Regulatory Focus™ > News Articles > Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 2017)

Regulatory Recon: BD to Acquire Bard for $24B WHO to Pilot GSK Malaria Vaccine (24 April 2017)

Posted 24 April 2017 | By Michael Mezher 

Regulatory Recon: BD to Acquire Bard for $24B WHO to Pilot GSK Malaria Vaccine (24 April 2017)

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

In Focus: US

  • Becton Dickinson to acquire Bard for $24 billion ( Reuters) ( MassDevice) ( Xconomy)
  • NASH: The next untapped pharma market gives investors many options ( Reuters)
  • Senate panel to vote on Trump's FDA pick Wednesday ( The Hill)
  • Murray: Gottlieb Vote Should be Delayed Unless Outstanding Questions Are Answered ( Senate HELP)
  • FDA Issues Marathon Priority Review Voucher for Emflaza ( FDA)
  • FDA Approves Sanofi's Thymoglobulin for Preventing Acute Kidney Transplant Rejection ( Press)
  • Our Costly Addiction to Health Care Jobs ( NYTimes)
  • Janssen acquires over 90% of Actelion ( Pharmafile)
  • Drugmakers Dramatically Boosted Lobbying Spending In Trump's First Quarter ( KHN) ( STAT)
  • Marathon Pharmaceutical Drops Out Of PhRMA Following Drug Price Controversy ( KHN)
  • A Spoonful Of Kids' Medicine Makes The Profits Go Up ( KHN)
  • Trump warns Democrats Obamacare will die without cash infusion ( Reuters)
  • GOP Keeps Obamacare 'Fragile' As Trump Nears 100 Days ( Forbes)
  • Healthcare giant J&J shares prescription for digital reinvention ( McKinsey)
  • Bristol-Myers shuffles management and its chief strategy officer is leaving ( STAT)
  • Biogen Hopes New Spine Drug Data Convinces Insurers to Loosen Patient Access, Boost Sales ( The Street) ( Endpoints) ( Press)

Sponsored Content: Trying to Map Out the Transition to Comply with IDMP Standards?

In Focus: International

  • Sanofi plays down need for pharma deals ( Financial Times) ( Endpoints)
  • Malaria: retreat of a centuries-old scourge ( WHO)
  • Ghana, Kenya and Malawi to pilot GSK malaria vaccine from 2018 ( Reuters) ( WHO)
  • European Commission Report on Pharmacovigilance ( EC)
  • Vaccination gaps lead to dangerous measles outbreaks in Europe: ECDC ( Reuters)
  • Novartis Gets Ready to Take on the EU Market with Two New Biosimilars ( Labiotech)
  • UK MHRA announces pre-election quiet period ( InPharmaTechnologist)
  • Canada Considers Performance-Based Outcome Reimbursement Deals For Oncology Drugs ( Pink Sheet-$)
  • England "really is not a good place" to get cancer, BMS UK General Manager says ( Pharmafile)
  • India to expand access to J&J's TB drug this year ( Reuters)
  • CHMP backs 11 medicines for European approval ( PharmaTimes) ( PharmaLetter-$) ( EMA)
  • EMA panel recommends nod for Sanofi, Regeneron's arthritis drug ( Reuters) ( Pharmafile)
  • Biomarin Rare Disease Drug Picks Up European Endorsement Ahead of FDA Action ( The Street) ( EMA)
  • Spinraza, First Medicine for Spinal Muscular Atrophy Recommended by CHMP ( EMA)
  • MDSAP Update: Health Canada Reports Single-Digit Participation Rate So Far ( Emergo)
  • Columbian regulators reduce medical device and IVD review timeframes ( MassDevice)

US: Pharmaceuticals & Biotechnology

  • ICER To Assess Tardive Dyskinesia Drugs ( BioCentury)
  • FDA Deluged With Feedback On Off-Label Policies ( Law360-$)
  • Hiding Data And Other Criticisms Of Big Pharma ( Forbes)
  • Immunotherapy Pioneer James Allison Has Unfinished Business with Cancer ( MIT Technology Review)
  • 1Q Pharma Results Preview: Biogen, Novartis, Lilly, Amgen, GSK, AstraZeneca, BMS, AbbVie, Roche, Bayer, Sanofi ( SCRIP-$)
  • Turing CEO and Shkreli ally Ron Tilles is out as CEO, R&D chief Salinas takes the helm and board vote looms ( Endpoints)
  • NIH Funds Seven International Centers of Excellence for Malaria Research ( NIH)
  • Will Manufacturers Have Trouble Verifying Some Drugs Next Year? ( RxTrace)
  • Many people stop taking life-saving drugs after heart attacks ( Washington Post)
  • Multispecific Approach Could Improve I-O Side Effect Profile, Says Numab ( SCRIP-$)
  • Could Be the Thyroid; Could Be Ennui. Either Way, the Drug Isn't Helping. ( NYTimes)
  • FDA Enforcement Statistics for 2016 ( Unger Consulting)
  • 2016 FDA Adverse Event Reporting System (FAERS) Data: An Infographic ( Advera)
  • Training Program for Regulatory Project Managers; Information Available to Industry ( FDA)
  • FDA Allows In Vitro Studies to Demonstrate Naloxone Bioequivalence ( FDANews-$) ( FDA)
  • Biomedical researchers need better work-life balance to succeed and flourish ( STAT)
  • Immune Pharma starts major R&D restructure, CEO jumps ship to spinoff ( Fierce)
  • Is clinical trial design complexity behind the high turnover rate for principal investigators? ( MedCityNews)
  • How Cytokine-Level Thinking is Guiding Pfizer's Clinical Immunology Plans ( BioCentury)
  • Guerbet Group; Withdrawal of Approval of Two New Drug Applications ( FDA)

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

  • Best in class? Eli Lilly claims a lead role awaits its CDK 4/6 drug abemaciclib after PhIII success ( Endpoints) ( Press)
  • Bristol-Myers NASH drug reduces liver fat in midstage study ( Reuters) ( Press)
  • Tecfidera and Tysabri Data Demonstrate Improved Outcomes with Early MS Treatment ( Press)
  • Merck Announces New Phase 2 Data on Investigational Triple Combination Therapy MK-3682B for Chronic Hepatitis C ( Press)
  • Merck-backed NGM Bio hits its marks in midstage NASH trial ( Fierce)
  • Novartis announces post-marketing data supporting Gilenya efficacy ( PharmaLetter-$)
  • Sunovion Announces Positive Results from Pivotal Study Evaluating Novel Drug Candidate Dasotraline in Children with ADHD ( Press)
  • Tiziana Life Sciences Announces Approval of a Phase II Clinical Trial Protocol for Milciclib in Patients with Hepatocellular Carcinoma ( Press)
  • Pivotal Phase III Study Underscores Efficacy Of Zavicefta (ceftazidime-avibactam) For Treatment Of Hospital-Acquired Pneumonia, A Leading Cause Of Mortality In Hospitals ( Press)
  • Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck's ZEPATIER (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C ( Press)
  • Ocular Therapeutix to Present Additional Phase 3 Data and Patient Reported Outcomes Results for DEXTENZA at the American Society of Cataract and Refractive Surgery (ASCRS) Symposium ( Press)

US: Medical Devices

  • Abbott CEO White optimistic on Alere buy ( MassDevice)
  • The 10 hottest medtech startups of 2017 ( Medical Design & Outsourcing)
  • Is That Cough Serious? ( MDDI)
  • Is It Time For Hearing Aids To Be Sold Over The Counter ( NPR)
  • Abbott issues select recall for NC coronary dilation & balloon caths ( MassDevice)
  • Millennium Medical Technologies (MMT) First in the Nation to Receive FDA Clearance for a Reusable Fat Collection and Grafting System ( Press)

US: Assorted & Government

  • As a competitor encroached, Mylan took one state to court to push EpiPen sales, documents show ( STAT)
  • Meet The Attys Arguing Supreme Court Biosimilars Battle ( Law360-$)
  • Surgeon general is removed by Trump administration, replaced by deputy for now ( Washington Post) ( NBC)
  • Forum Shopping for Agency Deliberative Documents? San Francisco is the Place to Be (For Now) ( FDA Law Blog)
  • Medtronic's $17M Patent Infringement Penalty Is Enhanced ( Law360-$)
  • Smoke Screens & Side Shows ( Drug & Device Law)
  • As MACRA Implementation Proceeds, Changes Are Needed ( Health Affairs Blog)
  • Medicaid Could Have Saved $1 Billion If Medical Marijuana Was Legalized ( Forbes)
  • Remember Those Temporary Officials Trump Quietly Installed? Some Are Now Permanent Employees. ( ProPublica)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Sentinel Training at the Food and Drug Administration; Public Workshop – 10 July 2017
  • FDA Small Business and Industry Assistance Regulatory Education for Industry Spring Conference – 9-10 May 2017
  • Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting – 15 June 2017
  • Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting – 9 May 2017
  • Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 17 May 2017
  • Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop – 12 September 2017
  • Vaccines and Related Biological Products Advisory Committee; Notice of Meeting – 17 May 2017
  • Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 17 May 2017

Europe

  • Dutch IGZ request to marketing authorization holders: questionnaire for pharmacovigilance ( PharmaLetter-$)
  • NASH frontrunner Genfit says phase 3 enrollment delayed by up to 6 months ( Fierce)
  • Sweden Heating Up ( BioCentury)
  • Sartorius Stedim Biotech announces French government-backed R&D project ( BioPharmaReporter)
  • A cracking new method: Valneva and Bavarian Nordic's hen egg alternative ( BioPharmaReporter)

Asia

  • Alteogen to transfer biosimilar technology to Chinese partner ( Biosimilar News)

India

  • Three MNC pharma companies want to recall its new generation stents from India ( Economic Times)
  • Post of DPCO Officer to be created for each state with pharmacy qualification for effective implementation of DPCO: Dr RN Gupta ( PharmaBiz)
  • Abbott notifies DCGI about post-marketing registries in Europe to monitor implantation technique for Absorb BVS stents ( PharmaBiz)
  • Ranbaxy-Daiichi deal: Singh brothers move HC to vacate order on unpledged assets ( Economic Times)
  • Doctors to prescribe generic drugs only or face action, says MCI ( Economic Times)

Australia

  • New Australian government campaign to encourage further childhood vaccination ( PharmaLetter-$)
  • Target processing timeline for MRA GMP clearance applications ( TGA)

General Health & Other Interesting Articles

  • Spend a Dollar on Drug Treatment, and Save More on Crime Reduction ( NYTimes)
  • Scientists don't do politics … until now ( BioWorld)
  • Should You Worry About Being the Next Henrietta Lacks? ( NYTimes)
  • Critically injured, she made a selfless decision to donate her organs — immediately ( 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

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