Recon: Regeneron to Invest $800M in Alnylam to Develop RNAi Treatments

• Regeneron to invest $800 million in Alnylam, betting on RNAi (STAT) (Reuters) (Endpoints) (Press)
• Why Big Pharma Is Winning the Drug Price Wars (Bloomberg)
• Audentes Therapeutics to develop gene therapies for two types of muscular dystrophy, including Duchenne (STAT) (Endpoints)
• Celgene, Acceleron submit FDA application for billed blockbuster luspatercept — will they get priority review? (Endpoints)
• Botox Rivals Create New Wrinkles for Allergan (WSJ)
• Criminal Trial Of Opioid-Peddling Drug Company Execs Goes To The Jury (NPR)
• Pain-care specialist agrees to testify against Purdue, other drug makers (Reuters)
• Mulvaney: GOP will unveil health plan 'fairly shortly' (Politico)
• Telemedicine tied to more antibiotics for kids, study finds (AP)
• Oversight Republicans accuse Cummings of partisan drug pricing probe (The Hill)
• Plan to End Drug Rebates Adds Protections for Insurers (WSJ)
• This week, five pharmacy ‘middlemen’ head to Capitol Hill’s hot seat. Some of them have an easier defense than others (STAT)
• Medtronic, Blue Cross sign glucose monitor deal linked to patient outcomes (Star Tribune) (Press)

• Merck KGaA wins Versum's support for sweetened $6.5 billion offer (Reuters) (Financial Times)
• Artificial intelligence: Commission takes forward its work on ethics guidelines (EC)
• Prosecutors expected to send Novartis file to Parl't on Monday (ekathimerini)
• Belgian pharma vote tests Commission on parallel trade (Politico)
• With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure (Fierce)
• UK NICE Review Will Look At Criteria For Appraising Highly Specialized Products (Pink Sheet-$)
• NICE turns down Astellas' Xtandi in prostate cancer (Pharmafile)
• J&J plans €100m expansion in Ireland, to add 100 jobs (MassDevice)
• In a Poor Kenyan Community, Cheap Antibiotics Fuel Deadly Drug-Resistant Infections (NYTimes)
• A Mysterious Infection, Spanning the Globe in a Climate of Secrecy (NYTimes)
• Researchers Are Surprised By The Magnitude Of Venezuela's Health Crisis (NPR)
• Democratic Republic of Congo Sees A Recent Surge In Ebola Infections (NPR)

• Revenge of the Bacteria: Why We’re Losing the War (NYTimes)
• What You Need to Know About Candida Auris (NYTimes)
• Coherus' Neulasta biosimilar surprises with strong early uptake (BioPharmaDive)
• Don't Use Recycled Raw Materials In Valsartan And Other ARBs, US FDA Says (Pink Sheet-$)
• 2018 Saw Record Launches, But No Big Splash (Scrip-$)
• FDA Warns Genetic Testing Lab in Virginia (Focus)
• Pfizer Uses EHR Data to Support Expanded Indication for Breast Cancer Drug (Focus)
• Protesters’ goodbye for Scott Gottlieb: a supersized heroin spoon and claims FDA did too little on opioids (STAT)
• Immunomedics Announces Promotion Agreement With Janssen for Erdafitinib in the U.S. (Press)
• Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews (Focus)
• The Diagnosis Is Alzheimer’s. But That’s Probably Not the Only Problem. (NYTimes)
• Amazon Alexa's first HIPAA-sanctioned skills open new doors for pharma (Fierce)
• Going gangbusters: The top 20 biotech platform deals by upfront cash (Endpoints)
• Value-based agreements could disrupt how we pay for new therapies (STAT)
• Protecting public health: Is real-world evidence the key? (Pharmafile)
• Roche says ‘discovery proteomics’ is heading for clinical trials (PMLive)
• CPI, GSK, AZ to establish wet granulation manufacturing facility (PharmaTimes)
• Rat study suggests Allergan’s failed antidepressant rapastinel may work as opioid addiction treatment (Endpoints)
• 6 things to know before the readout of BioCryst Pharma’s pivotal clinical trial (STAT)
• Can Trevi make it through the IPO window with an old opioid that failed their key PhII? (Endpoints)
• Battered and out of options, Histogenics turns to eye drug developer Ocugen for reverse merger (Endpoints)
• Tapped as Kymab CEO, Simon Sturge jumps back into biotech pond as Dave Chiswell steps aside (Endpoints)

• United kills its PhIII PAH drug after it fails Tyvaso combo study (Endpoints)
• FDA accepts Kyowa Hakko’s refiling for PD drug istradefylline (PharmaLetter-$)
• Tetraphase Pharmaceuticals to Present Data at the 29th European Congress of Clinical Microbiology and Infectious Diseases (Press)
• SanBio Announces SB623 Regenerative Cell Therapy for Traumatic Brain Injury Has Received Ministry of Health, Labour and Welfare (MHLW) Sakigake Designation (Press)
• GT Biopharma Receives Institutional Review Board Approval to Proceed With in Human FDA Phase 1 Clinical Trial (Press)
• Navidea Biopharmaceuticals Receives FDA Feedback Regarding Rheumatoid Arthritis Clinical Trial Design and Provides Business Updates (Press)

• Latest insights on FDA expectations from the HFES Health Care Symposium (Emergo)
• Abiomed touts new Impella study results (MDDI)
• LivaNova shares plummet on prelim Q1 miss (MassDevice)
• Medtronic touts economic data for HeartWare HVAD (MassDevice) (Press)
• Medtronic touts new targeted drug delivery study results (MassDevice) (Press)
• Spry Health Announces FDA Clearance of Groundbreaking Loop System, Designed to Transform Care for People with COPD (Press)

• Advocates say a Commerce Dept. report would preclude reclaiming patents as a way to lower drug prices (STAT)
• Busy Week for FDA (American Action Forum)
• Priority Open Recommendations: Department of Health and Human Services (GAO)
• Man Who Bribed Son Into Penn Found Guilty in $1.3 Billion Health Fraud (Bloomberg) (DoJ)
• Monroe County sues drug makers and sellers over opioid crisis in the Keys (Miami Herald)
• Justices Urged To Pass On Orexigen Disclosure Dispute (Law360-$)
• Pfizer's Lyrica Update Infringes Patent, Sun Pharma Says (Law360-$)
• Apotex Can't Sink Amgen's IP Suit Over Drugs To Aid Chemo (Law360-$)
• Lessons Learned from 23andMe Inc. v Ancestry.com (MDDI)
• Cleveland Clinic Foundation v. True Health Diagnostics LLC (Patent Docs)
• On Restatement (Second) of Torts §920 (Drug & Device)

• FDA Advisory Committee Calendar
• 2nd Fair Pricing Forum, Johannesburg – 11-13 April 2019

• MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates (Focus) (MHRA)
• Exporting active substance manufactured in the UK if we leave the EU without a deal (MHRA)
• ‘Use greener asthma inhalers’, encourages NICE (PharmaTimes)
• Leader named for NHS digital transformation unit, but scepticism persists (PMLive)
• Stargazing technology used to spot cancer (MHRA)
• Cancer patients to benefit from £6 million AI investment (PharmaTimes)
• Insera Earns CE Mark Approval for Cyclical-suction Stroke Thrombectomy Platform, the CLEAR Aspiration System (Press)

• Lupin recalls over 12K cartons of birth control tablets from US market (Economic Times)
• Indian pharma needs to shift from batch to continuous manufacturing to remain competitive in global arena: Kaushik Desai (PharmaBiz)

• Australia Unveils Device Action Plan (Focus)
• TGA presentation: How the TGA regulates software, 7 March 2019 (TGA)
• Australia’s TGA looks to strengthen medical device oversight (MassDevice)

• Health Canada clarifies “significant change” qualifications to Medical Device Licenses following Sterigenix shutdown (Emergo)