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AbbVie, Alector to develop novel treatments for Alzheimer's disease
By PBR Staff Writer
AbbVie has collaborated with Alector to develop and commercialize new treatments for Alzheimer's disease and other neurodegenerative disorders.
Drug Research > Drug Discovery & Development > News
Global Blood Therapeutics to terminate studies of idiopathic pulmonary fibrosis program
By PBR Staff Writer
Global Blood Therapeutics (GBT) has decided to terminate the GBT440 program for the treatment of idiopathic pulmonary fibrosis (IPF).
Contract Research & Services > Clinical Trials > News
Novartis’ cancer combo Tafinlar and Mekinist gets FDA breakthrough status
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation after complete resection.
Production & Manufacturing > Process & Production > News
ADC Therapeutics raises $200m to advance antibody-based cancer treatments
By PBR Staff Writer
Switzerland-based oncology drug discovery and development company ADC Therapeutics (ADCT) has closed $200m private financing to fund registrational trials of its two lead cancer programs.
Contract Research & Services > Clinical Trials > News
Celgene to stop clinical trials of Crohn's disease drug GED-0301
By PBR Staff Writer
Celgene has decided to stop the clinical trials of Crohn's disease drug GED-0301 (mongersen) due to lack of meaningful results.
Contract Research & Services > Clinical Trials > News
Aurinia to expand voclosoprin renal franchise
Aurinia Pharmaceuticals revealed plans to expand its voclosoprin renal franchise to include focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD).
Drug Research > Drug Discovery & Development > News
Janssen gets two US FDA approvals for Simponi Aria to treat active psoriatic arthritis
Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
News
FDA approves GSK’s Shingrix to prevent shingles in adults aged 50 and over
By PBR Staff Writer
GlaxoSmithKline’s (GSK) Shingrix (Zoster Vaccine Recombinant, Adjuvanted) vaccine has been approved by the US Food and Drug Administration (FDA) for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
Regulatory Affairs > News
Boehringer Ingelheim partners with TARGET to progress NASH research
TARGET PharmaSolutions announced that Boehringer Ingelheim International has entered into a multi-year strategic partnership for TARGET-NASH.
News
Alnylam, Vir to jointly advance RNAi therapeutics for infectious diseases
Alnylam Pharmaceuticals has announced an exclusive licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus (HBV) infection.
Drug Research > Drug Discovery & Development > News
FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma
By PBR Staff Writer
Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.
Regulatory Affairs > News
Teva seeks FDA approval for migraine drug fremanezumab
By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News
Takeda, HemoShear collaborate to develop drugs for liver diseases
By PBR Staff Writer
Takeda has collaborated with HemoShear Therapeutics to discover and develop novel therapeutics for liver diseases such as nonalcoholic steatohepatitis (NASH).
Drug Research > Drug Discovery & Development > News
Ignyta’s Entrectinib gets EMA prime designation for NTRK fusion-positive solid tumors
Ignyta’s entrectinib has been granted Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Production & Manufacturing > Process & Production > News
US FDA accepts sBLA for Imfinzi in locally advanced and unresectable NSCLC
AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Regulatory Affairs > News
136-150 of 50849 results