Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

• Biogen scraps two late-stage Alzheimer's trials (Reuters) (Fierce) (Endpoints) (Press)
• Inside the drug industry’s plan to disarm the DEA (Washington Post)
• While battling opioid crisis, US government weighed using fentanyl for executions (Reuters)
• Purdue Pharma Made, Then Ditched, Plans for Opioid-Treatment Nonprofit (WSJ)
• Chaotic talks show challenge of reaching opioid settlement (AP)
• An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening (STAT) (Press)
• AbbVie/Allergan's merger faces public opposition (PMLive) (STAT)
• Reuters asks judge to release secret Propecia documents (Reuters)
• Amgen shares hit after analysts expose buried FDA trial halt (Fierce) (Endpoints)
• US officials worried about Chinese control of American drug supply (NBC)
• Pelosi plan could drop next week with no major tweaks (Politico)

• Private equity firm to buy Sanofi's oldest plant in India (BioPharmaDive)
• Exclusive: One Of The Largest Pharma Companies In The World Just Got Into Cannabis (Forbes) (Fierce) (Endpoints)
• Novartis MS drug cuts relapse rate by half compared to Sanofi medicine (Reuters)
• Astellas, Iota Biosciences Partner on Ultra-Small Implantable Biosensors (Press)
• Kenya becomes third African nation to introduce malaria vaccine (Reuters)
• Indian pharma exports to touch $22 billion this fiscal, Q1 exports stand at $5 billion (Economic Times)

• Avoiding target misidentification (Nature)
• Breath test to reduce overprescribing of antibiotics (Financial Times)
• FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer (FDA)
• FDA OKs expanded use of Glaxo's asthma med Nucala (Seeking Alpha) (Press)
• Right to try ‘remains a bust,’ as many drug makers prefer FDA reviews (STAT)
• Chalk up a big win for Bain as SpringWorks IPO tops out at $162M (Endpoints)
• Ardelyx bags its first FDA OK for IBS, setting up a showdown with Allergan, Ironwood (Endpoints) (Press)
• IQVIA and partners set up cancer ‘data hub’ to speed up research (PMLive)
• Early snapshot of Adverum's eye gene therapy sparks concern about vision loss (Endpoints)
• From partner to knight in shining armor: Castle Creek to buy Fibrocell (Endpoints)
• Star founders, investigators huddle around new Boston accelerator spotlighting young entrepreneurs (Endpoints)
• Cancer patients use crowdfunding for medical bills, expenses (Reuters)
• Everything's Special At US FDA: Priority NDA/BLA Filings Surge (Pink Sheet-$)
• The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence' (Pink Sheet-$)
• Few people with peanut allergy tolerate peanut after stopping oral immunotherapy (NIH)
• CTD Holdings Announces FDA Approval of US Expanded Access Treatment Program in Niemann-Pick Disease Type C (Press)
• KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (FDA)

• Celgene's phase 3 AML test chalks up a win (Fierce) (Press)
• Ritter's microbiome modulator fails lactose intolerance phase 3  (Fierce) (Press)
• Amgen Announces Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) Meets Primary Endpoint Of Progression-Free Survival (Press)
• Positive Results Announced From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's Enhanze® Drug Delivery Technology (Press)
• Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis (Press)              
• Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer (Press)
• Crestone, Inc. (Boulder) Secures NIH Funding for Phase 2 Clinical Trial of Novel Antibiotic Candidate (Press)

• CDRH Issues Final Guidance on De Novo Submission Acceptance Review (FDA Law Blog)
• V-Wave’s interatrial shunt lands another breakthrough nod from FDA (MassDevice)
• Medtronic recalls certain balloon catheters (MassDevice)
• FDA clears HeartFlow Planner (MassDevice)
• Qfix® Announces FDA 510(k) Clearance of Encompass™ 15 Channel Head Coil for Siemens 3T MRI Systems (Press)

• Consumer Protection And Commerce Subcommittee Announces Hearing On Protecting Consumers From Pharmaceutical Market Gaming Tactics (House E&C)
• When will Democratic debates move past 'Medicare for All' fight? (Politico)
• The Unknown Unknowns – Differential Etiology and Idiosyncrasy (Drug & Device Law)
• MEDICAID: Efforts to Identify, Predict, or Manage High-Expenditure Beneficiaries (GAO)
• USPTO Increases Limit on Accepted Requests for Track I Examination (Patent Docs)
• Vanda Pharma Investor Accuses Brass Of Off-Label Marketing (Law360-$)
• 3rd Circ. Revives State-Law Fraud Claims By Merck Opt-Outs (Law360-$)

• FDA Advisory Committee Calendar

• Investigation against Cryo-Save: FOPH has filed charges (Swissmedic)
• New European Pharmacopoeia Reflects Regulatory And Scientific Progress (Pink Sheet-$)
• Herbal medicines granted a traditional herbal registration (THR) (MHRA)

• First Filing, In Japan, For Daiichi’s Lead ADC As Others Progress (Scrip-$)

• UK regulator reinstates full GMP status of Indoco Remedies Goa facility (Economic Times)

• Public submissions on scheduling matters referred to the ACMS #27, ACCS #25 and Joint ACMS-ACCS #22 meetings held in June 2019 (TGA)
• Webinar: The cybersecurity of medical devices (TGA)