Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Novartis' Rydapt for AML; Questions Raised Over UK Cancer Drugs Fund

Regulatory Recon: FDA Approves Novartis' Rydapt for AML Questions Raised Over UK Cancer Drugs Fund (28 April 2017)

Posted 28 April 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Novartis' Rydapt for AML Questions Raised Over UK Cancer Drugs Fund (28 April 2017)

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

In Focus: US

  • Novartis bags FDA OK for Rydapt, a new chemo combo drug for AML (Endpoints) (FDA)
  • FDA Approves First Treatment for a Form of Batten Disease (Focus) (Reuters)
  • FDA approves Bayer's Stivarga to treat most common liver cancer (Reuters) (FDA) (Press) (Pharmafile)
  • A Refreshing Voice At Bristol-Myers Squibb (Forbes)
  • CAR T therapies drive into new terrain (Nature)
  • The wider role of regulatory scientists (The BMJ)
  • Editorial: The phony war on high drug prices (Modern Healthcare)
  • With Exondys 51 approved, Sarepta chief Ed Kaye to bow out (Fierce)
  • Senate Committee Advances Gottlieb Nomination as FDA Commissioner (Focus)
  • Drug effectiveness should influence what doctors prescribe (STAT)
  • No vote on healthcare bill this week in US House (Reuters) (Washington Post)
  • Generic Drug Patent Cases Fell By One-Third In 2016: Report (Law360-$) (Pink Sheet-$)
  • FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics (Pink Sheet-$)
  • House and Senate Revive Bill Targeting Generic Drug Delays (Focus) (IHP-$)
  • Value-Based Pricing For Pharmaceuticals In The Trump Administration (Health Affairs Blog)
  • Sandoz, Amgen, and the Federal Government at the Supreme Court (Patent Docs) (SCOTUSblog)
  • Price: How the Trump administration is fighting the opioid epidemic (Cincinnati)

Sponsored Content: Trying to Map Out the Transition to Comply with IDMP Standards?

In Focus: International

  • Cancer Drugs Fund 'huge waste of money' (BBC) (The Guardian) (Reuters) (PharmaTimes) (Pharmafile)
  • CFDA Approves BMS' Daklinza and Sunvepra Combo for HCV (Press)
  • Sanofi Shares Hit 18-Mo High As Genzyme, Consumer Goods Deliver Strong Q1 (The Street) (Press)
  • Mystery deaths in Liberia linked to funeral: WHO (Reuters)
  • AstraZeneca shareholders revolt over chief executive's £13m pay (The Guardian)
  • AstraZeneca's pivot point might not come until 2018 (Financial Times)
  • European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (Focus)
  • Blood Disorders Overtake Cancer On EMA's PRIME Scheme (Pink Sheet-$)
  • Situation Far From Ideal But EU Network Will Survive Brexit (Pink Sheet-$)
  • NICE u-turn recommends some access to Takeda's Adcetris (PharmaTimes)
  • NICE backs new option for Crohn's disease (PharmaTimes)
  • Oncology Combo Drugs Face UK Market Access Disappointment (Pink Sheet-$)
  • UK Medical Device Regulators Introduce "Virtual Manufacturing" to Replace OBL (Emergo)
  • Reputation of the pharmaceutical industry a key focus for new ABPI President (ABPI)
  • European Medicines Agency closed 1 May 2017 (EMA)

US: Pharmaceuticals & Biotechnology

  • The five competencies of continuous regulatory compliance (Pharmafile)
  • Got Drugs? Saturday Is National Drug Take Back Day (Forbes)
  • CDER Officials: Nanomaterial Submissions on the Rise (Focus)
  • Innovative Contracting for Pharmaceuticals and Medicaid's Best-Price Rule (Journal of Health Politics, Policy and Law)
  • After Arkansas Execution, Questions Are Raised About Drug's Effectiveness (NYTimes)
  • This company hopes to make opioid addiction treatment for home use (STAT)
  • Takeda, Harrington set up rare disease research program (Fierce)
  • Medicaid, health care system confronting high cost of specialty drugs (Wisconsin State Journal)
  • Biopharma just can't get enough of Epic Sciences (MedCityNews)
  • Bristol-Myers drops option to buy HER2 cancer biotech (Fierce)
  • What's Next in Genomic Medicine? (Medpage)
  • Diabetes Tied to Brain Abnormalities (NYTimes)
  • Meet the Global Head of Bioclinica's Pharmacovigilance and Regulatory Operations (Bioclinica)
  • RoxyBond Clears US FDA With Abuse-Deterrent Properties, But No REMS Yet (Pink Sheet-$)
  • Seattle Genetics releases first quarter results and clinical development update (PharmaLetter-$)
  • General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children (FDA)
  • Building the Infrastructure for Outcomes-based Contracts (Drug Channels)
  • Merck's daring bid for lung cancer domination (EP Vantage)
  • FDA Reopens Comment Period for Pharmaceutical Distribution Supply Chain Pilot Projects (Federal Register)
  • Petition Calls for Sentinel Query on Off-Label Use of Ulcer Drug (FDANews-$)
  • Acorda misses on Q1 earnings, slashes expense guidance after restructuring (Drug Delivery)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Sanofi And Regeneron Announce Kevzara® (Sarilumab) Biologics License Application Resubmission Accepted For Review By US FDA (Press)
  • Moderna Announces Positive Interim Phase 1 Clinical Data Demonstrating First mRNA Vaccine Candidate, mRNA-1440, Induces High Levels of Immunogenicity (Press)
  • Ignyta Updates Progress towards Entrectinib Dual TRK and ROS1 NDA Submissions (Press)
  • Novo Nordisk Receives FDA Approval of Saxenda® (liraglutide) injection 3 mg Label Update Including Long-Term Safety and Efficacy Data from 3-Year Trial (Press)
  • Braeburn's risperidone implant meets primary endpoint in schizophrenia trial (Drug Delivery)

US: Medical Devices

  • Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices (MassDevice)
  • Galatea Surgical wins FDA 510(k) for GalaForm 3D plastic surgery scaffold (MassDevice)
  • Bausch & Lomb wins FDA 510(k) for Vitesse open-port vitrectomy system (MassDevice)
  • Nordisk wins label update for weight loss drug-device combo (MassDevice)
  • FDA approves J&J's Mentor MemoryGel Xtra silicone breast implants (MassDevice)

US: Assorted & Government

  • As Trump And Congress Flip-Flop On Health Care, Insurers Try To Plan Ahead (NPR)
  • Working to Raise Awareness and Reduce Health Disparities (FDAVoice)
  • Texas Sues FDA Over Ban On Import Of Execution Drug (Law360-$)
  • The Cheese Runneth Over . . . Into Illinois (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • 100% import substitution is impossible in Russian pharmaceutical industry, says trade group (PharmaLetter-$)
  • Boehringer Ingelheim upping capacity with €700m mammalian cell culture plant (BioPharmaReporter)
  • Contego Medical wins CE Mark for Vanguard IEP angioplasty system (MassDevice)
  • Advertising investigations: March 2017 (MHRA)

Asia

  • Daiichi Sankyo to invest 15 billion yen in manufacturing for ADC portfolio (PharmaLetter-$)
  • Singapore, UAE government funds' new investments put PPD at $9B (Fierce)
  • Thermo Fisher collaborates to establish single-use and automation site in China (BioPharmaReporter)
  • United BioPharma selects GE Healthcare's FlexFactory for Taiwan HIV drug plant (BioPharmaReporter)
  • Celltrion applied for biosimilar trastuzumab in Japan (Biosimilar News)
  • Celltrion agrees with Nippon Kayaku for rituximab biosimilar in Japan (Biosimilar News)
  • Transfer of 16 Long-Listed Products in Japan to LTL Pharma: Closing of Asset Purchase Agreement (Astellas)

India

  • Telangana health dept recalls 8 drugs from 2 hospitals after 5 maternal deaths (PharmaBiz)
  • State govts must make it mandatory for hospitals to publish clinical outcome data to protect patients' interest (PharmaBiz)
  • Maharashtra FDA Warns Hospitals for Reusing Single Use Devices (Economic Times)
  • Cardiac stents will continue to be made available at price stipulated as per govt price fixation notification: NPPA chairman (PharmaBiz)
  • Medtronic, Abbott could still seek exit from India's high-end stent market (MassDevice)
  • ICMR launches 'Indian Rare Disease Registry' to address unmet needs of patients with rare diseases (PharmaBiz)

Canada

  • Medtronic wins Health Canada nod for OsteoCool RF ablation system (MassDevice)

Other International

    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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

    A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


    Categories: Recon, Regulatory News

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