Regulatory Focus™ > News Articles > Regulatory Recon: Zika Impact Worse Than Expected; Questions on Cancer Moonshot Coordination (29 Apr

Regulatory Recon: Zika Impact Worse Than Expected Questions on Cancer Moonshot Coordination (29 April 2016)

Posted 29 April 2016 | By Zachary Brennan 

Regulatory Recon: Zika Impact Worse Than Expected Questions on Cancer Moonshot Coordination (29 April 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

  • Scientists worry as cancer moonshots multiply (Nature News)
  • Drugmakers Place Big Bets on Cancer Medicines (WSJ-$)
  • FDA Flouting Court On Orphan Drug Exclusivity, Suit Says (Law360-$)
  • Pfizer Who? Health-Care Deals Bounce Back From Inversion Scare (Bloomberg)
  • FDA sued over redacting its experts' job history (Focus) (FierceBiotech) (Mass Device)
  • ANDA Litigation Soars In 2014-2015; Patent Office Petitions Also Jump (Pink Sheet-$)
  • FDA Regulation of Marijuana: Past and Future (FDA)
  • CDER Export Certification and Tracking System (FDA)
  • FDA's Experience with Emerging Genomics Technologies—Past, Present, and Future (AAPS Journal)

In Focus: International

  • Brain Damage in Zika Babies Is Far Worse Than Doctors Expected (WSJ-$)
  • In China's tougher drug market, minnows open back door for 'Big Pharma' (Reuters)
  • Biogen, AbbVie multiple sclerosis drug wins EU green light (Reuters) (PR)
  • Device Reprocessing Provisions Could Be Dropped To Ensure Timely EU Reform Resolution (SCRIP-$)
  • Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (EMA)
  • Boosting care for newborn babies in low-income countries (EMA)
  • New treatment for rare white blood cell cancer (EMA)
  • NICE recommends Novartis skin cancer combo for NHS use (PharmaTimes)

US: Pharmaceuticals and Biotechnology

  • Merck Says Gilead Is Exploiting Atty 'Lie' In $200M Jury Loss (Law360-$)
  • Biotech Dumb Money Looks Smart in $6 Billion Stemcentrx Sale (MIT Tech Review)
  • $40 Billion Takeover Has Big Pharma Giddy (TheStreet)
  • With CRISPR in Humans On The Horizon, Will the Public Back Intellia? (Xconomy)
  • Wuxi sets up drug supplier network to ease pharma sourcing (Outsourcing-Pharma)
  • Prospective Grant of Exclusive License: AAV-Mediated Aquaporin Gene Transfer To Treat Sjögren's Syndrome (NIH)

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

  • Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11 (PR)
  • AstraZeneca Profit Falls as Recent Purchases Push Up Costs (Bloomberg) (Guardian) (Reuters)
  • Sanofi Profit Little Changed as Drugmaker Pursues Medivation (Bloomberg)
  • Discounts on Hepatitis C Drug Dent Gilead's Earnings (AP)
  • Amgen beats estimates thanks to strong 1st-qtr sales (PharmaLetter-$)
  • Valeant Files Annual Report, Says It Will Change Strategy (Bloomberg)
  • Gene therapy and curing brain diseases (Newsweek)
  • RNA splicing is a primary link between genetic variation and disease (Science)
  • NAD+ repletion improves mitochondrial and stem cell function and enhances life span in mice (Science)
  • KaloBios Gets Final Nod On 'Unusual' $3M Ch. 11 Package (Law360-$)
  • Novo Nordisk announce positive results for semaglutide in diabetes patients (PharmaLetter-$)

US: Medical Devices

  • Stryker pays $52m for Stanmore Implants (Mass Device)
  • Zika Test from Quest Diagnostics Authorized by the FDA for Emergency Use (PR)
  • Alere rejected Abbott's $50m offer to spike merger (Mass Device)

US: Assorted and Government

  • Eagle Follows Through on Threatened FDA Suit Over Exclusivity (FDANews-$)
  • Biden gets papal blessing for global war on cancer (Reuters)

Upcoming Meetings and Events

Europe

  • Progress Report: EAMS A Limited Success But Could Do Better (SCRIP-$)
  • European CHMP Adopts Positive Opinion for Gilead's TAF-Based Single Tablet Regimen Odefsey (PR)
  • Janssen's Imbruvica (ibrutinib) Receives Positive CHMP Opinion for Expanded Use in Previously Untreated Chronic Lymphocytic Leukaemia Patients (PR)
  • Concept paper on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use (EMA)

India

Zika

General Health and Other Interesting Articles

  • Mumps Outbreak at Harvard Threatens Graduation (NBC)
  • Got Drugs? DEA's Take-Back Day is April 30 (Forbes)

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? 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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