A part of Watch Media

MedWatchSaturday4 February 2023

  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Search
  • Log in
  • Latest
  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
Foto: Thomas Peter/Reuters/Ritzau Scanpix

Genmab gets new MS market rival after fresh FDA approval

TG Therapeutics enters the lucrative market for multiple sclerosis treatment with newly approved drug Briumvi, now in line to compete with Genmab and Novartis’ Kesimpta and Roches Ocrevus.
  • Genmab-developed drug nears blockbuster win as Novartis sees 172% sales boost
  • Subcutaneous version of Roche's blockbuster cancer drug meets study goals

For subscribers

Foto: Clodagh Kilcoyne

US won’t back 2022 patent waivers for Covid tests and treatments

For subscribers

Foto: Issei Kato

Alzheimer's drug wins priority review in Japan

For subscribers

Foto: Rob Acket/ema

CHMP recommends four drugs in January

For subscribers

Foto: Bonnerup Claus/Ritzau Scanpix

Denmark rejects Janssen and Genmab drug twice in January

For subscribers

Foto: Benoit Tessier/Reuters/Ritzau Scanpix

CHMP recommends expanded approval of Dupixent

For subscribers

  • Foto: Manuel Balce Ceneta/AP/Ritzau Scanpix

    FDA vaccine director flagged concerns over "hyper-accelerated" review of Pfizer's Covid-19 vaccine

    The FDA managed to process Pfizer’s Covid-19 jab in less than a third of usual time, but recently uncovered e-mails reveal that not all officials were on board with the accelerated review.

    For subscribers

  • Foto: Rob Acket/ema

    Patient groups urge EMA to tackle antibiotic shortages

    A consortium of organizations have signed a letter urging the European Medicines Agency to do more to address critical shortages of widely used antibiotics. 

    For subscribers

  • Foto: Asensus Surgical/pr

    Asensus Surgical wins CE Mark for intelligent surgical unit under MDR rules

    The EU’s Medical Device Regulation imposes stricter requirements for medical device manufacturers, but the US-based medtech firm still makes it through the regulatory eye of the needle.

    For subscribers

  • Henrik Vestergaard, deputy director at Lif | Foto: Lif / Pr

    Pharma association denies pandemic lobbying: "Interest protection was on standby"

    Though a new report points to increased pharma lobbying during the pandemic, a Danish trade association says public and private actors came together to solve the crisis in Denmark.

    For subscribers

  • Foto: Photo by Markus Spiske temporausch.com from Pexels

    EU launches imaging initiative to support cancer diagnosis and treatment

    The European Cancer Imaging Initiative will offer a database of cancer imaging data, for example enabling the use of AI to potentially accelerate drug development.

    For subscribers

  • Foto: Thomas Borberg

    Pharma lobby wielded "inordinate amount of influence" over EU during pandemic

    A new critical report says the EU Commission submitted to vaccine makers’ demands for prices, transparency, and IP rights during the pandemic crisis.

    For subscribers

  • Foto: Stine Rasmussen/Ritzau Scanpix

    Denmark recommends three drugs

    New treatments for arthritis, esophageal cancer, and depression will be available for Danish patients after the Danish Medicines Council has made new recommendations.

    For subscribers

  • Foto: Peter Dejong/AP/Ritzau Scanpix

    EMA expects antibiotics shortage to improve in coming months

    Production delays and a surge in respiratory infections have exacerbated an already short supply of antibiotics affecting the EU, but strong mitigation efforts will soon ease the situation.

    For subscribers

  • ”We are open to negotiating the price should the company want to do so,” says Einar Andreassen, functional area lead at LMV | Foto: Statens legemiddelverk / Pr

    Norway denies Novo Nordisk reimbursement for obesity drug

    A similar decision not to offer subsidies to patients undergoing obesity treatment with Wegovy was also made by Denmark.

    For subscribers

  • Foto: Leah Millis/Reuters/Ritzau Scanpix

    Pharma companies say new US drug price law leaves them in limbo

    Is the pharma industry crying wolf when it says that President Joe Biden’s Inflation Reduction Act will hurt innovation? Though companies’ priorities are staying the same, strategies might change.

    For subscribers

  • Foto: Yves Herman

    EU Commission to give more time for MDR transition

    A proposal meant to mitigate potential medical device shortages under the Medical Device Regulation is now headed to the European Parliament and Council under an accelerated procedure.

    For subscribers

  • Foto: Lundbeck / Pr

    Lundbeck and Otsuka win FDA priority review of Alzheimer's agitation drug

    The two pharmaceutical firms have taken a step toward entering the market with Alzheimer’s agitation drug brexpiprazol.

    For subscribers

  • Foto: BRIAN SNYDER/REUTERS / X90051

    Alzheimer’s drug from Eisai, Biogen gets FDA accelerated approval

    In trials, Alzheimer’s drug Leqembi clinically demonstrated that it can slow cognitive decline by 27% in people with Alzheimer’s disease, data which facilitated the FDA’s approval.

    For subscribers

  • Foto: Lægemiddelstyrelsen/pr

    Denmark acted coordinator in EU Commission's work on decentralized clinical trials

    New guidelines for decentralized clinical trials in the EU have been agreed to by participating parties, and the Danish representation claims to have had a special role.

    For subscribers

  • Coloplast still has to get products equaling 20% of the company's revenues approved under the EU's new strict rules | Foto: Coloplast / Pr

    Coloplast's products generating 80% of revenue have been MDR approved

    For six years, the Danish medtech company has been increasing its number of employees tasked with ensuring products comply with new EU regulation – but there’s still a ways to go.

    For subscribers

  • Christian Hedegaard, investment Director at Nordic Capital | Foto: NordicCapital

    ESG compliance makes companies more attractive

    ESG questions played a role when Nordic Capital invested in Leo Pharma in 2021, and the private equity firm says ESG is only becoming more and more important.

    For subscribers

  • Foto: Brian Snyder/Reuters/Ritzau Scanpix

    Investigation questions FDA approval of Aduhelm

    US Congress investigators level sharp criticism at health authorities’ approval process of Biogen’s medical treatment of Alzheimers.

    For subscribers

  • Foto: Paulo Amorim/AP/Ritzau Scanpix

    EU gets rolling on decentralized clinical trials with new guidelines

    New EMA recommendations are meant to facilitate decentralized clinical trials in the EU.

    For subscribers

  • Foto: Tami Chappell/Reuters/Ritzau Scanpix

    CDC expands BMI charts for children to include those with severe obesity

    The US Centers for Disease Control and Prevention (CDC) updates BMI charts to accommodate population health developments.

    For subscribers

  • Magnus Heunicke, current functioning Minister for Health of Denmark | Foto: Katrine Hørup Noer/Ritzau Scanpix

    Health ministers back EU Commission's staggered approach to new medtech requirements

    At an EPSCO meeting on Friday, EU health officials backed the Commission’s new proposal to extend the implementation of new medical device regulation, MDR, to prevent potential critical shortages.

    For subscribers

Latest news

  • Top news from MedWatch this week – 3 Feb
  • Coloplast to set new treatment standard with Luja – but keeps sales goal under wraps – 3 Feb
  • China accepts regulatory filing for ALK allergy tablet – 3 Feb
  • Another hurdle overcome in delaying MDR deadline – 3 Feb
  • Dupixent becomes ninefold blockbuster – 3 Feb
  • ALK forecasts lower growth in 2023 than strong 2022 result – 3 Feb
  • Unilabs and Siemens Healthineers enter million-euro strategic partnership – 3 Feb
  • Coloplast launches male catheter featuring new technology – 3 Feb
  • Novo Nordisk hopes to retain employees with share gift – 3 Feb
  • Coloplast's bottom line disappoints in otherwise strong report – 3 Feb
See all

Jobs

  • Clinical Operational Associate

  • Supply Chain Manager

  • Medical Advisor (Metabolism)

  • Commercial Director

  • Specialist for the supply of pharmaceuticals to Danish hospitals

  • Application Manager

  • Sr. Director, Drug Safety Physician

  • Senior Clinical Project Manager

  • Application Manager

  • Senior Health Economics and Outcomes Research (HEOR) Manager

  • Regulatory Affairs Professional

  • Experienced Patent Counsel

  • Lead Data Architect

See all jobs

Colophon

MedWatch
Search

Sections

  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Sitemap
  • RSS feeds

Editor

Mikkel Aabenhus Hemmingsen

mah@medwatch.dk

Tel.: +45 3330 8387

Editor-in-chief

Anders Heering

Publisher

JP/Politiken Media Group Ltd

Advertising

annoncering@infowatch.dk

Tel.: +45 7077 7441

Advertising

Job Advertising

job@infowatch.dk

Tel.: +45 7077 7441

Jobs

Subscription

Try MedWatch or get an offer for a subscription meeting the exact needs of you or your company.

medwatch@infowatch.dk

Tel.: +45 7077 7441

Learn more about subscriptions here

Address

MedWatch

Rådhuspladsen 37

1785 Copenhagen K, Denmark

Tel.: +45 3330 8370

Guidelines

  • Privacy Policy

Copyright © MedWatch — All rights reserved

Microsoft is in the process of discontinuing Internet Explorer – and so are we.
For a better experience, we recommend using one of the following browsers.

Kind regards,
MedWatch

Google ChromeMozilla FirefoxMicrosoft Edge