Vertex Reports Update to US Prescribing Info for INCIVEK; Endo Offers Comment on Dismissal of Suit Against FDA Print E-mail
By Staff and Wire Reports   
Wednesday, 19 December 2012 20:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 19, 2012.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified.

Rash and serious skin reactions are known adverse events associated with INCIVEK combination treatment and were previously included in the warnings and precautions section of the label. Given the severity of the events reported in the post-marketing setting, and the importance of discontinuing INCIVEK combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning.

“The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use INCIVEK properly,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “We will continue to educate physicians to follow the rash management plan developed while INCIVEK was in clinical trials and the information contained in the updated label.”

In Phase 3 clinical trials, less than 1 percent of people who received INCIVEK combination treatment experienced a serious skin reaction. These serious skin reactions required hospitalization and all patients recovered. For serious skin reactions, INCIVEK combination treatment must be discontinued immediately, and patients should be promptly referred for urgent medical care.

The INCIVEK label was also updated to include additional information on the time to onset and management of anemia.


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Endo Health Solutions Inc. (Nasdaq: ENDP)
announced U.S. District Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed the case of Endo's subsidiary, Endo Pharmaceuticals Inc., against the U.S. Food and Drug Administration (FDA).  Endo Pharmaceuticals argued that FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of OPANA ER was withdrawn from the market for reasons of safety.  The judge ruled against Endo, noting that he believes the FDA has not unduly delayed making a determination on the matter.  The FDA stated that it intends to make its determination by May 2013.

Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. The ruling by the court now allows for a generic non-tamper resistant version to enter the market on Jan. 2, 2013.


Also Wednesday:


Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced today that it will allow the shareholder approval it had received to complete a reverse split of its common stock prior to year-end to lapse, primarily due to market conditions and other corporate factors.

Amgen (NASDAQ: AMGN)
today announced it has finalized a settlement agreement with the U.S. government, 49 states and the District of Columbia related to previously disclosed investigations.

Arno Therapeutics, Inc. (OTCBB: ARNI)
, a clinical-stage biopharmaceutical company focused on the development of oncology therapeutics, announced today the sale and issuance of an additional $2.15 million of 8% senior convertible debentures and warrants to purchase 14.3 million shares of common stock.

Boston Therapeutics, Inc. (OTCQB: BTHE)
("Boston Therapeutics" or "the Company"), a leading developer of complex carbohydrate therapeutics to treat diabetes and inflammatory diseases, today announced that the French East IV Committee of Protection of Persons (Strasbourg) and the Ministry of Health has approved the Company's filing to initiate a clinical study of the efficacy and safety of SUGARDOWN®, taken together with a standard meal on post-meal sugar and insulin blood levels in patients with Type ll diabetes that have been treated with metformin.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the initiation of its global Phase 3 clinical trial of orally-administered solithromycin, the company's fluoroketolide antibiotic candidate, in patients with community-acquired bacterial pneumonia (CABP).

Covidien (NYSE: COV)
, a leading global provider of healthcare products, will present at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco, California, on January 7, 2013.

Global Green, Inc. (OTCBB:GOGC)
announced today that continuing internal field trial studies show that the use of Salmogenics, the Company's patented Salmonella Vaccine, may increase the performance of broilers, resulting in a healthier protein source and leading to increased profit for the poultry grower.

Idera Pharmaceuticals (NASDAQ: IDRA) today announced that 48% of patients with moderate-to-severe plaque psoriasis (12 of 25) treated with IMO-3100, a selective antagonist of Toll-like Receptors (TLRs) 7 and 9, demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35% to 90% from baseline at the completion of a randomized, double-blind, placebo-controlled Phase 2a clinical trial of two dose levels of IMO-3100 administered for four weeks, with a four-week follow-up period.

IGI Laboratories, Inc. (NYSE Amex: IG)
, a New Jersey based generic topical pharmaceutical company, today announced that Dr. Kenneth Miller has been appointed Senior Vice President of R&D at IGI Laboratories, Inc. effective December 17, 2012.

ImmunoGen, Inc. (NASDAQ: IMGN)
, a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Amgen has licensed the exclusive right to use the Company’s maytansinoid TAP technology to develop anticancer therapeutics to a third target, which is undisclosed.

Incyte Corporation (Nasdaq:INCY)
announced today it will present at the 31st Annual J. P. Morgan Healthcare Conference on Monday, January 7th at 8:30 a.m. (PST) / 11:30 a.m. (EST) in San Francisco.

LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Cytomedix, Inc. (OTCQX: CMXI), an autologous regenerative therapies company focused on the commercialization of innovative technologies for orthopedics and wound care.

Masimo (NASDAQ: MASI)
today announced that Ogden Regional Medical Center (ORMC),named by The Joint Commission as a Top Performer on Key Quality Measures™,  has standardized to Masimo rainbow® Pulse CO-Oximetry™ and sensor technologies for advanced patient monitoring.

Neptune Technologies & Bioresources, Inc. (NASDAQ: NEPT)
has seen its stock fall 45% from its closing price on November 7th.

Oncothyreon Inc. (Nasdaq: ONTY)
today announced that the pivotal Phase 3 clinical trial of L-BLP25 (formerly referred to as Stimuvax®) known as START did not meet its primary endpoint of an improvement in overall survival in patients with unresectable, locally advanced stage IIIA or stage IIIB non-small cell lung cancer (NSCLC).

PLX Technology, Inc. (NASDAQ: PLXT)
, a leading global supplier of high-speed connectivity solutions enabling emerging data center architectures, today announced the Federal Trade Commission (FTC) has issued an administrative complaint seeking to block the proposed merger between PLX® and Integrated Device Technology (IDT) announced on April 30, 2012, and is authorized to pursue a preliminary injunction in federal district court or other relief necessary to stop the deal pending a full administrative trial.

RXi Pharmaceuticals Corporation (OTC: RXII)
, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that the Company’s President and Chief Executive Officer, Dr. Geert Cauwenbergh, will present at the Biotech Showcase™ 2013 Conference on Tuesday, January 8, 2013 at 9:30AM PT.

TRIMEDYNE, INC. (OTCBB: TMED)
, today announced that Robert S. Cowles, III, M.D. has agreed to serve as Medical Director of Trimedyne.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment.



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