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1-15 of 50417 results
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Cancer frim Repare Therapeutics announces $68m Series A financing
Repare Therapeutics has secured $68m in a Series A financing round which it will use to advance its platform and pipeline of novel medicines that target genetically defined weaknesses of cancers.
Drug Research > Drug Discovery & Development > News
Eli Lilly completes $90m expansion of biotechnology center in San Diego
Eli Lilly and Company has completed the $90m expansion of its biotechnology center in San Diego, California, US.
Production & Manufacturing > Manufacturing > News
Novartis’ heart drug canakinumab meets primary endpoint in phase III study
By PBR Staff Writer
Novartis’ heart drug ACZ885 (canakinumab) has met primary endpoint in the global phase III Canakinumab anti-inflammatory thrombosis outcomes (Cantos) study.
Contract Research & Services > Clinical Trials > News
GSK’s shingles vaccine Shingrix succeeds in phase 3 revaccination trial
By PBR Staff Writer
GSK’s shingles vaccine candidate Shingrix (HZ/su) met its primary objective of inducing a strong immune response in older patients in a phase 3 revaccination trial.
Contract Research & Services > Clinical Trials > News
ImmunoCellular to suspend patient randomization in ICT-107 phase 3 trial
ImmunoCellular Therapeutics has provided an update on the strategic review of its financing and development strategies for ICT-107, its patient-specific, dendritic cell-based immunotherapy for patients with newly diagnosed glioblastoma.
Contract Research & Services > Clinical Trials > News
Rubius Therapeutics raises $120m to advance red blood cell technology
Rubius Therapeutics, which is developing red-cell therapeutics (RCTs) as a new class of medicines to address a range of indications, has raised $120m in a highly oversubscribed private financing.
Drug Research > Drug Discovery & Development > News
Shire gets FDA approval for ADHD drug Mydayis
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.
Regulatory Affairs > News
eFFECTOR partners with Pfizer, Merck to evaluate combination of two immuno-oncology agents
eFFECTOR Therapeutics has entered into a clinical collaboration and supply agreement with Pfizer and Merck to evaluate the combination of two immuno-oncology agents in patients with microsatellite stable colorectal cancer (CRC).
Contract Research & Services > Contract Services > News
EIB supports development of BiondVax’s universal flu vaccine candidate
BiondVax Pharmaceuticals, which is developing a universal vaccine for all strains of influenza, has signed an agreement with the European Investment Bank (EIB) for a €20m loan.
Drug Research > Drug Discovery & Development > News
Pamplona to buy US firm Parexel International for $5bn
By PBR Staff Writer
Pamplona Capital Management has agreed to acquire US-based biopharmaceutical services provider Parexel International for around $5bn.
Contract Research & Services > Contract Research > News
Pfizer initiates phase 1 study of streptococcus vaccine
Pfizer has commenced a phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine for the prevention of Group B Streptococcus (GBS) infection.
Contract Research & Services > Clinical Trials > News
Seattle Genetics scraps leukemia drug trial over safety concerns
By PBR Staff Writer
Seattle Genetics has suspended its phase 3 acute myeloid leukemia (AML) trial of vadastuximab talirine (SGN-CD33A) due to a higher rate of death incidents.
Contract Research & Services > Clinical Trials > News
Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
Production & Manufacturing > Process & Production > News
Sandoz gets EC nod for Rixathon to treat blood cancers and immunological diseases
By PBR Staff Writer
Novartis subsidiary Sandoz has secured approval from the European Commission (EC) for its Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.
Regulatory Affairs > News
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