Regulatory Focus™ > News Articles > Regulatory Recon: Tom Price Confirmed as HHS Secretary; FDA Approves Marathon's Emflaza for DMD (10

Regulatory Recon: Tom Price Confirmed as HHS Secretary FDA Approves Marathon's Emflaza for DMD (10 February 2017)

Posted 10 February 2017 | By Michael Mezher 

Regulatory Recon: Tom Price Confirmed as HHS Secretary FDA Approves Marathon's Emflaza for DMD (10 February 2017)

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

In Focus: US

  • Tom Price Is Confirmed as Health Secretary (NYTimes) (NPR) (Washington Post) (SNL)
  • Public Citizen Challenges Trump's Regulation Executive Order (Pink Sheet-$) (BioCentury)
  • Trump Wants the FDA to Move Faster. His Actions are Having the Opposite Effect (Vox)
  • Speedy Drug Approvals are Risky, But Drug Companies Have Another Idea That's Just Terrible (LA Times)
  • What Three Decades Of Pandemic Threats Can Teach Us About The Future (Health Affairs Blog)
  • Often Advocates Of Faster FDA, Patient Groups Wary Of Trump Deregulation (Xconomy)
  • The heat on pharmacy benefit managers is building (Axios)
  • Americans Are Putting Off Medical Treatments Because They Can't Pay (The Atlantic)
  • Internal HHS Memo: Some FDA Employees Will be Exempt From Trump Hiring Freeze (Focus)
  • FDA Details Combination Product Postmarket Safety Reporting Requirements (Focus)
  • FDA Warns of Risks From Stomach Balloons to Treat Obesity (Focus)
  • FDA Okays Marathon's Emflaza for DMD (Medpage) (FDA) (Reuters) (Press)
  • Senators question Kaleo' $4,500 tag on opioid overdose treatment (Reuters)
  • FDA's Personalized Medicine Leader Leaving for Liquid Biopsy Startup Grail (GenomeWeb) (BioCentury)
  • Big pharma faces costly setback in cancer fight (Financial Times)
  • Industry petitions FDA against new standard for intended use (BioCentury) (Law360-$)
  • Regeneron pins hope on eczema drug as Eylea sales slow (Reuters) (PharmaLetter-$)
  • Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients (KHN)
  • Immunomedics in up to $2 billion licensing deal with Seattle Genetics (Reuters)
  • Slow Medicine: Eyeing the Evidence for Laser Surgery (MedPage)
  • US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order (Pink Sheet-$)
  • Trial watch: Clinical trial cycle times continue to increase despite industry efforts (Nature)
  • How Much Longer Will We Put Up With $100,000 Cancer Drugs? (Cell)

In Focus: International

  • Operational challenges as European regulator prepares to depart U.K. HQ (BioWorld)
  • EMA panel recommends that use of Actelion's Uptravi may continue (Reuters) (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 February 2017 (EMA)
  • Purdue seeks rule that would give it edge in Canadian painkiller market (Reuters)
  • European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (Focus)
  • Brexit could delay key drugs to UK patients, ex-MHRA chairman claims (Pharmafile)
  • ICH Presentation on Integrated Addendum to E6(R1) (ICH)
  • Kitov opens up about fraud allegations, resumes trading (Fierce) (OutsourcingPharma) (Press)
  • Daiichi axes Japan R&D site a month after Indian research unit cull (Fierce)
  • Report of the PMDA-ATC Medical Devices Seminar 2016 (PMDA)
  • Better EU Electronic Application Forms Become Mandatory In March (Fierce)
  • India's 'Cautious' View Dulls Sanofi Hopes For Early Dengvaxia Launch (SCRIP-$)
  • Can A New Formulation Of An Old Drug Get An SPC? European Court To Decide (Pink Sheet-$)
  • Workers protest at Merck's Goa plant, demand wage revision (Indian Express)

US: Pharmaceuticals & Biotechnology

  • The Price of Everything and the Value of Nothing (Eye For Pharma)
  • Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a "Route of Abuse" Approach to Exclusivity (FDA Law Blog)
  • Doctors See Gains Against 'an Urgent Threat,' C. Diff (NYTimes)
  • States Getting into Pricing Issues - Look Out Below! (Lachman Consultants)
  • Indian Company Vikshara Trading & Investments Ltd Refuses FDA Inspection, Placed on Import Alert (FDA)
  • More lost than gained in shifting R&D forecasts (EP Vantage)
  • NSCLC Momentum Goes To Merck And Roche, Bodes Well For Combinations (SCRIP-$)
  • Tracon slips as brain cancer trial misses the mark (Fierce)
  • Epilepsy drug discovered in fish model shows promise in small pediatric clinical trial (NIH)
  • Cancer Drug for Dogs (Paccal Vet-CA1 ) No Longer Conditionally Approved (FDA)
  • What Happens When You Have A Disease Doctors Can't Diagnose? (NPR)
  • BIAL signs mega-million-$ deal for Parkinson's drug in North America (PharmaLetter-$)
  • Ovid, NeuroPointDX team up on rare disease trial (Fierce)
  • Biosimilars in 2016: the highlights (GaBI)
  • Non-biological complex drugs and pharmacopoeias (GaBI)
  • 1000 patient Phase III study required for Armetheon before FDA approval (EPR)

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

  • Aslan reports Phase II varlitinib results ahead of IPO (BioCentury)

US: Medical Devices

  • FDA approves ReMAP's 7D image guidance system for spine surgeries (MassDevice)
  • Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery (FDA)
  • Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error (FDA)
  • Medicare Is Reducing The Cost Of Knee Replacements (Here's How That Could Backfire) (Forbes)
  • Cheap Method for Printing Lab-on-Chip Devices Promises Diagnostic Revolution (Medgadget)
  • Dow Chemical's silicone business play: what it means for medtech (MassDevice)
  • First patients treated in pivotal trial for Theraclion's Echopulse device (MassDevice)
  • Abbott initiates recall of StarClose SE vascular closure system (MassDevice)
  • BIOLASE Announces the FDA Clearance and Worldwide Launch of New Waterlase Express™ All-Tissue Laser System (Press)

US: Assorted & Government

  • Feds Look To Intervene In 20-State Drug Antitrust Suit (Law360-$)
  • Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep (Drug & Device Law)
  • Federal judge approves consent decree with California dietary supplement distributor, Regeneca Worldwide (FDA)

Upcoming Meetings & Events

Europe

  • Tailored and reduced clinical programme for biosimilars (GaBI)

Asia

  • China punishes hospital staff after patients infected with HIV, hepatitis B (Reuters)

India

  • Aurobindo eyes US plant amid Donald Trump push on jobs (Economic Times)
  • Maha FDA to prosecute Mumbai based firm for illegal stocking and supplying of orthopaedic implants (PharmaBiz)
  • One in 3 stent implants in India is possibly unnecessary (Economic Times)
  • Dr Reddy's launches generic drugs in France; expands operations in Europe (Economic Times)
  • India to allow API firms to request EU quality confirmations online (InPharmaTechnologist)
  • Global health groups up in arms against Roche for 'inhuman' pricing of its breast cancer drug trastuzumab (PharmaBiz)

Australia

  • Implementation of reforms - public consultation forecast (TGA)

Zika

  • Zika doctor warns Brazil against lowering guard on birth defects (Reuters)

Other International

  • Position statement on approval of biosimilars in Latin America (GaBI)

General Health & Other Interesting Articles

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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