Regulatory Focus™ > News Articles > 2019 > 3 > Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies

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

Posted 21 March 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
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In Focus: International
  • 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 $832M buyout deal (Endpoints) (Reuters)
  • MHLW Orders Label Revisions for Takecab, Clozapine and More (PharmaJapan)
Pharmaceuticals & Biotechnology
  • Did a medical education course for doctors harbor a bias in favor of fentanyl products? (STAT)
  • Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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