|KYTHERA Announces FDA Acceptance of ATX-101 NDA; BMS Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo®|
|By Staff and Wire Reports|
|Thursday, 10 July 2014 19:30|
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced that its New Drug Application (NDA) for ATX-101 (deoxycholic acid) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
In addition, the FDA has informed the company that the FDA'sDivision of Dermatology and Dental Products is currently planning to hold an Advisory Committee meeting on the ATX-101 application during the review.
ATX-101 is an injectable treatment currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. KYTHERA submitted the ATX-101 NDA to the FDA on May 12, 2014.
"We are pleased that KYTHERA's NDA filing has been accepted by the FDA, representing another significant corporate milestone," said Keith Leonard, president and chief executive officer, KYTHERA. "While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area under the chin. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat."
Bristol-Myers Squibb Company (NYSE:BMS) announced, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S.
“We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb.
The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy® (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trade name for nivolumab.
About Opdivo -- Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. We are investigating whether by blocking this pathway, Opdivo would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
In 2013, the FDA granted Fast Track designation for Opdivo® (nivolumab) in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end. The FDA granted Opdivo Breakthrough Therapy Designation in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4th, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.
Reprinted from July 3, 2014, this material event warranted another release. For those who missed it the first time, Hemp, Inc. (OTC:HEMP) has purchased a whole line of automated Temafa decortication equipment designed to separate the fiber from the core of the hemp plant through a process known as decortication.
iKang Healthcare Group, Inc. (Nasdaq:KANG), the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, announced today it will attend the Bank of America Merrill Lynch Healthcare Corporate Day to be held on July 16th to 17th at Bank of America Merrill Lynch Client Centre, 55/F Cheung Kong Centre, 2 Queen's Road, Hong Kong.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) will release its second quarter 2014 financial results on Tuesday, August 5, 2014.
MedAssets (Nasdaq:MDAS) today announced that Centegra Health System (Centegra), located in McHenry County, Ill., has expanded its relationship with the company to include its comprehensive portfolio of revenue performance improvement solutions.
MELA Sciences, Inc. (Nasdaq:MELA), announced today that it has taken the first step in the process of seeking insurance reimbursement for its Multi-Spectral Digital Skin Lesion Analysis (MSDSLA) procedure that is performed by dermatologists utilizing the MelaFind® system as an aid in the detection of melanoma.
Ocera Therapeutics (Nasdaq:OCRX) announced that it has priced an underwritten public offering of 4,200,000 shares of its common stock at an offering price of $6.00 per share.
Management of QED Connect, Inc. (OTC Pink:QEDN) today announced that Emerald Med Farms will be complimenting the management team, with the addition of Mr. Thomas Szabo, PHD.
TESARO, Inc. (Nasdaq:TSRO) will announce its second-quarter 2014 financial results on Thursday, July 24, 2014, after the close of the U.S. financial markets.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that it will report financial results for the second quarter ended June 29, 2014 after the close of the regular trading market on Thursday, August 7, 2014.
Verde Media Group Inc. (OTC:VMGI), through its Verde Media Biotechnology Division is preparing for the next phase of construction for its Pilot and semi-commercial Omega-3 oil production facility in Asia.