Industry News

- Read more about FDA approves Bayer's KOVALTRY® antihemophilic factor (Recombinant)
The U.S. Food and Drug Administration has approved Bayer's KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which supported the approval of KOVALTRY for routine prophylaxis to reduce the frequency of bleeding episodes.
- Read more about Amgen Wins Patent case on repatha® (Evolocumab)
Amgen announced that a Delaware jury delivered a verdict in Amgen's favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Read more about Chugai receives orphan drug designation for Tocilizumab
Chugai Pharmaceutical Co., Ltd. announced that it received from the Minister of Health, Labour and Welfare, a notification of orphan drug designation for human anti-human IL-6 receptor monoclonal antibody "tocilizumab," a drug under development for treatment of systemic scleroderma.
- Read more about GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of children aged 4-11 years
GlaxoSmithKline plc announced results from the paediatric ‘LABA’ (long acting beta2-agonist) safety study. VESTRI (SAS115358) compared Advair® Diskus® (FSC), a combination of the LABA, salmeterol, and the inhaled corticosteroid (ICS), fluticasone propionate (FP), to FP monotherapy in children aged 4 – 11 years. The study assessed the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations).
- Read more about Orexigen and Takeda announce Orexigen's Acquisition of all rights to CONTRAVE® in United States
Orexigen Therapeutics, Inc. and Takeda Pharmaceuticals U.S.A., Inc., announced they have agreed to terminate the Amended and Restated Collaboration Agreement for CONTRAVE® (naltrexone HCl / bupropion HCl), the market leading national branded prescription treatment option for certain overweight and obese adults for chronic weight management. Completion of the transaction is subject to the parties’ receipt of clearance under the Hart-Scott-Rodino Antitrust Improvement Act (“HSR Act”).
- Read more about Biocon to co-develop insulin for US market
Biopharma major Biocon on Thursday announced that its subsidiary was tying up with a Mexican firm to co-develop generic recombinant human insulin for the US market.
- Read more about Baxter start US clinical trial for VIVIA investigational HD system
Baxter International Inc. announced enrollment of the first patient in a US clinical trial for VIVIA, an investigational home haemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.
- Read more about Novimmune’s NI-0501 granted breakthrough therapy designation by US FDA
Novimmune, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy. NI-0501 is a fully human, anti-interferon-gamma (IFNγ) monoclonal antibody discovered and developed by Novimmune.
- Read more about Takeda, Frazier healthcare launch outpost medicine to develop new therapeutics in Urology & Gynaecology
Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners announced the formation of Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gynaecologic diseases and disorders.
- Read more about Aralez resubmits to FDA new drug application for YOSPRALA
Aralez Pharmaceuticals Inc. announced that it has resubmitted to the U.S. Food and Drug Administration ("FDA") the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.