|Emergent BioSolutions up on revised forecast. FDA accepts MannKind's NDA. AspenBio falls on failed test|
|By BioMedReports.com Staff|
|Tuesday, 20 July 2010 18:28|
Below is a list of the companies that made news in the healthcare sector on Tuesday, July 20, 2010.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million. Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010. This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.
On heavy volume Emergent jumped 6.65%, closing todays session at $18.93, up $1.18.
MannKind Corporation (NASDAQ:MNKD) today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind’s resubmission of its New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.
In March 2010, MannKind received a Complete Response letter to its NDA for AFREZZA from the FDA requesting additional information. In response, MannKind has submitted clinical data from a recently completed efficacy study in patients with type 1 diabetes as well as updated pooled safety data related to AFREZZA and information on the comparability of MannKind’s next-generation delivery system to the device that was used in pivotal clinical studies.
"We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA," said Alfred Mann, Chairman and Chief Executive Officer. "We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible."
Shares of MannKind gained 47 cents or 7.5% to close the day at $6.68.
Shares of Aspen BioPharma (Nasdaq: APPY) plunged more than 28% today after the company reported after the close Monday that its AppyScore acute appendicitis test returned a high number of false positives in a clinical trial.
Aspen is currently working on two different versions of the test but said it would no longer seek marketing approval for the version that was involved in the faulty trial. The test works by measuring the amount of protein in the blood. During the clinical trial more protein showed up in the samples making it appear that more patients had appendicitis than actually had the condition.
Shares of Aspen fell 28 cents, nearly 29% to end the day at 69 cents.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), announced today it has signed an exclusive specialty distribution agreement with BioScrip (Nasdaq:BIOS) for its lead product, MuGard -- an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiotherapy and/or chemotherapy. The agreement aligns the Company with comprehensive access to BioScrip's nationwide distribution platform and the ability to leverage the company's extensive physician relationships, 110 BioScrip specialty pharmacies, mail distribution capability and diversified payor network.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine, announces that its Harvard Apparatus / Hugo Sachs Elektronik business collaborated with Dr. Harald Ott and Massachusetts General Hospital (MGH) to design and manufacture a novel bioreactor that was used to grow a functional lung. The lung was subsequently transplanted into a rat. The paper, titled "Regeneration and orthotopic transplantation of a bioartificial lung," was published online in Nature Medicine on July 13, 2010.
"We congratulate Dr. Harald Ott and Massachusetts General Hospital for achieving this major advance in the field of regenerative medicine," said David Green, President of Harvard Bioscience. He continued, "For nearly two years we have been collaborating with Dr. Ott and MGH to develop the sophisticated and novel bioreactor he needed to regenerate the lung. We believe Dr. Ott was the first doctor to achieve transplantation of a regenerated lung and that this achievement marks a milestone in the development of the field of regenerative medicine."
Neogen Corporation (Nasdaq:NEOG) announced today that its net income for its 2010 fiscal year, which ended May 31, increased 26% from the previous year to $17,521,000. Net income in the fiscal year increased to $0.76 per share, compared to the prior year's $0.61, adjusted for a 3-for-2 stock split that was effective Dec. 15, 2009.
Neogen's revenues for its FY 2010 increased 18% to $140,509,000, up from $118,721,000 in the company's previous fiscal year. Both revenues and net income for the 2010 fiscal year established new all-time highs for the 28-year-old company. Neogen's fourth quarter revenues increased 27% on a year-to-year comparison to $39,079,000. Net income in the fourth quarter jumped 36% to $4,634,000 from $3,417,000 in FY 2009, or to $0.20 per share compared to the prior year split-adjusted amount of $0.15 per share.
Seattle Genetics, Inc. (Nasdaq:SGEN) and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.
A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) today announced that it has signed an analytical services contract with BioActif Inc. of Blainville, Québec.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the National Heart, Lung, and Blood Institute (NHLBI) has awarded a $1 million Cardiac Translational Res arch Implementation Program (C-TRIP) grant to support research on Glial Growth Factor 2 (GGF2), a novel investigational agent for the treatment of patients with heart failure under development at Acorda.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, announced today that it has entered into a def nitive purchase agreement with Optimus Capital Partners, LLC d/b/a Optimus Life Sciences Capital Partners, LLC.
BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the second quarter ended June 30, 2010 on Wednesday, August 4, 2010.
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today a nounced its second quarter 2010 results.
Biomoda, Inc. (OTCBB: BMOD) filed a U.S. patent application on a quantitative method for scoring cells labeled with the CyPath® assay to determine whether cells are dysplastic or carcinomic by measuring the photon emission rate.
Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that a groundbreaking discovery regarding potential antiviral applications for the Company's Curaxin family of molecules was pre-published online in the Journal of Virology, the world's leading peer-reviewed journal in the field of virology (Gasparian, Neznanov, et al., Journal of Virology,doi:10.1128/JVI.02569-09; July 14, 2010).
Codexis, Inc. (Nasdaq: CDXS) today announced the company will host a conference call and webcast on Thursday, August 5, 2010 at 4:30 p.m. Eastern Time to discuss its second quarter financial results for the period ended June 30, 2010.
Compugen Ltd. (NASDAQ: CGEN) today announced that it will host a live webcast and conference call at 10:00 AM EDT on Tuesday, July 27, 2010 to review second quarter 2010 results.
Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that George J. Korkos, M.D., D.D.S., F.A.C.S., has been appointed to its board of directors.
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that diluted earnings per share equaled $0.39 in the f rst quarter of fiscal 2011.
Gentiva Health Services, Inc. (Nasdaq: GTIV), a leading provider of home health and hospice services, today reported preliminary operating results for the second quarter ended July 4, 2010.
GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB.OB) announced today that its financial results for the second quarter 2010 will be released on Tuesday, July 27, 2010 followed by a webcast conference call starting at 10:00 a.m. Eastern Time.
Helicos BioSciences Corporation (NASDAQ: HLCS) today announced a publication entitled "Amplification-free digital gene expression profiling from minute cell quantities" appearing on line in Nature Methods co-authored by Dr. Daniel A. Haber and colleagues from Massachusetts General Hospital.
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early detection of cancer, today announced the lau ch of an MRI product suite for breast, prostate, and other organs.
Incyte Corporation (Nasdaq:INCY) announced today that it has scheduled its second quarter 2010 financial results conference call for 8:30 a.m. ET on Thursday, August 5, 2010.
InterMune, Inc. (Nasdaq: ITMN) today announced that it will release second quarter 2010 financial results on Tuesday, July 27, 2010 at 4:00 p.m. Eastern time. A live conference call and webcast will be hosted by InterMune at 4:30 p.m. Eastern time that same day.
International Stem Cell Corporation (OTCBB: ISCO) and Insight Bioventures India Private Limited (IBVI), announced today that they have signed a letter of intent concerning funding and establishment of an Indian affiliate of ISCO (ISCO India).
Johnson & Johnson (NYSE:JNJ) today announced sales of $15.3 billion for the second quarter of 2010, an increase of 0.6% as compared to the second quarter of 2009. Operational results increased 0.1% and the positive impact of currency was 0.5%.
Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.'s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg. According to Wolters Kluwer, U.S. sales of Phentermine Hydrochloride Capsules USP, 30 mg in 2009 were approximately $36.5 million at Average Wholesale Price (AWP).
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) announces that effective today it will have completed the purchase of all the outstanding capital stock of he Bioline group of companies consisting of Bioline Ltd (UK), Bioline GmbH (Germany), Bioline (Aust) Pty Ltd (Australia), Bioline Reagents Ltd, and Bioline USA, Inc for $23.3 million in cash on hand.
Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Tuesday, August 3, 2010, at 8:30 a.m. Eastern Time, to revi w and discuss its financial results for the second quarter 2010.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it has entered into a purchase agreement to sell $3.9 million of its common stock and warrants to an existing institutional investor in a registered public offering.
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, will participate at CDISC Interchange Japan 2010, July 20-23 at the Toshi Center Hotel in Tokyo.
SDIX™ (Strategic Diagnostics Inc. d/b/a SDIX, NASDAQ: SDIX), today announced a multi-year collaboration with Banyan Biomarkers, Inc. to provide products and serv ces for Banyan's biomarker discovery work in the detection of traumatic brain injury (TBI).
SNM Global Holdings (PINKSHEETS: SNMN) announced today the signing of an Intellectual Property (IP) Transfer Agreement with EQ-ip Equities (EQ-ip) under which the Company acquires, for development and international distribution, core Small & Micro Hydro technology from the EQ-ip extensive Intellectual Property Portfolio.
STERIS Corporation (NYSE: STE) today announced that it will issue its fiscal 2011 first quarter earnings before the market opens on August 3, 2010, followed by a conference call at 10:00 a.m. Eastern time.
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that it will report its operating results for the second quarter and first six months of fiscal 2010 on Friday, July 30.
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