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.

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

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Alzheimer's drug wins priority review in Japan

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CHMP recommends four drugs in January

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Denmark rejects Janssen and Genmab drug twice in January

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Foto: Benoit Tessier/Reuters/Ritzau Scanpix

CHMP recommends expanded approval of Dupixent

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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Investigation questions FDA approval of Aduhelm
US Congress investigators level sharp criticism at health authorities’ approval process of Biogen’s medical treatment of Alzheimers.
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EU gets rolling on decentralized clinical trials with new guidelines
New EMA recommendations are meant to facilitate decentralized clinical trials in the EU.
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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.
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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.
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MedWatch

Genmab gets new MS market rival after fresh FDA approval

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

Alzheimer's drug wins priority review in Japan

CHMP recommends four drugs in January

Denmark rejects Janssen and Genmab drug twice in January

CHMP recommends expanded approval of Dupixent

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

Patient groups urge EMA to tackle antibiotic shortages

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

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

EU launches imaging initiative to support cancer diagnosis and treatment

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

Denmark recommends three drugs

EMA expects antibiotics shortage to improve in coming months

Norway denies Novo Nordisk reimbursement for obesity drug

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

EU Commission to give more time for MDR transition

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

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

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

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

ESG compliance makes companies more attractive

Investigation questions FDA approval of Aduhelm

EU gets rolling on decentralized clinical trials with new guidelines

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

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

Latest news

Jobs