Recon: BMS to Pay $1.85B for Rights to Nektar Cancer Drug; Merck Scraps Late Stage Alzheimer's Study

Posted 14 February 2018 | By Michael Mezher

Recon: BMS to Pay $1.85B for Rights to Nektar Cancer Drug; Merck Scraps Late Stage Alzheimer's Study

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

In Focus: US

  • Bristol-Myers To Pay Largest Fee In Biotech History For Nektar Cancer Drug (Forbes) (STAT) (Endpoints) (Reuters) (Press)
  • Merck scraps another late-stage Alzheimer's drug study (Reuters) (STAT) (Endpoints) (Press)
  • Senior Merck chemist charged with risking catastrophe after pouring cyanide into Pennsylvania stormwater drain (Endpoints)
  • FDA's Rachel Sherman on Right to Try, Succession Trouble & More (Xconomy) (Pink Sheet-$)
  • FDA Warns Bayer for Inadequate Cleaning, QC Questions (Focus) (Reuters)
  • Number of lawsuits challenging opioid industry still growing (AP)
  • Biologists would love to program cells as if they were computer chips (MIT Technology Review)
  • Will new migraine drugs be a boon — or a bust — for patients and investors alike? (STAT)
  • Drug makers loathe these patent challenges, and more are being filed than ever before (STAT)
  • Tetraphase's second PhIII for its lead antibiotic fails in a repeat setback for UTIs (Endpoints) (Reuters)
  • Gottlieb Statement on FDA's Request for Funding in Proposed 2019 Budget (FDA)
  • Amerisource deal may not keep Walgreens competitive: analysts (Reuters)
  • Walgreens Won't Buy An Insurer If AmerisourceBergen Stake Grows (Forbes)
  • USPSTF Says 'No' to Ovarian Cancer Screening (Medpage)
  • Apple CEO: We can make a 'significant contribution' in health care (CNBC)

In Focus: International

  • Novartis, Gates Foundation pen tropical disease drug pact (Fierce)
  • Germany's CureVac wins new vaccine funding from Gates Foundation (Reuters)
  • Bicycle, CR UK launch first trial of a bicyclic peptide (PharmaTimes)
  • Shire beats forecasts but signals slower growth ahead (Financial Times)
  • EMA Rejects 76% Of Requests To Label Info In Clinical Reports As Commercially Confidential (Pink Sheet-$)
  • Seeking safety in numbers, Ireland wants to join multinational coalition to fight high drug prices (STAT)
  • Key Role For China As Sanofi's Emerging Markets Business Grows (SCRIP-$)
  • In Race for Blood Cancer Therapy, a Chinese Biotech Firm Surges 500% (Bloomberg)
  • Astellas pledges $102.5M for universal donor cell company (Fierce) (Press)
  • Stem Cell Firm Cellular Dynamics to Provide Heart Cells to Takeda (Xconomy)
  • GlaxoSmithKline tops its peers with $7.16B in 2017 vaccine sales (Fierce)
  • New Merck Biotech Facility to Bring 350 Jobs to Dublin (Pharmafile) (Fierce)
  • Switzerland's Ferring Pharma to build $32M discovery, development and manufacturing center at HQ (Endpoints)
  • Lacking Backup Plan, WHO Allows Continued Use Of Contraceptives Barred From US (Pink Sheet-$)
  • FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves (FDA)

Pharmaceuticals & Biotechnology

  • NIH study will assess biomarker as potential indicator of whether lower respiratory tract infections improve with antibacterial treatment (NIH)
  • Researchers Investigate the Effect of Labeling Changes on PPI Use in Sentinel (Focus)
  • High cancer-related expenses take a toll on quality of life (Reuters)
  • What does biotech think about 'right-to-try'? It might surprise you (Endpoints)
  • Promising MSF Research Highlights Immense Benefits, Need for Expanded Use of DR-TB Drug Combination (MSF)
  • Tapping the Brakes on Machine Learning (Duke Forge)
  • Which opioid addiction treatments work? White House OKs study to find answers (Modern Healthcare)
  • Pfizer taps real world evidence for CVD in new partnership (Pharmafile)
  • Biotech Investment Outlook Remains Strong Despite Jitters (SCRIP-$)
  • FDA Highlights Advanced Drug Manufacturing Approaches In Budget Plan (Pink Sheet-$)
  • Opioid REMS Hearing Features Top-Level FDA Team – But No Manufacturers (Pink Sheet-$)
  • Beat you to it, Purdue. Other opioid makers already ditched promotions (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Toujeo® reduced risk of severe low blood sugar compared to insulin glargine 100 Units/mL and insulin detemir (Press)
  • Stock slumps for Tel Aviv's Galmed following PhIIa NAFLD flop (Endpoints)
  • Valeant's Ortho Dermatologics Says FDA Accepts NDA For IDP-122 Lotion (Press)
  • Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis (Press)
  • FDA Grants Priority Review for Genentech's Rituxan (Rituximab) for Pemphigus Vulgaris (Press)
  • Exelixis Announces Results from a Phase 2 Investigator-Sponsored Trial of Cabozantinib in the First-Line Treatment of Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma (Press)
  • IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3 (Press)
  • Therachon Announces Dosing of First Subject in Phase 1 Clinical Trial Evaluating TA-46, a Novel Investigational Therapy for the Potential Treatment of Achondroplasia (Press)
  • Mallinckrodt Enrolls First Patient in Phase 1 Study of ExpressGraft™C9T1 Skin Tissue (Press)
  • DARPA Awards MBio Diagnostics Phase II Contract for Acute Infection Point-of-Care System (Press)

Medical Devices

  • Device Companies Offer Perspective on CDRH Guidance Priorities (Focus)
  • Glooko wins FDA nod for mobile insulin dosing system (Drug Delivery) (Press)
  • FDA OKs Impella Heart Pump for Cardiomyopathy with Shock (Medpage)
  • Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2018 (Press)
  • FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients (FDA)
  • Ain't That a Pill: Device Could Replace Needles (MDDI)
  • TransEnterix files expanded 510(k) application for Senhance robotic platform (MassDevice)
  • Quidel Receives 510(k) Clearance for QuickVue® Influenza A+B Test, Assay Meets FDA's Class II RIDT Requirements (Press)
  • FDA Clears Roche Factor II, Factor V Gene Mutation Test for Inherited Thrombophilia (GenomeWeb) (Press)
  • FDA Approves BD HPV Genotyping Test (GenomeWeb)

US: Assorted & Government

  • US can sue UnitedHealth in $1 billion Medicare case, judge rules (Reuters)
  • Off-Label Marketing MDL Winds Down With Some Summary Judgment (Drug & Device Law)
  • PTAB Won't Review 2 Humira Patents In Sandoz Challenge (Law360-$)

Upcoming Meetings & Events

Europe

  • EC Approves Diurnal's Alkindi (BioCentury)
  • Dates of 2018 SAWP meetings and submission deadlines (EMA)
  • Strong UK-China collaborations in healthcare (GOV.UK)
  • Second international awareness session for international regulators, academia and non-governmental organisations (EMA)
  • French retailers say they continued to receive Lactalis baby milk after recall (Reuters)

Asia

  • CFDA Releases 2018 Legislative Plan (BioCentury)

India

  • India rejects pleas for liberalization of stent price cap policy (Fierce)
  • US stents dip in distribution in India after price caps (Economic Times)

Australia

  • Therakos Cellex Photopheresis System (TGA)

Other International

General Health & Other Interesting Articles

  • Obesity Tied to Survival in Men With Melanoma (NYTimes)
  • Family history increases breast cancer risk even for older women (Reuters)
  • NIH releases first dataset from unprecedented study of adolescent brain development (NIH)

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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