Regulatory Focus™ > News Articles > Regulatory Recon: Seven Blockbuster Drugs Expected in 2016; Zika Fears Spread (3 February 2016)

Regulatory Recon: Seven Blockbuster Drugs Expected in 2016 Zika Fears Spread (3 February 2016)

Posted 03 February 2016 | By Zachary Brennan 

Regulatory Recon: Seven Blockbuster Drugs Expected in 2016 Zika Fears Spread (3 February 2016)

In Focus: US

  • Seven $1 billion-plus drugs seen reaching market in 2016 (Reuters)
  • Free Speech and Pharmaceutical Regulation—Fishy Business (JAMA)
  • Obama Wants $1.1bn to Fight Opioid Abuse (Stat) (Politico) (MedPage Today)
  • Valeant, Turing Boosted Drug Prices to Fuel Preset Profits (WSJ-$)(SCRIP-$)(Law360-$)(In the Pipeline)(Stat)(Washington Post)(Focus)
  • FDA Guidance Output Plans for 2016 (Eye on FDA)
  • Editorial: Senators should end delay, cast vote on Obama’s pick to lead FDA (Pittsburgh Post-Gazette)
  • Anger and suspicion fuel big TB outbreak in rural Alabama (Stat)
  • Mammography Facilities: Understanding Your Role in Medical Device Reporting (FDA)
  • Like It Or Not, FDA Is At The Center Of Drug Pricing Debate (Pink Sheet-$)

In Focus: International

  • MPs pass innovative medicines bill (BMJ-$)
  • EMA reviews ‘restrictive’ prescribing advice for metformin (Pharmaceutical Journal)
  • UK better inside EU, says GlaxoSmithKline boss (Guardian)
  • How to facilitate development of cancer immunotherapies (EMA)
  • WHO calls for further investigation into sexual spread of Zika virus (Reuters)
  • Drug industry starts race to develop Zika vaccine (WSJ-$)(BMJ)[Editor’s note: More Zika news down below]
  • Teva upskilling of UK sterile site could lead to loss of 80 jobs (InPharma-Technologist)
  • AstraZeneca says new lung cancer pill Tagrisso approved by EU (Reuters)

US: Pharmaceuticals and Biotechnology

  • White House wants $1 billion for Vice President Biden’s cancer moonshot. Where will it come from? (Science)
  • Virginia the latest state to push drug pricing transparency bill (Stat)
  • Combination therapies in oncology (Nature Reviews Drug Discovery)
  • New targets for drug delivery across the BBB (Nature Reviews Drug Discovery)
  • 2015 FDA drug approvals (Nature Reviews Drug Discovery)
  • Sandoz, Pfizer and regulators back biosimilar data extrapolation (BioPharma-Reporter)
  • CRISPR hits Wall Street as Editas Bags $94m in IPO (Xconomy)(BioCentury)(Bloomberg)
  • Misfit Vets Out to Debug Science Experiments With Elemental Machines (Xconomy)
  • Top US cancer centers push for more use of HPV vaccine (BMJ-$)
  • 'Let this letter be a shot across the bow to the entire industry' (FierceBiotech)
  • Waksal’s Kadmon said to plan IPO, without Waksal (CNBC)
  • GSK, Adaptimmune expand cancer immunotherapy alliance (PharmaTimes)(Pharmafile)
  • Purdue Looks To Patent Portfolio, FDA Guidance To Delay OxyContin Generics (Pink Sheet-$)
  • J&J's Talcum Powder Goes on Trial in Ovarian Cancer Lawsuits (Bloomberg)
  • Single-use, double-digits: Sartorius riding high on disposable demand (BioPharma-Reporter)

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

  • Allergan deal will go ahead, says Pfizer chief (Pharmaphorum)
  • Pfizer revenues down, but above expectations (Pharmafile)(Pink Sheet-$)
  • Merck's Top-Selling Diabetes Drugs Miss Sales Estimates (Bloomberg)
  • Gilead’s 4th-qtr sales and earnings beat expectations, as Harvoni soars (PharmaLetter-$)(Bloomberg)
  • Biosimilar User Fee Cover Sheet (Federal Register)
  • Spero closes $30M series B round (BioCentury)
  • Axovant Sinks on Pfizer Alzheimer's Drug Blowup (TheStreet)
  • Roche eyes acquisition of Pacific Biosciences-sources (Reuters)
  • Valeant to Pay Interim CEO $400,000 per month (SEC)
  • Suing over drug prices, although a clever ploy, is unlikely to succeed (Stat)

US: Medical Devices

  • Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff (Federal Register)(Clinica-$)
  • FDA Issues Draft Guidance Regarding Post-Market Cybersecurity for Devices (FDA Law Blog)
  • Survey: 71 percent of adults would use a health tracking device if it was clinically accurate (MobiHealthNews)
  • Ex-Tech CEO Steps Out of Retirement to Re-invent Medical Walker (Xconomy)
  • Boston Scientific, Bard Beat $28M Pelvic Mesh Defect Suit (Law360-$)
  • Johnson & Johnson escapes DePuy Pinnacle hip implant lawsuit (Mass Device)
  • Becton, Dickinson tops earnings estimates with Q1 results (Mass Device)
  • Insulet deals Neighborhood Diabetes biz to Liberty Med for $5m (Mass Device)

US: Assorted and Government

  • Top Congressional Recipients of Funds from Pharmaceutical Companies (OpenSecrets)
  • House Falls Short On Veto Override For ACA Repeal Bill (Law360-$) (The Hill)
  • House Energy & Commerce Committee Members Introduce Comprehensive Behavioral Health System Reform Bill (Press)
  • If SAMHSA doesn’t fix the problem, maybe Congress will (Incidental Economist)
  • Md. lawmaker pushing for 'Right to Try' Act for terminally ill patients (Fox)
  • 340B Hospitals Playing 'Outsize' Medicare Role In Many Therapeutic Categories (Pink Sheet-$)
  • 5 Tips for Traveling to the U.S. With Medications (FDA)

Upcoming Meetings and Events              


  • Samsung's Benepali biosimilar wins first EU sales in Norway (FiercePharmaAsia)
  • London launches new cancer drug development hub (Pharmafile)
  • Statutory regulation needed to expose and stop medical fraud (BMJ-$)
  • Editorial: Misrepresenting harms in antidepressant trials (BMJ)
  • Updated: Send and receive information on adverse drug reactions (ADRs) (MHRA)


  • FDA inspects two units of Aurobindo Pharma; makes observations (Economic Times)

Zika Virus

  • Dallas reports case of Zika spread through sex; CDC urges condom use (Washington Post)(NPR)
  • Zika and Microcephaly: Jury Still Out (MedPage Today)
  • U.S. health secretary to brief lawmakers on efforts over Zika virus (Reuters)
  • Zika Outbreak Means It Is Now Time To Cancel Rio Olympics (Forbes)
  • Why Zika is a huge Catch-22 for pregnant women (Vox)
  • Zika-linked microcephaly cases rising in Brazil (Reuters)
  • U.S. Red Cross asks blood donors to wait 28 days after visiting Zika areas (Reuters)
  • Inside the Brazilian town at epicenter of Zika virus (CBS News)
  • Congressman Gene Green Calls For Briefing from CDC Health Experts on Zika Virus (Press)
  • Bharat Biotech says working on two possible Zika vaccines (Reuters)
  • GeoVax to Develop Vaccine Against Zika Virus (Press)
  • First Irish cases of Zika virus detected: health executive (Reuters)
  • Researchers Design Malaria-Resistant Mosquitoes (JAMA)
  • U.S. experts to visit Brazil to begin Zika vaccine work (Reuters)
  • Zika mosquitoes’ habits may foil US elimination efforts (Reuters)


  • Lancet retracts paper by disgraced Canadian researcher (BMJ)

General Health and Other Interesting Articles

  • Turning Plants into Drug Factories (Scientific American)
  • Google’s Approach To Healthcare Investing: An Interview With Dr. Krishna Yeshwant (Tech Crunch)
  • NFL games are magnets for drug ads. But the Super Bowl isn’t (Stat)
  • Professor Who Helped Expose Crisis in Flint Says Public Science Is Broken (Chronicle of Higher Education)

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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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