|FDA Warns on Cholesterol Drugs; Alimera Announces Positive Outcome for Approval of ILUVIEN(R)|
|By Staff and Wire Reports|
|Tuesday, 28 February 2012 20:45|
The Food and Drug Administration on Tuesday raised safety concerns about the popular class of cholesterol-fighting drugs called statins, warning that patients taking the drugs may face a "small increased risk" of higher blood sugar levels and of being diagnosed with diabetes.
The federal safety agency said Tuesday it plans to add the diabetes-risk language to the "warnings and precautions" sections of labeling for the statin drugs. The drugs that will get the warning include top-selling brand names such as Lipitor, Lescol, Pravachol, Crestor, Mevacor, Altoprev, Livalo and Zocor. Under these and a range of generic names, the drugs have been taken for years by tens of millions of people to prevent heart attack, stroke and cardiovascular disease.
The largest manufacturers of statins didn't have immediate comments on the FDA's action.
In addition, the FDA said that labels for statin drugs now will contain information about patients experiencing memory loss and confusion, though this side effect was classified as an "adverse reaction" rather than being put in the more serious warnings and precautions category.
Dr. Amy Egan, the FDA's deputy director for safety of metabolic and endocrinological products, said "these cognitive changes can be quite dramatic" and "sustained," but that they do disappear when statin therapy is stopped. She cautioned that the agency isn't able to identify a specific drug or age group of people who might be prone to such cases of memory loss and confusion, but that patients should notify their doctors if such symptoms occur.
Alimera Sciences, Inc., (NASDAQ:ALIM) +1.52% (Alimera), a biopharmaceutical company which specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced the positive outcome of the Decentralized Procedure (DCP) for ILUVIEN(R) in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that ILUVIEN is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that, in these seven countries alone, 22.1 million people are currently living with diabetes. By comparison, the Centers for Disease Control and Prevention estimate that Americans with diabetes now number 25.8 million. Alimera estimates that within the seven CMS countries, 1.2 million people suffer from DME.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it will report its financial results for the fourth quarter and year ended December 31, 2011 on Tuesday, March 6, 2012, after the U.S. financial markets close. ACADIA's management will host a conference call and webcast on Tuesday, March 6, 2012, at 5:00 p.m. Eastern Time to discuss ACADIA’s financial results and development programs.
Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company (the “Company”), announced today that its wholly owned subsidiary, Akorn India Private Limited (“AIPL”), has completed and closed the previously announced acquisition of certain assets of Kilitch Drugs India Limited (“KDIL”), a leading contract manufacturer of sterile injectables in India, as well as certain assets of NBZ Pharma Limited.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2011 and provided an update on corporate developments.
The final results from AspenBio Pharma’s (NASDAQ: APPY) 503-patient pilot study of AppyScore™ will be presented from the podium at the annual meeting of the Society for Academic Emergency Medicine being held in Chicago, May 9-12.
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that it will release its 2011 fourth quarter and fiscal year-end results on Monday, March 5, 2012.
Baxter International Inc. (NYSE:BAX) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced that Amarin Corporation plc has chosen the eClinical suite from BioClinica to capture and manage clinical data for their Phase IIIb cardiology clinical trial, including: electronic data capture (EDC) and data management, interactive response technology (IRT/IVR/IWR), and clinical trial management (CTMS) solutions.
Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that, based on a preliminary review of its financial performance for the fourth quarter ended December 31, 2011, the Company expects to report net revenue of approximately $13.1 million.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the 32nd Annual Cowen and Company Health Care Conference on Tuesday, March 6, 2012, in Boston.
Bristol-Myers Squibb Company (NYSE:BMY) and Duke Translational Medicine Institute (DTMI) today announced the formation of a strategic relationship to broaden interactions between the two organizations.
Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Raymond James 33rd Annual Institutional Investors Conference in Orlando, Florida, on March 6, 2012.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) today announced that it is scheduled to make an investor presentation at the 2012 RBC Capital Markets’ Global Healthcare Conference at 10:00 AM on February 29, 2012.
ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the acquisition of PriceSpective LLC, a global leader in value strategy consulting.
Idera Pharmaceuticals (NASDAQ: IDRA) today announced that Sudhir Agrawal, D. Phil., Chairman and Chief Executive Officer of Idera, will present a company overview at the Cowen and Company 32nd Annual Healthcare Conference on March 7th 2012, at 10:00 am EST in Boston, Massachusetts.
Impax Laboratories, Inc. (NASDAQ: IPXL) today reported fourth quarter and full year ended December 31, 2011 financial results.
Medistem Inc. (PINKSHEETS: MEDS) announced today its Annual "Evening with Medistem" Event will take place in Portland, Oregon on March 7th, 2012.
Natus Medical Incorporated (Nasdaq:BABY) today announced financial results for the fourth quarter and full year ended December 31, 2011.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the Cowen and Company 32nd Annual Health Care Conference on Wednesday, March 7, 2012 at 8:40 a.m. EST.
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2011.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the positive outcome of the Decentralized Procedure (DCP) for the approval of ILUVIEN® in Europe.
Revitas announced today that Impax Laboratories, Inc. (NASDAQ: IPXL), a technology-based specialty pharmaceutical company, will move forward with adoption of Revitas’s strategic Flex™ technology platform and expand its use of Revitas’s Enterprise Revenue Dynamics (ERD) solutions across the enterprise.
Rite Aid Corporation (NYSE: RAD) announced today it has selected CaptureRx® as its preferred 340B technology vendor and administrator.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at the Cowen and Company 32nd Annual Health Care Conference in Boston, MA on Tuesday, March 6, 2012 at 10:40 a.m. ET.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the 2012 RBC Capital Markets’ Global Healthcare Conference in New York.
Today Biogen Idec (NASDAQ: BIIB) announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS).
Viral Genetics, Inc. (Pinksheets: VRAL) today announced that Nathan Tinker, PhD, has joined the company’s list of industry-leading advisors.