)
• Sierra Announces Momelotinib Granted FDA Fast Track Designation (Press)
• Concert Pharmaceuticals Completes Enrollment in Open Label Trial to Evaluate Once-Daily vs. Twice-Daily Dosing of CTP-543 in Patients with Alopecia Areata (Press)

• The National Evaluation System for health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from Across the Medical Device Community (Press)
• Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health (mobihealthnews)
• Medtronic wins $150m radiology, imaging equipment DoD supply contract (MassDevice)
• Acandis stent retriever wins CE Mark (MassDevice)
• Companion Medical, Glooko ink InPen insulin pen data integration deal (MassDevice)
• ReWalk Robotics wins FDA nod for ReStore soft exo-suit (MassDevice) (Press)
• FDA Premarket Approval Granted for DT MedTech's Hintermann Series H3™ Total Ankle Replacement System (Press)

• Pandemic prep bill heads to Trump's desk (Politico)
• Top lawmaker signals support to classify all illicit fentanyl copycats like heroin (Reuters)
• House Committee Votes To Continue Ban On Genetically Modified Babies (NPR)
• What We Learned From FDA's Public Hearing On Cannabis (Law360-$)
• Haven wants to help ‘the American public get better health and reduce the costs,’ JPMorgan CEO says (STAT)
• CVS Makes Its Pitch for the Future of Health Care (Bloomberg)
• Protein Shake Preemption (Drug & Device Law)
• 7.7M LabCorp Customers Info. Exposed in Collections Agency Breach (MDDI)
• Opening Statement of Amanda Liskamm, Director of Opioid Enforcement and Prevention Efforts, Before the Senate Judiciary Committee (DoJ)
• Teenagers can be seriously harmed by dietary supplements (NBC)
• Pfizer Wins NJ High Court Review Of Forced-Arbitration Ruling (Law360-$)

• FDA Advisory Committee Calendar

• Disorderly Brexit May Necessitate Drug Airlifts, Sanofi UK Head Warns (Scrip-$)
• MHRA Consults on Analytical Quality by Design Principles (Focus)
• MHRA Chief Underlines Support For UK Innovation In Any Brexit Scenario (Pink Sheet-$)
• Overhaul Call For Outdated EU Innovation Incentives (Pink Sheet-$)

• Chinese NMPA update: ePRS, predicate device data, technical review guidelines (Emergo)
• Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations (Focus)
• Guided Therapeutics Reports New Progress with Chinese FDA and Increased Sales Forecast from Shandong Medical Device Technology Company (Press)

• Dhanuka Laboratories leads race for Orchid Pharma (Economic Times)

• Melanoma can occur on skin that doesn't get much sun (Reuters)