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FDA approves Dova’s Doptelet for thrombocytopenia in adults with CLD
By PBR Staff Writer
Dova Pharmaceuticals’ subsidiary AkaRx has secured approval from the US Food and Drug Administration (FDA) for its Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in patients with chronic liver disease (CLD).
Regulatory Affairs > News
Roche's two phase 3 studies show Hemlibra reduces bleeding in hemophilia patients
By PBR Staff Writer
Roche's Hemlibra (emicizumab) has significantly reduced bleeding in hemophilia patients, which was demonstrated in two phase 3 Haven studies.
Drug Research > Drug Discovery & Development > News
FDA approves AstraZeneca’s Lokelma to treat hyperkalemia in adults
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
Regulatory Affairs > News
South Korea’s GC Pharma establishes vaccine development firm Curevo
South Korean biopharmaceutical company GC Pharma has established a new company, named Curevo, in the US for the development of new vaccines.
Drug Research > Drug Discovery & Development > News
Janssen's Erleada shown to reduce PSA progression by 94% in nmCRPC patients
By PBR Staff Writer
Janssen Pharmaceutical's androgen receptor inhibitor Erleada (apalutamide) succeeded in a phase 3 trial by significantly cutting down the risk of prostate specific antigen (PSA) progression in patients having non-metastatic castration-resistant prostate cancer (nmCRPC).
Contract Research & Services > Clinical Trials > News
Biopharmaceutical firm Accent Therapeutics launches with $40m financing
By PBR Staff Writer
Accent Therapeutics has been launched with $40m Series A financing for precision cancer treatments targeting RNA-modifying proteins.
Drug Research > Drug Discovery & Development > News
Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer
The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).
News
Pfizer’s Lyrica meets primary endpoint in phase 3 pediatric epilepsy trial
Pfizer has reported positive top-line results from a phase 3 study, which assessed the use of Lyrica (pregabalin) oral solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.
Contract Research & Services > Clinical Trials > News
Novartis and Amgen secure FDA approval for migraine drug
By PBR Staff Writer
Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.
Regulatory Affairs > News
OptiBiotix Health signs manufacturing and supply deal in India with Akums
OptiBiotix Health has entered into a five year agreement with Akums Drugs and Pharmaceuticals to exclusively manufacture and supply products featuring OptiBiotix's cholesterol and blood pressure reducing strain LPLDL in India.
Drug Research > Drug Delivery > News
IDMC recommends to expand Tiziana’s phase 2a trial of Milciclib
Tiziana Life Sciences announces that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial.
Contract Research & Services > Clinical Trials > News
FDA declines to approve Evolus' DWP-450 for glabellar lines
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Evolus' application seeking approval of DWP-450 to treat glabellar lines in adult patients.
Regulatory Affairs > News
HiFiBiO Therapeutics raises $37.5m in Series B funding
By PBR Staff Writer
HiFiBiO Therapeutics has secured $37.5m Series B financing to accelerate pipeline of antibody drugs to treat cancer and autoimmune disorders.
Drug Research > Drug Discovery & Development > News
Surface Pharmaceuticals secures $20m funding from Flying L Partners
Surface Pharmaceuticals, an affiliated company of Imprimis Pharmaceuticals, has entered into a definitive stock purchase agreement with an affiliate of Flying L Partners to raise proceeds of about $20m in a private placement of its Series A preferred stock.
Drug Research > Drug Discovery & Development > News
Novartis completes $8.7bn acquisition of AveXis
Novartis has completed its $8.7bn acquisition of US-based clinical stage gene therapy company AveXis via the consummation of a merger of its indirect wholly-owned subsidiary, Novartis AM Merger with and into AveXis.
Drug Research > Drug Discovery & Development > News
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