Pharmaceuticals, Biotechnology and Life Sciences
Q-linea AB has received the official response including a number of clarifications and very positive feedback from the US Food and Drug Administration, FDA, regarding the company’s planned pivotal clinical trial with ASTar in the United States.
Ubiquigent and LEO Pharma A/S have entered into an option agreement granting LEO Pharma access to two novel compounds, which comes after an earlier agreement between the parties entered into as part of LEO Pharma Open Innovation, without disclosing financial terms.
There are many health and safety concerns surrounding seniors living alone. According to the Administration on Aging, approximately 20 percent of men and 36 percent of women over the age of 65 currently live alone, and accidents and close calls are among their biggest risks.
European Commission has approved a third indication for Dupixent® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. It is also approved for moderate-to-severe atopic dermatitis and severe asthma.
Blueprint Medicines Corporation said in an update on its New Drug Application (NDA) for avapritinib for the treatment of adults with PDGFRA , that the FDA has said it plans to administratively split the proposed indications for avapritinib into two separate NDAs, one for PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and one for fourth-line GIST.
FDA has expanded the duration of use of Allergan’s Lilleta to prevent pregnancy for up to six years, after Supplemental…
Actinium Pharmaceuticals on Monday announced key interim findings from the pivotal Phase 3 SIERRA trial of Iomab-B at 50% of total of 150-patient, compared to physician’s choice of salvage chemotherapy in patients age 55 and above with active, relapsed or refractory AML (Acute Myeloid Leukemia).
Biohaven Pharmaceutical has enrolled over 880 patients in less than nine months, in its pivotal Phase 3 clinical trial of troriluzole in generalized anxiety disorder (GAD).
Bausch Health Companies’s gastroenterology business, Salix Pharmaceuticals, one of the largest specialty pharmaceutical companies in the world committed to the…
Alvogen is selling its Central and Eastern European business to Zentiva, for an undisclosed amount, to focus on developing other areas, with the transaction to be closed in first quarter of 2020.