Regulatory Focus™ > News Articles > 2019 > 5 > Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M

Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M

Posted 22 May 2019 | By Michael Mezher 

Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • The real drug pricing debate is upon us (Axios)
  • Eli Lilly's half-price insulin goes on sale, but critics say it's still too costly (CBS)
  • Latecomer Lilly preps its IL-23 drug for Crohn’s disease (PMLive) (BioPharmaDive)
  • China’s ban on fentanyl drugs won't likely stem America’s opioid crisis (LA Times)
  • US measles outbreak spreads to Maine, 25th state to report case (Reuters)
  • Vermont Attorney General Sues Owners of Opioid Manufacturer (AP)
  • Baltimore sues J&J for 'sham' Zytiga patent to fend off generics (Fierce) (Baltimore Sun)
  • Lawmakers contend WHO pain treatment guidelines are really Purdue ‘marketing materials’ (STAT)
  • We have the technology to customize our babies. It needs regulation. (Washington Post)
In Focus: International
  • The global battle over high drug prices (The Economist)
  • Amgen to buy Copenhagen-based Nuevolution for $167 million (Reuters) (Endpoints) (Fierce) (Pharmafile) (Press)
  • Roche’s Chugai to set up new $1B+ lab in Yokohama, consolidating R&D (Endpoints)
  • TÜV SÜD Becomes Second NB to be Designated Under EU MDR (Focus)
  • UniQure snags patents on Huntington's gene therapy as it preps for the clinic (BioPharmaDive)
  • Another Eli Lilly oncology drug is in trouble, as Japan issues Verzenio safety warning (Endpoints)
  • Regenerative medicine firm CollPlant launches Israel R&D center (Reuters)
  • Takeda scores Japanese Entyvio approval in Crohn's disease (Pharmafile)
  • UK BIA To Lobby New EU Parliament On Need For Close Regulatory Ties After Brexit (Pink Sheet-$)
  • Publicly Funded R&D In EU Should Come With Conditions, Says Report (Pink Sheet-$)
  • GSK’s booming Shingrix, after VIP invite, wins nod to tackle China (Fierce)
  • The Ebola response effort is struggling. Experts say these steps could help (STAT)
  • Vaccine doubts spread like disease, must be taken offline: vaccine chief (Reuters)
  • Novartis CEO says cannabis isn’t a focus despite Tilray partnership (CNBC)
Pharmaceuticals & Biotechnology
  • NASEM Releases Nominees for International Commission on the Clinical Use of Human Germline Genome Editing (National Academies)
  • ‘We as a species need to come to terms’ with CRISPR technology as China awaits birth of third genetically modified baby (CNBC)
  • We don’t yet have the technology to cure Alzheimer’s, health-care investor says (CNBC)
  • Drug Regulators Look to Harmonize How They Tackle Innovation (Focus)
  • FDA Chief of Staff Calls OTC Monograph Reform a Top Priority (Focus)
  • MIT professor is accused of claiming others’ scientific discoveries as his own (STAT) (Endpoints)
  • Children wait six and half years longer than adults for new cancer drugs, study says (Pharmafile)
  • Daiichi Sankyo comes up way short of promised avian flu vaccine production (Fierce)
  • Computerized Model Reveals Details Of How Human Cells Divide (NPR) (Fierce)
  • Time To Create A Viable Path To Biosimilar Interchangeability (Law360-$)
  • Immune To Drugs: Antimicrobial Resistance Could Kill 10 Million A Year (Forbes)
  • How Drug Effects Are Assessed In Renally Impaired Patients Could Be Headed For A Change (Pink Sheet-$)
  • Gene Therapy In The Real World: Long-Term Follow Up Is Key – If Patients Are Willing (Pink Sheet-$)
  • Expanded Access: Reducing The Contract Delay (Pink Sheet-$)
  • Cegedim, Sanofi enter healthcare improvement RWD collaboration (PharmaTimes)
  • Which PBM Best Managed Drug Spending in 2018: CVS Health, Express Scripts, MedImpact, or Prime Therapeutics? (Drug Channels)
  • Abuse Deterrent Opioid Formulations: The Answer to an Epidemic or Wolf in Sheep’s Clothing?  (Harvard Bill of Health)
  • Another gene therapy company launches with VC cash and a CRISPR tech to target toxic RNA (Endpoints)
  • Florida OTC Maker Warned for Testing and Quality Issues (FDANews-$)
  • With $120M, AlloVir Faces Big Test of Cell Therapy to Fight Infection (XConomy)
  • Affimed hangs onto Genentech alliance after dropping stranded PhI program as CSO exits (Endpoints)
  • David Hallal brings his first cell therapy company into the fold, and it’s tied to a major league financing deal (Endpoints)
  • Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions (FDA)
  • Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Novartis drums up anticipation for blockbuster-to-be with PhII data on asthma drug, beating Advair in head-to-head (Endpoints) (Fierce)
  • Tocagen continues a brain cancer gene therapy clinical trial. Investors fear the worst (STAT) (BioPharmaDive)
  • Positive Phase I results for Allergy’s Acarovac (PharmaTimes)
  • Altasciences Leads Research on Chemical Nerve Agent Therapeutic from Preclinical to Clinical Phase I (Press)
  • Novo Nordisk to present data on oral semaglutide at the 79th Annual American Diabetes Association Scientific Sessions (Press)
  • BELLUS Health Presents Phase 1 Data for BLU-5937, its Lead Product Candidate for the Treatment of Refractory Chronic Cough, at the American Thoracic Society International Conference (Press)
Medical Devices
  • FDA Warns Orthopedic Implant Manufacturer Over Quality System Violations (Focus)
  • Integra LifeSciences recall draws Class I label from FDA (MedTechDive)
  • FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study (Focus) (Press)
  • Apple Watch app for nightmare disorder receives FDA breakthrough designation, opens enrollment for two RCTs (mobihealthnews)
  • Comcast is working on an in-home device to track people’s health (CNBC)
  • Class 1 Device Recall EV1000 Clinical Platform (FDA)
  • Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) (FDA)
  • Gore Scores FDA Nod for More Precise TEVAR Solution (MDDI)
  • DARPA Funds Ambitious Brain-Machine Interface Program (IEEE Spectrum)
  • Results Announced from Two Renal Denervation Studies at EuroPCR Show Positive Outcomes in High-Risk Hypertensive Patients (Press)
  • AngioDynamics Receives FDA Approval to Initiate Pilot Study for the Use of NanoKnife to Treat Prostate Cancer (Press)
US: Assorted & Government
  • Rep. Steve King Releases Bill to Compel FDA to Approve Single Compassionate Use Request (Bill)
  • ‘Medicare for All’ Falters as Top Democrats Fret Over Backlash (Bloomberg)
  • Harris targets maternal mortality crisis in new 2020 proposal (Politico)
  • Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2019) (Patent Docs)
  • Torrent Pharma Accused Of Distributing Tainted Pills (Law360-$)
  • Law Review Article Critiques Local Government Public Nuisance Suits (Drug & Device Law)
  • J&J Tells 7th Circ. Missing FDA Evidence Dooms $20M Verdict (Law360-$)
  • J&J Hit With $25M NY Talc Verdict, But Wins Trial In SC (Law360-$)
  • A Grain of Potassium Chloride Salt (FDA Law Blog)
  • Aegerion Files Ch. 11, Plans $400M Sale To Amryt Pharma (Law360-$)
Upcoming Meetings & Events Europe
  • Europe’s MDR and combination products: Clarifications for drug-device product oversight (Emergo)
  • Labeling requirements could leave Russia ‘without drugs,’ says trade group (PharmaLetter-$)
India
  • Dr Reddy's Labs net zooms by 106% to Rs. 1,950 crore in 2018-19 (Pharmabiz)
  • Medical Investigation: How Did 494 Children In One Pakistani City Get HIV? (NPR)
  • Medtronic recommends physicians to continue patient follow-up with pacemakers despite safety alerts (Pharmabiz)
General Health & Other Interesting Articles
  • How a synthetic genome could be used to repurpose lifeforms (Financial Times)
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.
 
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