Regulatory Recon: Democrats Say Trump 'Enthusiastic' on Drug Cost Proposal; Novo Nordisk Reportedly in Bid to Buy Global Blood Therapeutics (9 March 2017)

Posted 09 March 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Show drugs work before selling them (Nature) (Sydney Morning Herald)
  • Novo Nordisk in bid for Global Blood Therapeutics (Reuters) (Drug Delivery) (The Street)
  • The inconvenient path of precision medicine in drug development (Plenge Gen)
  • Democrats say Trump likes drug cost proposal (CNBC) (KHN) (Washington Post) (Fierce)
  • Obamacare repeal takes first step forward (Politico) (Reuters)
  • AMA Says Trumpcare Is 'Critically Flawed' (Forbes) (NYTimes)
  • Why Republicans Are Battling Republicans on Obamacare Repeal (NYTimes)
  • Trump's FDA Commissioner Choice Coming Soon (Focus)
  • Anesthesia and Developing Brains — Implications of the FDA Warning (NEJM)
  • The 'Gnarly 9' biotechs will test FDA mettle (The Street) (In the Pipeline)
  • Cost and Approvals – A Give and Take (Lachman Consultants)
  • BMS finds replacement for retiring CSO (Pharmafile) (Press)
  • FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance (Focus)
  • Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes (Focus)
  • Lower $1,000 Pill Price? We'd Love It, Says Express Scripts (Bloomberg) (Fierce)
  • Grassley probes EpiPen rival over its $4,500 list price (STAT)
  • Nicox resubmits eye drug after factory inspection (PharmaLetter-$) (Press)
  • Surgery or Drugs? Doctors' Pay May Influence Choice (NYTimes)
  • Off-Label Wish List: Industry Groups Want US FDA's Guidances To Do More (Pink Sheet-$)
  • Apotex Plans 150 New Jobs in $184M U.S. Expansion (GEN)
  • District Court Rules that BPCIA Does Not Limit Innovator's Remedy If Patent Dance Not Followed (Biologics Blog)

In Focus: International

  • FDA/EU Differences in cGMP Outcomes (PharmaCompass)
  • Brazil, Mexico Taking Divergent Paths On Regulatory Reform (Pink Sheet-$)
  • Pfizer Japan Looks To Regain Ground Lost After Tough 2016 (SCRIP-$)
  • Brexit And International Reference Pricing To Cost Companies Billions Of Dollars (SCRIP-$)
  • Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 (Focus)
  • European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (Focus)
  • EU nod for Actelion's rare immune system cancer drug (PharmaTimes) (PMLive)
  • Looming Brexit sparks fears for child cancer trials, experts warn (Pharmafile)
  • 13 FDA observations on Dr Reddy's plant send shares to 3 year low (Pharmafile) (Economic Times)
  • German court hands down another mixed decision in TAVR spat between Boston Scientific, Edwards Lifesciences (MassDevice)
  • Merck KGaA in advanced talks to sell off biosims unit—and others could follow (Fierce)
  • Germany's Merck saw 17% sales growth in 2016 (PharmaLetter-$)
  • China FDA Lays Out eCTDs, Bioequivalence, Patent Linkage As Priorities (Pink Sheet-$)
  • Ireland's HPRA did not recommend GMP cert renewal for Wockhardt Shendra plant (InPharmaTechnologist)
  • Delhi High Court quashes Cipla's appeal, says it can't market generics of Novartis' Onbrez (Economic Times)
  • Indian drug makers can export patented meds for approval: Delhi High Court (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Heat to buy Pelican for preclinical cancer pipeline (Fierce) (Reuters) (Press)
  • Drug Industry Bets Big On Precision Medicine: Five Trends Shaping Care Delivery (Forbes)
  • Drugs to combat hair loss could raise risk for erectile dysfunction, study finds (STAT)
  • Q&A: Repurposing existing drugs for new uses in cancer — for no profit (STAT)
  • People on treatment with suppressed HIV levels can't transmit virus: HIV/AIDS group (Reuters)
  • Tylenol First To Move On Single Dosage For Children's Acetaminophen (Pink Sheet-$)
  • Impax Labs weighs M&A options, figuring bigger is better in struggling generics industry (Fierce)
  • Intellia CRISPR Tech Leads To 97% TTR Knockout (BioCentury)

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

  • Tyrogenex Completes Patient Enrollment in its Phase 2 Trial of Orally Administered Vorolanib for Wet Age-related Macular Degeneration (Press)
  • FDA grants orphan drug designation to Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 for treatment of myelodysplastic syndromes (Press)
  • PolyPid wins FDA designation for antibiotic drug reservoir (Drug Delivery)
  • ProtoKinetix Announces Start of Phase 1 & Phase 2 Clinical Trials for the use of AAGP PKX-001 Treated Islet Cells in the Treatment of Type 1 Diabetes (Press)
  • Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia (Press)
  • Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide (Drug Delivery)

US: Medical Devices

  • NovaBay Pharmaceuticals to Present Features and Benefits of the intelli-Case at FDA Public Advisory Meeting (Press)
  • Behind Grail, Illumina's billion-dollar diagnostics startup (MedCityNews)
  • FDA Warns About Risky Procedure to Treat Multiple Sclerosis, Other Nervous-System Disorders (WSJ) (Medpage)
  • Making Pacemakers and ICDs MRI-Safe (MDDI)
  • FDA labels Physio-Control's Lifepak 1000 recall as Class I (MassDevice) (FDA)
  • Intersect ENT seeks FDA nod for Resolve steroid-releasing implant (MassDevice)
  • Stryker halts enrollment early in Trevo study on high probability of success (MassDevice)

US: Assorted & Government

  • In re Depomed, Inc. (Fed. Cir. 2017) (Patent Docs)
  • Stryker Says Biomet Poached Sales Reps, Customers, Secrets (Law360-$)
  • Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL (Drug & Device Law)
  • Pfizer wins TRO against ex-marketing manager accused of stealing launch plans (Fierce)
  • Bard Stent Grafts Don't Infringe Gore Patents, Jury Finds (Law360-$)
  • Roche Wants Russian Co., Counsel Penalized For Drug Suit (Law360-$)
  • Pharma Co. Hit With Investor Suit Over Freeze Of Drug Study (Law360-$)
  • US to expand mental health care for some veterans (Reuters)
  • A Shift To Medicaid Block Grants Is A Threat To People With Disabilities (Forbes)
  • How to Name that Food: The Good Food Institute Petitions FDA for Clarity (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • The ideal process for launching your medical device in the UK: Interview with Michael Branagan-Harris, CEO of Device Access UK (MassDevice)
  • GW Pharma unveils new financial head (PharmaTimes)
  • UK High Court Invalidates AbbBie Humira Patents (Big Molecule Watch)
  • Parkinson's UK, Sheffield University launch virtual biotech (PharmaTimes)
  • Cambridge University announces 'world-leading' industry-academia collaboration initiative (Pharmafile)
  • Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology (Press)
  • Spring Budget 2017: Reaction from the UK pharmaceutical industry (ABPI)

Asia

  • Malaysia reports highly pathogenic H5N1 bird flu: OIE (Reuters)

India

  • Indian pharma cos rates WHO's stability testing norms for APIs & finished drugs high (Pharmabiz)
  • Lupin launches pain relief drug in US (Economic Times)

Australia

  • Counterfeit Tadalafil 100mg Tablets (TGA)
  • Placebo Tablets - Safety advisory (TGA)

General Health & Other Interesting Articles

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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