Regulatory Focus™ > News Articles > 5 > Recon: Accent Therapeutics Launches with $40M, J&J Drops Alzheimer’s Candidate

Recon: Accent Therapeutics Launches with $40M, J&J Drops Alzheimer’s Candidate

Posted 18 May 2018 | By Ana Mulero 

Recon: Accent Therapeutics Launches with $40M, J&J Drops Alzheimer’s Candidate

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US [Paid Advertisement]
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In Focus: International
  • Pharma and biotech leaders back ’no deal’ Brexit warning (PMLiVE) (pharmaphorum)
  • WHO Raises Ebola Health Risk to 'Very High' in DR Congo, but Says Conditions for International Emergency not yet Met (CNN) (Fox) (WHO)
  • CDC prepares to join Ebola fight in Africa (The Hill) (VOA)
  • EU releases emergency aid and starts humanitarian flight service to contain Ebola in Democratic Republic of Congo (EC)
  • Experimental drugs poised for use in Ebola outbreak (Nature)
  • WHO prioritizes diagnostic tests for global health threats (Axios) (The Conversation)
  • Stempeutics partners with Cipla for its stem cell drug (Economic Times) (Pharmabiz)
  • MTaI urges govt to separate medical device cost from package rates under Ayushman Bharat (Pharmabiz)
  • US opioid crisis hits Indian pharma companies (Economic Times)
  • No, raising drug prices in Canada will not help the U.S. (The Conversation)
Pharmaceuticals & Biotechnology
  • AstraZeneca pay report rejected by 35 percent of shareholders (Reuters)
  • Pulse Check: Azar to drug plan critics: Bring on the fight (Politico)
  • Shorter breast cancer treatment could hurt providers' pockets (Modern Healthcare)
  • FDA looking at ways to include price info in drug ads, Gottlieb says, as questions loom (STAT)
  • LISTEN: Inside the Theranos collapse, Valeant’s latest legal lumps, and a bunch of biotech hot takes (STAT)
  • Here’s how Sanofi separates true innovation from all the hype in digital health (Drug Delivery Business News)
  • $9.7M Valeant Payment Was Legal, Ex-Execs Argue In Closing (Law360-$)
  • GSK, Zofran Users To Pick 16 Potential MDL Bellwether Cases (Law360-$)
  • Agile bristles after FDA’s third snub, promising a fight for its contraceptive (Endpoints)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Trials show benefit of ‘on demand’ use of AZ’ asthma inhaler (PharmaTimes)
  • Encouraging trial results for Daiichi anti-stroke therapy (The Pharma Letter) (Press)
  • ICER to review biologic treatments for asthma (The Pharma Letter)
  • Pierre Fabre and Roche extend pact on companion diagnostic for cancer (Fierce)
  • Syndax is hit with a setback during the ASCO preview round as lead drug flops in mid-stage study (Endpoints)
  • Experimental MERS treatments enter clinical trial (NIH)
  • Homology Medicines Presents Data from PKU Gene Therapy Program Demonstrating Long-Term Durability of Treatment in IND-Enabling Studies (Press)
  • RXi Pharmaceuticals Announces Positive Results from Phase 2 Trial with Samcyprone for the Treatment of Common Warts (Press)
Medical Devices
  • Medical Device QMS Harmonization: US Considers Aligning to ISO 13485 (Emergo Group)
  • Valeritas touts new data for insulin delivery device (Drug Delivery Business News)
  • MIT develops cheap, build-your-own paper diagnostic tests (Fierce)
  • FDA clears Additive Ortho’s patient specific 3D printed bone segments (MassDevice)
  • Market Intel: Insulin Pumps Dominate $7bn-Plus Global Infusion Devices Market (Medtech Insight-$)
  • FDA Approves Industry’s First Off-the-Ear Audio Processor with Wireless Charging: MED-EL’s RONDO 2 (Press)
  • NeoTract Announces American Urological Association (AUA) Recommendation of UroLift System as a Standard of Care Option for the Treatment of Enlarged Prostate (Press)
  • KARL STORZ Announces New Non-Muscle Invasive Bladder Cancer Detection System: Photodynamic Diagnosis (PDD) Blue Light Flexible Video Cystoscopy (Press)
US: Assorted & Government
  • Trump to nominate Acting VA Secretary Wilkie to lead the agency (Fierce)
  • FDA Issues Report on Medical Device Servicing, Declining to Impose New Regulatory Requirements For Now (FDA Law Blog)
  • The health care industry is awash in cash (Axios)
  • How Cigna and Express Scripts decided to merge amid Anthem drama (Modern Healthcare)
  • Bill Gates: Trump asked me the difference between HIV and HPV (CNBC)
  • 'Outrageous' drug prices are a fair trade issue: Mt. Sinai CEO (CNBC)
  • Verily Advisory Board series: Linda Avey discusses health data sharing & ownership (Verily)
  • House Committees Advance Slate of HITN Opioid Safety Alliance-Endorsed Bills (HITN)
Upcoming Meetings & Events Europe
  • Concerns Rise For Notified Bodies Over Potential Reopening Of PIP Case (Medtech Insight-$)
  • Government proposal leaves markets gasping -- and Italians vaping (Reuters)
  • Diabetes test strips recalled in new alert (MHRA)
  • How digital is your country? Europe needs Digital Single Market to boost its digital performance (EC)
Asia
  • Notice of the Office of the State Drug Administration on the Project Amendment of the Medical Device Industry in 2018 (CFDA)
  • Ucare.ai is using AI to make healthcare more efficient in Southeast Asia (TechCrunch)
  • Does The Growing Global Sextech Industry Have A Place In Asia? (Forbes)
  • Japan Seeks Private Sector's Help With Blowout Health Costs  (Bloomberg)
  • South Asian pharmaceutical companies to see a growth spurt amid high demand (Baltimore Post Examiner)
  • Chinese insurtech startup CareVoice launches voice-based virtual assistant (MobiHealthNews)
  • China Approves $18B Sale Of Toshiba's Memory Unit (Law360-$)
  • Profectus and MediSun launch Asian joint venture (BioPharma Dive)
India
  • India’s health spending a dismal $63 (The Tribune)
  • How the WHO List for Essential Diagnostics Could Boost India's Primary Health Care (News18)
Australia Canada
  • Canada Post halts deliveries to 220 senior and disabled residents due to 'health and safety concerns' (CBC News)
  • This 12-year-old leukemia survivor is fighting for equal access to medicine for all Canadians (The Globe and Mail)
General Health & Other Interesting Articles
  • Parents' mental health issues may spoil children's friendships (Reuters)
  • App helps doctors screen for opioid dependency (pharmaphorum)
  • More patients are taking home recordings of their doctor visits. But who else could listen?  (STAT)
  • US birth rates hit record low and diaper, baby bottle companies are feeling the pinch (CNBC)
  • Vecna, Imprivata partner on biometric palm vein scanning for secure patient check-in (MobiHealthNews)
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.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.

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