Regulatory Recon: FDA Expands Use of Amgen's Fracture Prevention Drug Xgeva Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018)

Posted 05 January 2018 | By Michael Mezher 

Regulatory Recon: FDA Expands Use of Amgen's Fracture Prevention Drug Xgeva Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018)

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

In Focus: US

  • Drug Industry Is Ripe for a Wave of Deals (WSJ)
  • FDA expands use of Amgen's blockbuster drug (Reuters)
  • Look out, Teva: Mylan's Copaxone copy has already captured serious share (Fierce)
  • Johnson & Johnson pens Alzheimer's gene therapy pact (Fierce) (Endpoints)
  • Kala Pharma shares damaged by mixed data from PhIII dry eye program (Endpoints) (Press)
  • Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine (NEJM)
  • Shire's cytomegalovirus therapy wins 'Breakthrough' status (PharmaTimes)
  • 'Jeff can't help himself': A frenzied CEO's push to get depression drugs to market (STAT)
  • HHS' OIG to PhRMA: Free Pharmaceuticals Needed in 2018 (Focus)
  • FDA Warns Stem Cell Supplier Over Unapproved Treatment (Focus)
  • FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics (Focus)
  • An $850,000 Price Tag on Gene Therapy Shouldn't Freak You Out—Yet (MIT Technology Review)
  • Cancer Deaths Fall to Lowest Rate in Decades (Bloomberg) (Medpage) (Cancer Statistics 2018)
  • Snow, Skiing, And My 2018 Outlook For Biotech (LifeSciVC)
  • Neurontin prescriptions surge amid opioid crisis (Reuters)
  • To catch Apple, Fitbit invests in a company that makes a small patch to track blood sugar for diabetics (CNBC)
  • Remember Trump's Pitch on Health Care Associations? Now We Know What He Meant (NYTimes) (Politico)
  • Trump administration drops Obama-era easing of marijuana prosecutions (Reuters) (FDA Law Blog)

In Focus: International

  • Takeda swoops in to buy stem cell partner TiGenix for $630M, putting it on the threshold of a likely approval (Endpoints) (Fierce)
  • Neurodegeneration star Denali nabs a cash-rich, $1B-plus Alzheimer's partnership with Takeda  (Endpoints) (Fierce)
  • Cash-Strapped Venezuela Offers to Pay for Medicines With Diamonds (WSJ)
  • 28 New Drug Approvals In EU: Cancer Dominates, But RA, Skin & Blood Disorders Well Served Too (Pink Sheet-$)
  • China's KBP gains GlaxoSmithKline executive as chief, an American headquarters and a cash boost (Fierce) (Endpoints)
  • European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (Focus)
  • Roche's emicizumab cleared for early access in the UK (Fierce) (PharmaTimes)
  • Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs (Emergo)
  • Opdivo, Repatha and Lynparza likely among China's 2018 blockbuster nods: report (Fierce)
  • The pharma deals that CCGs fail to declare (BMJ)
  • Drug shortages cost NHS £38m in November (BMJ)

Pharmaceuticals & Biotechnology

  • Accelerated approval of medicines: fit for purpose? (Nature)
  • Toward Better-Quality Compounded Drugs — An Update from the FDA (NEJM)
  • More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve (Focus)
  • The 'smart pill' market could be worth $3B by 2025 – meet the key players (Drug Delivery)
  • Global Post-Approval Changes Outlook Murky As Q12 Lurches Into Consultation (Pink Sheet-$)
  • Novartis Pharma Ex-CEO takes three roles in two days (Pharmafile)
  • Vantage view – Payers OK with CAR-T? Not so fast (EP Vantage)
  • Shire seeks FDA sign-off on plasma manufacturing facility (BioPharmaDive)
  • Dispute brewing over exit of Protein Sciences CEO after Sanofi buyout (Fierce)
  • Former Receptos executives launch Gossamer Bio with $100M war chest (Fierce)
  • Atlas-backed Generation Bio promises 'druglike' gene therapy (Fierce)
  • Crispr Raises $113.8m In Follow-On (BioCentury)
  • Adverse Experience Reporting for Licensed Biological Products; and General Records (FDA)
  • Troubled OvaScience axes half of workforce (BioPharmaDive)
  • Microbiome Clinical Studies Loom Large In 2018 (SCRIP-$)
  • Adaptive, Microsoft To Develop Universal TCR-Antigen Map (BioCentury)
  • US FDA's New Hypogonadism Guidance Focuses On Non-Testosterone Products (Pink Sheet-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Novartis' Kisqali, playing from behind, grabs 'breakthrough' in younger women (Fierce)
  • BioCardia Submits Clinical Trial to FDA for New Indication of Chronic Myocardial Ischemia for CardiAMP Cell Therapy (Press)
  • Avelas Biosciences Completes Period 1 Patient Enrollment in Phase 2 Study of AVB-620 in Women with Primary, Nonrecurrent Breast Cancer Undergoing Surgery (Press)
  • Neurotrope's Bryostatin Improves Cognition in Patients with Advanced Alzheimer's Disease Based on Further Analysis of Phase 2 Clinical Trial Data (Press)

Medical Devices

  • Dexcom shares take a hit as Abbott's CGM system gets CMS nod (MedCityNews)
  • ANSI/AAMI PB70: Closing the Gap (MDDI)
  • Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas (Press)
  • Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer (FDA)
  • NuVasive wins expanded FDA nod, launches interbody fusion devices (MassDevice)
  • Pixium Vision wins FDA nod for Prima sub-retinal implant study (MassDevice)
  • Mevion wins FDA 510(k) for S250i proton therapy system (MassDevice)

US: Assorted & Government

  • Gilead Takes Key FCA Battle To Supreme Court (Law360-$)
  • Devil is in the Details Daubert Decision (Drug & Device Law)
  • Celgene Hits Supplier With Cancer Drug Trademark Suit (Law360-$)
  • Fed. Circ. Revives Infringement Row Over Pill Coating (Law360-$)
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance (FDA)

Upcoming Meetings & Events


  • Chemocentryx Gains After Ema Validates Avacopan MAA (BioCentury)


  • Chinese Biotech KBP Raises $76 Million Series A (BioCentury)
  • FiercePharmaAsia—J&J-Legend CAR-T team-up, Eisai-Biogen Alzheimer's flop, Impax's deals (Fierce)
  • Highlighting History: Japan's Accelerated Innovations (BIO)


  • Health ministry's mini drug testing lab project moves at snail's pace due to slow procurement of equipment (PharmaBiz)


  • Special Access Scheme: Guidance for health practitioners and sponsors (TGA)


  • Health Canada Approves DermTech's Pigmented Lesions Assay (GenomeWeb)

General Health

  • Resolutions of a Cancer Doctor (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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles