Regulatory Recon: Obama to Sign Opioids Bill; Woodcock on 30 Years at FDA (14 July 2016)

Posted 14 July 2016 By Zachary Brennan

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

In Focus: US                                          

  • Janet Woodcock on 30 Years at FDA (Director’s Corner Podcast) (Transcript)
  • Drugmakers’ Pricing Power Remains Strong (WSJ-$)
  • The GOP Needs To Tackle The High Price Of Prescription Drugs (Forbes)
  • Obama to sign bill to battle heroin addiction (Reuters) (STAT) (MedPage Today) (The Hill) (WSJ-$) (NY Times)
  • And then there were 4: Juno adds another victim in CAR-T death tally (Endpoints)
  • Biosimilars go 2-0 in an FDA double-header favoring Novartis, Amgen (Focus) (Endpoints)
  • FDA Denies Citizen Petitions on Biosimilar Labeling (Big Molecule Watch)
  • Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says (Pink Sheet-$)
  • FDA Guidance Gives Trial Advice for Bacterial Vaginosis Drugs (FDANews-$) (Guidance)
  • Lawmakers: Smartphone health apps need to be smarter (The Hill) (MedCity News) (E&C Hearing)
  • GAO on Drug Shortages: FDA’s Prioritization of Generic Injectable ANDAs is Helping (Focus)
  • FDA clears Vent-Os sinus dilation devices from SinuSys (Mass Device)
  • DARPA Wants Mutant Viruses to Fight New Diseases (Bloomberg)
  • At The Intersection Of Quality And Metrics: What's Ahead In FDA’s Effort To More Objectively Measure Quality (Medtech Insight-$)

In Focus: International

  • Health Canada approves drug doctors call cure for hepatitis C infection (Globe and Mail)
  •  Amgen inks deal with Daiichi Sankyo to commercialize biosimilars in Japan (PharmaLetter-$)
  • South Africa Ushers in a New Era for HIV (Nature/Scientific American)
  • Cipla to build biosimilars plant in South Africa to serve global markets (BioPharma-Reporter)
  • New competency framework for all UK prescribers (NICE)
  • 2015 Annual Report for China’s National Adverse Drug Reaction Monitoring released (CFDA)
  • Greece: MSF Denounces High Price of Vaccines for Refugee Children (Press Release)
  • Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US (Focus)

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US: Pharmaceuticals and Biotechnology

  • Public biotech in 2015 – the numbers (Nature Biotechnology)
  • The 15 top R&D spenders in the global biopharma business (Endpoints)
  • Biotech’s Paradox: A Robustly Valued, Highly Active, And Seemingly Terrible IPO Market (Life Sci VC)
  • National Academies Hit the Brakes on Gene Drive–Modified Organisms (JAMA)
  • Chemistry Amendment Saves Sun From Forfeiting 180-Day Exclusivity Eligibility for Generic GLEEVEC (FDA Law Blog)
  • A Threat to Biotechs, but a Slow-Motion One (WSJ-$)
  • Global Regenerative Medicine Market Is Poised for Strong Growth (Tufts CSDD)
  • Gilead avoided nearly $10 billion in taxes last year thanks to tax dodges (Pharmalot)
  • Valeant shares drop 3% after new short bet, ex-CEO stock sale (CNBC) (WSJ-$)
  • Deal Watch: Flagship Ventures Doubles Down On Microbiome (Scrip-$)
  • Court Says Mylan Infringed Three of Forest’s Patents (FDANews-$)
  • AstraZeneca OKs Sandoz Cancer-Drug Generic For 2019 (Law360-$)
  • J&J Urges Pa. Judge To Nix $70M Risperdal Verdict (Law360-$)
  • Life Sciences Cases To Watch In The 2nd Half Of 2016 (Law360-$)
  • Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent (National Law Review)
  • CDMO Vetter to invest $320m in US-based manufacturing facility (Outsourcing-Pharma)

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

  • Duchenne Drug Developer (Not Sarepta) Hit with Lengthy FDA Delay (TheStreet) (Press Release)
  • Alzheimer’s Effects on the Brain Found in Young People (WSJ-$)
  • Liquid biopsy and therapeutic response: Circulating tumor cell cultures for evaluation of anticancer treatment (Science)
  • The genetic architecture of type 2 diabetes (Nature)
  • How Much Clinical Research Is Useful? (In the Pipeline)
  • Pfizer’s crisaborole meets endpoints in Ph III studies (PharmaLetter-$)
  • UCLA study finds why some cancers stop responding to immunotherapy (Reuters)
  • Antipsychotic drug also relieves nausea from cancer chemotherapy (Reuters)
  • Hospital to Pilot Ingestible Medication Sensors in Kids (MedPage Today)
  • Old Drugs May Offer New Hope in Resistant TB (MedPage Today)
  • BI, Lilly hook up to test breast cancer combo (PharmaTimes)
  • Boehringer Ingelheim, University of Dundee to Develop PROTAC Therapies (GEN)
  • Roivant Sciences and Plexcera Therapeutics Announce the Formation of Enzyvant Sciences to Focus on the Treatment of Farber Disease (Press)

Medical Devices

  • Final FDA guidance issued on medical device electromagnetic compatibility (Mass Device)
  • Pavmed eyes Q4 FDA submission for PortIO vascular access device (Mass Device)
  • Southlake Equity gets in on Titan Spine (Mass Device)
  • Health Canada OKs trial for InVivo Therapeutics spine scaffold (Mass Device)
  • Johnson & Johnson’s DePuy wants expedited appeal of $151m Pinnacle hip loss (Mass Device) (Law360-$)
  • How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls (Greenlight Guru)

US: Assorted and Government

  • National Health Expenditure Projections, 2015–25: Economy, Prices, And Aging Expected To Shape Spending And Enrollment (Health Affairs) (HA Blog) (The Hill) (WSJ-$)
  • Senate bill to require the use of prescription drug monitoring programs and to facilitate information sharing among State (Bill)
  • House bill to amend the Public Health Service Act to prohibit wellness programs from sharing personally identifiable information related to individuals' use of or prescriptions for contraceptives (Bill)
  • Medicare Spending at the End of Life: A Snapshot of Beneficiaries Who Died in 2014 and the Cost of Their Care (Kaiser)
  • FDA Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments (Federal Register)
  • Requests for Nominations: Tobacco Products Scientific Advisory Committee (Federal Register)
  • FTC Approves Four Final Orders Barring Companies from Making False All-Natural Claims (FTC)

Upcoming Meetings and Events               

Europe                                                                                         

  • Applications invited to join the NICE Board (NICE)
  • NICE advises immediate referral for suspected childhood diabetes (PharmaTimes)
  • UK officials reject calls to expand men B vaccination (PharmaTimes)
  • European Innovation Scoreboard (European Commission)
  • EMA reviewing several drugs made by Pii in light of MHRA inspection (InPharma-Technologist)

India

  • Govt issues draft Medical Devices Rules 2016; introduces 'Quality Management System' for notified medical devices in place of Schedule M (PharmaBiz)

Zika

  • Global Zika Risk Is Low for Rio Olympics, CDC Says (WSJ-$)
  • Texas reports Zika microcephaly; CDC says Olympic risk low (CIDRAP)
  • The CDC wants your semen (if you've had Zika) (CNN)
  • Zika vector control measures in the EU Flash report (European Commission)
  • Valneva granted $25m loan for Zika and Lyme disease vaccine R&D from EIB (BioPharma-Reporter)

General Health and Other Interesting Articles

  • The 7 biggest problems facing science, according to 270 scientists (Vox)
  • A young doctor fights to cure his own rare, deadly disease (Science)
  • ‘Affordable care’? Not so fast. (Politico)
  • At Gene Editing Meeting, Scientists Discuss God, Racism, Designer Babies (BuzzFeed Science)
  • History credits this man with discovering Ebola on his own. History is wrong (STAT)
  • LISTEN: The superbugs are winning the battle against us (STAT)
  • This team is showing movies to mice in hopes of unlocking the brain’s secrets (STAT)
  • Health problems have worsened for obese in U.S. (Reuters)
  • Mainlining Vitamins Is Silly and Harmful (Atlantic)

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.

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