Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies

• Biogen scraps Alzheimer drug trials, wiping $17 billion off its market value (Reuters) (WSJ) (Endpoints)
• CRISPR is ascending again, after scientists find ‘elegant’ fix for cancer worry (STAT)
• Roche sues US executives in fight over diabetes test strips (Reuters) (Forbes)
• Feng Zhang, heavyweight collaborators unveil latest CRISPR upstart — a diagnostic company (Endpoints)
• Jazz Pharma's sleep disorder treatment gets FDA nod (Reuters) (Endpoints) (Press)
• Mystery solved: the pharma-backed group with a lot to say on Trump’s pitch to end drug rebates (STAT)
• Fentanyl-Linked Deaths: The US Opioid Epidemic's Third Wave Begins (NPR)
• Novo uses voucher for speedy answer on oral semaglutide (PMLive)
• Celgene taps Exscientia’s AI drug discovery tech for 3 new programs (Fierce) (Endpoints)
• Amgen, Servier heart failure drug clears trial hurdle (PMLive)

• China’s strong-arm approach to drug addiction does not work (The Economist)
• Congo Ebola outbreak spreads to city of Bunia (Reuters)
• UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs (Focus)
• Biotech growth in UK booms 65% since 2016 (PharmaTimes) (Endpoints)
• EU Publishes First Corrigenda for MDR, IVDR (Focus)
• International recruitment needed to fix NHS staff shortages says new report (PharmaTimes) (PMLive)
• Venezuela relaunch pharmaceutical industry with Chinese and Russian backing (Pharmafile)
• Merck KGaA investing €1B at headquarters site as part of 5-year work agreement (Fierce)
• Dutch regulators weigh in on no-deal Brexit impact for medical device companies (Emergo)
• New U.K. Partnership Aims To Improve Access Immunotherapy For Cancer Patients (Forbes)
• Billionaire Bertarelli’s Waypoint steers allergy drugmaker Stallergenes Greer private in $832M buyout deal (Endpoints) (Reuters)
• MHLW Orders Label Revisions for Takecab, Clozapine and More (PharmaJapan)

• Did a medical education course for doctors harbor a bias in favor of fentanyl products? (STAT)
• Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality (Pink Sheet-$)
• There’s finally a drug for postpartum depression. Too bad it’s $34,000. (Vox)
• Opioid prescriptions after plastic surgery tied to long-term use (Reuters)
• Off-Label Promotion Still A Litigation Risk For Pharma Cos. (Law360-$)
• With ADHD, amphetamine has double the psychosis risk of methylphenidate (Reuters)
• Alexion strikes Zealand deal to further pipeline rebuild (Fierce)
• Founding Forma CEO Steve Tregay follows 61 staffers out the exit, replaced by Genentech strategy vet (Endpoints) (Fierce)
• Ely Benaim to leave Rexahn, take CMO role at Novocure (Fierce)
• Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk (FDA)

• Innovent Announces First Patient Dosed in a Phase IIa Clinical Study of IBI306, an Anti-PCSK9 Monoclonal Antibody (Press)
• Modra Pharmaceuticals Announces First Patients Treated in Phase IIa Metastatic Breast Cancer Trial (Press)
• Lead Pharma Announces Start of Phase I Clinical Trials with SAR441169 Candidate Treatment for Psoriasis (Press)
• Aerie Pharmaceuticals Initiates Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Designed to Support Requirements for Future Regulatory Filing (Press)
• Aura Biosciences to Present Interim Phase 1b/2 Clinical Data for AU-011 at the International Society of Ocular Oncology 2019 Annual Meeting (Press)
• Adlai Nortye Receives NMPA Approval for Pelareorep (AN1004) in China to Initiate Phase III Clinical Trials (Press)
• Last Participant out in USA Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate (Press)
• CStone receives approval in China to initiate Phase 1 clinical trial for RET inhibitor BLU-667 (CS3009) (Press)

• Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies (Focus)
• IMDRF Explains How to Build Submissions Using its Table of Contents Structure (Focus)
• GenePOC Strep A Test Granted FDA Clearance (GenomeWeb)

• OMB Reviews Proposal to Add Prices to Pharma TV Ads (Focus)
• Azar, Gottlieb pen op-ed warning of regulatory crackdown on e-cigarettes (The Hill) (Washington Post)
• The FDA is putting together a group of experts to figure out how to handle the $1 billion CBD industry (Business Insider)
• CVS has started selling cannabis-based products in 8 states (CNBC)
• Sen. Kirsten Gillibrand Tweeted An Opioid Proposal: Here's The Reaction (Forbes)
• Why advocates are suing over New Hampshire's Medicaid work requirements (Politico)
• CMS Looks To End Pharma Co.'s Drug Classification Suit (Law360-$)
• That’s The Way We Like It: Stroke Warnings Claims Preempted in Yaz Case Out of Eastern District of Tennessee (Drug & Device Law)

• FDA Advisory Committee Calendar

• EMA Follows FDA Warning on Xeljanz Blood Clot Risks (Focus)
• Management Board re-elects Christa Wirthumer-Hoche as chair Share (EMA)
• Draft agenda for the 103rd meeting of the Management Board (EMA)
• Medical Device Alerts issued in February 2019 (MHRA)
• Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve (MassDevice)
• Drug Safety Update: monthly PDF newsletter (MHRA)
• Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects (MHRA)
• Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events (MHRA)
• Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed? (MHRA)
• Letters and drug alerts sent to healthcare professionals in February 2019 (MHRA)

• Ono Pharma files for supplemental approval of Kyprolis in Japan (PharmaLetter-$)
• Why Singapore's Wealthiest Are Backing This Lawyer In The Fight Against Childhood Cancer (Forbes)

• Pharma MNCs wary of illegal import of innovator drugs (Economic Times)

• Listed and assessed listed medicines: Application and submission user guide (TGA)
• Tofacitinib - clinical study finds increased risk of blood clots in the lungs and of death in rheumatoid arthritis patients on high dose (TGA)