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Recon: Apple Watch Identifies Irregular Heart Beat in Large Study

Posted 18 March 2019 | By Michael Mezher 

Recon: Apple Watch Identifies Irregular Heart Beat in Large Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Apple Watch detects irregular heart beat in large US study (Reuters) (STAT)
  • The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs (STAT)
  • Amarin’s Vascepa prevents second and third heart attacks in analysis, fueling debate (STAT) (Endpoints) (Reuters)
  • Going Generic: Big Brands Poised To Lose Marketing Exclusivity In The US In 2019 (Scrip-$)
  • New results show benefits of Esperion’s cholesterol drug — but leave big questions unanswered (STAT)
  • GW Pharma sells Priority Review Voucher to Biohaven for $105M (Seeking Alpha) (Focus) (Endpoints) (Press)
  • A Regeneron drug dominates eczema treatment. With new data, a small biotech believes it can compete (STAT)
  • What’s in a name? For the newly christened Haven, maybe another legal fight (STAT)
  • Powerful Medicare advisory group criticizes Congress for ‘donut hole’ changes (STAT)
  • These tech companies aim to cure pain without pills (CNBC)
  • Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid (CBO)
  • Purdue Pharma vow not to profit from fast tracked opioid overdose antidote (Pharmafile)
  • ‘Project Facilitate’: US FDA Plans May Meeting On Expanded Access Call Center (Pink Sheet-$)
  • Klobuchar, Lee, Durbin, Grassley Introduce Bipartisan Legislation to Increase Competition in the Pharmaceutical Industry and Lower Prices for Consumers (Senate Finance) (Bill)
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In Focus: International
  • An AIDS therapy involving parasite injections was discredited. China is reviving it — for cancer (STAT)
  • Doctors Without Borders blasts coalition working on vaccine development (STAT)
  • CMA drops anti-competitive case against MSD (PharmaTimes)
  • Oncology dominates a ‘Cambrian explosion’ in China’s drug pipeline as McKinsey guru bets on a burst of innovation (Endpoints)
  • Biosimilar Samfenet wins patent invalidation against Herceptin in Korea (The Korea Herald)
  • China Proposes 50% Reimbursement for Chronic Disease Therapies (BioCentury)
  • US Government Beefs Up Presence Near Congo's Ebola Epicenter (NPR)
  • NICE to set out new opioid prescription guidelines for GPs (Pharmafile)
  • Why biotechnology can be Indian economy's next success story (Economic Times)
  • With high-tech glasses, Japanese ALS patient makes the beat go on (Reuters)
  • Keytruda adds another NSCLC approval in Europe (PMLive)
  • EU regulators expand Praluent’s label (PharmaTimes) (Press)
  • EMA Begins Review of Screening Patients Before Fluorouracil (Focus)
Pharmaceuticals & Biotechnology
  • Older Americans Are Awash in Antibiotics (NYTimes)
  • Medicines Only Work if Patients Can Afford Them: Solutions For The High Drug Prices Era (Forbes)
  • When the Benefits of Statins Outweigh the Risks (NYTimes)
  • CDER Looks Ahead at Real World Evidence (Focus)
  • Tiny PhaseBio gets the New England Journal’s spotlight. Can its shares rebound? (STAT)
  • Harvard to Offer Free Online Course on Pharma Controversies (Focus)
  • Arch-backed biotech hauls in a fast B round as its reborn anti-psychotic zooms to a PhII finish line (Endpoints)
  • Months away from completing a key sickle cell trial, upstart Imara scores $63M in round co-led by Arix, Orbimed (Endpoints)
  • ICER Suggests Novartis' MS Therapy Siponimod Won't Be Cost-Effective (BioCentury)
  • After a hiring blitz, Karuna nabs $68M funding round (Fierce)
  • Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter (FDA)
  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API) (FDA)
  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API) (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD (Press)
  • US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy (Press)
  • Puma Biotechnology’s Licensing Partner Specialised Therapeutics Asia Receives Regulatory Approval to Commercialize NERLYNX (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer (Press)
  • Arrowhead Pharmaceuticals Files IND for Pivotal Phase 2/3 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
  • Takeda Receives US FDA Approval to Manufacture FLEXBUMIN at New Plasma Manufacturing Facility near Covington, Georgia (Press)
  • Daré Bioscience Announces Publication of Positive Clinical Findings for Vaginal Administration of Tamoxifen for the Treatment of VVA (Press)
  • Allergan Announces FDA Approval of AVYCAZ (ceftazidime and avibactam) for Pediatric Patients (FDA)
  • Allergy Therapeutics’ immunotherapy prospect tarnished after birch vaccine flops in PhIII (Endpoints)
  • Alkahest Doses First Subject in Phase 2 Clinical Trial of Lead Candidate in Patients with Severe Alzheimer's Disease (Press)
  • GenSight Biologics Announces Presentation of 72-Week Data From the REVERSE Phase III Trial of GS010 at the 45th Annual Meeting of NANOS (Press)
  • Aerie Pharmaceuticals Initiates Phase 2 Clinical Trial of AR-1105 (Dexamethasone Intravitreal Implant) in Patients with Macular Edema Associated with Retinal Vein Occlusion (Press)
  • Enanta Pharmaceuticals Completes Enrollment in Two Ongoing Phase 2 Studies (Press)
  • CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ (atezolizumab) (Press)
  • Aerpio shares tumble as lead eye drug trips up in mid-stage diabetic retinopathy study (Endpoints) (Press)
  • Little Dermira’s shares zoom up on promising PhIIb atopic dermatitis data — but the road ahead is ultra risky and flanked by heavily armed giants (Endpoints)
  • AUGUSTUS Demonstrates Favorable Safety Results of Eliquis Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention (Press)
Medical Devices
  • Early FDA Review Finds Increased Mortality for Some Treated With Paclitaxel-Coated Devices (Focus)
  • Edwards, Medtronic heart valve systems prove worth in low-risk patients -studies (Reuters) (Press)
  • CDRH Program Seeks to Resolve 510(k) Issues in New Way (Focus)
  • Intuitive Surgical wins another indication for da Vinci SP (MassDevice)
  • New Clinical Trial Shows Medtronic TYRX(TM) Envelope Signficantly Reduces Major Infections in Cardiac Implantable Device Patients (Press)
  • Neovasc retains EC Marking after EU surveillance audit (MassDevice)
  • Should Medtech—Not Healthcare IT Departments—Take the Lead in Cybersecurity? (MDDI)
  • Via Surgical Receives FDA Clearance for Its FasTouch™ Absorbable Fixation System (Press)
US: Assorted & Government
  • Bayh, 91, Dies; Co-Author of Law that Made Biotech Possible (BioCentury)
  • Methadone Helped Her Quit Heroin. Now She’s Suing US Prisons to Allow the Treatment. (NYTimes)
  • Hikma V. Vanda Exaggerates Treatments' Patent Eligibility (Law360-$)
  • Insys Exec Denied Mistrial Bid After 'Salacious' Testimony (Law360-$)
  • Pfizer, Hospira Beat FCA Suit Over Faulty Infusion Pumps (Law360-$)
  • Purdue Says Cameras Will Turn Opioid Trial Into 'Media Circus' (Law360-$)
  • Pfizer’s Prevnar 13 Patent Claims Wiped Out by PTAB (FDANews-$)
  • Amazon takes another step into the medical space by accepting pre-tax health spending accounts (CNBC)
  • Guest Post -- Antibody-Drug Conjugates: Further Patents on Linkers (Patent Docs)
  • Ghostwriters in Disguise (Drug & Device Law)
  • To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device Establishments (FDA Law Blog)
Upcoming Meetings & Events Europe
  • EMA Guide To Help Regulators Assess Subgroup Analyses In Confirmatory Trials (Pink Sheet-$)
  • EC Details Plan for Eudamed and Medical Device Nomenclature System (Focus)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019 (EMA)
  • Quarterly reports on the import of unlicensed medicines (MHRA)
  • Company-led drug alert - Ozurdex implant recall (MDR 95-08/18) (MHRA)
  • Biocad plans to launch biosimilar of Humira in Russia (PharmaLetter-$)
  • Chugai in new filing for entrectinib in Japan (PharmaLetter-$)
  • Exclusive: India's health ministry calls for blocking Juul's entry into country – document (Reuters)
  • USFDA classifies Lupin's Somerset facility as 'Official Action Indicated' (Economic Times)
  • Notice to Stakeholders: Updates to the Opioid Patient Information Handout (Health Canada)
  • Brexit - Implications for therapeutic goods in Australia (TGA)
General Health & Other Interesting Articles
  • Tens of Thousands of Heart Patients May Not Need Open-Heart Surgery (NYTimes)
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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