Gilead to Stop Phase 3 Study 116 of Idelalisib; Chelsea Says FDA Panel to Review Northera Print E-mail
By Staff and Wire Reports   
Wednesday, 09 October 2013 18:10
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 9, 2013.

Following a recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences (Nasdaq: GILD) announced that its Phase 3 study (Study 116) evaluating idelalisib in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early. This DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the U.S. Food and Drug Administration (FDA) of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL. Data from Study 116 will be submitted for presentation at an upcoming scientific conference.

“Given the significant unmet medical need in CLL, particularly in this population of patients who are not fit for chemotherapy, we are pleased that idelalisib has shown a clinically meaningful benefit for patients,” said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. “This is the first Phase 3 study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signaling as a major component of their mechanism of action, an important area of focus in the development of chemotherapy-free regimens in CLL and other B-cell malignancies. We extend thanks to the investigative sites and to the other research collaborators participating in this study, as well as to the patients who volunteered, and we look forward to sharing these data with the hematology community.”

Patients from Study 116 randomized to idelalisib will continue receiving idelalisib and patients in the control arm (placebo plus rituximab) will become eligible to receive open-label idelalisib therapy in an extension study. Gilead is also planning an expanded access program (EAP) for patients with recurrent CLL who are not fit for chemotherapy and require treatment.

A new drug application (NDA) for idelalisib was submitted for refractory indolent non-Hodgkin's lymphoma (iNHL) on September 11, 2013. Gilead plans to file for regulatory approval of idelalisib in the European Union later this year.



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Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP)
announced the U.S. FDA has notified the Company that the New Drug Application (NDA) seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) will be reviewed by the Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014.

The FDA recently assigned to NORTHERA™ a Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014. NORTHERA™ was previously granted Orphan Drug Designation and received Fast Track designation from the FDA.  Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.




Also Wednesday:




Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) today announced that it will be presenting at the upcoming 2013 Stem Cell Meeting on the Mesa.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that its New Drug Application (NDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review.

Diagnostic Imaging International Corp. (OTCQB:DIIG) announced today that the Company has repaid $400,000, representing the entire issue, of its Series A notes.

Ebix, Inc. (Nasdaq:EBIX)
, a leading international supplier of On-Demand software and E-commerce services to the insurance industry, today announced that the Company's A.D.A.M. Health Content Exchange will be exhibiting at the 2013 National Users Conference in San Antonio, which will bring eClinicalWorks customers together for networking and training.

An eHealth, Inc. (NASDAQ: EHTH) analysis of over 46,000 unique user sessions on eHealthMedicare.com and PlanPrescriber.com revealed that less than nine percent (9%) of individuals who take prescription medication for diabetes, heart disease, Alzheimer's disease, and Chronic Obstructive Pulmonary Disorder (COPD) are in the Medicare Part D plan with the lowest total out-of-pocket costs available to them.

Most people do not factor in their out-of-pocket costs for prescription drugs when comparing Medicare drug coverage, according to a recent study conducted by eHealth, Inc (NASDAQ: EHTH).

Fewer than one-in-ten (9%) Medicare customers will hit Medicare's coverage gap (the "donut hole") in 2013, according to an analysis by eHealth, Inc. (NASDAQ: EHTH).

GeoVax Labs, Inc. (OTCQB: GOVX)
, a biotechnology company developing vaccines to prevent and treat HIV/AIDS, today presented additional results from HVTN 205, a multicenter, randomized Phase 2a trial evaluating the safety and immunogenicity of the Company's first generation preventive HIV vaccine, at the 2013 AIDS Vaccine Meeting in Barcelona, Spain.

Stanley T. Crooke, Ph.D., M.D., founder, CEO and chairman of the board of directors of Isis Pharmaceuticals, Inc. (NASDAQ: ISIS), has been awarded the 2013 Distinguished Scientist Award by the San Diego section of the American Chemical Society (ACS).

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced top-line results from a pilot study exploring the use of telotristat etiprate in ulcerative colitis. Telotristat etiprate, a serotonin synthesis inhibitor, is currently in Phase 3 development for carcinoid syndrome, a condition caused by metastatic, functioning neuroendocrine tumors.

Limitless Venture Group Inc.'s (OTC Pink: LVGI) G.E.A.R.™ sports nutraceuticals subsidiary today announced two new "ambassadors" to its growing team of IFBB pros: Aaron Clark and Justin Ray Compton.

Nuvilex, Inc. (OTCQB: NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, would like to inform shareholders that its Chief Operating Officer, Dr. Gerald Crabtree, has been interviewed by Stock Market Media Group.

ReliaBrand Inc. (OTCQB: RLIA) announced today that it will launch its new "Adiri® MD+ Nurser™" at their feature booth located in the 'Modern Child®' Showcase at the ABC Kids Expo being held at Las Vegas, Nevada October 15th to 18th, 2013.

Stanley T. Crooke, Ph.D., M.D., founder, CEO and chairman of the board of directors of Isis Pharmaceuticals, Inc. (NASDAQ: ISIS), has been awarded the 2013 Distinguished Scientist Award by the San Diego section of the American Chemical Society (ACS).

Stevia First Corp. (OTCQB: STVF)
, an early-stage agribusiness based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, is pleased to announce entry into a retail distribution and marketing support agreement with GAB Innovations of Vancouver, Canada.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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