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Merck gets FDA approval for Prevymis to prevent CMV infection and disease in adult allogeneic stem cell transplant patients
Merck has announced that the US Food and Drug Administration (FDA) has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion.
Regulatory Affairs > News
Sage’s brexanolone meets primary endpoints in phase 3 postpartum depression trials
Sage Therapeutics has reported positive top-line results from two phase 3 clinical trials with its i.v. formulation of brexanolone (USAN; formerly SAGE-547); Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD.
Contract Research & Services > Clinical Trials > News
Sanofi to develop Principia’s MS drug candidate in $805m deal
By PBR Staff Writer
Sanofi has agreed to develop Principia Biopharma’s Bruton’s tyrosine kinase (BTK) inhibitor (PRN2246) for the treatment of multiple sclerosis (MS) and possibly other central nervous system (CNS) diseases.
Drug Research > Drug Discovery & Development > News
Boehringer, MiNA Therapeutics partner to develop novel treatments for fibrotic liver diseases
By PBR Staff Writer
Boehringer Ingelheim has entered into collaboration and licensing agreement with MiNA Therapeutics for the development of novel treatments to treat fibrotic liver diseases.
Drug Research > Drug Discovery & Development > News
Cerenis Therapeutics acquires Lypro Biosciences
Cerenis Therapeutics has acquired Lypro Biosciences to expanding its HDL strategy into immuno-oncology and chemotherapeutic drug delivery.
Drug Research > Drug Discovery & Development > News
Tricida announces closing of $57.5m series D financing
Tricida has closed an oversubscribed $57.5m series D financing, bringing the company’s total capital raised to-date to $153.3m.
Contract Research & Services > Clinical Trials > News
Novartis’ breast cancer drug Kisqali succeeds in phase 3 study in premenopausal women
By PBR Staff Writer
Novartis’ Kisqali (ribociclib) combination therapy has succeeded in a phase 3 study in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Contract Research & Services > Clinical Trials > News
New international consortium formed to speed up drug discovery in kidney diseases
By PBR Staff Writer
A new international consortium, including academic institutions such as the Universities of Bristol and Cambridge and drugmaker Evotec, has been established to enhance the discovery of drugs to treat kidney diseases.
Drug Research > Drug Discovery & Development > News
Spark Therapeutics, Pfizer amend license deal for investigational SPK-9001 in hemophilia B
Spark Therapeutics and Pfizer have entered into an amendment to their license agreement for SPK-9001, an investigational gene therapy for hemophilia B.
Drug Research > Drug Discovery & Development > News
Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa
By PBR Staff Writer
Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).
Regulatory Affairs > News
Recursion Pharmaceuticals uses Splunk machine learning to treat genetic diseases
Biotechnology company Recursion Pharmaceuticals is using Splunk Enterprise and the Splunk Machine Learning Toolkit to reach its target of treating 100 molecular genetic diseases by 2025.
Automation > IT & Software > News
Boehringer says Cyltezo and Humira have similar efficacy, safety in people with RA
Boehringer Ingelheim has revealed one-year data from VOLTAIRE-RA, a pivotal phase 3 clinical trial evaluating Cyltezo (adalimumab-adbm) with reference product Humira.
Contract Research & Services > Clinical Trials > News
FDA lifts clinical hold on Cellectis phase 1 trials with UCART123 in AML and BPDCN
The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Regulatory Affairs > News
Novartis seeks EMA approval for CTL019 for two indications
By PBR Staff Writer
Novartis is seeking approval from the European Medicines Agency (EMA) for its CTL019 (Kymriah or tisagenlecleucel) to treat two forms of blood cancer.
Regulatory Affairs > News
Valeant to divest Sprout Pharmaceuticals to former owners
By PBR Staff Writer
Valeant Pharmaceuticals International's affiliate has agreed to divest its female libido-pill business Sprout Pharmaceuticals to a buyer associated with the latter’s former shareholders.
Production & Manufacturing > Manufacturing > News
91-105 of 50849 results