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Amgen's Xgeva matches zoledronic acid in phase 3 trial in multiple myeloma-related bone complications
By PBR Staff Writer
A phase 3 study assessing Amgen’s Xgeva (denosumab) compared to zoledronic acid (ZA) for the prevention of bone complications in newly diagnosed multiple myeloma (MM) patients met its primary endpoint.
Contract Research & Services > Clinical Trials > News
Sanifit starts first clinical trial of SNF472 in patients with calciphylaxis
Laboratoris Sanifit has started the first clinical trial of its lead candidate, SNF472, for the treatment of the orphan disease calciphylaxis (calcific uraemic arteriolopathy, CUA).
Contract Research & Services > Clinical Trials > News
Theravance and Mylan’s COPD treatment shows benefits in phase 3 trials
By PBR Staff Writer
A drug that is being developed by Theravance Biopharma and Mylan has shown promise in two phase 3 efficacy studies treating patients with chronic obstructive pulmonary disease.
Contract Research & Services > Clinical Trials > News
NBE Therapeutics, Sotio partner to develop next-generation antibody-drug conjugates
NBE Therapeutics and Sotio have partnered to develop next-generation antibody-drug conjugates (ADCs) for improved cancer therapy.
Drug Research > Drug Discovery & Development > News
Redx Pharma identifies drug development candidate for leukaemia program
Redx Pharma has identified a drug development candidate for its reversible Bruton’s Tyrosine Kinase (BTK) inhibitor program.
Drug Research > Drug Discovery & Development > News
Merck's letermovir succeeds in preventing CMV infection in phase 3 study
A phase 3 clinical trial evaluating Merck's letermovir for prevention of cytomegalovirus (CMV) infection in high-risk bone marrow transplant patients, met its primary endpoint.
Contract Research & Services > Clinical Trials > News
FDA approves Lilly's LARTRUVO in combination with doxorubicin for soft tissue sarcoma
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Regulatory Affairs > News
Eiger doses first patient in phase 2 LIMT HDV study
Eiger BioPharmaceuticals has dosed the first patient in the Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a (Lambda) as a potential treatment for chronic hepatitis D virus (HDV) infection.
Contract Research & Services > Clinical Trials > News
SOBI003 receives EC orphan designation to treat mucopolysaccharidosis type IIIA
Swedish Orphan Biovitrum AB (Sobi) has secured orphan designation from the European Commission (EC) for its development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome).
Production & Manufacturing > Process & Production > News
Sun Pharma, ICGEB partner to develop dengue vaccine
Drugmaker Sun Pharmaceutical Industries has partnered with the International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a new dengue vaccine.
Drug Research > Drug Discovery & Development > News
Domain Therapeutics creates new company to stop Parkinson’s disease progression
France-based biopharmaceutical firm Domain Therapeutics has established a new company, Mavalon Therapeutics, dedicated to develop a drug candidate to stop the progression of Parkinson’s disease.
Drug Research > Drug Discovery & Development > News
Shire's ONIVYDE approved in Europe for pancreatic cancer
The European Commission (EC) has granted marketing authorization for Shire's ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), also known as nal-IRI or MM-398, to treat metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy.
Regulatory Affairs > News
LLS launches collaborative clinical trial for acute myeloid leukemia
The Leukemia & Lymphoma Society (LLS) has launched a collaborative clinical trial for acute myeloid leukemia (AML), a deadly disease which has seen few improvements in treatments in over 40 years.
Contract Research & Services > Clinical Trials > News
Clinigen expands operations into Japan
Pharmaceuticals and services group Clinigen Group has opened an office in Tokyo from which it will run its newly-launched Japanese business.
Drug Research > Drug Delivery > News
FDA approves Genentech’s Tecentriq for metastatic non-small cell lung cancer
Roche’s subsidiary Genentech has secured approval from the US Food and Drug Administration (FDA) for cancer immunotherapy Tecentriq (atezolizumab) to treat people with metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.... Suppliers
Sanofi CEPiA - Suppliers of APIs, Custom Synthesis and Pharmaceutical Contract Manufacturing
CEPiA (Commercial & External Partnership, Industrial Affairs) is an organization fully dedicated to third-party activities within the industrial affairs of Sanofi. ... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
MSP Kofel – Analytical Accessories and Software Specialists
MSP Kofel provides analytical scientists with software and databases for interpretation, confirmation and archival of spectra, chromatographic data, structures and chemical compound information.... Suppliers
Life Chemicals - Specialists in Development, Production and Sales of Novel Screen Compounds
Life Chemicals Inc, established in 2004, specialises in development, production and sales of novel screening compounds for HTS, targeted screening libraries and core building blocks for drug discovery projects.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
Hybrigenics Services - Protein Interactions Expert
Who else knows your protein better than you? Who else knows proteins interactions better than us?... Contract Research & Services > Contract Research > Suppliers
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PBR White Paper Recommendations

Going with the Flow: Malvern Instruments' Basic Introduction to Rheology By Malvern Instruments
Rheology concerns itself with materials that have aspects of both solids and liquids, and researches the flow and deformation of matter. Malvern Instruments explores this study, and reveals its fundamental in relation to force, deformation and time.... White Papers Malvern Instruments Shares its Buyer's Guide to Protein Stability Measurement Platforms By Malvern Instruments
As a leader in best practices during biopharmaceutical development, Malvern Instruments sheds light on effective protein stability analysis technologies for the biopharmaceutical industry.... White Papers Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Contract Research & Services > Clinical Trials > White Papers Five Ways That the Mastersizer 3000 Saves you Money By Malvern Instruments
To earn its place in today’s busy analytical laboratories, an instrument must meet certain practical criteria, and stand-up to rigorous economic evaluation. For labs that need particle sizing, laser diffraction systems are typically the technology of choice; delivering accurate and reliable information for the broadest range of sample types. Here, we look at how the Mastersizer 3000, the market leading laboratory particle size analyzer from Malvern Instruments, can save you time, money and resources, and ultimately deliver a healthy return on investment.... White Papers Time to Spec up? Top Five Reasons to Replace a Viscometer with a Rheomete By Malvern Instruments
Is your viscometer approaching the end of its life? Are you starting to feel that your trial and error, ‘rheology-light’ approach to formulation is becoming dated? Or are there longstanding product performance issues that you’re failing to gain traction with, where you suspect rheology may hold the answer?... White Papers See more
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