FDA Cancels Repligen (RG1068) Advisory Committee Meeting; FDA Votes in Favor of HeartWare® Ventricular Assist System Print E-mail
By Staff and Wire Reports   
Thursday, 26 April 2012 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 26, 2012.

Repligen Corporation (NASDAQ:RGEN)
announced the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA. The Company expects to receive a Complete Response letter on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the New Drug Application (NDA).

While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need, stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068.

RG1068 is a synthetic version of human secretin which was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. On December 21, 2011 we filed a NDA, and on February 21, 2012, the FDA accepted the filing of our NDA and granted it priority review based on its prior Orphan Drug and Fast Track designations. Under the Prescription Drug User Fee Act (PDUFA), the FDAs goal for completing review of the NDA is June 21, 2012.

On March 5, 2012 we submitted an MAA to the EMA, which has been successfully validated for full review by the EMAs Committee for Medicinal Products for Human Use. The U.S. and EU marketing applications are based on positive outcomes from a re-read of our Phase 3 clinical study, supporting the use of RG1068 in combination with MRI to improve detection of pancreatic duct abnormalities in patients with known or suspected pancreatitis.


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HeartWare International, Inc. (NASDAQ:HTWR)
, a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, announced the FDA Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

"We are pleased with the panel's strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study," said Doug Godshall, CEO and President of HeartWare.  "The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare® Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA.  HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future."

The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application that HeartWare submitted for the HeartWare®Ventricular Assist System in December 2010.




Also Thursday:




Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that it will host a conference call and live webcast to report its first quarter 2012 financial results on Thursday, May 3 at 8:30 a.m. ET.

Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced that it will webcast today’s corporate presentation at 9:15 a.m. PDT, after the formal portion of its Annual Shareholders’ Meeting has concluded.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, today announced that it will report financial results for the first quarter ending March 31, 2012 on Thursday, May 3, 2012, after the U.S. financial markets close.

AmerisourceBergen Corporation (NYSE:ABC) today reported that in its fiscal year 2012 second quarter, ended March 31, 2012, diluted earnings per share were $0.81, a 5.2 percent increase. Revenue in the quarter was $20.1 billion, up 1.6 percent.

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN)
today reported financial results for the quarter ended March 31, 2012.

Anika Therapeutics, Inc. (Nasdaq: ANIK)
today announced that it plans to issue its first-quarter 2012 financial results after the close of the market on Thursday, May 3, 2012.

Antares Pharma, Inc. (NYSE Amex: AIS)
today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Teva, Antares’ pharmaceutical partner, that will resolve pending patent litigation related to its abbreviated new drug application (ANDA) for a generic epinephrine auto-injector.

ArQule, Inc. (NASDAQ: ARQL) today announced that it will report its financial results for the first quarter of 2012 on Thursday, May 3, 2012 at 7:00 a.m. eastern time.

Array BioPharma Inc. (NASDAQ: ARRY) today announced that Ron Squarer has been appointed Chief Executive Officer, effective immediately.

AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO)
today announced that financial results for the company's first quarter ended March 31, 2012 will be released before the market opens on Thursday, May 3, 2012.

Baxter International Inc. (NYSE:BAX)
announced today it has exercised its option and completed the purchase of SIGMA International General Medical Apparatus, LLC., a privately held company based in Medina, New York, by acquiring the remaining 60 percent of the company for a cash payment of approximately $90 million.

BioScrip (NASDAQ: BIOS)
today announced that the Company will release its 2012 first quarter financial results before the market opens on Wednesday, May 9, 2012, and host a conference call at 8:30 a.m. Eastern Daylight Time (EDT) to discuss the results.

Bristol-Myers Squibb Company (NYSE: BMY)
today announced first quarter results that included double-digit earnings growth and important R&D milestones in its metabolics and hepatitis C (HCV) franchises.

Celgene Corporation (NASDAQ: CELG)
reported Non-GAAP net product sales of $1,245 million for the first quarter of 2012, a 17 percent increase from the same period in 2011.

Codexis, Inc. (Nasdaq:CDXS)
, a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, tomorrow will celebrate 10 years as a company.

Colgate-Palmolive Company (NYSE:CL)
today reported worldwide Net sales of $4,200 million in first quarter 2012, an increase of 5.0% versus first quarter 2011.

CytRx Corporation (Nasdaq:CYTR)
, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies.

Emergent BioSolutions Inc. (NYSE:EBS) today announced its support of the North Atlantic Treaty Organization (NATO) Emerging Security Challenges Division (ESCD) in hosting a biopreparedness workshop entitled “A Bio-Attack: Are We Prepared?”

Epizyme and Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced the formation of a strategic partnership to discover, develop and commercialize personalized therapeutics for patients with genetically-defined cancers by inhibiting histone methyltransferases (HMTs), an important epigenetic target class.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone.

Gilead Sciences, Inc. (Nasdaq: GILD)
announced today its results of operations for the quarter ended March 31, 2012.

Greatbatch, Inc. (NYSE: GB)
today announced results for its first quarter ended March 30, 2012.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK)
announced today the signing of a definitive agreement under which Hi-Tech acquired rights to market generic Lidocaine 5% Ointment from Septodont, Inc. Lidocaine 5% Ointment is indicated for use as a local anesthetic.

Incyte Corporation (Nasdaq: INCY)
today reported first-quarter 2012 financial results, including revenue from its first commercial product, JakafiTM (ruxolitinib), which was approved by the US Food & Drug Administration (FDA) for the treatment of patients with intermediate or high-risk myelofibrosis (MF) in November 2011.

IntriCon Corporation (NASDAQ: IIN)
, a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced financial results for its first quarter ended March 31, 2012.

Natus Medical Incorporated (Nasdaq:BABY)
today announced financial results for the three months ended March 31, 2012.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, has been named one of the “Best Places to Work in New Jersey.”

Orthofix International N.V. (NASDAQ:OFIX)
(the Company) today announced its results for the first quarter ended March 31, 2012.

PerkinElmer, Inc. (NYSE: PKI)
, a global leader focused on improving the health and safety of people and the environment, today reported financial results for the first quarter ended April 1, 2012.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX)
(“Pernix” or the “Company”), a specialty pharmaceutical company, today announced that it has completed its At-the-Market (ATM) offering with Cantor Fitzgerald & Co.

PURE Bioscience, Inc. (NASDAQ: PURE)
, creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced Dallas-based AHI Facility Services, Inc. as a regional strategic customer in the contract facilities services market for the PURE Complete Cleaning, Sanitizing and Disinfecting System.

Repligen Corporation (NASDAQ:RGEN)
announced today that midday yesterday, the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA.

Safeguard Scientifics, Inc. (NYSE: SFE)
, a holding company that builds value in growth-stage life sciences and technology companies, today announced that its consolidated net loss for the three months ended March 31, 2012 was $9.7 million, or $0.46 per share, compared with net loss of $9.0 million, or $0.44 per share, for the same period in 2011.

Senomyx, Inc. (NASDAQ:SNMX)
, will release its financial results for the first quarter ended March 31, 2012 on Thursday, May 3, 2012 before the opening of the U.S. financial markets.

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today reported financial results for the three month period ended March 31, 2012.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)
today announced interim data from a prospective, open label survey study evaluating spasticity in patients with relapsing-remitting multiple sclerosis (RRMS) who transitioned to COPAXONE® (glatiramer acetate injection) from interferon-beta treatment.

Verastem, Inc., (NASDAQ: VSTM)
a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will present at the Deutsche Bank 37th Annual Health Care Conference on May 9, 2012, in Boston, MA.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today reported consolidated financial results for the quarter ended March 31, 2012.

Zalicus Inc. (NASDAQ: ZLCS)
provided an update today on its research collaboration with Novartis, based on its combination High Throughput Screening (cHTS) platform.



"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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