Recon: Alexion to Acquire Achillion for $930M; Lilly’s Pancreatic Cancer Drug Fails in Phase III Trial

• Alexion acquiring Achillion to expand reach into rare, immune-related disease (STAT) (Xconomy) (Endpoints) (Press)
• Drug Distributors in Talks to Settle Opioid Litigation for $18 Billion (WSJ) (Reuters)
• J&J Makes $4 Billion Opioid Offer as Distributors Seek Deal (Bloomberg)
• Teva Proposes $15 Billion Deal To Settle Opioid Claims (Jerusalem Post)
• Lilly's pancreatic cancer treatment fails late-stage study (Reuters) (Endpoints) (Press)
• The China Connection: How One DEA Agent Cracked a Global Fentanyl Ring (NYTimes)
• Health Care Stayed Front And Center At Democratic Debate (KHN)
• US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating' (Pink Sheet-$)

• Time is of the essence for patients who have serious and life-threatening conditions. Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

• There are solutions to the global drug price problem (Financial Times)
• Roche Boosts Outlook for Third Time as New Drugs Surge (Bloomberg) (PMLive) (Reuters) (Press)
• China approves Eisai's Fycompa for partial onset epileptic seizures (Pharmafile)
• Novartis’ Sandoz unit breaks up with digital therapeutics outfit Pear (Endpoints) (mobihealthnews)
• Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster (Pink Sheet-$)
• UK Bill To Speed Up Post-Brexit Access To Innovative Drugs (Pink Sheet-$)
• French Law Tackles Biologic Originator Tactics (Pink Sheet-$)
• The $102B club: The top 15 R&D spenders in the global biopharma business (Endpoints)
• Calling embryo editing ‘premature,’ Russian authorities seek to ease fears of a scientist going rogue (STAT)

• Big Pharma Needs A Better Business Model, Not More Legislation (Forbes)
• 2019 Biologics Recalls (FDA)
• Glenmark spin-out aims to challenge Amgen, others in cancer bispecific field (BioPharmaDive) (Xconomy) (Press)
• NIH Eyes Expansion Of US FDA Partnerships To Gene Therapy (Pink Sheet-$)
• New Tool To Help Evaluate Quality of RWD (Pink Sheet-$)
• Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs (Pink Sheet-$)
• Cell therapy GammaDelta spins off Adaptive to direct body's surveillance system (Endpoints)
• Ipsen bags Blueprint drug to move deeper into ultra-rare disease (Fierce) (Endpoints)
• MedImmune's top cancer researcher jumps ship to small biotech (Fierce)
• Healx raises $56M to launch 40 rare disease R&D programs (Fierce)
• FDA approves first and only transdermal patch for schizophrenia (Pharmafile)
• Another hit for AbbVie: Unexpected $673M Irish tax bill adds to Allergan merger woes (Fierce)
• FDA Finalizes Guidance on Developing Drugs for Patients with Amyotrophic Lateral Sclerosis (ALS) (FDA Law Blog)

• Incyte's cash cow Jakafi chugs along with positive frontline results for GVHD (Endpoints)
• ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1 (Press)
• Denovo Biopharma Receives FDA's Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM) (Press)
• Boehringer Ingelheim Announces First Patient Enrolled in Phase II Trial of Novel Cystic Fibrosis Treatment (BALANCE-CFTM 1) (Press)
• Results from STELLAR Trial of Tumor Treating Fields with Chemotherapy in Malignant Pleural Mesothelioma Published in The Lancet Oncology (Press)
• ArQule Announces Presentations on ARQ 751 at the 2019 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Press)
• Aura Biosciences Announces Updated Phase 1b/2 Clinical Data for AU-011 Presented at the American Academy of Ophthalmology 2019 Annual Meeting (Press)
• Imbrium Therapeutics Announces First Patient Dosed in Phase 2 Study of Potential First-in-Class Molecule for Insomnia Associated with Alcohol Cessation (Press)
• NOXXON Enrolls First Patient in the Phase 1/2 Clinical Trial Combining NOX-A12 With Radiotherapy in Newly Diagnosed Brain Cancer (Press)
• Aurinia Reports Last Patient Study Visit in Aurora Phase 3 Lupus Nephritis Study and Provides Update on ATM Facility (Press)

• How AI Is Shaping FDA Medical Device Regulation (Law360-$)
• Guide to improve usability for wearable injector devices (Emergo)
• Cleveland Diagnostics Announces FDA Breakthrough Device Designation for Novel Prostate Cancer Diagnostic Test (Press)

• Warren takes heat on health plan (Politico)
• CBO estimate on Pelosi drug bill misses its long-term impact on health (STAT)
• AbbVie Says Humira's Many Patents Is No Antitrust Violation (Law360-$)
• CSL accuses rival Pharming of participating in a scheme to rip off IP on HAE while recruiting senior R&D staffer (Endpoints)
• Missouri appeals court overturns $110 million Johnson & Johnson talc verdict (Reuters)
• Medical Bills Establish Amount In Controversy for Federal Jurisdiction (Drug & Device Law)
• Bayer expects significant surge in number of U.S. glyphosate cases (Reuters)
• PTAB Sheds Light On Its Discretion To Hear IPRs (Law360-$)
• Akebia Files Lawsuit Against CMS for 2018 Action Rescinding Medicare Part D Coverage of FDA-Approved Auryxia® for its Iron Deficiency Anemia Indication and Imposing a Prior Authorization Requirement for its Hyperphosphatemia Indication (Press)

• FDA Advisory Committee Calendar

• European MDCG weighs in on legacy medical device certification issues and MDR (Emergo)
• Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19) (MHRA)
• Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127-09/19) (MHRA)

• India yet to adopt EHR data for clinical trials even as hospitals document patient information (Pharmabiz)
• Health Ministry directs state DCs to use common software to process application for grant of drug manufacturing license (Pharmabiz)

• Psoriasis Tied to Increased Cancer Risk (NYTimes)
• Scientists find how deadly malaria parasite jumped from gorillas to humans (Reuters)