|FDA Orders New Label For Biogen Idec's MS Drug; Exact Sciences Announces Final Payment Decision for Cologuard®|
|By William Kent|
|Tuesday, 25 November 2014 20:39|
Biogen Idec Inc. (NASDAQ: BIIB) 0.44% was little changed Tuesday when regulators ordered new labeling information for its blockbuster multiple sclerosis treatment Tecfidera concerning a patient's death from a brain infection.
Biogen disclosed the incident October 22 in a conference call with analysts.
Chief Executive George A. Scangos told analysts that despite the death, "we believe that the overall positive benefit risk profile of Tecfidera remains unchanged."
The drug has been taken by more than 100,000 patients within just 18 months of the U.S. launch, Scangos said.
The patient died of progressive multifocal leukoencephalopathy, or PML, after taking Tecfidera for more than four years in a long-term study.
The U.S. Food and Drug Administration on Tuesday ordered that new labeling information that describes the event be added to Tecfidera.
"This is the only confirmed case reported in patients taking Tecfidera," the FDA said.
Tecfidera, approved for U.S. marketing in March 2013, accounted for $787 million of Biogen's $2.51 billion in third-quarter revenue.
The drug currently has about a 50 percent market share as a second-line treatment for multiple sclerosis and a 7 percent share as a first-line treatment, according to the market research concern Decision Resources Group.
Biogen traded recently at $304.94, down 0.6 percent.
Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test. Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test.
The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program. Cologuard is the first technology to gain approval through this program.
“CMS’ final payment decision represents a major milestone by providing 50 million Medicare patients access to this noninvasive colorectal cancer screening option,” said Kevin Conroy, president, CEO and chairman of Exact Sciences. “We thank FDA and CMS for giving Exact Sciences the opportunity to bring this new screening option to patients and physicians.”
Colorectal cancer is highly treatable with early detection through screening. However, 23 million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cause of cancer-related deaths in the United States.
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), is hosting a web conference on masitinib in the treatment of asthma with key opinion leaders from this disease.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced positive effects of Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF) for the protection from vision loss in an animal model of retinitis pigmentosa (RP). MANF was discovered utilizing Amarantus' proprietary PhenoGuard™ Protein Discovery Engine.
Analogic Corporation (Nasdaq:ALOG) announced today that it will conduct a conference call on Tuesday, December 9, 2014, at 5:00 p.m. (ET) to discuss results for the first quarter ended October 31, 2014.
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced that it will demonstrate its new bk3000™ ultrasound system at the 100th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 30 – Dec. 5.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will participate in a fireside chat at the 26th Annual Piper Jaffray Healthcare Conference on Tuesday, December 2nd, 2014 at 3:00 p.m. Eastern Time.
Balchem Corporation (Nasdaq:BCPC) today announced that its SensoryEffects business segment will make a multi-million dollar investment in agglomeration technology and production equipment to complement its market leading capabilities in drying and blending of emulsified powders for various markets.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Dr. Derek Chalmers, President and CEO, will present a company overview at the 26th Annual Piper Jaffray Healthcare Conference on Tuesday, December 2, 2014, at 2:30 p.m. ET in New York City.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that Dr. William (Wei) Cao, Chief Executive Officer of the Company, will present "48-week Clinical Results from Phase IIa Trial of Human Adipose Mesenchymal Progenitor Cell (haMPC) Treatment for Knee Osteoarthritis" at the 10th Annual World Stem Cell Summit (WSCS) and RegMed Capital Conference (RMCC) held at the Marriott Rivercenter, San Antonio, Texas, December 3-5, 2014.
DS Healthcare Group, Inc. (NASDAQ: DSKX), a leading developer of personal care products, today announced that the Brazilian Health Surveillance Agency, ANVISA, has approved the Company's Spectral.LASHeyelash extender product for marketing in Brazil.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that Company management is scheduled to participate at two investor conferences in December.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that Christian Weyer, M.D., M.A.S., President and Chief Executive Officer, will present an overview of the company's programs at the Piper Jaffray 26th Annual Healthcare Conference on Tuesday, December 2nd, 2014 at 12:10 pm EST in New York, NY.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer of Five Prime, will present at the 26th Annual Piper Jaffray Healthcare Conference on Wednesday, December 3 at 12:30 PM Eastern Time.
IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems that are safe for use during magnetic resonance imaging (MRI) procedures, announced today that it has filed a submission for premarket notification under Section 510(k) of the Federal Food, Drug and Cosmetic Act with the US Food and Drug Administration (FDA) relating to its MRidium 3860+ MRI IV infusion pumps.
MannKind Corporation (Nasdaq:MNKD), focused on discovering, developing and commercializing therapeutic products for diabetes, announced today that it will present at The 26th Annual Piper Jaffray Healthcare Conference on Tuesday, December 2, 2014 at 3:00 PM (ET) at the New York Palace Hotel in New York City.
mCig(R), Inc. (OTCQB:MCIG), a technology company that owns, manufactures, and distributes the mCig(R), VitaCig(R), and Vapolution products is pleased to announce that the company has received approval from the Financial Industry Regulatory Authority ("FINRA") for the VitaCig, Inc. dividend, and spinoff.
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Michael Cola, President and CEO, will participate in a fireside chat discussion at the 26th Annual Piper Jaffray Healthcare Conference in New York.
Medgenics, Inc. (NYSE MKT:MDGN) today announced the pricing of 5,125,000 shares of its common stock in a previously announced underwritten public offering at a price to the public of $4.10 per share.
Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that management will participate in a fireside chat presentation at the Piper Jaffray 26th Annual Healthcare Conference on Wednesday, December 3, 2014 at 11:30 a.m. Eastern Time at the Palace Hotel in New York, NY.
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced that it has entered into agreements to issue to certain subscribers 2,000,000 ordinary shares at $9.50 per share and 850,000 pre-funded warrants at $9.49 per warrant, exercisable for up to 850,000 ordinary shares at $0.01 per ordinary share.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today the closing of the sale of 6,500,000 shares at $9.00 per share in an underwritten public offering for an aggregate offering amount of $58.5 million.
TESARO, Inc. (Nasdaq:TSRO) announced today that Mary Lynne Hedley, Ph.D., President and COO of TESARO, will present at the 2014 Deutsche Bank BioFEST Conference on Tuesday, December 2, 2014 at 4:00 p.m. ET in Boston.
TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that Michael S. Weiss, the Company's Interim Chief Executive Officer, will be presenting at the 2014 Deutsche Bank BioFEST Conference being held at the Four Seasons Hotel in Boston.
VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases, today announced that management is scheduled to present a company overview at the following investor conferences in December: 2014 Deutsche Bank BioFEST in Boston, MA on Monday, December 1, 2014 at 11:00 a.m. EST. The session will be conducted as a fireside chat; Oppenheimer 25th Annual Healthcare conference in New York, NY on Wednesday, December 10, 2014 at 1:35 p.m. EST.