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FDA approves Pfizer’s epoetin alfa biosimilar Retacrit to treat anemia
By PBR Staff Writer
Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s anemia drug Epogen/Procrit (epoetin alfa), has been approved by the US Food and Drug Administration (FDA) for all indications of the reference product.
Regulatory Affairs > News
Zymeworks, Daiichi Sankyo expand immuno-oncology partnership
Zymeworks and Daiichi Sankyo have entered into a new license agreement, building upon their cross-licensing and collaboration agreement signed in 2016.
Drug Research > Drug Discovery & Development > News
Aquestive settles Suboxone drug patent infringement case with Par Pharmaceuticals
Aquestive Therapeutics has reached a settlement agreement resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film with Par Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
Lilly to acquire AurKa Pharma in $575m deal
By PBR Staff Writer
Eli Lilly and Company (Lilly) has agreed to acquire Canadian cancer drug developer AurKa Pharma from TVM Capital Life Science in a deal worth $575m.
Drug Research > Drug Discovery & Development > News
AstraZeneca’s COPD drug Fasenra fails to meet primary endpoint in phase III trial
By PBR Staff Writer
AstraZeneca’s respiratory drug Fasenra (benralizumab) has failed to meet its primary endpoint in the Galathea phase III trial.
Contract Research & Services > Clinical Trials > News
Hemogenyx collaborates with undisclosed global pharmaceutical firm on CDX antibodies development
Hemogenyx Pharmaceuticals has signed a development agreement with an undisclosed global pharmaceutical company engaged in the research, development, manufacture and marketing of pharmaceutical products.
Drug Research > Drug Discovery & Development > News
RXi Pharmaceuticals enters into research collaboration with Iovance Biotherapeutics
RXi Pharmaceuticals has partnered with Iovance Biotherapeutics to evaluate its sd-rxRNA therapeutic compounds with the latter’s autologous cell therapy based on tumor-infiltrating lymphocytes (TILs) for the use in the treatment of cancer.
Contract Research & Services > Contract Research > News
FDA expands approval of Novartis’ Gilenya to treat MS in pediatric patients
By PBR Staff Writer
Novartis has secured an expanded approval of Gilenya (fingolimod) in the US for the treatment of children and adolescents, in the age group of 10-18 years, with relapsing forms of multiple sclerosis (RMS).
Regulatory Affairs > News
Amryt, Aegerion sign expanded deal for Lojuxta capsules
Amryt has signed an agreement with Aegerion Pharmaceuticals to expand its exclusive licence agreement for Lojuxta (lomitapide) into Russia and the Commonwealth of Independent States (CIS), as well as the non-EU Balkan states.
Production & Manufacturing > Manufacturing > News
FDA committee recommends approval of Akcea’s FCS drug
The US Food and Drug Administration’s (FDA) division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Akcea Therapeutics' Waylivratm (volanesorsen) for the treatment of familial chylomicronemia syndrome (FCS).
Production & Manufacturing > Process & Production > News
Lilly to buy immuno-oncology firm Armo BioSciences for $1.6bn
By PBR Staff Writer
Eli Lilly and Company (Lilly) has agreed to acquire Armo BioSciences, a US-based late-stage immuno-oncology company, for about $1.6bn in an all-cash deal.
Drug Research > Drug Discovery & Development > News
Genentech, Lodo Therapeutics form $969m drug discovery collaboration
Roche’s subsidiary Genentech has entered into a strategic drug discovery collaboration with Lodo Therapeutics, which is focused on the creation of therapeutics derived from nature that will impact patients across the world.
Drug Research > Drug Discovery & Development > News
Escient Pharmaceuticals raises $40m
Escient Pharmaceuticals has been launched with $40m Series A financing to advance G protein-coupled receptor (GPCR)-targeted drugs to address serious, unserved medical needs.
Drug Research > Drug Discovery & Development > News
Forma Therapeutics, University of Oxford partner to advance DUB inhibitors development
Forma Therapeutics and the University of Oxford have entered into a collaboration and license agreement to identify, validate and develop deubiquitinating enzyme (DUB) inhibitors for the treatment of neurodegenerative diseases.
Drug Research > Drug Discovery & Development > News
FDA turns down Lipocine’s application for oral testosterone product Tlando
By PBR Staff Writer
The US Food and Drug Administration (FDA) has refused to approve Lipocine's Tlando, an oral testosterone product candidate for testosterone replacement therapy (TRT).
Regulatory Affairs > News
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