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1-15 of 50285 results
Pfizer's Zavicefta matches standard-of-care in treating hospital-acquired pneumonia in phase 3 study
Results from the phase 3 REPROVE study assessing Pfizer's fixed-dose antibacterial combo Zavicefta (ceftazidime-avibactam) in patients with hospital-acquired pneumonia (HAP) demonstrated a comparable cure rate to carbapenem antibiotic therapy, considered the standard of care.
Contract Research & Services > Clinical Trials > News
EMA's CHMP recommends approval for Kevzara for rheumatoid arthritis
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.
Production & Manufacturing > Process & Production > News
Fresenius Kabi agrees to acquire Akorn for $4.3bn
By PBR Staff Writer
German healthcare firm Fresenius Kabi has agreed to acquire US prescription and over-the-counter (OTC) pharmaceutical products manufacturer Akorn for around $4.3bn.
Production & Manufacturing > OTC > News
Lack of demand forces uniQure to withdraw Glybera gene therapy in Europe
By PBR Staff Writer
uniQure said that due to low patient demand it will not pursue a renewal of its European marketing authorization for Glybera (alipogene tiparvovec), which is due to expire on 25 October.
Drug Research > Drug Delivery > News
NGM Bio’s NGM282 succeeds in nonalcoholic steatohepatitis phase 2 trial
NGM Bio’s NGM282 has met the primary and key secondary endpoints in a Phase 2 trial in nonalcoholic steatohepatitis (NASH) patients.
Contract Research & Services > Clinical Trials > News
Biosimilars to rituximab, etanercept recommended for approval in Europe
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.
Production & Manufacturing > Process & Production > News
FDA rejects Vernalis’ NDA for cough cold treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Vernalis’ new drug application for cough cold treatment, CCP-07.
Regulatory Affairs > News
AbbVie's pan-genotypic HCV regimen achieves 99% cure rate in phase 3 study
By PBR Staff Writer
A phase 3 study demonstrated that AbbVie's pan-genotypic ribavirin-free HCV regimen of glecaprevir/pibrentasvir (G/P) achieved a 99% cure rate after 12 weeks of treatment.
Contract Research & Services > Clinical Trials > News
H3 Biomedicine, Foundation Medicine extend precision oncology collaboration
H3 Biomedicine has extended its multi-year collaboration, which was signed in February 2015, with Foundation Medicine to discover and develop precision medicines in oncology.
Drug Research > Drug Discovery & Development > News
Immune Pharmaceuticals licenses cancer treatment's Latin America rights to Pint
Immune Pharmaceuticals has entered into a letter of intent with Pint Pharma regarding license and commercializion of Ceplene in Latin America.
Contract Research & Services > Contract Services > News
Sawai to buy Upsher-Smith’s generic pharmaceuticals business for $1.05bn
By PBR Staff Writer
Japan-based Sawai Pharmaceutical has agreed to acquire Upsher‐Smith’s generic pharmaceuticals business from its parent firm Acova for around $1.05bn.
Production & Manufacturing > Process & Production > News
Novartis signs collaboration deal with Parvus for diabetes nanomedicine
By PBR Staff Writer
Pharma giant Novartis has acquired the exclusive, worldwide rights for Parvus Therapeutics’ Navacim technology for type 1 diabetes (T1D) treatment.
Drug Research > Drug Discovery & Development > News
Ultragenyx's hypophosphatemia drug succeeds in phase 3 study
Ultragenyx Pharmaceutical, Kyowa Hakko Kirin and Kyowa Kirin International have reported positive 24-week data from the randomized, double-blind, placebo-controlled Phase 3 trial of burosumab (KRN23) in X-linked hypophosphatemia (XLH) adult patients.
Contract Research & Services > Clinical Trials > News
Alpine Immune Sciences to merge with Nivalis Therapeutics
Alpine Immune Sciences has agreed to merge with a subsidiary of Nivalis Therapeutics in an all-stock transaction.
Drug Research > Drug Discovery & Development > News
Relypsa’s Veltassa shows consistent efficacy in phase 4 trial to treat hyperkalemia
By PKBR Staff Writer
Relypsa’s Veltassa (patiromer) has demonstrated consistent effficacy and safety in phase 4 Tourmaline study in patients with hyperkalemia.
Contract Research & Services > Clinical Trials > News
1-15 of 50285 results