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1-15 of 50289 results
Akebia expands anemia drug collaboration with Otsuka
By PBR Staff Writer
US-based Akebia Therapeutics has expanded its collaboration with Japan's Otsuka Pharmaceutical on an anemia treatment.
Contract Research & Services > Contract Services > News
uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe
uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).
Production & Manufacturing > Process & Production > News
Clinical trial technology firm Science 37 raises $29m funding
Science 37 has raised $29m in Series C funding, led by Glynn Capital Management with participation from GV, to bring clinical trials directly into patients’ homes.
Contract Research & Services > Clinical Trials > News
EC approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC
By PBR Staff Writer
AstraZeneca has secured full marketing authorization from the European Commission (EC) for its Tagrisso (osimertinib) 40mg and 80mg once-daily tablets to treat adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
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
1-15 of 50289 results