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136-150 of 50417 results
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
Mateon’s phase 2/3 trial in platinum-resistant ovarian cancer yields positive results
Mateon Therapeutics has revealed encouraging data from its first interim scheduled analysis of the ongoing phase 2/3 trial (FOCUS) in platinum resistant ovarian cancer (prOC) patients.
Contract Research & Services > Clinical Trials > News
HitGen, Pfizer to build and screen novel DNA-encoded libraries
HitGen has entered into a multi-year research collaboration and license agreement with Pfizer to build and screen novel DNA-encoded libraries (DELs) to potentially discover unique small molecule leads to be used in developing drugs.
Drug Research > Drug Discovery & Development > News
Novartis gets FDA breakthrough therapy status for CTL019 to treat r/r DLBCL
By PBR Staff Writer
Novartis has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019, to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.
Production & Manufacturing > Process & Production > News
136-150 of 50417 results