Regulatory Focus™ > News Articles > Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws

Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017)

Posted 22 June 2017 | By Michael Mezher 

Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017)

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

In Focus: US

  • Obamacare replacement bill takes center stage in Senate (Reuters)
  • Senate healthcare bill expected to cut back Medicaid expansion (Reuters)
  • Most Americans say Republican healthcare plan will be harmful: Reuters/Ipsos poll (Reuters)
  • Robert Califf: 'The clinical trials enterprise has gone awry' (STAT)
  • Pharma recovers composure as price concerns ease (Financial Times) (Fierce)
  • Biotech stocks are on fire as Obamacare repeal vote looms (CNBC)
  • Novartis Drug Becomes First To Prevent Heart Attacks And Strokes By Targeting Inflammation (Forbes) (Reuters) (Endpoints) (Press)
  • Gottlieb Looks to Boost Generic Drug Competition (Focus)
  • Regulating CRISPR: FDA and Industry Offer Perspective (Focus)
  • Mylan offered EpiPen discounts to states in exchange for privileged status, docs show (STAT)
  • Flu vaccine nasal spray is out for next season, as expert committee deems it ineffective (STAT)
  • US panel considers giving a nod to new vaccine, and a competitor objects (STAT)
  • FDA padlocks any new human tests on Seattle Genetics' cancer drug in the wake of more deaths (Endpoints)
  • GSK wins $235 million from Teva in Coreg patent trial (Reuters)
  • FDA Ruling On Aussie Biotech Could Boost Congressman's Investment (KHN)
  • Amgen Defends Drug Pipeline, Says the Best is Yet to Come (The Street)
  • Missouri sues opioid manufacturers, joining two other US states (Reuters)
  • Sarepta signs another Duchenne gene therapy pact as it aims for wider treatment (Fierce)

In Focus: International

  • EU Court Says Vaccines can be Blamed for Illnesses Without Proof (AP)
  • Criteria Out For EMA's Future Home; Bid Procedure About To Be Approved (Pink Sheet-$)
  • ICH Agrees On New Extrapolation Guideline To Support Pediatric Development (Pink Sheet-$)
  • AbbVie's New Hep C Drug Will Break Gilead's Dominance If Approved In EU (SCRIP-$)
  • EU regulators review Novartis' migraine drug (PharmaTimes)
  • In another setback, Kamada pulls an application at the EMA and retrenches on a PhIII drug (Endpoints)
  • UN blames warring sides for Yemen's 'man-made' cholera 'catastrophe' (Reuters)
  • Brazilian plant to make Humira biosimilar in 'tobacco-based bioreactors' (BioPharmaReporter)
  • David Cameron: Biotech execs can still count on doing business in a post-Brexit U.K. (STAT)

Pharmaceuticals & Biotechnology

  • #BIO2017 Day 3 roundup: Building value and what it costs (BioPharmaDive)
  • Eli Lilly completes expansion of San Diego biotech center (Fierce) (Press)
  • FDA Warns Chinese API Maker for Data Integrity Issues (Focus)
  • Heart healthy lifestyle tied to lower drug costs (Reuters)
  • Clinigen makes 3 exclusive compassionate-use deals (Fierce)
  • Real World Evidence: Between 'Nirvana' And Electronic Roadblocks (Pink Sheet-$)
  • Biomarkers: FDA/Industry Group Shaping 'Points-To-Consider' On Assay Validation (Pink Sheet-$)
  • Sanofi Sees Immunology Momentum Heading Toward Cures (SCRIP-$)
  • Opioids, a Mass Killer We're Meeting With a Shrug (NYTimes)
  • Can Shire's new Mydayis, its latest Adderall iteration, really nab $500M in sales? (Fierce)
  • Will Pfizer Reexamine a Sale of its Consumer Division? (The Street)
  • Celgene-backed cancer biotech Repare emerges from stealth with $68M (Fierce)
  • Implementing continuous manufacturing a challenge, say industry delegates (InPharmaTechnologist)
  • U.S. Department of Defense Officials Introduce New Strategies to Stimulate Medical Countermeasures Development (BIO)
  • On Drug Costs, "We All have Accountability and Responsibility" (BIO)
  • Start-Up CEO: Making the Choices to Develop a Novel Medicine (BIO)
  • White House Opioid Commission: Access To Drug Therapy, Coverage 'Parity' Urged (Pink Sheet-$)
  • FDA Pediatric Cancer Advisory Panel Recommends Moving Away From Single-Agent Studies (FDANews-$)
  • Deloitte to upgrade Daiichi Sankyo's global drug safety platform (OutsourcingPharma)
  • Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older (NEJM)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • GSK presents new Phase III data on candidate shingles vaccine Shingrix (PharmaLetter-$)
  • Chi-Med Initiates a Phase I/II Clinical Trial of Novel FGFR Inhibitor HMPL-453 in China (Press)
  • 22nd Century Receives Guidance from FDA on Phase III Clinical Trials (Press)

Medical Devices

  • 1 in 10 TAVR Procedures Done Off-Label (Medpage)
  • The Power Struggle behind Wearable Medical Device Design (MDDI)
  • 5 secrets of contract manufacturing longevity (Medical Design & Outsourcing)
  • Zimmer Biomet cleaned house after FDA inspection at Warsaw plant (MassDevice)
  • Additive Ortho wins FDA nod for 3D printed bunion correction system (MassDevice)
  • LivaNova wins expanded MR indication for VNS Therapy device (MassDevice)
  • Bard shareholder looks to scuttle $24B merger with BD (MassDevice)
  • Cochlear shares jump on FDA nod for Nucleus 7 sound processor (MassDevice)
  • Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use (FDA)

US: Assorted & Government

  • "Just Because" Not Good Enough for TwIqbal (Drug & Device Law)
  • Cigna stays in Obamacare for now; Anthem reduces participation (Reuters)

Upcoming Meetings & Events

Europe

  • Queen's Speech 2017: ABPI analysis (ABPI)
  • Verona Pharma names former Sanofi exec as VP regulatory affairs (PharmaLetter-$)
  • Germany's Merck invests in immune-oncology in Switzerland (BioPharmaReporter)
  • Italian Boy Becomes Youngest Patient Bridged to Transplant with the SynCardia Total Artificial Heart (Press)
  • Impedimed wins CE Mark for Sozo monitoring system (MassDevice)

India

  • Indian pharma needs energy efficient cleaning equipment to keep US FDA warnings at bay: Torben Andersen (PharmaBiz)
  • Gujarat FDCA, CDSCO to set up drug testing lab at Patan to strengthen lab infrastructure (PharmaBiz)
  • CDSCO releases revised draft guidelines on post marketing surveillance of pharmaceutical products (PharmaBiz)
  • Glenmark Pharma's overactive bladder drug gets USFDA nod (Economic Times)
  • Ex-Ranbaxy promoters Malvinder and Shivinder Singh asked to maintain award amount (Economic Times)

General Health & Other Interesting Articles

  • Researchers uncover genetic gains and losses in Tourette syndrome (NIH)
  • Dr. Lawrence Weed, Pioneer in Recording Patient Data, Dies at 93 (NYTimes)

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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