Articles By Marcus Johnson
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Amgen's Evolocumab Can Lower LDL Levels By As Much As 75 Percent
5/16/2014
A new study led by the University of Iowa’s Dr. Jennifer Robinson has demonstrated the clinical effectiveness of adding the monoclonal antibody evolocumab to the patient’s statin therapy routine to reduce LDL cholesterol levels. The researchers found that the experimental drug injection could decrease LDL levels by as much as 75 percent when taken in conjunction with statins. The study was funded by evolocumab’s drug maker, Amgen. The study included 2067 patients from 17 different countries.
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Bristol-Myers Announces Clinical Trial Collaboration With Celldex Therapeutics
5/16/2014
Bristol-Myers Squibb has announced that it is entering into a clinical trial collaboration with Celldex Therapeutics. Both companies will be collaborating in research to evaluate the combination of immunotherapies nivolumab and varlilumab. The safety, tolerability, and efficacy of both drugs will be tested in a Phase I/II study. The study will test the drugs against various tumors, such as those present in non-small cell lung cancer, metastatic melanoma, ovarian, colorectal, squamous cell head, and neck cancers.
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Novasep Boosts Manufacturing Capacity At Le Mans Facility
5/16/2014
Novasep announced that it invested $5.5 million to increase the manufacturing capacities at its Le Mans facility in France, and that the plant is now fully qualified. The investment has expanded the company’s ability to manufacture highly potent active pharmaceutical ingredients (HPAPI). The new extension to the facility is now being used to scale up an antibody drug conjugate (ADC) payload.
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WuXi PharmaTech Completes St. Paul Facility, Begins New R&D, cGMP Facility Construction
5/15/2014
WuXi PharmaTech, a pharmaceutical, biotechnology, and research and development company based out of China, has announced that it has completed construction on a new facility in St. Paul, Minnesota. The St. Paul facility, which is expected to be in operation by the end of June, will give the company added capacity for current services such as particle identification and extractable/leachable testing.
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Tesaro Nausea Drug Meets Late Stage Trial Endpoints
5/15/2014
Tesaro has announced that its drug treating chemotherapy-induced nausea and vomiting has met company goals in a late stage trial. The drug, rolapitant, achieved statistical significance over traditional therapies in the 532 patients enrolled in the final Phase III study. The drug was generally well tolerated by patients, with the most adverse side effects reported being fatigue, loss of appetite, and constipation.
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Quintiles Acquires Encore Health Resources
5/15/2014
Quintiles has announced that it has entered in an agreement to acquire Encore Health Resources, which is a health information and analytics company that provides technology services to healthcare providers. Encore helps its clients through the use of analytics and big data, helping clients through strategy, advisory, implementation, optimization, and performance improvement processes. Quintiles acquired Encore in order to improve the company’s own electronic health records (EHR) capabilities, as EHR expertise is becoming a larger focus for biopharmaceutical clients focused on clinical effectiveness and performance in the market.
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Late Stage Trials Prove Lilly Diabetes Drug Set To Battle Sanofi's Lantus
5/15/2014
Eli Lilly has announced that its type 2 diabetes drug served as an effective treatment for lowering patients’ blood sugar levels. The Eli Lilly drug, basal insulin peglispro, was in three late-stage trials. The three trials tested three types of patients: those who had not previously taken insulin, those who were taking insulin at meals, and those who were taking another type of basal insulin. Following the trials, the company has found that the drug met its primary endpoint of non-inferior reduction in hemoglobin A1c compared to insulin glargine.
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Lannet and Sunshine Lake Enter Into CMO Agreement
5/15/2014
Lannett Company has announced that it is entering into a distribution and contract manufacturing services (CMO) agreement with Sunshine Lake, which is the US based subsidiary of the HEC Pharm Group. HEC is based out of the Guangdong Province in China. Under the terms of the deal,
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Gene Signal Seeking Partner To Help Develop Eye Disease Drug
5/14/2014
Biotech firm Gene Signal is currently in talks with potential partners to help the company develop its wet age-related macular degeneration (AMD) drug. AMD is the leading cause of blindness for seniors, and the market for AMD is considered particularly lucrative by industry analysts. Gene Signal’s AMD drug, aganirsen, is administered as an eye drop or as an emulsion. This is different from current drugs currently on the market from Roche (Lucentis) and Regeneron (Eylea). Those drugs must be physically injected into the eye, which can be difficult for certain patients.
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CSL Opens New Manufacturing Facility For Hemophilia Therapies
5/14/2014
CSL, which is based out of King of Prussia, Pennsylvania, has announced that the company has opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. This new facility will be located directly adjacent to the company’s plant dedicated to manufacturing plasma products in Melbourne. The new expansion cost the company $250 million and was part of the overall expansion of the company’s Broadmeadows site. The new facility will be used primarily for the late stage development of hemophilia products. The advanced technology at the facility will allow for the large-scale production of therapies for international clinical trials.