Regulatory Focus™ > News Articles > Regulatory Recon: Drugmakers Band Together in Cancer Fight, Senate HELP OKs Califf Nomination (12 Ja

Regulatory Recon: Drugmakers Band Together in Cancer Fight, Senate HELP OKs Califf Nomination (12 January 2016)

Posted 12 January 2016 | By Michael Mezher 

Regulatory Recon: Drugmakers Band Together in Cancer Fight, Senate HELP OKs Califf Nomination (12 January 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Senate HELP Committee Votes in Favor of Califf for FDA Commissioner (Focus)
  • Drug Companies to Try a Unified Front Against Cancer (NYTimes) (SCRIP-$)
  • FDA Needs to Change How It Regulates Novel Technologies (Forbes)
  • Upton Welcomes Vice President Biden to Effort to Deliver #CuresNow (E&C Committee)
  • FDA Denies Supernus Pharmaceuticals Petition (FDA)

In Focus: International

  • Asia's Drug Makers Must Focus on Compliance as Aggressive Growth Targets Increase Risk of (Thomson Reuters)
  • After Ebola, two other tropical diseases pose new threats (Reuters)
  • Malaysia Clarifies Policy Position On Refurbished Medical Devices (SCRIP-$)
  • European Commission's MD Groups: Committee Ready To Help With Implementing (Clinica-$)

Sponsored Content: The Regulatory Affairs Landscape has Evolved. Will You?

US: Pharmaceuticals and Biotechnology

  • Statins May Help, Not Hinder, Heart Bypass Recovery (NYTimes)
  • Engineered Stem Cells May Help in ALS (MedpageToday)
  • Who's on board with Twitter's 10,000-character limit? Pharma brand managers (FiercePharmaMarketing)
  • Doctors Split on the FDA's New Policy on Blood Donations from Men Who Have Sex with Men (Press)
  • When Good Medicine Mixes With Bad (NYTimes)
  • Nestle signs $120 million deal with Seres for 'healthy gut' drugs (Reuters)
  • Popular heartburn medication linked to chronic kidney disease (Washington Post)

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

  • US copy of GSK's Advair a step closer as Mylan files generic version (Reuters) (Press)
  • AbbVie has announced it has begun six global Phase III trials of its once-daily, ribavirin-free investigational hepatitis C virus regimen, ABT-493/ABT-530, in patients with genotypes 1-6 chronic infections (Pharmafile)
  • FDA Grants Priority Review for Venetoclax New Drug Application (Press)
  • Gilead Submits New Drug Application to US Food and Drug Administration for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B (Press)
  • Sorrento announces positive data from Phase 3 studies of biosimilar/biobetter antibodies, STI-001 and STI-002 (Press)
  • Coherus and Baxalta announce etanercept biosimilar met primary endpoint in Phase 3 study (Press)
  • Group B Strep Vaccine For Pregnant Women Found Safe, Effective In Phase 2 Trial (Forbes)
  • Cancer Vaccine Granted Orphan Drug Status for AML (MPR)
  • FORMA Therapeutics Enrolls First Patient in Phase 1 Study of FT-1101 in Advanced Hematological Malignancies (Press)
  • Aimmune Therapeutics Enrolls First Patient in Phase 3 PALISADE Trial of AR101 for the Treatment of Peanut Allergy (Press)
  • Santalis Pharmaceuticals Announces First Subject Enrolled in Phase 2 Trial of East Indian Sandalwood Oil (EISO) in Oral Mucositis (Press)

US: Medical Devices

  • Class 1 Recall: Portable Life Support System (FDA)
  • Class 1 Recall: Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman (FDA)
  • FDA approves J&J's Animas Vibe insulin pump & CGM for kids (MassDevice)
  • FDA approves LivaNova's Perceval heart valve (MassDevice)
  • HHS Idea Lab launches initiative to help consumers participate in medical device development (MedCityNews)
  • Neovasc wins FDA nod to expand Tiara TMVR trial (MassDevice)
  • Some stats on medical device and diagnostics investment/M&A patterns from 2015: Ups and downs (MedCityNews)
  • California hospital becomes first in US to prescribe ingestible sensors from Proteus (mobihealthnews)
  • Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for a Fusion Implant System for Extremities Surgery (Press)
  • OptMed Receives FDA Marketing Clearance For Its Topical Surgical Skin Adhesive, BondEase (Press)

US: Assorted and Government

  • Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently Awaited (FDA Law Blog)
  • Former Food and Drug Administration Lawyer Joins Sidley Austin LLP (Press)
  • Lawmakers: Time To 'March In' On Drug Price Gouging  (SCRIP-$) (Focus)
  • Federal judge enters consent decree against Downing Labs (FDA)
  • Supreme Court declines to review Medtronic win in InFuse lawsuit (MassDevice)
  • U.S. justices reject Johnson & Johnson unit's anti-psychotic drug appeal (Reuters)
  • US panel finalizes breast cancer screening recommendations (Reuters) (Washington Post)

Upcoming Meetings and Events

Europe

  • Thomas Senderovitz To Lead Denmark's Drug, Device Agency (Clinica-$)
  • Exelixis Submits Marketing Authorization Application in the European Union for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma (Press)
  • Fujifilm wins CE Mark for Vevo MD UHF ultrasound (MassDevice)
  • MobiusHD Awarded EU CE Mark of Approval to Treat Hypertension (medGadget)
  • Six new therapies approved for NHS Scotland (PharmaTimes)
  • Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease (Press)

India

  • Government showcases low-cost medical innovations (Economic Times)
  • India Deregulates Academic Clinical Trials (SCRIP-$)
  • Torrent Pharma launches Adalimumab biosimilar in India (Economic Times)
  • Written Confirmation of API Exports From India to EU (24 Insight)

Japan

  • Eisai Submits New Application in Europe for In-House Developed Anticancer Agent Lenvatinib Seeking Approval for Indication Covering Renal Cell Carcinoma (Press)

China

  • China's Mandated Use Of Generic Terms To Name All Medical Devices (Clinica-$)
  • CFDA Accepts CASI Pharma's (CASI) MARQIBO IND for Review (Press)
  • Medtronic to build Chinese facility for the manufacture of advanced diabetes devices (FierceMedicalDevices) (MDDI)

Other International

  • Institut Pasteur Completes Genome Sequence of the Zika Virus (ICT)
  • Robotic glove invented by NUS researchers helps patients restore hand movements (MNT)

General Health and Other Interesting Articles

  • Researchers discover three glaucoma-related genes (NIH)
  • This Germ Can Live Decades In Distilled Water, Kill Humans In 48 Hours (NPR)
  • Small declines in kidney function may subtly affect the heart (Reuters)
  • Rare diseases in children identified by DNA project (OnMedica)

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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