|FDA Lets 2 Cancer Drugs Be Imported; Vivus Counting Votes for the QNEXA FDA Advisory Committee|
|By Staff and Wire Reports|
|Tuesday, 21 February 2012 20:23|
In order to alleviate a critical shortage of cancer drugs, the FDA says it will allow drug shipments into the U.S. within weeks from a number of new suppliers including Hospira (NYSE:HSP) and App Pharmaceuticals.
Dire shortages of two critical cancer drugs — shortfalls that have threatened the lives and care of thousands of patients — should be resolved within weeks, federal drug officials said.
The two drugs are Doxil and methotrexate, and in both cases supplies in the United States are being bolstered by shipments from abroad. Shortages of scores of other drugs continue. The causes of the shortages are multiple.
On February 22, 2012, the Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss new drug application (NDA) 22-580 for QNEXA (phentermine/topiramate), submitted by VIVUS (NASDAQ:VVUS).
VVUS’ panel is different from the AMGN, ASTX, and NGSX panels earlier this month. In those panels, we felt our behavioral analysis was unnecessary because the clinical and statisical data clearly did not support approval, even before the briefing documents were released. But for VVUS, we know from past obesity drug panels that the committee decision will be difficult and the vote will be split. Therefore, it’s worthwhile to go beyond our normal behavioral analysis and attempt to predict the make-up/votes of the upcoming VVUS QNEXA panel *before* the roster and draft documents are released.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Jane Wasman, J.D., Chief, Strategic Development and General Counsel will present at the Citi 2012 Global Health Care Conference on Monday, February 27, 2012 at 10:30 a.m. ET at the Waldorf Astoria, New York City, NY.
Allos Therapeutics, Inc. (NASDAQ: ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics, today announced that the Company will report its financial results for the fourth quarter and full year ended December 31, 2011 on Tuesday, March 6, 2012, after the financial markets close.
Aradigm Corporation (OTCBB: ARDM) (“Aradigm” or the "Company") today announced that the United States Patent and Trademark Office has issued an important composition of matter patent (U.S. Patent No. 8,119,156) covering formulations of liposomal and free ciprofloxacin, including its lead preparation, Pulmaquin™ (Dual Release Ciprofloxacin for Inhalation, DRCFI, ARD-3150).
Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that its investigational compound, AR-42, has been granted orphan-drug designation by the U.S. Food and Drug Administration for the treatment of meningioma and schwannoma of the central nervous system.
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the 2012 RBC Capital Markets’ Global Healthcare Conference on February 28, 2012 at 8:30 a.m. and at the Citi 2012 Global Health Care Conference on February 28, 2012 at 4:00 p.m.
AstraZeneca (NYSE: AZN) announced today that the American College of Chest Physicians (ACCP) has updated its guidelines on Antithrombotic Therapy and Prevention of Thrombosis to include a recommendation for giving the oral antiplatelet medicine, BRILINTA® (ticagrelor) tablets with low-dose aspirin to patients who suffer from Acute Coronary Syndrome (ACS).
BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development company, announced the publication of pre-clinical results demonstrating that BL-7010, an orally available treatment for celiac disease, reduces gluten toxicity (the negative effect of gluten on the patient’s body).
Bristol-Myers Squibb Company (NYSE: BMY) will take part in the Citi 2012 Global Health Care Conference Monday, February 27, 2012, in New York. Giovanni Caforio, president, U.S. Pharmaceuticals will answer questions about the company at 10:30 a.m. EST.
BSD Medical Corporation (NASDAQ: BSDM) reports initiation of a randomized, multicenter, Phase III clinical study using the BSD-2000 Hyperthermia System to deliver hyperthermia in combination with chemotherapy for the treatment of pancreatic cancer patients.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI), today announced its financial results for the fourth quarter and year ended December 31, 2011.
Celgene Corporation (NASDAQ: CELG) today announced its presentation at the Citi 2012 Global Health Care Conference on Tuesday, February 28, 2012 at 9:30 a.m. EST will be webcast live and will be available in the investor relations section of the Company’s Web site at www.celgene.com.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Charles J. Dockendorff, Executive Vice President and Chief Financial Officer, will represent the Company at two upcoming conferences.
Elan Corporation, plc (NYSE: ELN) announced today that it will present at the Cowen & Co., 32nd Annual Healthcare Conference on Tuesday, March 6, 2012 at 9.20 a.m. Eastern Standard Time and 2.20 p.m. Greenwich Mean Time.
Exelixis, Inc. (NASDAQ:EXEL) today announced that Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, will present at the 2012 Citi Global Health Care Conference at 10:00 a.m. EST / 7:00 a.m. PST on Tuesday, February 28, 2012, in New York.
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today reported its financial and operating results for the quarter and year ended December 31, 2011.
GTx, Inc. (Nasdaq: GTXI) announced today that the U.S. Food and Drug Administration (FDA) notified the Company in a telephone call on Friday, February 17, 2012, that the agency has placed a clinical hold on the Company’s clinical trials evaluating Capesaris® (GTx-758) for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment.
GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the fourth quarter and full year 2011.
ImmunoCellular Therapeutics (OTCBB: IMUC) today announced that it has entered into an agreement with the University of Pennsylvania under which University of Pennsylvania has granted the Company an exclusive, worldwide license for a patent pending technology for the production of high-activity dendritic cells (DCs).
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Monday, March 5, 2012, at 4:50 p.m. ET in Boston, Massachusetts.
InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries, today announced the full exercise of the over-allotment option granted to the underwriters to purchase 1,242,236 additional shares, at a public offering price of $2.10 per share, in connection with its previously announced underwritten public offering of 8,281,574 shares, bringing aggregate gross proceeds from the offering to $20 million dollars.
IntelliCell BioScience, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC); (“IntelliCell”) or the (“Company”), A full page Daily News article, titled “Stem Sells” written by Sean Brennan published February 19, 2012, http://www.nydailynews.com/sports/college/manhattan-basketball-torgrim-sommerfeldt-turned-stem-cell-treatment-back-court-article-1.1025227, describes how Torgrim Summerfeldt’s budding basketball career was saved through Dr. Anthony Maddalo’s treatment using IntelliCell BioSciences proprietary SVF Cells (Stem Cell Therapy).
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced it will host its fourth quarter 2011 investor update conference call and webcast at 4:30 p.m. Eastern Time on Tuesday, February 28, 2012.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and Retrophin, LLC announced that the companies have entered into an agreement in which Ligand has licensed rights to DARA (a Dual Acting Receptor Antagonist of Angiotensin and Endothelin receptors) to Retrophin.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand, will present at the Citi Global Health Care Conference on Tuesday, February 28, 2012 at 12:00 p.m. Pacific (3:00 p.m. Eastern Time).
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that it will release its fourth quarter 2011 financial results before the open of the market on Tuesday, March 6, 2012.
Medtronic, Inc. (NYSE:MDT) today announced financial results for its third quarter of fiscal year 2012, which ended January 27, 2012.
Metabolix, Inc. (NASDAQ:MBLX), a bioscience company focused on bringing clean, sustainable solutions to the plastics, chemicals and energy industries, announced today that it will be releasing its fourth quarter and fiscal 2011 financial results after the market close on Tuesday, March 6, 2012.
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that David Stack, president and chief executive officer of Pacira Pharmaceuticals, is scheduled to participate in a panel titled “New Developments in Neurology” at the RBC Capital Markets Global Healthcare Conference on Tuesday, Feb. 28, 2012, at 2:35 p.m. EST at the New York Palace Hotel & Conference Center in New York City.
PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today commented on the decision by Omnicare (NYSE: OCR) to allow its unsolicited tender offer to expire.
Repligen Corporation (NASDAQ:RGEN) today reported preliminary financial results for the quarter and nine-month fiscal period ended December 31, 2011.
Repligen Corporation (NASDAQ:RGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Company’s new drug application (NDA) for SecreFlo™ for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review.
Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today that on February 16, 2012, the Company was notified that it has regained compliance with The NASDAQ Capital Market and its minimum market value of listed securities requirement.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at the 2012 RBC Capital Markets Healthcare Conference in New York, NY on Tuesday, February 28, 2012 at 2:35 p.m. ET.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the initiation of TARGET 3 - a Phase 3 study to evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin 550 mg TID for 14 days.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the fourth quarter and year ended December 31, 2011.
TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that it expects to report preliminary first quarter revenue for the quarter ending February 29th, 2012 in the range of $130,000 to $150,000, versus 2011 Q1 Revenue of $48,298.