Recon: Merck KGaA Appears to Machine Understanding to Avert Drug Shortages J&ampJ Raises Outlook Regardless of Mounting Legal Challenges – Regulatory Concentrate


Posted 15 October 2019 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your everyday regulatory news and intelligence briefing.
In Concentrate: US

  • J&ampJ boosts outlook regardless of uncertainty more than legal charges  (Monetary Instances) (WSJ) (CNBC)
  • ‘Gene therapy headwinds’ are blamed for biotech stock woes (STAT)
  • Property progressives plot overhaul of Pelosi drug pricing bill (STAT)
  • Eli Lilly to shutter neuroscience R&ampD center subsequent year  (Fierce) (Endpoints)
  • Faced With a Drug Shortfall, Physicians Scramble to Treat Kids With Cancer (NYTimes) (Fierce)
  • Allergan investors back AbbVie deal, but is a tax charge looming? (PMLive)
  • The wellness angles to watch in tonight&#8217s debate (Politico) (Axios)
  • Health-related Device Stocks Are in Rude Overall health (WSJ)
  • Gottlieb: Lack of Permanent FDA Commissioner Has an Influence (CHC)

Sponsored: Requesting Quickly Track designation: What you require to know

  • Time is of the essence for sufferers who have significant and life-threatening situations. Quickly Track designation is a single of 4 applications that can support expedite the improvement and overview of drugs intended to address unmet healthcare require in the remedy of significant situations. If you are interested in pursuing a Quickly Track designation for your therapy, right here are some of the fundamentals you will require to know.

In Concentrate: International

  • Merck KGaA to Test Machine Understanding to Avert Drug Shortages (WSJ) (Fierce)
  • Life sciences suffers ‘lost decade’ as investment falls (Monetary Instances)
  • Indivior shares rise as it boosts guidance for a second time (Monetary Instances) (Reuters)
  • European nations raise commitment to accountable antibiotic use in animals (EMA)
  • Danish biotech: white coat catalyst (Monetary Instances)
  • Takeda Sheds Pick Solution Assets In Mid-East, Emerging Markets To Acino (Scrip-$)
  • Boehringer Ingelheim-backed Abalos tosses hat into packed oncolytic virus ring (Endpoints)
  • Woodford fired from flagship fund — which won&#8217t reopen following all (Endpoints) (Scrip-$)
  • Floating in stormy seas, RTW seeks $350M for new London-listed venture fund (Endpoints)

Pharmaceuticals &amp Biotechnology

  • Surprising Wall Street, Reata unveils optimistic pivotal information on Friedreich’s ataxia drug (Endpoints) (Evaluate)
  • Horizon shares information on eye illness drug as FDA selection nears (PMLive)
  • The Ethical Dilemmas AI Poses for Overall health Care (WSJ)
  • Ode to Sufferers (LifeSciVC)
  • Gilead&#8217s chief technique exec gets a huge promotion following orchestrating multibillion-dollar offers (Endpoints) (Press)
  • Gilead vet Alessandro Riva steers Glenmark&#8217s biotech spinoff on independent course (Endpoints)
  • For pharma solutions firms, huge assets can pose key dangers (C&ampEN)
  • Novo Nordisk, Bluebird Targeting ‘Lifelong’ Gene Therapies (Scrip-$)
  • Sanofi US plant sets new bar for biologics production (Fierce) (Press)
  • RWE: Comparators, Therapeutic Location May well Be Crucial For Trial Replication (Pink Sheet-$)
  • Concerns and Answers: NDMA impurities in ranitidine (frequently recognized as Zantac) (FDA)
  • To ease dementia agitation, drugs might not be most effective selection (Reuters)
  • Popular joint discomfort remedy might be a lot more damaging than believed (NBC)
  • Wanted: superior policies and incentives to revitalize R&ampD for new antimicrobial drugs (STAT)
  • DIY drugs: really should hospitals make their personal medicine? (The Guardian)
  • BIO: Two heads are superior than a single (BioCentury)
  • Aeglea, extended-term Eli Lilly veteran nabs CMO job at Checkmate (Fierce)
  • Ancestry launches customer genetics tests for wellness, intensifying rivalry with 23andMe (STAT)
  • Utilizing CRISPR to edit eggs, sperm, or embryos does not save lives (STAT)
  • Drug reverses indicators of liver illness in individuals living with HIV (NIH)
  • Checkmate Pharmaceuticals brings two new execs on board Takeda sheds 30 drugs, gains $200M in Acino deal (Endpoints)
  • Cyteir nets $40M for rad synthetic lethality platform — throwing yet another monkey wrench at cell repair (Endpoints)
  • C-Path, CDISC Create Normal to Represent Information for Animal Rule Research (Press)

Pharmaceutical &amp Biotechnology: Study Final results, Filings &amp Designations

  • U.S. FDA Approves SECUADO® (asenapine) Transdermal Program, the Initially-and-Only Transdermal Patch for the Therapy of Adults with Schizophrenia (Press)
  • CEL-SCI Reports Current Information Overview by the Independent Information Monitoring Committee for Its Pivotal Phase three Head and Neck Cancer Study (Press)
  • Relmada Therapeutics to Announce Final results of Phase two Study of REL-1017 for Therapy Resistant Depression and Conduct Conference Get in touch with on Tuesday, October 15 (Press)
  • Can-Fite Completes Patient Enrollment in Phase II NASH Study of Namodenoson™ (Press)
  • Lineage Cell Therapeutics Presents New OpRegen® Information at American Academy of Ophthalmology Annual Meeting (Press)
  • Can CBD temper Parkinson&#8217s-associated psychosis? UK researchers will appear for answers in PhII study (Endpoints)

Health-related Devices

  • Rx for Physicians: Quit With the Urine Tests (NYTimes)
  • 3M closes $six.7B Acelity buyout (MassDevice)
  • Denterprise International, Inc. Warning Letter (FDA)
  • Reports: Medtronic eyes Colorado for new plant (MassDevice)
  • Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Overall health (MassDevice)
  • Subtle Health-related Receives FDA 510(k) Clearance for AI-Powered SubtleMR™ (Press)

US: Assorted &amp Government

  • Partial CBO score offers enhance to Speaker Pelosi&#8217s drug pricing bill (Politico)
  • ATR Leads Coalition Opposed to Pelosi&#8217s 95% Drug Tax (ATR)
  • Drug Value Controls Gaining Traction At Federal And State Levels (Forbes)
  • Most Americans back many tips to decrease drug charges, but some worry impeachment will get in the way (STAT)
  • Trump Is Attempting Really hard To Thwart Obamacare. How&#8217s That Going? (NPR)
  • How Non-Profit Hospitals Are Driving Up The Price Of Overall health Care (NPR)
  • Topic: Final FY 2020 Funding Requestsfor Domestic HIV and Connected Applications (FAPP)
  • DOJ Casting Wider Net In Pharma Kickback Probes (Pink Sheet-$)
  • Ninth Circuit Says “No” to Res Ipsa-Primarily based Parallel Claims (Drug &amp Device Law)
  • NeuroGrafix v. Brainlab, Inc. (Fed. Cir. 2019) (Patent Docs)

Upcoming Meetings &amp Events

  • FDA Advisory Committee Calendar
  • Strategies &amp Indicates Committee: Investing In The US Overall health Program By Lowering Drug Rates, Decreasing Out-Of-Pocket Fees, And Enhancing Medicare Advantages – 17 October 2019
  • Antimicrobial Drugs Advisory Committee Meeting – 16 October 2019
  • Webinar: Consideration of Uncertainty in Producing Advantage-Danger Determinations in Health-related Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions &#8211 Final Guidance – 16 October 2019


  • IMI Future Get in touch with Subjects (IMI)
  • HIV-optimistic British living in Spain could drop healthcare post-Brexit (Reuters)
  • Marketing investigations: August 2019 (MHRA)
  • Determine if your item is a medicine or a healthcare device (MHRA)
  • Survey reveals &#8216workforce crisis&#8217 in NHS (PharmaTimes)
  • New UK Medicines Bill could increase access to new dementia remedies (Pharmafile)


  • Overall health ministry approves transition time of six months to implement provisions of new Health-related Device Guidelines, 2017 (Pharmabiz)


  • Ontario Expanding Trade and Investment with South Korea (Ontario)
  • Astellas Transfers 3 Solutions in Asia Area to Daiichi Sankyo (Press)

Common Overall health &amp Other Exciting Articles

  • An Oncologist Asks When It is Time to Say ‘Enough’ (NYTimes)

Regulatory Reconnaissance is our everyday intelligence briefing for the regulatory affairs space, bringing you the leading regulatory news stories from about the globe. Every single weekday morning, we aim to bring you the most current highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the most current trends with the prospective to effect regulatory affairs specialists and the business in which they function.
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