BioMimetic Receives Augment® Bone Graft PMA Response Letter from FDA; Arena Submits Response to FDA for Lorcaserin Print E-mail
By Staff and Wire Reports   
Tuesday, 03 January 2012 20:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 3, 2012.

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced it received a comprehensive post-panel response letter from the FDA related to the Company's Pre-Market Approval (PMA) application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

The FDA acknowledged that the independent Advisory Panel voted in favor of a reasonable assurance of safety, effectiveness and a positive benefit:risk ratio; however the FDA went on to state that “[n]otwithstanding [the Advisory Panel’s] recommendation, the PMA, without additional information, must be considered not approvable [and that]. . . to place [the Company’s] PMA in approvable form, [the Company] must amend it to include the following . . .”

The FDA then listed the information that BioMimetic would need to submit for the application to be approvable, and outlined a pathway that could potentially lead to approval without additional clinical trials to support the safety and effectiveness of Augment.

In the letter, the FDA requests that the Company submit additional information from the Augment pivotal study as it relates to the product’s safety and effectiveness, as well as additional information relating to antibody safety and reproductive issues. The FDA also requests that the Company submit additional information relating to post-approval studies to monitor the cancer safety of the product and further evaluate its pharmacokinetic (PK) profile in humans.

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Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) and Eisai Inc. announced Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA). Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. The companies expect that later this month the FDA will confirm acceptance of the response and assign a new Prescription Drug User Fee Act (PDUFA) date.

"We have worked diligently with Eisai to prepare this submission that we believe will address the issues raised in the complete response letter," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to providing on today's call an overview of the submission contents, including the results of the recently completed rat mechanistic studies, which we believe provide additional data supporting lorcaserin's benefit-risk profile."

Lonnel Coats, President and Chief Executive Officer of Eisai Inc., said, "Weight loss for obese patients and overweight patients with co-morbid conditions remains an area of unmet need. Eisai is pleased to collaborate with Arena in its response to the FDA, an important milestone toward lorcaserin's potential approval."

The response to the lorcaserin CRL includes data and analyses that were not incorporated in the original NDA, including the results of Arena's Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) clinical trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes. The new information also includes data and analyses from activities intended to address tumors observed in a two-year lorcaserin rat carcinogenicity study, cell culture experiments intended to further refine serotonin subtype 2 receptor activity and rat studies designed to further assess abuse potential. It is important to note that the FDA may analyze or weigh the data differently than Arena and Eisai.



Also Tuesday:




Accelrys, Inc. (NASDAQ: ACCL), a leading scientific enterprise research and development software and services company, today announced that it has acquired privately-held VelQuest Corporation for $35 million in an all-cash transaction.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that its Japanese partner, Yakult Honsha ("Yakult"), has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the Company's PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer ("CRC").

Alkermes plc (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live at the 30th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2012, at 9:00 a.m. PST (12:00 p.m. EST/5:00 p.m. GMT) from the Westin St. Francis Hotel in San Francisco.

Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing MANF, a first-in-class disease–modifying therapeutic protein, today provided shareholders with an update on the execution of its expanded corporate strategy, first announced on November 1st, 2011, to position Amarantus as a neurology-focused biotechnology company.

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) will be presenting at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 9, 2012 at 5:00 p.m. ET / 2:00 p.m. PT.

Apricus Biosciences, Inc. ("Apricus Bio") (NASDAQ:APRI) (http://www.apricusbio.com) and Stellar Pharmaceuticals Inc. ("Stellar Pharma") (OTCQB:SLXCF)(OTCBB:SLXCF)(PINKSHEETS:SLXCF), a Canadian public company, announced today the signing of an exclusive license agreement.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the Company has been upgraded to trade on the NASDAQ Global Select Market, the top listing tier for NASDAQ companies with the highest initial listing standards of any exchange in the world based on financial and liquidity requirements.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel therapeutics, today announced that James S.J. Manuso, Ph.D., chairman and chief executive officer, will present at Biotech Showcase 2012 on Monday, January 9th in San Francisco.

BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI).

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN)
today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will present a company update at the J.P. Morgan Healthcare Conference in San Francisco on Monday, January 9, 2012 at 11:30 a.m. PT.

Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that it has entered into a $5 million securities purchase agreement with Socius CG II, Ltd. ("Socius"), a Bermuda-based subsidiary of Socius Capital Group, LLC.

BioTime, Inc. (NYSE Amex: BTX) today announced that it has elected to market progenitors of muscle stem cells bearing hereditary diseases.

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy.

Chelsea Therapeutics (Nasdaq:CHTP) has announced that FDA regulators have scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on February 23, 2012 to review the New Drug Application (NDA) for NORTHERA

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco, California on Monday, January 9, 2012.

Generex Biotechnology Corporation (OTCBB: GNBT) today provided an update to the clinical development & regulatory strategy for its cancer vaccine, AE37.

Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) announced today that Idenix management will present a corporate overview at the 30th Annual J.P. Morgan Healthcare Conference on January 11, 2012 at 2:00 p.m. PST at the Westin St. Francis in San Francisco.

Illumina, Inc. (NASDAQ:ILMN) today announced that it will webcast the company's presentation at the J. P. Morgan Healthcare Conference in San Francisco, California on January 10, 2012.

Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) announced today that Idenix management will present a corporate overview at the 30th Annual J.P. Morgan Healthcare Conference on January 11, 2012 at 2:00 p.m. PST at the Westin St. Francis in San Francisco.

MELA Sciences, Inc. (NASDAQ: MELA) announced today that Joseph V. Gulfo, MD, President and CEO, will present at the 14th Annual Needham Growth Conference taking place at The New York Palace Hotel in New York City.

MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records ("PHR"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals (www.mmrprovideos.com), today announced that on Friday, December 30, 2011, the Company received a Notice of Allowance from the United States Patent and Trademark Office for its "Method and System for Providing Online Medical Records."

mPhase Technologies, Inc. (OTCBB: XDSL) today said that it has refined its prototype of a new automotive and marine product featuring advanced battery technology with a renowned European Automotive Manufacturer.

Dear NeoStem Shareholders,  We would like to take a moment to both look back at 2011 - a transformative year for NeoStem (NYSE Amex: NBS) – and to look ahead to near term catalysts that we expect to move the company forward in 2012 and beyond.

Osiris Therapeutics, Inc. (NASDAQ: OSIR), today provided an update on its Phase 2 trial evaluating Prochymal, a formulation of adult mesenchymal stem cells (MSCs), in patients with newly diagnosed type 1 diabetes.

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that on December 22, 2011 the Compensation Committee of its Board of Directors approved the grant of inducement stock options to purchase an aggregate of 39,625 shares of common stock to 4 new employees.

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Company will present at the 30th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10 at 8:30 AM Pacific Time.

PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the Second Quarter of Fiscal Year 2012 on Monday, January 30, 2012 after the close of the stock market

Rainbow Coral Corp.’s (OTCBB: RBCC) potential acquisition of emerging Nano3D Biosciences (n3D) exemplifies the company’s new approach in biotechnology investment.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Company has entered into a non-exclusive license and partial settlement agreement (Agreement) with Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) relating to U.S. ophthalmic sales of EYLEA™ (aflibercept) Injection.
TrovaGene, Inc. (Pink Sheets: TROV), a developer of trans-renal molecular diagnostics,  today announced that it has obtained an exclusive worldwide license to mutations of the SF3B1 splicing factor, which have been shown to be associated with disease progression and chemotherapy response in patients suffering from chronic lymphocytic leukemia (CLL).

Stellar Pharmaceuticals Inc. ("Stellar") (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF), a Canadian public company, announced today that the Company intends host a conference call at 4:00 p.m. Eastern Time on Tuesday, January 3, 2012, to discuss the details of the MycoVa™ agreement entered into with Apricus Biosciences, Inc. on December 30, 2011, as noted in the press release dated today's date.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, president and chief executive officer, will present at the J. P. Morgan Healthcare Conference being held at the Westin St. Francis, San Francisco, Calif.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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