Pharmaceuticals, Biotechnology and Life Sciences
The U.S. FDA has granted accelerated approval to Karyopharm Therapeutics’s Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of certain adult patients with relapsed refractory multiple myeloma (RRMM).
Swedish Cyxone has submitted an application to the CEC in Poland for permission to start a clinical phase IIb trial with Cyxone’s drug candidate Rabeximod in RA , marking the first regulatory step towards the initiation of the study.
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, this week said that the European Commission has granted Marketing Authorisation for HIV-1 infection treatment, Dovato.
The award-winner of the 2019 Hansen Family Award is Professor Edith Heard. The Board of Trustees of the Bayer Science & Education Foundation and the Scientific Committee for this award have presented her with one of Germany’s most prestigious scientific accolades including a prize money of EUR 75,000.
The European Commission (EC) has granted conditional marketing authorization for Libtayo to treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
Amid Oasmia’s decision to report certain suspicious transactions that has been made by to company during several years, to the Swedish authority, Sven Rohmann, has today been appointed as acting CEO of the company, to replace the present CEO, Mikael Asp.
Basilea Pharmaceutica has enrolled the first patient in a newly opened cohort in the ongoing FIDES-01 phase 2 registrational study with the panFGFR kinase inhibitor derazantinib in intrahepatic cholangiocarcinoma (iCCA).
Wize Pharma and Cannabics Pharmaceuticals have formed a joint venture (JV), to work on cannabinoid products to treat ophthalmic conditions, Wize said on Friday.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has nodded for extension for Dupixent, following USFDA’s approval for nasal polyposis, enabling its approval in the European Union (EU) to also include adolescents 12 to 17 years of age with moderate-to-severe AD who are candidates for systemic therapy.
Indian Glenmark Pharmaceuticals has been granted final approval by the U.S. FDA for Ezetimibe and Simvastatin Tablets, for several doses.