Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Pharmaceutical Business Review
Return to: PBR Home
Search Refinements
Search Results:
1-15 of 55304 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

PBR Supplier Recommendations

CTL Laboratories - Contract Immune Monitoring and Research
Cellular Technology Limited (CTL), headquartered in Shaker Heights, OH, is a privately held biotechnology company that built its reputation as the global leader in the ELISPOT field over the past two decades by establishing the ELISPOT instrumentation and scientific principles that have helped to define the parameters of ELISPOT research for monitoring of Cell-Mediated Immunity.... Contract Research & Services > Clinical Trials > Suppliers
WeylChem Group - We Live Know-How
WeylChem Group of Companies (WCGC) was established in 2005 as the Fine Chemicals platform of International Chemical Investors Group (ICIG), a privately owned industrial holding company. We are a specialised service provider to the agrochemical, pharmaceutical, polymer and specialty chemicals industries, offering custom-, toll-manufacturing as well as advanced intermediates, reagents and performance products.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
SHL Healthcare - Developer and Manufacturer for Equipment Solutions
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long-term care use with a focus on patient comfort and functionality. Our broad range of products include medical slings, rehabilitation beds, pressure mattress systems, lifting equipment, medical soft goods and a variety of related accessories. ... Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Suppliers
See more

PBR White Paper Recommendations

FlexyPlant – Scale-Up Application Example from the Pharmaceutical Industry By SYSTAG
Scale-up by a factor of 300; from 70ml reactor into 25lt pilot plant. A scale-up step by factor 300 takes place in different laboratories, in fully diversified plants mostly. A great deal of information may be lost, and the knowledge of development Chemists can not be implemented optimally.... Automation > Laboratory Instrumentation > White Papers Optimizing Development Resources for Efficient Product Development By SYSTAG
Nowadays, efficient process research and development are, more than ever, an absolute must for contract manufacturers and API manufacturers. New products/processes need to be pushed through to market readiness faster and faster.... Automation > Laboratory Instrumentation > White Papers NSF - Site Director: KPIs Should Look Forward as well as Measure Results By NSF Health Sciences Pharma Biotech PBR
A Site Director expresses his views on how to use KPIs most productively. ... White Papers NSF asks a Production Director for their views on moving forward with KPIs By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics... White Papers NSF determines what KPIs mean for Employees By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures... White Papers See more
1-15 of 55304 results