Recon: FDA Approves SK Life Science’s Seizure Drug Xcopri Rewrite Coming for Grassley-Wyden Drug Pricing Bill – Regulatory Concentrate


Posted 22 November 2019 | By Michael Mezher&ampnbsp

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

  • Alterations coming to Grassley-Wyden drug bill (Politico) (Senate Finance)
  • FDA approves new epilepsy therapy, a very first for Korea&#039s SK Life Science (BioPharmaDive) (FDA) (Press)
  • AstraZeneca wins FDA approval for Calquence in chronic lymphoma (PMLive) (Endpoints) (Press)
  • ViiV inks bNAb deal with National Institutes of Well being (PharmaTimes) (Endpoints)
  • US vaping-connected deaths rise to 47, circumstances of illness to two,290 (Reuters)
  • Obtaining gobbled up Celgene, the Bristol-Myers CEO ducks inquiries about his important rival (STAT)
  • Biogen&amprsquos prime scientist almost dares FDA not to approve Alzheimer&amprsquos drug (STAT) (BioPharmaDive) (Endpoints)

In Concentrate: International

  • Bayer AG discussed plans to give not-for-profit funding for influence (The Guardian)
  • Sanofi&#039s approach boss to leave as CEO readies revamp (Reuters) (Endpoints)
  • Pakistan grapples with drug-resistant typhoid outbreak (Reuters)
  • Well being Canada Creates New Healthcare Devices Directorate (Concentrate)
  • Brexit Fees EMA Just about &ampeuro60M in 2019 (Concentrate)
  • Italy&amprsquos program to make &ampeuro300-million analysis agency draws fire (Nature)
  • WHO Forges Ahead With New Framework To List Regulatory Authorities (Pink Sheet-$)
  • UK is a leader in early clinical analysis but falls in later study stages, says ABPI (PMLive)
  • Roche extends supply deadline for Spark Therapeutics once more (Reuters) (Endpoints)
  • Across numerous continents, infecting mosquitoes with bacteria outcomes in dramatic drops in dengue illness, trials show (STAT)

Pharmaceuticals &ampamp Biotechnology

  • A bold prediction: Machine finding out will yield new drug candidates inside 3 years (STAT)
  • AI&#039s effect in drug discovery is coming quickly, predicts GSK&#039s Hal Barron (BioPharmaDive)
  • NASEM Committee Calls to Expand Agreements Involving Drug Regulators (Concentrate)
  • FDA Releases 81 Solution-Certain Guidances (Concentrate)
  • Alexandria is pondering massive as it lays out plans for 1.6M square foot Bay Region biotech campus (Endpoints)
  • Azeria raises &amppound32M to take breast cancer drug into humans (Fierce)
  • A study showed RWE can replicate only 15% of RCTs &ampndash is this precise? (MedCity)
  • Generic Drug Approvals In US Off To Slow Begin In FY 2020 (Pink Sheet-$)
  • Cancer cells&amprsquo loss is T cells&amprsquo acquire (Nature)
  • Compound nestled in parasitic worm delivers guarantee as antibiotic against obstinate superbugs (Endpoints)
  • Novel Clinical Trial Styles for Gene Therapies: An Exploration of Challenges by the National Academies&amprsquo Forum on Regenerative Medicine (FDA Law Weblog)
  • Teva to Resume Production of Vital Pediatric Oncology Drug: Also Small, Also Late (Harvard Bill of Well being)
  • International Reference Pricing Beneath H.R.three Would Devastate the Emerging Biotechnology Sector, Top to 56 Fewer New Medicines Coming to Marketplace More than 10 Years (Crucial Transformation) (PhRMA)
  • Vaccine Improvement Challenges Include things like In depth Excellent Handle, Sanofi&#039s Loew Notes (Pink Sheet-$)

Pharmaceutical &ampamp Biotechnology: Study Outcomes, Filings &ampamp Designations

  • BioMarin Submits Promoting Authorization Application to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Serious Hemophilia A (Press)
  • Endo&#039s (ENDP) BLA for Cellulite Therapy Accepted by FDA (Press)
  • Genentech Presents Pivotal Information Demonstrating Tecentriq in Mixture With Avastin Improves General Survival in Individuals With the Most Widespread Type of Liver Cancer (Press)
  • Zymeworks Highlights Advancing Clinical Collaboration with BeiGene and Updated ZW25 Phase 1 Information in HER2-Expressing Cancers at ESMO Asia Congress (Press)
  • Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film (Press)
  • Immunomic Therapeutics&amprsquo Collaborator, University of Florida Presents New Clinical Information from ATTAC-II Study in GBM at the 2019 Society for Neurology (SNO) Annual Meeting (Press)
  • VBI Vaccines Presents Early GBM Tumor Response and Immunologic Information from Aspect B of Ongoing Phase 1/2a Study of VBI-1901 at the 2019 SNO Annual Meeting (Press)
  • Clover Biopharmaceuticals Doses Initially Patient in Phase I Study of SCB-313 in Australia for Malignant Pleural Effusions (MPE) (Press)

Healthcare Devices

  • FDA approves Medtronic balloon to treat lesions hindering dialysis (MassDevice)
  • Medtronic warns individuals of MiniMed insulin pump security concern (MassDevice)
  • Genedrive Receives CE Mark for Hearing Loss Assay (GenomeWeb)
  • Myriad Genetics BRACAnalysis Authorized by Japanese Regulators (GenomeWeb)
  • Life Spine Announces FDA 510(k) Clearance of the Award-winning LONGBOW&ampreg Titanium Lateral Expandable Spacer Program (Press)

US: Assorted &ampamp Government

  • FEDERAL Study: Extra Actions Necessary to Boost Public Access to Study Outcomes (GAO)
  • As FDA toils more than how to regulate CBD, aggravation builds on all sides (STAT)
  • Fed. Circ. Ruling Might Influence Eligibility Of Life Sciences Patents (Law360-$)
  • Residence Advances Bills Targeting Pharma IP Practices (Law360-$)
  • Teva Gets PTAB To Overview Cushing&#039s Syndrome Drug Patent (Law360-$)
  • Democratic Candidates Advocate For Busting Drug Patents (Law360-$)
  • Insys Reaches Creditor Deal For Tiered Ch. 11 Recoveries (Law360-$)
  • PTAB Probes Authenticity Of Prior Art In Discomfort Therapy Case (Law360-$)
  • Ex-FDA chief says Trump got &amplsquospooked by the politics and pushback&amprsquo on banning flavored vapes (CNBC)
  • Trump set to meet with tobacco executives, vaping advocates and public well being groups (CNBC) (Politico)
  • Walgreens Closes Practically 160 Stroll-In Clinics &ampndash What It Signifies for Retail Healthcare (Forbes)
  • Medicare&amprsquos new major care payment rule is excellent news for individuals (STAT)

Upcoming Meetings &ampamp Events Europe

  • EU-Singapore trade agreement enters into force (EC)
  • Possible nitrosamine contamination: request to carry out a threat evaluation (Swissmedic)
  • Contamination Possible Leads UK to Fifth Recall of Ranitidine Drugs (Concentrate)
  • UK Labour Govt Would Enhance Well being Spending, Place Stress On Drug Costs (Pink Sheet-$)
  • EU Regulatory Roundup: Swissmedic Creates Signal Notification Type in Modify to 2020 Specifications (Concentrate)


  • Indian excipient business to method DCGI to curb irrational usage of excipients in domestic industry (Pharmabiz)


  • Medicines: Suspensions from the ARTG (TGA)
  • Consultation: Overview of the regulation of specific self-testing IVDs in Australia (TGA)

Canada Other International

  • Drone firm in talks in Uganda on health-related provide delivery deal (Reuters)

Common Well being &ampamp Other Exciting Articles

  • Sedentary teens threat well being, hearts and minds: WHO study (Reuters)

Regulatory Reconnaissance is our day-to-day intelligence briefing for the regulatory affairs space, bringing you the prime regulatory news stories from about the globe. Every weekday morning, we aim to bring you the most recent highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the most recent trends with the prospective to effect regulatory affairs specialists and the business in which they function.
Want to speak to the editor of Regulatory Reconnaissance? E-mail us at [email protected].
A story&#039s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Concentrate or RAPS.


The post Recon: FDA Approves SK Life Science&#8217s Seizure Drug Xcopri Rewrite Coming for Grassley-Wyden Drug Pricing Bill &#8211 Regulatory Concentrate appeared very first on CBD Oil Headlines.


Latest posts