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Recon: GSK Commercial Reboot; EC Clears Bayer Acquisition of Monsanto

Posted 21 March 2018 | By Ana Mulero 

Recon: GSK Commercial Reboot; EC Clears Bayer Acquisition of Monsanto

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

In Focus: US
  • Novartis Sales Reps Will Testify About Lavish Meals, U.S. Says (Bloomberg) (STAT-$)
  • GlaxoSmithKline prescribes commercial reboot for pharma division (Reuters) (Endpoints) (Fierce) (pharmaphorum)
  • AbbVie chief racks up $22.6M in 2017 pay, complete with $600K in personal jet use (Fierce)
  • Prothena, Celgene ink neuro R&D pact potentially worth $2B+ (Fierce) (Endpoints) (Fierce)
  • Falling behind giant migraine drug rivals, Alder ousts founder Randy Schatzman — could a buyout be next? (Endpoints) (Fierce) (Xconomy)
  • Celgene goes all-out on neurodegeneration and Alzheimer’s, triggering blockbuster deal with $150M in cash for Prothena (Endpoints) (BioWorld)
  • Drug prices are still going through the roof (Axios)
  • FDA In Brief: FDA updates public information about known risk of lymphoma from breast implants (FDA)
  • Amazon's secretive health team talking with AARP about making products for older people (CNBC)
  • AstraZeneca owes $192M in royalties from massive Merck deal, selumetinib licensor Array argues (Fierce) (Law360-$)
  • NYC’s biotech scene gets cash and office space with Beacon’s new incubator (Endpoints) (Fierce)
  • FDA expands lymphoma indications for Seattle Genetics’ Adcetris (pharmaceutical-technology) (Endpoints) (MedPage Today) (Reuters)
  • Walgreens settles overcharging claims with Massachusetts for $5.5M (Chicago Tribune) (Law360-$) (Boston Business Journal-$)
In Focus: International
  • U.K. Lifts National Health Service Pay Cap, Ending Austerity (Bloomberg) (BBC News)
  • Indian medical device industry decry draft policy (The Hindu)
  • China's Aim to Remove Cancer Drug Taxes May Boost Pfizer, Glaxo (Bloomberg) (Fierce)
  • NICE rejects rare eye disease therapy (pharmaphorum) (PharmaTimes)
  • NHS and digital health firms must improve cybersecurity – report (pharmaphorum) (PMLiVE)
  • Shakeup at China FDA after chief vaults to the helm of a regulatory umbrella group, new agency head named (Endpoints)
  • Another mega-startup: China investors back TCR2’s $125M cash round to fuel a preclinical assault on solid tumors (Endpoints) (Fierce)
  • Shortchanging global health now will cost us later (STAT)
  • Europe's GDPR privacy law is coming: Here's what US health orgs need to know (HealthcareITNews)
  • Council of Europe concerned with Trump's death penalty plan (ABC News)
  • WHO Director-General calls for health to be used as a bridge for peace between Israel and Palestine (WHO)
  • Pharma payments to docs in Europe are often inadequately reported or hard to find (STAT-$)
  • Asia a key battleground in fight against killer air pollution: U.N. (Reuters)
  • The global quest to eliminate tuberculosis by 2030 hinges on India’s success (Quartz)
  • Brazil to vaccinate entire country against yellow fever (AP News)
  • Mergers: Commission clears Bayer's acquisition of Monsanto, subject to conditions (EC)
Pharmaceuticals & Biotechnology
  • Johnson and Johnson CFO Dominic Caruso to retire in September, to be replaced by Joseph Wolk (CNBC)
  • FCB Health launches stand-alone agency for pharma and healthcare branding (Fierce)
  • A doctor speaks, a biotech stock tanks. What happened at this invite-only health care investor conference? (STAT-$)
  • Rocked by short attack, Proteostasis withdraws stock offering (Fierce)
  • NIH says dozens of drug makers interested in partnering to develop drugs to address opioid epidemic (STAT-$)
  • Janssen’s New Transparency Report: A Peek Behind the Drug Pricing Curtain Raises Troubling Questions About Rebates (Drug Channels)
  • Trump admin keeping drug price info under wraps (CNN)
  • Therapeutic Area Standards Initiative Summary Report for the Prescription Drug User Fee Act (PDUFA) FY2013 - FY2017 (FDA)
  • 2018 Center for Biologics Evaluation and Research Science Symposium (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • ‘That’s $425,000 right there’ — the anxious launch of a gene therapy with a record sticker price (STAT)
  • Ocugen preps dry eye disease drug for phase 3 (Fierce)
  • New FDA transparency push begins with J&J's Erleada (BioPharma Dive)
  • Eylea positive in diabetic retinopathy, but analysts skeptical (BioPharma Dive)
  • Sun Pharma Announces U.S. FDA Approval of ILUMYA (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis (Press)
  • The Use of Methadone for Pain by Medicaid Patients (The Pew Charitable Trusts)
  • Horizon Discovery’s Bioproduction Cell Line Used as Part of a Successful Drug (IND) Filing (Press)
  • Symbiotix Biotherapies Announces License Agreement with Harvard University (Press)
  • Teligent, Inc. Announces FDA Approval of Halobetasol Propionate Ointment, 0.05% (Press)
Medical Devices
  • Corporates pump yet more venture cash into medtech (EP Vantage)
  • Boston Scientific lays out $406m for NxThera (MassDevice) (Press)
  • UnitedHealth Group Gets Pushback On Bid To Exit ERISA Suit (Law360-$)
  • This Woman Won National Geographic's 'Chasing Genius' Contest For A Remote Physical Therapy App (Forbes)
  • VA Secretary Shulkin taps UPMC exec to lead agency's open API project (HealthcareITNews)
  • Boston Scientific touts safety, effectiveness in Rhythmia mapping system study (MassDevice) (Press)
  • Bard wins 3DMax hernia mesh appeal (MassDevice)
  • Cantel Medical picks up healthcare software dev Aexis Medical for $25m (MassDevice) (Press)
  • Mass General, Brigham and Women’s launch digital pathology project with Royal Philips (HealthcareITNews)
  • Enigma Biomedical Group and Yale Sign Memorandum of Understanding to License Novel Investigational Synaptic Density Imaging Biomarker Technology (Press)
US: Assorted & Government
  • Cigna CEO on Express Scripts deal: More than a pharmacy acquisition, 'this is a broadening of capabilities' (CNBC)
  • Why Trump’s opioid plan falls short (STAT)
  • Trump’s Bluster on the Opioid Epidemic (NYT)
  • After Illinois Primary, Public Option Takes Shape For November Elections (Forbes)
  • Mississippi's new law restricting abortion blocked by judge for 10 days (Reuters)
  • More Sharing Of Opioid Sales Data Possible, DEA Chief Says (Law360-$)
  • Medicaid Rule Can't Govern Radioactive Drugs, Suit Says (Law360-$)
  • Trump’s Health Chief Wants to Change How Doctors Do Business (Bloomberg)
  • U.S. high court skeptical toward California law on anti-abortion centers (Reuters)
  • AHIMA calls on Congress to fight opioids with information sharing, patient matching (HealthcareITNews)
  • “Right to Try” Is Merely “Thoughts and Prayers” for the Terminally Ill (Slate)
  • A GOP Right-To-Try Fumble (WSJ)
  • Azar Says He Is Not Aware Of Discussions On Blocking ‘Silver-Loading’ In 2019 (InsideHealthPolicy)
  • Omnibus Bill in Sight After ‘Big Four’ Meet to Iron Out Kink (s (Roll Call)
  • DEA ripped for failing to stop drug firms from flooding WV with painkillers (Charleston-GazetteMail)
  • New HHS secretary: Opioid addiction is not a moral failing and should be treated as a medical condition (CNBC)
Upcoming Meetings & Events Europe
  • EMA recommendation on hydroxyethyl starch solutions obscured controversy (The BMJ)
  • Shortage of Arixtra (EMA)
  • Developing healthcare innovations: apply for business funding (MHRA)
  • UK’s pharma and biotech support new Health and Social Care Committee report into Brexit (EPM Magazine)
  • In Europe, 14 people die each day from unsafe water, sanitation, and poor hygiene (Quartz)
  • Inovio Pharma, Apollo Bio ink deal for cervical cancer drug (BioSpectrum)
  • Oxford Performance Materials Receives Japanese Accreditation of Foreign Medical Device Manufacturer (Press)
  • E-health apps help meet Southeast Asia’s healthcare needs (The ASEAN Post)
  • South Sudan Stops Spread of Guinea Worm Disease (AP News)
  • India’s Ambitious Health Care Protection Scheme Gets Cabinet Nod (Bloomberg)
  • Genetic disorders to hike health insurance premiums? (Times of India)
  • IT Minister wants ‘Made in India’ MRI machine to be ready by end-2019 (The Hindu)
  • Ending TB in India by 2025 is ambitious, not impossible (Hindustan Times)
  • Abbott India gets aggressive on new product launches, plans 110 in 5 years (Business Standard)
  • Half of Australians with private health insurance say it isn’t worth it (The New Daily)
  • New South Wales woman is sixth to die in rockmelon listeria outbreak (The Guardian)
  • Cronos Group finishes the day up 11 percent after announcing MedMen partnership (CNBC)
  • Canada’s health-care system more restrictive (The Nelson Daily)
  • Veritas Pharma Completes the 100% Takeover of Cannevert Therapeutics (Press)
  • Cipher Pharmaceuticals and Cardiome Pharma Announce Strategic Transaction for Canadian Business Portfolio of Cardiome (Press)
General Health & Other Interesting Articles
  • Birth control pill for men shows promise in early study (USA Today)
  • Doctors endorse counseling of some kids, young adults to prevent skin cancer (Reuters)
  • Guns tied to high suicide risk for teens with self-harm history (Reuters)
  • NIH To Investigate Outreach to Alcohol Companies (NYT)
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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