Regulatory Focus™ > News Articles > Regulatory Recon: AstraZeneca, Endo to Cut Hundreds of US Jobs; More Promising Data From Biogen Alzh

Regulatory Recon: AstraZeneca, Endo to Cut Hundreds of US Jobs More Promising Data From Biogen Alzheimer's Study (9 December 2016)

Posted 09 December 2016 | By Michael Mezher 

Regulatory Recon: AstraZeneca, Endo to Cut Hundreds of US Jobs More Promising Data From Biogen Alzheimer's Study (9 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Bristol-Myers Squibb to pay $19.5 million to settle off-label promotion case (Reuters)
  • Under Trump, Congress likely to pull plug on medical device tax (Reuters)
  • AZ to terminate 700 US jobs (Pharmafile)
  • Endo Sells Back Rights for Opioid Painkiller, Plans to Cut 375 Jobs (WSJ) (Fierce)
  • Further promising data seen with Biogen Alzheimer's drug: study (Reuters) (The Street) (STAT) (Press)
  • Astra, Lilly stick with Alzheimer's approach despite setback (Reuters)
  • Novel Precision Medicine Trial Designs: Umbrellas and Baskets (JAMA)
  • 340B Reform Remains Elusive Even As Spending Increases (Pink Sheet-$) (National Law Review)
  • Cures bill heads to Obama's desk (Politico)
  • Cures Act Gains Bipartisan Support That Eluded Obama Health Law (NYTimes) (InThePipeline)
  • The Sharing Economy: Pharma is opening up its libraries to draw in external partners (BioCentury)
  • Why Donald Trump's Putative FDA Pick Could Scare Pharma (Forbes) (Pink Sheet-$)
  • Would an FDA radical make any real difference? (Health Business Blog)
  • US Drug Reimportation 'Trump Proposal' Risky and Inefficient, AmerisourceBergen (OutsourcingPharma)
  • FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions' (Focus)
  • US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches  (Focus) (FDA Law Blog)
  • Horizon Pharma Shares Plunge on Failed Late-Stage Study (WSJ) (Fierce)
  • These drug price hikes cost taxpayers millions (STAT)
  • Payers expect drug prices to rise 3 percent to 6 percent over the next three years, survey finds (STAT)
  • Former Insys Executives Arrested on Racketeering Charges (Focus) (NYTimes) (Forbes)
  • FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section (Focus)
  • In the Wake of the Election, What's Next for State Drug Pricing Initiatives? (National Law Review)
  • Highlights of Medical Device Related Provision in the 21st Century Cures Act (FDA Law Blog) (Emergo)
  • Top of 2017's pharma heap? Pfizer, Novartis, Roche—and 7 drugs headed for biosim attack (Fierce) (MedCityNews) (EP Vantage Report)

In Focus: International

  • French biotech jumps after gaining license to regulatory T cell patents (PharmaLetter-$)
  • Strategic US-German 'superbug' alliance (PharmaLetter-$)
  • European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) (Focus)
  • Perrigo Starts Branded Consumer Product Rescue Mission In Belgium (Pink Sheet-$) (Fierce)
  • Safety, Real World Data, Pricing & More: Takeaways From Adaptive Pathways Workshop (Pink Sheet-$)
  • Spain: Technical proposal to health authorities to combat therapeutic non-compliance (PharmaLetter-$)
  • Teva, already facing $500M-plus penalties for bribery, probes claims it paid off docs in Romania (Fierce)

US: Pharmaceuticals & Biotechnology

  • Study finds opioids not helpful in treating chronic pain (PharmaLetter-$)
  • Biomarker Qualification Program (FDA)
  • The Next PCSK-9 Pricing Debate: PBM Says Outcomes Data Should Mean Deeper Discount (Pink Sheet-$)
  • Analysts on amyloid thesis: It's not dead yet (Fierce)
  • Ready, Set, Go! Program Fee Cleanup List Now Available -Timeline Outlined (Lachman Consultants)
  • NH to receive $243K in Abilify drug settlement (NH Union Leader)
  • Event – Novartis writing second act in heart failure (EP Vantage)
  • Radius slips after Phase I readouts for SERM program (BioCentury)
  • Two US men get jail terms for trafficking fake ED drugs (Securing Industry)
  • Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

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

  • Lilly Announces Detailed Results of Solanezumab Phase 3 EXPEDITION3 Study at the Clinical Trials on Alzheimer's Disease (CTAD) 2016 Meeting (Press)
  • Alzheon Presents Analyses from Phase 3 Clinical Studies Showing Largest Clinical Effects of Tramiprosate, the Active Molecule of ALZ-801, in APOE4/4 Homozygous Patients with Mild Alzheimer's Disease (Press)
  • Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) (Press)
  • Biohaven' BHV-0223 is Granted Orphan Drug Designation in the Treatment of Amyotrophic Lateral Sclerosis (Press)

US: Medical Devices

  • Edwards Unveils Structural Heart Pipeline (MDDI)
  • Can virtual reality games help with phantom limb pain? (Reuters)
  • Immunodiagnostics: A breakthrough technology revolutionizing infectious and chronic disease diagnosis (PharmaLetter-$)
  • Provision Healthcare Receives FDA Clearance of the ProNova SC360 Proton Therapy System (Press)
  • AMI's TubeClear® System Receives Additional FDA Clearances (Press)
  • Gordian Surgical wins FDA clearance, raises $2m for TroClose1200 (MassDevice)
  • Verily launches Liftware smart utensils (MassDevice)
  • Class 1 Device Recall SynCardia Freedom Driver System (FDA)

US: Assorted & Government

  • Trump Plan To Increase Health Savings Accounts Should Ensure That They Do Not Only Benefit The Wealthy And Healthy (Health Affairs Blog)
  • This Is How A False Claims Act Case Works—And Fails (Drug and Device Law)
  • Novartis Loses At BALCA In Case Over Exec. Director Job (Law360-$)
  • Inside The 2nd Circ. Ruling In Abbott V. Adelphia (Law360-$)
  • In re Nuvasive (Fed. Cir. 2016) (Patent Docs)

Upcoming Meetings & Events

Europe

  • Bert Leufkens stepping down as MEB chairman (CBG MEB)
  • Conditional European marketing approval for Venclyxto in CLL (PharmaLetter-$)
  • St. Jude Medical wins CE Mark for full-body MRI scans with Proclaim Elite SCS device (MassDevice)
  • Demonstrating biosimilarity in the EU (GaBI)
  • Demand from French hospitals ensures healthy trade in leeches (Reuters)

India

Australia

  • Microport Orthopedics metal-on-metal hip implant components (TGA)
  • balanSys UNI convex PE inlays x/5 - used in knee replacements (TGA)

General Health & Other Interesting Articles

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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