Regulatory Focus™ > News Articles > 6 > Recon: Novo Reportedly Considering up to 3,000 Layoffs

Recon: Novo Reportedly Considering up to 3,000 Layoffs

Posted 08 June 2018 | By Michael Mezher 

Recon: Novo Reportedly Considering up to 3,000 Layoffs

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

In Focus:

  • Two weeks after Trump unveiled plan to lower drug prices, two cancer drugs got a $1,000-per-month price hike (Washington Post)
  • FierceBiotech BIO breakfast—CAR-T 2.0: Biomedical science at the cutting edge (Fierce)
  • Visualize: ASCO 2018's winners and losers (Endpoints)
  • At BIO convention, business boomed, and drug pricing loomed (C&EN)
  • An Unlikely Biotech Investor: The Government (Forbes)
  • Blockbuster Drugs? How About Doing More With What We've Got (Bloomberg)
  • Trump administration won't defend ACA in court. What now? (Politico) (Reuters) (NYTimes)
  • US lawmakers seek answers from new head of WHO's cancer agency (Reuters)
  • Relocating its US HQ to Boston, French pharma Ipsen to add 250 jobs (Endpoints)
  • Researchers say they're on the verge of creating a revolutionary, non-addictive painkiller (CBS)
  • AbbVie's Humira, Merck's Keytruda and more: The top 10 drugs of 2024 (Fierce)
  • FDA Approves Rituxan For Pemphigus Vulgaris (BioCentury) (PharmaTimes) (Press)
  • Gottlieb at BIO: FDA developing processes around right-to-try law (MedCity)
  • PTAB Nixes Patent For Valeant's Antifungal Jublia (Law360-$)
  • Biogen, Drugmaker Settle Angiomax Patent Royalties Row (Law360-$)
  • Every Time I Thought the Purdue Pharma OxyContin Story Was Over, I Was Wrong (NYTimes)

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In Focus: International

  • Diabetes giant Novo said to consider up to 3,000 layoffs as US pricing storms gather: report (Endpoints) (Pharmaceutical Manufacturing) (Borsen)
  • WHO chief says Ebola outbreak in Congo is stabilizing (Reuters)
  • Congo reports first confirmed Ebola case in over a week (Reuters)
  • Pharma industry seeks early EU-UK drugs agreement (Financial Times)
  • French emergency room tests virtual reality path to pain relief (Reuters)
  • Pfizer, Flynn Pharma win appeal against CMA's £90m fine (PharmaTimes) (Financial Times)
  • Novartis won't face Swiss criminal probe over payments to Trump lawyer (BioPharmaDive)
  • China SDA Joins ICH Management Committee (BioCentury)
  • 'Historical Moment' As Global Generics Body Gets Seat On ICH Management Committee (Pink Sheet-$)
  • Vertex and NHS England Set Date For Next Round Of Orkambi Pricing Talks (Pink Sheet-$)
  • UK investigation into generics price hikes (TPL-$)
  • Australian Orphan Fee Waivers To Expire As Transition Period Ends (Pink Sheet-$)
  • Egypt's CAPA to Require Registration for All Medical Devices (Emergo)
  • Global Standard for Managing Post-Approval Changes Moves Forward (PharmTech)

Pharmaceuticals & Biotechnology

  • Sarepta poaches Biogen development executive for CMO position (Fierce)
  • Ten insights on the US opioid crisis from claims data analysis (McKinsey)
  • Advaxis cuts staff as it seeks partner for troubled cancer vaccine (Fierce)
  • Overcoming the legal and regulatory barriers to drug repurposing (Nature)
  • Burden of "Right to Try" Implementation on Sponsors (for Now); Risk of Unexpected SAEs Negatively Impacting Development and Approval Still Remains (FDA Law Blog)
  • Brainstorm Considering Right To Try For ALS Therapy (BioCentury)
  • FDA wants social media giants to help crack down on illegal opioid marketers (Fierce)
  • BIO Notebook Day 4: Gottlieb Seeks Early Engagement On Gene Therapy; Ireland's Brexit Opportunities; AMAG's Bremelanotide Strategy; Alzheimer's 'Learnings' (Pink Sheet-$)
  • New Biotech Working Group at FDA seeks modern, flexible regulatory framework (TPL-$)
  • Servier opens Kendall Square site, plans Chinese office to access external innovation (Fierce)
  • Emergent initiates $50m expansion, expects to hire 60 (InPharma)
  • New 'genetic atlas' of plasma proteins could unveil potential drug targets (Fierce)
  • ICER final report calls for Vertex restraint and increased pricing transparency for CF drugs (TPL)
  • Vertex presents real-world data highlighting benefit of CF drug Kalydeco (PharmaTimes)
  • Janssen sees a potential myeloma CAR-T edge, exec says at BIO (MedCity)
  • Ex-Takeda executive takes up CMO post at CD47 biotech Trillium (Fierce)
  • Should Doctors Consider Body Size When Prescribing Drugs? (NYTimes)
  • NIH Prompts Formal Review Of Medication-Assisted Treatment For Opioid Addiction (BioCentury)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • OPHTHOTECH GAINS GENE THERAPY FOR ORPHAN VISION-LOSS DISEASE (BioCentury)
  • Novartis publishes positive data for recently-acquired Lutathera (TPL)
  • Ironwood Pharmaceuticals Announces FDA Orphan Drug Designation for Olinciguat for the Treatment of Sickle Cell Disease (Press)
  • Alnylam Reports Updated Positive Results from Phase 1/2 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 (PH1) (Press)

Medical Devices

  • Blood Test Might Predict Pregnancy Due Date and Preterm Birth (NYTimes)
  • FDA labels IABP recall for Getinge's Maquet, Datascope as Class I (MassDevice)
  • Class 1 Device Recall Draeger Jaundice Meter JM105 (FDA)
  • TransEnterix Announces FDA 510(k) Submission for 3mm Senhance Instruments (Press)
  • Medical Devices; General and Plastic Surgery Devices; Classification of the Microneedling Device for Aesthetic Use (FDA)
  • Medical Devices; Orthopedic Devices; Classification of the In Vivo Cured Intramedullary Fixation Rod (FDA)

US: Assorted & Government

  • Blame The Criminals, Pharmacies Facing Opioid Lawsuits Say (Forbes)
  • White House Preparing Bio-Defense Strategy As Germ Warfare Fears Rise (Forbes)
  • Limits for Use of Genealogy Databases in Criminal Investigations Must be Legislated, Experts Say (GenomeWeb)
  • Guest Post – Don't Come to West Virginia Without Your Expert (Drug & Device Law)
  • Celltrion, Inc. v. Genentech, Inc. (N.D. Cal. 2018) (Patent Docs)

Upcoming Meetings & Events

Canada

  • Canada clears major hurdle in legalizing recreational marijuana (Reuters)

Australia

  • Fees and charges: summary - from 1 July 2018 (TGA)

General Health & Other Interesting Articles

  • CDC: U.S. Suicide Rates Have Climbed Dramatically (NPR)

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? Email us at news@raps.org.

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


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