Regulatory Recon: Tom Price Confirmed as HHS Secretary

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

IN Focus US:

• Tom Price is confirmed as Secretary of Health (New York Times) (NPR) (Washington Post) (SNL)
• Public Citizen's Trump Challenges Liquidation Order (Pink Leaves $) (BioCentury)
• Trump wants the FDA to be moving faster. Your actions have the opposite effect (Vox)
• Rapid drug approvals are risky, but drug companies have another idea that is simply terrible (Los Angeles Times)
• Three decades of pandemic threats can teach us about the future (Health Affairs blog)
• Often, FDA's fastest advocates, patient groups will resist deregulation Trump (Xconomy)
• Heat in pharmacy benefits managers is construction (Axios)
• Americans discourage medical treatment because they can not afford (the Atlantic)
• The HHS internal memory: Some employees will be exempt from ambush FDA hiring (Focus)
• Details of FDA filing requirements for post-marketing safety product combination (focus)
• FDA warns of stomach swelling risks to treat obesity (Focus)
• FDA approves for DMD Emflaza Marathon (MedPage) (FDA) (Reuters) (Presse)
• Senators question Kaleo's $ 4,500 opioid overdose label (Reuters)
• The leader of personalized medicine for the FDA comes out of the initial liquid biopsy Grial (GenomeWeb) (BioCentury)
• The big pharmaceutical industry faces costly failure in the fight against cancer (Financial Times)
• FDA industry petitions against a new standard for intended use (BioCentury) ($ Law360-)
• The pair hope drug Regeneron against eczema due to slow sales of Eylea (Reuters) ($ PharmaLetter-)
• Dozens of new anticancer drugs to improve survival, frustrating patients (KHN)
• Immunomedics a licensing agreement of up to 2 billion with Seattle Genetics (Reuters)
• Slow Medicine: Examining Laser Surgery Tests (MedPage)
• FDA of the United States is probably not "significant" could be largely saved by the order of reducing regulatory Trump ($ -pink leaf)
• Eve of the test: clinical trial cycles continue to rise despite the efforts of industry (Nature)
• How long will we end up with $ 100,000 of cancer drugs? (Cell phone)

In Focus: International

• Operational challenges as European regulator is preparing to leave the UK headquarters (BioWorld)
• The EMA Group recommends that the use of Uptravi Actelion may continue (Reuters) (EMA)
• Highlights of the meeting of the Pharmacovigilance Risk Assessment Committee (PAC) 6-9 February 2017 (EMA)
• Purdue look for a rule that would give him an edge in the Canadian analgesia market (Reuters)
• European regulatory summary: ENVI budget request EMA for Brexit volatility (Focus)
• Brexit could delay major drugs for UK patients, former president claims MHRA (Pharmafile)
• ICH E6 addition integrated display (R1) (ICH)
• Kitov opens on allegations of fraud, takes Commerce (OutsourcingPharma) (Presse)
• Daiichi axis Japanese site R & D and a month after the Indian unity of the abolished research (fiera)
• Seminar Report PMDA medical devices ATC-2016 (PMDA)
• The best forms of electronic application of the EU become mandatory in March (Fair)
• Sanofi's "conservative" India vision for the initial launch of Dengvaxia ($ scriptures)
• A new formulation of a drug for the old can formulate a CCP? The European Court decided (petal of rose $)
• Workers protest against the Merck plant in Goa, will require a salary review (Indian Express)

US: Pharmaceuticals & Biotechnology

• The price of everything and the value of nothing (eye for Pharma)
• Dissuasive Abuse and 3-Year Exclusivity: FDA Decisions Clarify Content and Focus on Exclusively "Abuse" (FDA Law Blog)
• Doctors see gains against an "immediate threat", C. Difficile (New York Times)
• States enter into price issues - Look out down! (Lachman consultants)
• The Indian company Vikshara Trading & Investments Ltd denies FDA inspection, placed on the import alert (FDA)
• More lost than won in the planned R & D change (EP Vantage)
• Momentum NSCLC Merck and Roche, augurs well for scripture combinations ($)
• TRACON slides as brain cancer test loses the mark (fierce)
• Epilepsy discovered in the fish model is promising in the small pediatric clinical trial (NIH)
• Anti-cancer drug for dogs (Paccal Vet-CA1) already approved (FDA)
• What will happen when you have a disease doctors can not diagnose? (National Public Radio)
• BIAL signed a mega-million agreement for Parkinson's disease $ in North America ($ PharmaLetter-)
• Ovid, NeuroPointDX team on rare disease tests (fierce)
• Biosimilars in 2016: Highlights (Gabi)
• Non-biological complex drugs and pharmacopoeia (Gabi)
• 1,000 patients Phase III trial for Armetheon required prior to FDA approval (EPR)

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

Aslan reports results of Phase II varlitinib before the IPO (BioCentury) - See more about:

US: Medical Devices

• FDA Approves 7D Reassignment Image Guided System for Spinal Surgery (MassDevice)
• Physio-Control Recalls LIFEPAK15 Monitor / Defibrillator Due to the failure of an electric shock delivery (FDA)
• Alaris syringe pump (high flow), 8100 and AIL sensor kits by CareFusion: withdrawal Class I - Error Alarm (FDA)
• Medicare reduces the cost of knee replacement (This is how it could be counterproductive) (Forbes)
• Cheap method for printing Lab-on-Chip Diagnostic devices and instruments Revolution (Medgadget)
• Silicone trading game Dow Chemical: what it means for medical technology (MassDevice)
• The first patients in the pivotal trial of Echopulse Theraclion device (MassDevice)
• Abbott initiates withdrawal of the vascular closure system StarClose SE (MassDevice)
• BIOLASE announces the launch of the FDA and the worldwide launch of the new Waterlase® Express ™ (All Press)

US: Assorted & Government

• The tax authorities are considering drug prohibition and 20 state prosecution ($ Law360-)
• Nebraska Daubert Order a mile from the expert mouth, but only six inches (law and drug devices) deep
• The federal judge approves the Consent Decree with the California Food Supplement, Regeneca Worldwide (FDA)

Upcoming meetings and events

Europe

• Adapted and reduced clinical program for biosimilars (Gabi)

Asia

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

India

• Aurobindo sees America plant amid thrust Donald Trump in employment (Economic Times)
• Maha FDA to follow a company based in Mumbai for the storage and supply of illegal orthopedic implants (Pharmabiz)
• A 3-stent implant in India is probably unnecessary (Economic Times)
• Dr. Reddy launches generic drugs in France; Develops its activities in Europe (Economic Times)
• India to allow API companies to request EU quality confirmations online (InPharmaTechnologist) World Health Groups in arms against Roche for the "inhuman" price of its anti-breast cancer drug (trastuzumab Pharmabiz)

Australia

• The implementation of reforms - the public consultation forecasts (TGA)

Zika

• Zika doctor warned Brazil against reducing the guard of congenital malformations (Reuters)
• Another international
• Statement of position on the approval of biosimilars in Latin America (Gabi)
• General health and other interesting articles
• The first genetic transmission in mammals could help the great New Zealand eradication plan (MIT Technology Review)

Regulatory compliance is our daily intelligence report for the Regulatory Affairs area, which gives you the best of the new regulations around the world. Each day of the week, our objective is to present the last moments of the approval of new developments, meetings, legal and political, regulations and guides, as well as the latest trends that can affect the professionals of the regulators and the industry in the That work.