Recon: Allergan Depression Drug Fails Three Phase III Trials

• Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices (KHN)
• FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names (Focus)
• J&J prices ketamine-like depression treatment at $590-$885 for two doses (Reuters)
• Allergan depression treatment fails studies, shares slip (Reuters) (STAT) (Endpoints)
• The Atul Gawande health care company finally has a name: Haven (STAT) (Endpoints) (NYTimes)
• Patient group asks BIO to denounce Catalyst over the $375,000 price of its rare disease drug (STAT)
• Another influential voice takes Bristol-Myers’ top execs to task as they scramble to shore up the big Celgene buyout (Endpoints)
• Forget about an international pricing index for drugs. Cost-effectiveness is a better bargain (STAT)
• Gottlieb: Drug rebates not benefiting sicker patients (The Hill)
• Attention to Detail: Gottlieb Sets High Bar for Future FDA Commissioners (Focus) (STAT) (Endpoints)
• GOP lawmakers lambast Democratic push to strip exclusivity patents from drug companies (STAT)

• WHO chief unveils reforms, with more science, apps and an academy (Reuters) (NYTimes)
• Bayer’s Other Big Challenge: Finding Its Next Blockbuster Drugs (WSJ)
• Battle against Ebola being lost amid militarized response, MSF says (Reuters)
• Germany’s Merck posts 10% earnings slide after forex losses (Financial Times)
• BD’s Bard pulls all pelvic mesh products from EU market (MassDevice) (MHRA 1, 2)
• US FDA chief’s exit could impact Indian pharma (Economic Times)
• Indian Pharma Regaining Form, Helped By Easing US Price Pressures (Scrip-$)
• MHRA Reinforces Brexit Road-Map, Indian Firms Expect Tough Transition (Pink Sheet-$)
• WHO Consults on QMS Guideline for Regulators (Focus)
• Canada should create a new drug agency to oversee negotiations and a formulary, advisory panel says (STAT) (Reuters)
• From dinner in Munich to $5.85 a share, Immune Design execs pushed for every penny they could get from the Merck bargain buyout (Endpoints)
• Sick children being denied drugs are a grim foretaste of a post-Brexit NHS (The Guardian)
• Dutch Move On Pharmacy Compounding Could Deter Orphan Drug Launches (Pink Sheet-$)
• Gilde raises €200M European healthcare investment fund (Fierce)

• The current state and future directions of RNAi-based therapeutics (Nature)
• What’s scary, and appealing, about real-world evidence (STAT)
• Good News: Opioid Prescribing Fell. The Bad? Pain Patients Suffer, Doctors Say. (NYTimes)
• Joining AI Drug Discovery Race, Erasca Adds $22M For Cancer Work (Xconomy)
• A Moonshot For Diabetes Prevention, Part Three: The Urgent Goal (Forbes)
• FDA Warns Teva Subsidiary Over Quality Failures, CGMP Violations (Focus)
• Long-term use of hormone therapy pills linked to increased Alzheimer's risk, study finds (NBC)
• Study finds Ebola survivors in Liberia face ongoing health issues (NIH)
• Jeff Marrazzo sparked a bidding war for Spark that spurred a thrifty Roche CEO to seal the winning deal with a blockbuster premium (Endpoints)
• Private oncology outfit Oncternal uses GTx as shell to make Nasdaq debut (Endpoints) (Fierce)
• CAR-T shows promise for lupus in mouse study — will it inspire hope in a beleaguered field?  (Endpoints)

• Gilead scores key HIV data as Descovy proves non-inferior to Truvada (BioPharmaDive)
• Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions (Press)
• The Journal of Addiction Medicine Publishes Patient-centered Outcomes from the Phase 3 Study of SUBLOCADE™ (Buprenorphine Extended-Release) Injection in Patients with Moderate to Severe Opioid Use Disorder (OUD) (Press)
• Alligator Bioscience: First Patient Dosed in Phase I study of ATOR-1015 (Press)
• Forendo Pharma Successfully Completes Phase 1a Clinical Trial of FOR-6219 for the Treatment of Endometriosis (Press)
• SanBio to Announce the Results of a Phase 2 STEMTRA Trial Regarding the Use of Regenerative Cell Medicine SB623 as a Treatment for TBI at an Annual Scientific Meeting of the American Association of Neurological Surgeons (Press)
• BioArctic: Eisai Announces Timelines for the Single Confirmatory Phase 3 Study With BAN2401 in Warly Alzheimer's Disease (Press)

• MDIC Works to Standardize Oversight of NGS-based Assays (Focus)
• MedTech Europe Urges Tailored Approach to Validating Biomarker Assays (Focus)
• FDA Grants Breakthrough Designation to Paige.AI (Press)
• FDA slaps Class 1 designation on corneal implant recall (MassDevice)
• Patient deaths prompt renewed warning to heed LifeVest alert (MassDevice)
• Saranas’ Early Bird catches nod from FDA (MassDevice)
• Co-Diagnostics Gets CE-IVD Mark for Multiplex Zika, Dengue, Chikungunya Test (GenomeWeb)
• Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (FDA)

• The Ripples Of The Fosamax Reversal (Drug & Device Law)
• Biologic Patent Thickets: New Bill Aims to Publicize Info (Focus)
• The $100,000 dark-money mystery group behind a pharma-bashing Facebook campaign (STAT)
• FDA chief Scott Gottlieb’s resignation leaves ‘billion-dollar question’ for CBD industry (CNBC)
• House appropriators hold rare hearing on gun violence (Politico)
• Alabama judge allows man to sue clinic on behalf of aborted fetus (Washington Post)
• Horizon Pharma Facing DOJ Probe Into PBM Payments (Law360-$)
• Abbott Ruling Dulls Insurers' 'Knowing Violation' Sword (Law360-$)
• GSK's Avandia Marketing Was Racketeering, 3rd Circ. Told (Law360-$)
• Hospira Tells Fed. Circ. To Reverse Sedative Patent Loss (Law360-$)

• FDA Advisory Committee Calendar

• EU food agency must release glyphosate studies: court (Reuters)
• Italian medical device nomenclature to be adapted for Eudamed database (Emergo)
• Public satisfaction with NHS falls to lowest point since 2007 (Pharmafile)
• Clinical trials for medicines: manage your authorisation, report safety issues (MHRA)

• Major hike in Japan drug review fees take effect April 1 (Pacific Bridge Medical)
• Vietnam will require all medical devices be approved, registered (Pacific Bridge Medical)
• Eisai's files for approval of potential insomnia disorder treatment in Japan (PharmaLetter-$)

• Abbott fined Rs 96 lakh for profiteering from GST (Economic Times)
• Mumbai HC asks Nuziveedu Seeds Ltd to pay Rs 138 cr dues of Mahyco Monsanto Biotech (Economic Times)

• TGA Proposes 5 Medical Device Classifications in Line With EU MDR (Focus)
• Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites (TGA)