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1-15 of 50345 results
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News
UK’s CMA accuses Merck of breaching competition law
The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
Nektar, Takeda to explore combination cancer therapy approaches
Nektar Therapeutics and Takeda Pharmaceutical have entered into a research collaboration to explore the combination of the former’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214, with five oncology compounds from the cancer portfolio of Takeda.
Drug Research > Drug Discovery & Development > News
Recordati to buy AstraZeneca’s European beta-blocker treatments for $300m
By PBR Staff Writer
Italian pharmaceutical firm Recordati has agreed to acquire AstraZeneca’s metoprolol-based treatments in Europe for around $300m.
News
Proteorex, Corbin partner to discover ubiquitin-specific protease inhibitors
Proteorex Therapeutics has commenced its research and development collaboration with Montreal-based Corbin Therapeutics.
Drug Research > Drug Discovery & Development > News
Iterum Therapeutics raises $65m in new financing round
Ireland-based Iterum Therapeutics, which is focused on the development and commercialization of anti-infectives for patients with infectious diseases and other acute illnesses, has raised $65m in a Series B investment round.
Drug Research > Drug Discovery & Development > News
EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Amgen submits BLA of migraine prevention drug to FDA
Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News
FDA places clinical hold on Concert Pharmaceuticals’ hair loss drug
The US Food and Drug Administration (FDA) has placed a clinical hold on Concert Pharmaceuticals’ CTP-543 Phase 2a clinical trial for alopecia areata.
Contract Research & Services > Clinical Trials > News
Shire’s swelling disorder drug meets primary and secondary endpoints in phase 3 study
By PBR Staff Writer
Shire’s swelling disorder treatment, lanadelumab, has met its primary endpoint and all secondary endpoints in a phase 3 study.
Contract Research & Services > Clinical Trials > News
ImmunoGen unveils promising data with mirvetuximab soravtansine in ovarian cancer
ImmunoGen has reported promising safety and efficacy data from monotherapy and combination trials with mirvetuximab soravtansine in patients with folate receptor alpha (FRα)-positive epithelial ovarian cancer (EOC).
Contract Research & Services > Clinical Trials > News
Aduro Biotech expands clinical collaboration with Merck
Aduro Biotech has expanded its clinical collaboration with Merck to include an additional Phase 2 clinical trial.
Contract Research & Services > Clinical Trials > News
Bayer lymphoma candidate secures FDA priority review designation
By PBR Staff Writer
Bayer has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).
Production & Manufacturing > Process & Production > News
Biogen acquires Remedy Pharmaceuticals' stroke drug
Biogen has acquired Remedy Pharmaceuticals' Cirara, a Phase 3 candidate in development for large hemispheric infarction (LHI).
Drug Research > Drug Discovery & Development > News
1-15 of 50345 results