Regulatory Focus™ > News Articles > Regulatory Recon: HHS Warns Zika Funding Running Out; PhRMA Plans Drug Pricing Counterattack (4 Augu

Regulatory Recon: HHS Warns Zika Funding Running Out PhRMA Plans Drug Pricing Counterattack (4 August 2016)

Posted 04 August 2016 | By Michael Mezher 

Regulatory Recon: HHS Warns Zika Funding Running Out PhRMA Plans Drug Pricing Counterattack (4 August 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

  • Adaptimmune sinks on FDA partial hold for pivotal engineered T-cell trial (Fierce) (Press)
  • Disease With $78 Billion Cost Draws Drugmakers to Women's Health (Bloomberg)
  • The FDA's Dueling Priorities (The Atlantic)
  • With FDA approval, GM mosquitoes could join Florida's Zika fight (Reuters)
  • Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels (Focus)
  • Zika Funding Gone by the End of September, HHS Says  (Roll Call) (Reuters)
  • New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities (Focus)
  • Drug lobby plans counterattack on prices (Politico)
  • NEJM Publishes Four Perspectives on Data Sharing (NEJM 1, 2, 3, 4)
  • Top Clinical Investigators Seek To Dampen Impact Of Data Sharing in NEJM (CardioBrief)
  • Pay-Formula Glitch Could Lead to Drastic Cuts For Certain Diagnostics (InsideHealthPolicy)
  • Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives (PLOS)
  • NIH Calls for Comments on Changes to Human-Animal Chimera Guidelines (NIH)
  • Aetna is notifying some doctors about their drug-dispensing habits (Washington Post)
  • Biosimilars emerge as winners in annual payer muscle flexing (EP Vantage)
  • Theranos founder's conference invitation sparks row among scientists (Financial Times)
  • Is Prediabetes An Epidemic Or A Creation Of Drug Companies? (Forbes)

In Focus: International

  • European Commission Updates Official 'Blue Guide' Underpinning Medtech Rules (Medtech Insight-$)
  • EMA to Continue Adaptive Pathways Program as Pilot Ends (Focus)
  • Marketing Applications Continue To Fall In Canada, But MEDEC Expects Recovery Ahead (MedtechInsight-$)
  • Roche returns second Inovio candidate, ends immunotherapy deal (Fierce) (PharmaTimes)
  • NICE now recommends Celgene's Otezla (BioCentury) (PharmaTimes)
  • India's NPPA Plans App  for Patients to Check Drug Prices Before Buying (Economic Times)
  • India Looks to Further Ease Process of Running Clinical Trials (Focus) (CDSCO 1, 2)

US: Pharmaceuticals & Biotechnology

  • Pediatric Study Requirements For Cancer Have FDA Support, But Pose Industry Challenges (Pink Sheet-$)
  • Barnyard Dust Offers a Clue to Stopping Asthma in Children (NYTimes)
  • How Incepta Is Shaping Bangladesh's Vaccines Future (SCRIP-$)
  • New Fitbit exec charged with building out pharma partner deals (Fierce)
  • Therapy focus – One step forward but two steps back in Huntington's (EP Vantage)
  • Piramal announces $25m Kentucky site investment (In-PharmaTechnologist)
  • AbbVie hints PhIII pan-genotype HCV therapy may revive sales target of $3B (Fierce)

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

  • Ocular Therapeutix™ Provides Update on NDA for DEXTENZA™ for the Treatment of Post-Surgical Ocular Pain (Press)

US: Medical Devices

  • Baebies is an FDA attention Seeker (EP Vantage)
  • Report shows 85% of devicemakers not prepared for upcoming UDI compliance deadline (Modern Healthcare)
  • Safety recall could spell the end for the Basis Band (MobiHealthNews)
  • Bio-Rad Quality Control Products Receive FDA Clearance (GenomeWeb)
  • Luminex Receives FDA Clearance for Influenza A/B, Respiratory Syncytial Virus Assays (GenomeWeb)
  • A Health-Monitoring Sticker Powered by Your Cell Phone (MIT Technology Review)
  • Fujifilm wins FDA nod for digital radiography suite (MassDevice) (Press)
  • EndoChoice Receives FDA Clearance for Lumos™ with Adaptive Matrix Imaging (Press)
  • Nemaura Medical Inc., completes second FDA Pre-submission meeting and appoints Navigant to submit IDE for Nemaura's sugarBEAT system (Press)
  • Insulet Q2 tops the street, lifts guidance (MassDevice)

US: Assorted & Government

  • Hey Opioid Bill, You're A Law! (Energy & Commerce)
  • All But Six States Keep Consumers in the Dark on the Cost of Medical Procedures (Public Citizen)
  • Federal courts could shape drug-database access and privacy balance (Modern Healthcare)
  • Pharma party: Led by Pfizer, DTC ads proliferate during Democratic and Republican national conventions (Fierce)
  • Mixed and Matched Hip Components Equal Express Preemption (Drug and Device Law)
  • FDA Publishes Industry Resources re the New Nutrition Labeling Requirements; Many Questions Remain Unanswered (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Ex-Google venture capitalist turns up at medtech's TrialReach (Financial Times)
  • LivaNova posts beat-and-raise Q2 (MassDevice)
  • Increasing the availability of veterinary vaccines in the EU (EMA)
  • Reva Medical looks to CE Mark for Fantom scaffold (MassDevice)

Asia

  • South East Asia's type 2 diabetes market will be worth $2.7 billion by 2022, research says (PharmaLetter-$)
  • Astellas Announces Transfer of U.S. Manufacturing Subsidiary to Avara (Press)
  • Takeda and TiGenix publish 24-week results of Cx601 trial in Crohn's (PharmaLetter-$)
  • Alere Inc. to strengthen its footprint in APAC  (BioSpectrum)

India

  • India's Cupid Is A Rare Company Making Female Condoms (Forbes)
  • Natco Pharma gets ANDA nod for Tamiflu's generic version (Economic Times)
  • Dr. Reddy's completes acquisition of product portfolio from TEVA (BioSpectrum)
  • Alere eyes over 3-fold jump in India revenue to Rs 1,000 crore (Economic Times)

Australia

  • Online applications for registered complementary medicines (TGA)
  • General process for amending the Poisons Standard: Nicotine (TGA)

Zika

  • More than 1,800 people at risk of Zika in Florida targeted for testing, outreach (CNBC)
  • New York attorney general targets phony Zika-protection products (Reuters)
  • Few people have been screened so far in United States for Zika virus, data shows (CNBC)
  • Cuba reports two cases of Zika contracted locally (Reuters)
  • White House doesn't rule out pesticides in Zika fight (Reutes)
  • Pentagon says 33 U.S. military personnel infected with Zika (Reuters)

Other International

  • Ebola after-effects threaten food shortages in West Africa: U.N. (Reuters)

General Health & Other Interesting Articles

  • Women with common ovary problem may not get recommended tests (Reuters)
  • Risk of diabetes and heart disease may spike before menopause (Reuters)
  • Why 'Useless' Surgery Is Still Popular (NYTimes)
  • Novel genetic mutation may lead to the progressive loss of motor function (NIH)
  • Sickle cell trait may not increase the risk of death (Washington Post)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe