Regulatory Focus™ > News Articles > Regulatory Recon: WHO Says Low Risk of Zika Spreading to EU; FDA Approves BMS' Opdivo for Classical

Regulatory Recon: WHO Says Low Risk of Zika Spreading to EU FDA Approves BMS' Opdivo for Classical Hodgkin's Lymphoma (18 May 2016)

Posted 18 May 2016 | By Michael Mezher 

Regulatory Recon: WHO Says Low Risk of Zika Spreading to EU FDA Approves BMS' Opdivo for Classical Hodgkin's Lymphoma (18 May 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

  • FDA Official Dispels '100 Hours' Myth on Time it Takes to Fill Out Compassionate Use Form (Focus)
  • Medicine: A Very Personal Problem (Scientific American)
  • FDA approves Bristol Myers-Squibb's Opdivo in rare blood cancer (PharmaLetter-$) (BioCentury) (Press)
  • FDA Rebuked For Blocking Cancer Patient's Treatment (Law360-$) (GoLocalProv)
  • Valeant Said to Weigh Sale of Skin, Cancer Drugs to Cut Debt (Bloomberg)
  • Studies that intentionally infect people with disease-causing bugs are on the rise (Science)
  • Is High Prescription Drug Spending Becoming Our New Normal? (Health Affairs Blog)
  • The Importance of Transparency in Scientific Innovation (Harvard Bill of Health)
  • House to vote on Zika package today after Senate Advances Funding Bill (Politico) (Focus)
  • Some Generic Medications Are Too Expensive. Here's How To Reduce Their Price (Forbes)

In Focus: International

  • Novartis splits drugs business into two, pharma chief to leave (Reuters) (WSJ-$)
  • How much should patients know about pharma payments to doctors? (The Guardian)
  • India eyes oil-for-drugs deal with Venezuela to recoup pharma cash (Reuters)
  • Zika virus may spread to Europe in coming months, WHO warns (Reuters)
  • Zika must remain a high priority (Nature)
  • Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (Focus)   
  • Has the yellow fever outbreak tipped over into a global health emergency? (STAT)
  • Comparing EU Vs. US Accelerated Pathway Approval Times Makes Senior UK Regulator 'Slightly Defensive' (Pink Sheet-$) (PharmaPhorum)
  • Pascal Soriot's big experiment: reinventing AstraZeneca (Reuters)

Drug Approval - Speed your time to market with FDA's Expedited Programs

US: Pharmaceuticals & Biotechnology

  • Publishers announce new way to link clinical trials with publications (All Trials)
  • FDA Searching for Applicants for Director of the Division of Human Tissues in CBER (FDA)
  • Bankruptcy filing worries developers of nanoparticle cancer drugs (Nature)
  • 'Pay For Performance' Drug Plans Could Impact Biopharma's R&D Priorities (Forbes)
  • Novartis breast cancer drug set to take on Pfizer's Ibrance (Reuters)
  • BMS expands biologics facility in MA (BioPharma-Reporter) (Press)
  • Andrew Left Challenges Mallinckrodt to Do Proper Study of Its Main Drug (The Street)
  • New Report: Nearly 4.5 Million U.S. Jobs and $1.2 Trillion Economic Output Supported by Biopharmaceutical Sector in 2014 (PhRMA)
  • Braeburn to move ahead with $20M Durham expansion, despite objection to HB2 (Boston Business Journal)
  • NIH funds new studies on ethical, legal and social impact of genomic information (NIH)
  • Snake antivenom boost adds bite to BTG (Financial Times)
  • Glaxo's Bexsero supply rebounds after demand for MenB jab outstrips supply (Fierce)
  • Benchmarking Biomarkers In Clinical Trials (In Vivo-$)
  • Preclinical outsourcing to grow 20% in 2016 says new report (Outsourcing-Pharma)
  • Novartis considers new sales model for experimental cancer therapy (MM&M)
  • Is this the Uber of pharmacies? These entrepreneurs think ordering prescription drugs needs a revamp (MedCityNews)
  • Bayer, ERS announce licensing agreement for genome-editing patents (BioPharma-Reporter)
  • FDA To ANDA Sponsors: Don't Forget Quality When Rushing For 10-Month Review Goal (Pink Sheet-$)
  • Rethinking the Role of Regulatory in Innovation: Part 2 (Pharmaceutical Compliance Monitor)
  • Will Pfizer renew with Icon, Parexel? Analyst says yes (Outsourcing-Pharma)
  • SPRINT Strategy Would Be Cost Effective (Medpage)
  • J&J commits $740M for its second cancer R&D pact with MacroGenics (Fierce)
  • Empagliflozin CV Outcomes Data: Is Sum Of The Parts Greater Than Whole? (Pink Sheet-$)
  • HIV-infected patients less likely to get cancer treatment (Reuters)
  • Treating Opioid Addiction With A Drug Raises Hope And Controversy (NPR)
  • Prospective Grant of Start-up Exclusive License: Development of Virus Like Particles for the Treatment of Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, and Hepatocellular Cancer (NIH)
  • Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers (NIH)

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

  • Novartis wraps LEE011 PhIII early, barrels toward Pfizer showdown (Fierce)
  • AstraZeneca's Lynparza fails in gastric cancer combination test (Reuters) (Pharmafile)
  • Newron receives go ahead to test Sarizotan for treatment of Rett Syndrome (EPR)
  • Oramed says oral insulin succeeds in midstage type 2 diabetes trial (Reuters)
  • Novo Nordisk files long-acting factor IX for haemophilia B in US (PharmaPhorum)
  • Wilson Therapeutics AB: Wilson Therapeutics Announces That the Ongoing Phase II Study Has Been Fully Enrolled (Press)
  • VM BioPharma Announces FDA Fast Track Designation Granted for Investigational Gene Therapy VM202 for Patients with Amyotrophic Lateral Sclerosis (ALS) (Press)
  • Mission Pharmacal Receives FDA Approval for Liquid Potassium Iodide Oral Solution for Nuclear Emergency Management (Press) (MPR)
  • FDA Grants IND Approval to Stemedica for a Traumatic Brain Injury Phase IIa Clinical Trial (Press)
  • Aratana Therapeutics Granted FDA Approval of ENTYCE (capromorelin oral solution) (Press)
  • Moberg Pharma Announces Multiple Patent Approvals for MOB-015 (Press)

US: Medical Devices

  • J&J and HP partner on 3-D printing for medical, consumer products (Fierce) (MassDevice) (Press)
  • Monitoring Data Shows Adequacy of New Payment Amounts for DMEPOS in Non-Competitively Bid Areas (CMS)
  • With a Patient's Virtual Heart, Doctors Predict Cardiac Arrest (IEEE Spectrum)
  • U.S. trial test machine that 'reconditions' lungs outside body (Reuters)
  • FDA Unveils Its Approach to Infectious Disease Sequencing Diagnostics (MDDI) (Focus)
  • Renal Dynamics launches post-market trial for Redy 3rd-gen renal denervation device (MassDevice)
  • Digital "fingerprint" for medical devices could help thwart hackers (MassDevice)
  • Waltham diagnostics firm Interleukin Genetics gets ready to relist on the Nasdaq (Boston Business Journal)
  • ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA (Gray Sheet-$)
  • FDA Finalizes Postmarket Device Surveillance Guidance (FDA Law Blog)
  • Positive results for Pacific Edge's bladder cancer diagnostic (PharmaPhorum)
  • Millennium Dental Technologies Receives First-of-Its Kind FDA Clearance for Tissue Regeneration (Press)

US: Assorted & Government

  • Mass Appeal of Off Label Use (Drug and Device Law)
  • Divide Runs Deep Over Medicare B Drug Payment Experiment (SCRIP-$)
  • J&J to stand behind talc's safety at upcoming trials: lawyer (Reuters)
  • Pfizer ban on lethal drug sales complicates executions in 20 states (Reuters) (Montgomery Advertiser)
  • Office Of National Drug Control Policy: Progress toward Some National Drug Control Strategy Goals, but None Have Been Fully Achieved (GAO)
  • U.S. FDA approves first appetite-stimulating drug for dogs (Reuters)
  • FDA Gets Serious about Regulating E-Cigarettes (Harvard Bill of Health)
  • Patent Office to Review a Regimen of AbbVie's Humira (WSJ-$) (Reuters)
  • Amgen And Sandoz Do Biosimilar Patent Dance Over Neulasta (National Law Review)

Upcoming Meetings & Events

Europe

  • AstraZeneca cuts 1,600 contract reps, in-house force in drive to save $1.1B: sources (Fierce)
  • UK To Launch Single £6bn Innovation Fund To Promote Collaboration Across Research Fields (SCRIP-$)
  • Sonova misses targets as Costco, cochlear implants hurt results (Reuters)
  • EMA's 2015 Annual Report: Interest in Scientific Advice Increasing (Focus)
  • EMA accepts submission for Zebinix use as a monotherapy for partial-onset seizures (EPR)
  • Swedish Regulators Find Capsugel's Oregon Site Not GMP Compliant (Focus)
  • Juniper invests in mixer tech for UK plant (In-PharmaTechnologist)
  • Roche confirms it will cease operations at Co Clare plant with 240 job losses (NewsTalk)

Asia

  • Turkey Pushing Hard For Local Production But Multinationals Cautious (PharmasiaNews-$)
  • Solasia files New Medical Device Application for episil in Japan, China (BioSpectrum)

India

  • Dr Reddy's recalls 50,000 bottles of tablets in US (Economic Times)
  • Roche presses on biosimilar labels in India with Avastin challenge (Fierce)
  • Pharma exports growth heading for a sharp decline: Crisil (Economic Times)
  • Karnataka DC to act tough against pharmacy outlets & cos engaged in wrong disposal of expired drugs (PharmaBiz)
  • Health ministry to expand list of experts in expert panels & SECs to advise DCGI in matters relating to approval of new drugs (PharmaBiz)
  • Patent experts welcome National IPR Policy creating conducive environment for pharma industry growth (PharmaBiz)
  • NIH OBTAINS INDIAN PATENT FOR DENGUE VACCINE (24 Insight)
  • USFDA Grants Tentative Approval For Aurobindo's ANDA For Ampyra (24 Insight)
  • Macleods Receives Tentative Approval For A Generic Version Of Staxyn (24 Insight)

Canada

Australia

  • Australia approves Vela Diagnostics' HCV Genotyping Assay (BioSpectrum)

Zika

  • A Primer: How The Fight Against Zika Might Be Funded (KHN)
  • White House opposes House Zika bill, calls funding inadequate (Reuters)
  • Brazil's Abortion Restrictions Compound Challenge of Zika Virus (NYTimes)

Other International

  • South Africa's Aspen Pharmacare signs U.S. supply deal with ANI (Reuters)
  • Large-scale HIV vaccine trial to launch in South Africa (NIH)

General Health & Other Interesting Articles

  • You Say Potato, I Say Worthless Epidemiology (CardioBrief)
  • Potatoes four times a week could cause high blood pressure, says study (The Guardian)
  • Glyphosate And Cancer (In The Pipeline)
  • COPD symptoms common in current, former smokers without diagnosis (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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