ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above […]

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee […]

FDA approves Tavneos for vasculitis – ChemoCentryx

ChemoCentryx announced that the FDA has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. […]

Hugo Robotic-Assisted Surgery System receives European CE Mark approval – Medtronic

Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Hugo robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today. The Hugo RAS system was designed to address the historic cost and utilization barriers that […]

CHMP recommends Artesunate Amivas for the initial treatment of severe malaria – Amivas

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Artesunate Amivas, intended for initial treatment of severe malaria in adults and children. The applicant for this medicinal product is Amivas Ireland Ltd. Artesunate Amivas will be available as 110 mg powder and solvent for solution […]

Two studies of Remsima SC shows switching to subcutaneous therapy has no impact on treatment for inflammatory bowel disease – Celltrion Healthcare

Celltrion Healthcare announced two data sets relating to the use of the subcutaneous formulation of infliximab, Remsima SC (CT-P13 SC), in inflammatory bowel disease (IBD). The first study investigated clinical impact of switching from intravenous (IV) to subcutaneous (SC) treatment of infliximab in patients with Crohn’s disease (CD) or ulcerative colitis (UC) from the pivotal randomised controlled trial of CT-P13 […]

Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients

Real-world data looking at biologic treatment and vaccine hesitancy in psoriasis patients is being presented at EADV’s 30th Congress. The findings of two studies are helping to advance understanding of the safety of biological therapies for psoriasis and reasons for COVID-19 vaccine hesitancy in psoriasis patients. Researchers in Spain have studied sentiment towards COVID-19 vaccination in biologic-treated patients with psoriasis […]

Medtronic announces NAVABLATE study results with the Emprint Ablation Catheter Kit for bronchoscopic ablation at the European Respiratory Society International Congress 2021

Medtronic plc has announced new clinical data from the NAVABLATE study, which highlights the much anticipated safety and performance results on microwave ablation used bronchoscopically with the Emprint Ablation Catheter Kit with Thermosphere Technology in conjunction with the Medtronic electromagnetic navigation bronchoscopy system. Results were reported as a late-breaking presentation at the virtual European Respiratory Society International Congress 2021, September […]

FDA approves Opzelura cream for mild to moderate atopic dermatitis – Incyte

Incyte announced that the FDA has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a […]

CHMP recommends Qinlock to treat advanced gastrointestinal stromal tumor – Deciphera Pharmaceuticals

Deciphera Pharmaceuticals, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. “The majority of GIST patients who […]