EMA

Mar 05, 2024

Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...

Sep 19, 2023

EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...

Dec 05, 2017

KINECT 4 Phase III Study Demonstrating INGREZZA® Improves Tardive Dyskinesia Symptoms Neurocrine Biosciences, Inc. announced new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA® (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesi...

Nov 21, 2017

EMA to relocate to Amsterdam by March 2019 Results of the Monday's vote for the European Medicines Agency relocation led to the emergence of Amsterdam as the new headquarters, beating the other finalists Milan and Copenhagen. Nineteen European Union member states submitted proposals for the EMA headquarters, and Mil...

Jun 27, 2017

With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition Takeda’s multiple myeloma blockbuster Velcade is quickly running out of patent protection, but the drug maker has filed a citizen petition it hopes can stave off competition for a little while longer. The Japanese pharma giant asked th...

May 26, 2017

Steele-Richardson-Olszewski syndrome, commonly known as Progressive Supranuclear Palsy, is an uncommon brain disorder that causes serious problems for patients in terms of walking, balance and eye movements. The disorder arises as a result of deterioration of cells in areas of the brain that control body movement an...

May 23, 2017

AstraZeneca's new benralizumab helps severe asthma patients cut back on steroids AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found tha...

Apr 17, 2017

BREXIT shook the whole world when United Kingdom voted in favour of leaving the EU. After the vote, the country has been wrought in uncertainty related to political, regulatory and economic scenario. Brexit has led to deliberations regarding modified supply chain requirements, uncertain regulatory scenario, revised ...

Mar 28, 2017

Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...

Jan 13, 2017

The high cost of pharmaceuticals, especially Biologics, has been proven as an issue in the battle to control healthcare costs. The Biologics Price Competition and the Innovation Act has put forward the generic competition of Biologics or what is popularly called the Biosimilars. Biosimilars have been available in th...