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Regulatory Recon: Lilly CEO Says Tax Reform May Boost Pharma Deal Making 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018)

Posted 09 January 2018 | By Michael Mezher 

Regulatory Recon: Lilly CEO Says Tax Reform May Boost Pharma Deal Making 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018)

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

In Focus: US

  • Eli Lilly CEO Says Tax Reform May Lead to More Successful Deals (Bloomberg) (CNBC)
  • Drug Industry Isn't Giving Up on Alzheimer's (WSJ)
  • The Winners And Losers Of JP Morgan Monday (Forbes)
  • Axovant: That positive p-value we reported yesterday? Um, we screwed that up too (Endpoints)
  • Pfizer program seeks closer ties with top universities (Fierce) (Press)
  • What to watch during health-care investing's biggest week of the year (CNBC)
  • Biotech stocks fail to lift on so-so JP Morgan conference's first day (Fierce)
  • Illumina Unveils $20,000 Desktop Sequencer Aimed At Sequencing Germs (Forbes)
  • This year's top 10 new drugs (Washington Post)
  • 2018 M&A Firepower Report: Life Sciences Deals and Data (EY)
  • We're Not Ready for a Flu Pandemic (NYTimes)
  • Celgene 2018 revenue forecast shy of estimates, shares fall (Reuters)
  • BioMarin's chief calls hemophilia treatment results 'extremely encouraging' (CNBC)
  • Merck CEO says more of drug rebates should end up with consumers (CNBC)
  • Bill Gates Tells Healthcare's Capitalists How To Save Five Million Kids (Forbes)
  • In an era of cures, price-prohibitive drugs are an even harder pill to swallow (MedCityNews)
  • Drug charity sues US over restrictions on donor communications (Reuters) (Washington Post) (Suit)
  • US faces IV bag shortage amid flu season (CBS)

In Focus: International

  • Glaxo CEO Replaced 50 Top Managers in Shakeup to Spur Growth (Bloomberg)
  • On a mission to save Teva from crippling debt, Schultz stands by cost-cutting measures, scrutinizes per product profitability (Endpoints)
  • Asia wins 2017's mid-cap race (EP Vantage)
  • Siemens to list Healthineers unit in March: sources (Reuters)
  • Switzerland Allows Use Of US-Origin Products For Comparability With Biosimilars (Pink Sheet-$)
  • Five Biologic Blockbusters Opened Up To EU Biosimilar Competition In 2017 (Pink Sheet-$)
  • Europe's Biopharma Sector Could Be In For Bumper Year (SCRIP-$)
  • Merck closes in on adjuvant melanoma indication for Keytruda (PMLive)
  • UCB, Amgen's Evenity under review in Europe (PharmaTimes)
  • Hunt resists move from health secretary position, receives expanded role (Pharmafile)
  • Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth (Emergo)
  • India's NPPA lens on five drugmakers for Hepatitis C drug overcharge (Economic Times)
  • WHO Director-General: invest in health to end plague in Madagascar (WHO)

Pharmaceuticals & Biotechnology

  • Texas Families Urge Lawmakers To Move Faster To Screen Newborns For Deadly Genetic Disease (CBS)
  • JPMing while female: Women share their experiences at biopharma's big gathering (STAT)
  • Men named Michael outnumber female CEOs presenting at #JPM18 (STAT)
  • Allergan CEO Saunders Says Stock Price Doesn't Reflect Company's True Value (The Street)
  • Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (FDA)
  • 'Best days are still ahead' for top opioid addiction treatment Vivitrol, CEO says (CNBC)
  • Long-Term Ibuprofen Use May Impact Men's Testicular Health And Fertility (Forbes)
  • Usage remains low for pill that can prevent HIV infection (NBC)
  • Ex-Genentech exec named as new Juno Therapeutics CIO (Pharmafile)
  • 'Patient Experience Data' Section Added To US FDA Drug Reviews (Pink Sheet-$)
  • From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program (Pink Sheet-$)
  • Case Studies: How Patient Input Is Changing R&D (Pink Sheet-$)
  • Cellectar Biosciences Shutting Down Manufacturing Operations (Xconomy)
  • Tamiflu shortage reported in some Bay Area Walgreens stores (Mercury News)
  • Hot flashes caused by cancer therapy can be prevented, treated (Reuters)
  • Common Rule delayed: Is the regulated community ill-prepared? (Outsourcing Pharma)
  • The first effective drugs for preventing migraine may be available soon (PBS)
  • Express Scripts CEO: "I Don't Mind If Amazon Comes In" (SCRIP-$)
  • Billionaire-backed Juvenescence primes the anti-aging pipeline pump with a $12M seed round (Endpoints)
  • Boasting a late-stage Botox me-too, Evolus files for $75M IPO (Endpoints)
  • Perrigo Taps CEO With Global Operations Expertise At Pharma Packaging Firm (Pink Sheet-$)
  • US FDA Officials Exhort Compounding Pharmacies To Improve Drug Quality (Pink Sheet-$)
  • Mexican Drugmaker Warned for Adulterated Product (FDANews-$)
  • Agency Information Collection Activities; Submission for Office of Management and Budget  Review; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Celixir's cell therapy gets green light for heart failure trial (PharmaTimes)
  • Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab) as Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma (Press)
  • Application for Marketing Approval Submitted for Bispecific CD19-directed CD3 T Cell Engager (BiTE®) Antibody Construct Blinatumomab for Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Japan (Press)
  • Ionis' TTR Amyloidosis Candidate Under Priority Review (BioCentury)
  • BerGenBio Meets First Efficacy Endpoint in Phase II Trial With Selective AXL Inhibitor BGB324 (bemcentinib) in NSCLC (Press)
  • InflaRx receives IND acceptance to proceed with a Phase IIb Trial with lead candidate IFX-1 in Hidradenitis Suppurativa (Press)
  • GT Biopharma Announces Completion of Dosing in Phase 1 Clinical Trial of GTP-004 for Myasthenia Gravis (Press)

Medical Devices

  • Brain Surgery in 3-D: Coming Soon to the Operating Theater (NYTimes)
  • Recently Approved: ZOLL X Series, R Series, AED Pro & AED 3 BLS Professional Defibrillators (FDA)
  • CMS considering first revisions to lab rules in 26 years (Modern Healthcare)
  • Glucose monitor maker Intuity Medical brings in $40M (MobiHealthNews)
  • At JPM, Medtronic CEO talks value-based care, pushes back on criticism of M&A strategy (MedCityNews)
  • Baxter buys Mallinckrodt's Recothrom, Preveleak sealants for $153m (MassDevice)
  • Insulet lands Medicare Part D coverage for Omnipod insulin delivery system (MassDevice)
  • Masimo Announces FDA Clearance for Home Use of Rad-97 (Press)
  • Clearbridge Gains FDA Registration for ClearCell FX1 System (GenomeWeb)
  • Medtronic Enrolls First Patient In Pain Study to Assess Optimized Spinal Cord Stimulation Programming (Press)
  • Pulmonx Submits Premarket Approval (PMA) Application to FDA for Zephyr Endobronchial Valve as Treatment for Emphysema (Press)
  • Attune Medical Receives 510(k) Clearance from FDA: New Device for Feeding and Medication Administration Using Standardized Connector and EnsoETM (Press)
  • Xcision Receives FDA 510(k) Clearance for the GammaPod Stereotactic Radiotherapy System for Breast Cancer (Press)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices (FDA)

US: Assorted & Government

  • The maker of Oxycontin likes Rick Scott's plan to limit opioids. So why don't others? (Miami Herald)
  • The PTAB Strikes Back -- Issues Order Prohibiting St. Regis Mohawk Tribe from Filing Any Additional Papers in IPR (Patent Docs)
  • Court May Confirm the Rigorous Materiality Standard Required by the False Claims Act (FDA Law Blog)
  • Centene says over 1.4 million sign up for Obamacare plans (Reuters)
  • Medicaid: Further Action Needed to Expedite Use of National Data for Program Oversight (GAO)
  • Court Gives Biopharma Patent Owners (A Little) Help In Inter Partes Review (Pink Sheet-$)
  • Improper Motive and Sloppy Drafting Defeat Remand (Drug & Device Law)
  • J&J May Face Punitive Damages In Pa. Risperdal Cases (Law360-$)
  • Restasis Antitrust Suits Paused For MDL Panel Review (Law360-$)
  • Genomics IP Trial Between Illumina And Ariosa Kicks Off (Law360-$)
  • Supreme Court Declines To Rehash Stryker Noncompete Win (Law360-$)
  • Seattle Genetics Mounts 3rd Bid To Defeat Stock Fraud Suit (Law360-$)
  • GSK Wants 3rd Circ. To Rehear La. Flonase Decision (Law360-$)
  • CSL Must Face Shire's Willful Infringement Claim (Law360-$)

Upcoming Meetings & Events


  • BeiGene in-licenses sitravatinib in the Asia Pacific Region (PharmaLetter-$)
  • Beigene And Boehringer Ingelheim Announce Commercial Supply Agreement For Tislelizumab (Reuters) (Press)



  • Special Access Scheme (TGA)

Other International

  • Iraq reports outbreak of highly pathogenic H5N8 bird flu: OIE (Reuters)
  • Sri Lanka to build first-ever pharmaceutical manufacturing zone (Pharmafile)

General Health

  • Already 'Moderately Severe,' Flu Season in US Could Get Worse (NYTimes)
  • A Heart Risk Factor Even Doctors Know Little About (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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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