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240 Current news about the topic regulatory approval


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Do some prescriptive sleeping pills posses a danger?

Novel class of sleeping pills might prevent ability to wake in response to threat


In a trial of one of the main class of prescription sleeping pills, half the participants slept through a fire alarm as loud as someone vacuuming next to their bed. But a newer alternative preserves the ability to wake in response to danger signals, according to a new research. The study showed ...


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Multinational companies continue to produce unregulated antibiotics in India


Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University. The research found that multinational companies continued to manufacture many unapproved formulations, despite pledging to tackle rising ...


Drug Approval: New Country Comparison Shows Great Savings Potential


The regulatory requirements for the approval of new drugs vary greatly internationally in regards to the resources allocated to the authorities, the evaluation periods for approval and the fees for the pharmaceutical companies. This reports a study of the European Center of Pharmaceutical ...


FDA advisory committee recommends first-ever CAR-T gene therapy treatment for cancer


Today the FDA's Oncologic Drugs Advisory Committee, an independent panel of experts, voted unanimously to recommend to the FDA approval of Novartis' experimental CAR-T therapy called Tisagenlecleucel, also known as CTL019. This form of gene therapy has demonstrated impressive results in ...


Regulation of advanced therapy medicines

Report details concrete proposals to encourage development and authorisation of ATMPs in the EU


The European Medicines Agency (EMA) today published a report from a multi-stakeholder expert meeting held on 27May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue engineered ...


Bayer’s Riociguat submitted for regulatory approval in the U.S. and EU


Bayer HealthCare has submitted the oral investigational drug Riociguat to treat patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) for regulatory approval in the United States and in the European Union. “These regulatory ...


Merck KGaA Sells Théramex To Teva for EUR 265 million

Acquisition will provide Teva with a strong platform to expand its Global Women’s Health Business


Merck KGaA announced that it will sell Théramex, its Monaco-based pharmaceutical company specialized in women’s health and gynecology, to Teva. Merck and Teva have signed an agreement whereby Teva will acquire all Théramex operations including 100% of the shares of Théramex S.A.M of Monaco and ...


QIAGEN and Abbott Enter Into Agreement on Molecular Tests for HIV, HCV and HPV


QIAGEN and Abbott announced that they have entered into an agreement that significantly strengthens both companies’ testing menus for automated in-vitro diagnostic applications in the United States and Canada. Financial terms were not disclosed. Under the terms of the agreements, QIAGEN will ...


Galapagos starts Phase II clinical trial in rheumatoid arthritis patients


Galapagos NV announced that it has started a Phase II clinical study for the Company's flagship program GLPG0259, a novel drug being developed for rheumatoid arthritis (RA). In this clinical trial, the safety and efficacy of this novel candidate drug will be tested in RA patients. Galapagos ...


Santhera Announces Intent To File Marketing Authorization Application for Leber's Hereditary Optic Neuropathy


Santhera Pharmaceuticals announced that it has formally notified the European Medicines Agency of its intent to file for Leber's Hereditary Optic Neuropathy (LHON). In the recent RHODOS study, Catena® showed consistent superiority over placebo and, in particular, improved or protected visual ...


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