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Takeda, Harrington to advance development of rare disease therapeutics
Takeda Pharmaceutical has entered into a multi-year partnership with Harrington Discovery Institute at University Hospitals in Cleveland, Ohio to advance the development of rare disease rherapeutics.
Drug Research > Drug Discovery & Development > News
FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s lorlatinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who were earlier treated with one or more ALK inhibitors.
Production & Manufacturing > Process & Production > News
AstraZeneca elects to return AZD9412 drug rights to Synairgen
By PBR Staff Writer
AstraZeneca has opted to return rights on drug AZD9412 (inhaled interferon beta) to Synairgen, which did not meet the pharma giant's predefined criteria for progression in a trial.
Contract Research & Services > Clinical Trials > News
Shire wins EC conditional approval for Natpar to treat hypoparathyroidism
By PBR Staff Writer
Shire has secured conditional marketing approval from the European Commission (EC) for its Natpar (rhPTH[1-84]) to treat patients with chronic hypoparathyroidism.
Regulatory Affairs > News
Teva launches generic Vytorin tablets in US
Teva Pharmaceutical Industries has launched the generic Vytorin (ezetimibe and simvastatin) tablets in the US.
Drug Research > Drug Delivery > News
Gates Foundation leads $45.5m round for biotechnology firm Arsanis
Clinical-stage biopharmaceutical firm Arsanis has secured $45.5m in a Series D financing round led by the Bill & Melinda Gates Foundation.
Drug Research > Drug Discovery & Development > News
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

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
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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 55311 results