The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.
The healthcare contract research outsourcing market is expected to grow from $25.1 billion in 2011 to $65 billion by 2018. Eight industry experts discuss how to turn your CRO into a strategic partner.
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. By BARRY van der STRATE, PhD, Associate Director of Science, Large Molecules, PRA Health Sciences; CHAD BRISCOE, PhD Executive Director of Science & Innovation Bioanalytical Services, PRA Health Sciences
ChromaDex Corporation® (OTCQB: CDXC) ("ChromaDex" or the "Company"), an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, announced today the initiation of the first human clinical study in the U.S. for PURENERGY™.
Accelrys, Inc., a leading provider of scientific innovation lifecycle management software, recently announced that the cloud-based Accelrys HEOS information management and collaboration workspace is now live on BT for Life Sciences R&D cloud platform.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOARx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis.
Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.
NeuroDerm, Ltd. announced today the results of a Phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously sub-cutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson's disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson's disease.
PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
The Michael J. Fox Foundation (MJFF) is today announcing the launch of four new funding programs focused on driving forward research toward transformative treatments and a cure for Parkinson's disease (PD).
Quanticate, one of the worlds leading data-focused CROs specializing in the provision of biostatistics, programming, data management, medical writing and pharmacovigilance services has been named category winner for Innovation in the 2013 CRO Leadership Awards presented by Life Science Leader magazine.
Ability Pharmaceuticals, a privately held biopharmaceutical company, announced recently that it was awarded a 36 month 1.2 Million Euros grant under the INNPACTO-2012 Collaborative Program from the Ministry of Economy and Competitiveness of the Government of Spain.
Xceleron, a U.S.-based leader in the application of ultra-sensitive analytical technology to novel clinical designs, has announced a partnership that will offer drug developers early bioavailability data that will lead to optimized solid-state forms and formulations. The partnership with Crystal Pharmatech, a China-based, technology-driven, solid-state research CRO, will enable sponsors to make faster decisions in the early stages of development.
Lorus Therapeutics Inc. (TSX:LOR) ("Lorus"), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that its Phase I clinical study of LOR-253 has successfully escalated to the target dose level based on predicted and observed clinical effects without limitation by toxicity.
Theravance, Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD.
Upsher-Smith Laboratories, Inc., (Upsher-Smith) announced that Phase I data for USL261 (intranasal midazolam) in patients with epilepsy were presented at the American Epilepsy Society Annual Meeting in San Diego, CA.
Final Phase 2b data from Boehringer Ingelheim's interferon (IFN)-free Phase 2b SOUND-C2 study showed that up to 85 percent of genotype 1b (GT1b) hepatitis C (HCV) patients achieved sustained virologic response (SVR or viral cure) 12 and 24 weeks after the end of treatment with the investigational treatment regimen of faldaprevir (BI 201335) and BI 207127, in combination with ribavirin (RBV)