Rigel Pharmaceuticals has obtained its first FDA approval, with a green light to market Tavalisse for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have failed to respond to previous treatment. Chronic ITP is a rare autoimmune disease where the immune system destroys platelets, which are necessary for normal blood
Regulatory Professionals, part of the Clinical Professionals Group will be exhibiting at the DIA Europe 2018 conference in Basel, Switzerland on the 17th – 19th April. Visit The Clinical Professionals Group at Stand 6 In attendance: Josh Craven – Clinical Professionals / Regulatory Professionals Mos Francis – Only Medics Sarah Goddard – Clinical Professionals /
Sanofi and Regeneron have announced that EU regulators have agreed to review Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma. The French pharmaceutical company is seeking approval for Dupixent as an supplementary maintenance treatment in certain adults and adolescents, aged 12 years old and higher, with inadequately controlled moderate-to-severe asthma. The drug
An announcement from the EMA has endorsed strengthened regulatory measures for prescribing valproate to women who are pregnant and of child-bearing age. The agency’s Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed strengthened measures to avoid pregnant women being exposed to the drug. Under the new measures proposed by the
Boehringer Ingelheim announces the FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation enables development of new therapies that treat serious conditions and fulfil an unmet medical need in an effort to get treatments to those in need sooner.
US regulators will conduct a priority review of MSD’s Keytruda to treat patients with advanced cervical cancer. The company is seeking approval for the drug’s use in patients with cervical cancer who experience disease progression during or post chemotherapy. The FDA’s decision marks the first filing acceptance and priority review issued for an anti-PD-1 therapy
The US regulators have approved a label update to BMS’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks. The company says the approval will allow physicians to customise patient care with the option of using the new dose of 480mg every four weeks in addition to the previously available
Amgen has announced that the Committee for Medicinal Products for Human Use, has issued a positive opinion recommending a label variation for Neulasta to include the Neulasta Onpro Kit. The Neulasta Onpro Kit combines the efficacy of Neulasta with an innovative on-body injector (OBI) delivery system. Neulasta is indicated in the EU for the reduction
NICE has recommend that three separate treatments for thyroid cancer should be made available for use on the NHS: Ipsen’s Cometriq, Bayer’s Nexavar, and Eisai’s Lenvima. The former two were previously only available via the Cancer Drugs Fund (CDF), and Eisai’s finally gains approval after delays of over two years. Eisai’s tyrosine kinase inhibitor was
EUSA Pharma has gained backing from NICE for its first-line treatment for advanced renal cell carcimona (RCC), Fotivda. The recommendation from the UK’s regulatory body was decided on the result of the phase III trial TiVO-1, which evaluated the efficacy and tolerability of Fotivda compared to Bayer’s Nexavar.