Regulation

FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients

The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).

AstraZeneca’s bladder cancer drug imfinzi gets accelerated approval from FDA

The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer.

Takeda’s Alunbrig granted accelerated approval for Metastatic NSCLC

Takeda Pharmaceutical’s Alunbrig (brigatinib) has secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or are intolerant to crizotinib.

FDA approves Novartis’ Rydapt for AML and rare blood disorders

Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).

uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe

uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).

EMA’s CHMP recommends approval for Kevzara for rheumatoid arthritis

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.

Biosimilars to rituximab, etanercept recommended for approval in Europe

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.

Genentech’s ranibizumab injection approved by FDA for diabetic retinopathy

The US Food and Drug Administration (FDA) has approved Genentech’s Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.

IBM scientists secure patent on machine learning models for drug discovery

Technology giant IBM has secured a patent on machine learning models for drug discovery.