|Life Technologies Wins FDA 510(k) Clearance for HLA Typing Kits; Novo Shares Plunge for Tresiba, Ryzodeg|
|By Staff and Wire Reports|
|Monday, 11 February 2013 20:02|
Life Technologies Corporation (NASDAQ: LIFE) announced it has received U.S. FDA 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits. The development represents additional execution against the company's strategy to become a leader in the diagnostics market by offering both novel clinical assays and best- in-class molecular testing products.
"This successful application for our Sanger sequencer with HLA typing kits is further demonstration of Life Technologies' track record in obtaining FDA regulatory clearance for genetic analysis in the clinical market," said Greg Lucier, chairman and chief executive officer of Life Technologies. "We will continue to aggressively pursue a regulatory pathway for our leading technologies in the clinical space, including next-generation sequencing."
The company's 7500 Fast Dx Real-time PCR system was cleared for diagnostic use with the Center for Disease Control's H1N1 assay in 2008. Life Technologies has also announced plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM™) for 510(k) clearance.
The Applied Biosystems™ 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore® HLA Sequencing Kits, and uTYPE® Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the United States. Tissue typing is an essential component of determining compatibility between donors and patients for organ and bone marrow transplantation. HLA typing on the 3500 Dx offers labs an optimized, streamlined workflow with higher resolution than other molecular HLA typing technologies such as sequence-specific oligonucleotide (SSO) methods.
"With clearance of this system, transplant patients can now have the confidence that their HLA tissue typing was performed utilizing a thoroughly tested, high resolution technique that has passed the strict test requirements of the FDA," said Ronnie Andrews, president of medical sciences at Life Technologies. "Precise HLA matching between donor and patient significantly improves overall transplant survival."
The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Sanger, also known as capillary electrophoresis, sequencing is the technology that powered the Human Genome Project and remains the "gold-standard" for its accuracy, reliability and ease of use. It is expected that clearance will facilitate development of additional assays using the 3500 Dx and open up new partnerships with assay developers.
"Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab," said Andrews. "The instrument was designed with the clinical laboratory in mind, featuring a novel design that incorporates the ability to track patient samples with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software."
Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore® HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe, has been approved by China's State Food and Drug Administration (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.
Additional products offered by Life Technologies for the diagnostics lab market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument, which is CE-IVD marked for use in Europe and under review by FDA; the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool is available for assisting in the validation and verification of molecular tests.
Novo Nordisk (NYSE: NVO) announced on February 8th, 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba ® (insulin degludec) and Ryzodeg ® (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form. In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data.
Novo Nordisk does not expect to be able to provide the requested data during 2013. In the letter, the FDA also states that approvals for Tresiba ® and Ryzodeg ® cannot be granted until the violations cited in the previously announced Warning Letter, dated 12 December 2012, have been resolved. “We are convinced that Tresiba ® and Ryzodeg ® offer significant benefits for people who require insulin”, said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. “We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review.” The New Drug Applications for Tresiba ® and Ryzodeg ® were submitted by Novo Nordisk to the FDA in September 2011.
In November 2012, at an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favour of approving the products with a post-approval cardiovascular outcomes trial commitment. Tresiba ® and Ryzodeg ® are approved in Japan, the EU and Mexico and under regulatory review in a number of countries throughout the world. The Complete Response Letter is not expected to significantly impact Novo Nordisk's expectations for the company's financial results for 2013, which were provided on 31 January 2013 in connection with the release of the financial results for 2012.
Advanced Cell Technology, Inc.’s (OTCBB: ACTC), clinical partner, the University of California, Los Angeles (UCLA), has received approval of its Investigator Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA), led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase I/II study using ACT’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (MMD, or myopia), commonly known as nearsightedness.
Aethlon Medical, Inc. (OTC: AEMD), announced today that their February 7th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company focused on developing drugs to treat prevalent inflammatory diseases, such as osteoarthritis (OA) and diabetic macular edema (DME), announced the incorporation and initiation of operations of Luoxis Diagnostics, a subsidiary of Ampio that will initially be funded through a private placement, with Ampio maintaining approximately 80% ownership post financing.
AMRI (NASDAQ: AMRI) announced today that it has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer.
BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions and JLL Partners, Inc. (“JLL”), a leading private equity investment firm, announced today that BC Acquisition Corp. (“Purchaser”), which is a wholly-owned subsidiary of BioCore Holdings, Inc. (“Parent”), each of which is an affiliate of JLL, has commenced a tender offer for all outstanding shares of BioClinica at a price of $7.25 per share net to the seller in cash.
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that REVLIMID® (lenalidomide) has been granted full approval, which includes an Import Drug License (IDL) by the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Leerink Swann 2013 Global Healthcare Conference in New York, New York, on February 14, 2013.
DARA BioSciences, Inc. (NASDAQ: DARA) (the "Company" or "DARA"), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today the Company will be presenting at the 15th Annual BIO CEO & Investor Conference. Hosted by the Biotechnology Industry Organization (BIO), the 15th Annual BIO CEO & Investor Conference will take place February 11-12 at the Waldorf-Astoria in New York City.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that a member of the company’s senior management team will provide a corporate overview presentation at the Cowen and Company 33rd Annual Health Care Conference in Boston on Monday, March 4, 2013 at 3:30PM Eastern.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that their February 7th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the promotion of Mark Currie, Ph.D. to senior vice president, chief scientific officer (CSO), and president of research and development (R&D).
LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (NYSE MKT:BTX), announced today that according to Google Analytics, the Company’s databases have attracted over two million unique visitors in the previous 12 months.
Life Technologies Corporation (NASDAQ: LIFE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its receipt of four new issued patents related to tissue grafts derived from the placenta.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") and Fairway Physicians Insurance Company, RRG ("Fairway") jointly announced today that MMR has agreed to provide Fairway the ability to offer hospital malpractice insurance clients a prepaid license for the use of its MyMedicalRecords, Inc. Patent Portfolio.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its President, Dr. Anil Diwan, will present an overview of the company at the 15th Annual BIO CEO and Investor Conference.
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has signed a definitive merger agreement and has completed the acquisition of Leeds, U.K.-based Rosemont Pharmaceuticals Ltd. ("Rosemont") for approximately £180 million or $283 million in cash.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it received from Sanofi a notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) that Sanofi intends to acquire Common Stock of Regeneron through open market purchases and direct purchases from shareholders.
Sigma-Aldrich Corporation (NASDAQ: SIAL), will hold its Business Review with the financial community on Thursday, March 21, 2013 at 8:30 AM Central Time. Presenters will include: President & CEO, Rakesh Sachdev; EVP & CFO, Jan Bertsch; EVP & President, SAFC Commercial Markets BU, Gilles Cottier; EVP & President, Applied Markets BU, Frank Wicks; and EVP & President, Research Markets BU, Eric Green.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification for medical devices, today introduced SurModics Serene™ lubricious coatings for endovascular medical devices.
Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, today announced that the first patient initiated treatment in the ARISE trial (Acid Lipase Replacement Investigating Safety and Efficacy), a global, Phase 3, randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with late onset lysosomal acid lipase deficiency (LAL Deficiency).
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that Dr. Arie Belldegrun was appointed by the Board of Directors of Teva, at its meeting of February 5, 2013, to fill a vacancy on the Board effective immediately. Dr. Belldegrun's term of office will extend until Teva’s 2013 Annual Meeting of Shareholders.
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the appointment of Barry Glassman, D.M.D., as Vice President of Training and Education.
Unilife Corporation (NASDAQ: UNIS, ASX: UNS), a U.S. based designer, developer and supplier of injectable drug delivery systems, today announced it will exhibit at the Pharmapack Europe Annual Meeting in Paris, France between February 13th and 14th.
YaFarm Technologies, Inc. (PINKSHEETS: YFRM) (YaFarm, or the Company) announced today the appointment of top level management for the Integrative Stem Cell Institute (ISCI), a premier provider of point-of-care, stem cell-based therapies.