Regulatory Focus™ > News Articles > Regulatory Recon: Trump Meets with NIH Contenders; NICE Backs Novartis Kidney Cancer Drug (12 Januar

Regulatory Recon: Trump Meets with NIH Contenders NICE Backs Novartis Kidney Cancer Drug (12 January 2017)

Posted 12 January 2017 | By Michael Mezher 

Regulatory Recon: Trump Meets with NIH Contenders NICE Backs Novartis Kidney Cancer Drug (12 January 2017)

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

In Focus: US

  • Shire fined $350 million in largest-ever bribery case of its kind (Pharmafile) (Financial Times)
  • AbbVie vows to keep drug price  increases below 10 percent (Reuters)
  • Cigna drops coverage of Mylan's EpiPen in favor of cheaper generic (Modern Healthcare) (The Street)
  • Trump's Obamacare Plan: Still Optimistic, Still Vague (NYTimes)
  • Senate Takes Major Step Toward Repealing Health Care Law (NYTimes) (Reuters)
  • Freedom Caucus Won't Block Obamacare Repeal Plan (NationalJournal)
  • Trump's Obamacare impatience challenges GOP (Politico)
  • Trump meets with two contenders to lead NIH (STAT)
  • HHS Nominee Might Not Be Confirmed Until Mid-February, Says Senator (Roll Call)
  • Trump Sides With HHS' Burwell and Democrats on Drug Price Negotiations -(Focus) (Forbes 1, 2) (Bloomberg)(InsideHealthPolicy)
  • Trump's Plan to Cut Drug Imports Could Raise Prices, Not Lower Them (NYTimes)
  • Pandemic Vaccines Probably Can't Use Accelerated Approval – US FDA Chief Scientist (Pink Sheet-$)
  • CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming (Focus)
  • FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices (Focus)
  • IBM Watson, FDA to explore blockchain for secure patient data exchange (ComputerWorld) (Press)
  • FDA Warns on MRI in Patients with Implantable Pumps (Medpage) (FDA)
  • FDA rejects Tesaro's IV version of rolapitant, citing manufacturing issues (Endpoints) (Nasdaq)
  • CureVac's lead mRNA program flunks a critical PhIIb study, raising questions for high-profile biotech unicorns (Endpoints)

In Focus: International

  • Pfizer launches production in Russia (PharmaLetter-$)
  • Success/failure business models in Japan's Pharma (PharmaLetter-$)
  • European Regulatory Roundup: EMA Maps International Regulatory Coordination (Focus)
  • EU nod for Novo's new fast-acting insulin (PharmaTimes)
  • NICE supports use of asthma smartinhaler (PharmaTimes)
  • NICE recommends Novartis' kidney cancer drug (PharmaTimes) (EPR)
  • Takeda invests $125m in Maverick T-cell platform partnership (Pharmafile)
  • No new antidepressants in sight despite growing need, experts warn (Reuters) (The Guardian)
  • Malaysian Authorities Publish Medical Device Registration Transfer Policy (Emergo)
  • New European Monographs Set 'Robust Standards' For Biosimilar Development (Pink Sheet-$)
  • Mali eradicates Guinea worm in global milestone against parasitic disease (Reuters)
  • Vertex grants Merck KGaA rights to cancer programs (BioCentury)
  • FDA and MHRA Break Down Foreign Inspection Data (Focus)

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US: Pharmaceuticals & Biotechnology

  • Team Discovers Novel Target for Attacking Ebola (GEN)
  • Shire Accused Of Cutting Pay-For-Delay Deal On ADHD Drug (Law360-$)
  • NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs (Focus)
  • Five big mysteries about CRISPR's origins (Nature)
  • J.P. Morgan Notebook Day 3: Novartis' Cancer Reorg, Abbvie's Price Pledge, Genentech's Partnering And More (Pink Sheet-$)
  • Combination Product Regulatory Improvements Remain High on Pharma's 2017 Wish List (IPQ)
  • Jet-setting CAR-Ts: Kite details commercialization plans at #JPM17 (MedCityNews)
  • Cardinal Health fined $44 million for opioid reporting violations (Washington Post)
  • BMS' Eliquis is 'relatively close' to snagging market lead from J&J's Xarelto, CEO says (Fierce)
  • What can CROs and CMOs expect in 2017? (OutsourcingPharma)
  • Hold the tPA? Study Probes Necessity of IV Thrombolysis Prior to Endovascular Therapy for Acute Stroke (TCTMD)
  • Teva: 'Celltrion deal will double biosimilar sales to $600m' (BioPharmaReporter)
  • Drug Compounding: FDA Issues Final Guidance on Section 503A's Individually Identified Prescription Requirement – With At Least Three Noteworthy Changes (FDA Law Blog)
  • Biogen spin-out Bioverativ 'not your normal upstart', says new chief (Fierce)
  • Ionis to get volanesorsen in front of the FDA 'ASAP' – CEO (Fierce)
  • How Much Are Docs Responsible for Patients' Opioid Abuse? (Medpage)
  • FDA Reports Uptick in Antibiotic Use in Food Animals (National Law Review)
  • FDA Issues Newest Guidance Regarding Biosimilar Application Process (Patent Docs)
  • Strategic partnership forms single-source solution for biopharma (OutsourcingPharma)

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

  • MorphoSys Partner to Start Phase 2 Trial with Bimagrumab in Obese Patients with Type 2 Diabetes (Press)
  • VivaGel® BV granted QIDP and Fast Track designation by US FDA (Press)

US: Medical Devices

  • NIST submits a draft update of the federal gold standard for cybersecurity (Modern Healthcare)
  • Cheaper Over-The-Counter Hearing Aids Could Be On The Way (KHN)
  • Layoffs ahead for ReWalk Robotics (MassDevice)
  • Arterys wins 510(k) clearance for medical imaging analytics software (MassDevice)
  • FDA clears next-gen Sonablate prostate device from SonaCare (MassDevice)
  • Integra LifeSciences to acquire Derma Sciences for $200m (MassDevice)
  • Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens (FDA)

US: Assorted & Government

  • MDL Court: Preemption Leaves No "Glimmer of Hope" for Labeling Claims Against a Pharmacy (Drug & Device Law)
  • ACA Repeal Would Lavish Medicare Tax Cuts on 400 Highest-Income Households (Center on Budget and Policy Priorities)
  • 7 Key Policies In HHS Inspector General's Exclusion Rule (Law360-$)
  • Bicameral Leaders Request Details on Coverage of Optional State Medicaid Eligibility and Benefit Categories (E&C)
  • How do higher deductibles impact care for chronic disease? (Reuters)
  • U.S. states mull contraception coverage as Obamacare repeal looms (Reuters)
  • Novo Nordisk Accused Of Fixing Prices To Hide Sales Slump (Law360-$)
  • Theranos Seeks Out Of Blood-Testing Suits (Law360-$)
  • Seattle Genetics Hid Cancer Drug Concerns, Investors Say (Law360-$)

Upcoming Meetings & Events

Europe

  • Aerie to build manufacturing facility in Ireland (In-PharmaTechnologist)
  • Phase II trial for F2G's antifungal drug following EU approval (EPR)
  • New production of drugs from human blood plasma to be established in Russia (PharmaLetter-$)
  • GenePOC Instrument, Assays Get CE Mark (GenomeWeb)

Asia

  • China's Pharmaron in Xceleron buyout deal (Fierce)
  • Eisai to launch medication administration support device e-okusuri-san® (Press)
  • Be Very Careful in China's Medical Device Market (Pacific Bridge Medical)

India

  • India's pharma market showing healthy growth, and domestic drugmakers making forays into USA and Europe (PharmaLetter-$)
  • India Pharma 2017: 3Cs And D (Disruption)? (SCRIP-$)
  • Indian cardiac stents as expensive as imports: MNC association (Economic Times)
  • Gujarat govt to sign 250 MoUs related to pharma sector at Vibrant Gujarat Global Summit-2017 (PharmaBiz)
  • Drug manufacturers in Bihar gear up to approach state govt to demand for exclusive pharma policy for the state (PharmaBiz)

Australia

  • 2016-2017 Technical Review of Australian Gene Technology Regulations 2001 (National Law Review)

Zika

  • Angola reports first two cases of Zika virus (Reuters)
  • Dermatitis Was Main Symptom in First Local US Zika Case (Medpage)

General Health & Other Interesting Articles

  • I Abstained From Sex for a Year to Donate Blood (NYTimes)
  • Eggs from Skin Cells? Here's Why the Next Fertility Technology Will Open Pandora's Box (MIT Technology Review)
  • Does All Mental Illness Derive from a Common Source? "Yes," Says Former FDA Commissioner (Big Think)
  • Study finds how stress raises heart disease and stroke risk (Reuters)
  • Toddlers born by reproductive treatments develop normally (Reuters)
  • Top prevention priorities for patients and doctors (Reuters)

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.


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