Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).
Teva Pharmaceutical Industries, along with Celltrion, has secured approval from the US Food and Drug Administration (FDA) for breast cancer drug Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin.
Novartis has secured approval from the European Commission (EC) for Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.
RNAi therapeutics firm Alnylam Pharmaceuticals has entered into a settlement and license agreement with Silence Therapeutics, a biotechnology company that develops gene therapeutic technology based on RNA interference.
Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which is being proposed by the company as a biosimilar to Humira.
Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xxxx), which was formerly known as AVXS-101, has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA) Type 1.
Novartis has secured approval from the European Commission (EC) for its Gilenya (fingolimod) to treat children and adolescents, aged between 10 and 17 years, with relapsing-remitting forms of multiple sclerosis (RRMS).
The US Patent and Trademark Office (USPTO) issued US Patent No. 10,137,155 related to Vor Biopharma's technology platform.
Teva Pharmaceutical and Celltrion have secured approval from the US Food and Drug Administration (FDA) for Truxima (rituximab-abbs), a biosimilar to Roche’s cancer drug Rituxan (rituximab), for three non-Hodgkin’s lymphoma indications.
Swissmedic has granted marketing authorization for Octapharma’s new fibrinogen concentrate product fibryga for the treatment of congenital and acquired fibrinogen deficiencies.
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