|Impax Provides an Update on Hayward Facility; Vertex Announces VX-787 Showed Significant Antiviral Activity|
|By Staff and Wire Reports|
|Monday, 04 March 2013 20:28|
Impax Laboratories (NASDAQ: IPXL) announced that the U.S. FDA completed its re-inspection of the Company's Hayward manufacturing facility in connection with the previously disclosed Form 483 issued in March 2012. In addition to the re-inspection, the FDA conducted a Pre-Approval Inspection (PAI) for RYTARYTM, as analytical method validation and a portion of the stability data were generated in Hayward, and a general Good Manufacturing Practices (GMP) inspection. At the conclusion of this inspection, the FDA issued a new Form 483 with twelve (12) observations, three (3) of which are designated as repeat observations from inspections that occurred prior to the Warning Letter.
“We have committed significant resources in our efforts to meet FDA requirements and are clearly disappointed by this news,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “The analytical method assessment observations arose from our internal work and review as a part of the ongoing quality improvement program designed to assess and enhance our Quality Control Laboratory Analytical Methods and to ensure they meet or exceed internal and industry standards. Resolving the FDA concerns remains a top priority and we intend to complete this work as quickly as possible.”
The Company is working diligently to address the observations raised by the FDA and will respond to these new observations within the fifteen (15) business day period from the receipt of the Form 483.
Currently, the Company has not been informed by the FDA of the impact this latest Form 483 will have on the resolution or timing of resolving the warning letter or whether any further regulatory action may be taken as to its manufacturing operations. Until remedial action is complete and the FDA has confirmed compliance with current GMP, approval of pending and new applications listing the Hayward facility as a manufacturing location of finished dosage forms may be withheld.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that treatment with VX-787 in a Phase 2 influenza challenge study resulted in statistically significant improvements in viral and clinical measurements of infection. VX-787 is an investigational new class of medicine for the treatment of influenza and is designed to directly inhibit replication of the virus. The study met its primary endpoint, and showed a statistically significant decrease in the amount of virus in nasal secretions (viral shedding) over the seven-day study period. In addition, at the highest dosing regimen evaluated in the study, there was a statistically significant reduction in the severity and duration of influenza-like symptoms. People in this dose group experienced influenza-like symptoms for a median of 1.9 days, compared to 3.7 days in the placebo group. In addition, 93 percent of people in this dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group. In this study, VX-787 was generally well-tolerated, with no adverse events leading to discontinuation. Based on these data, Vertex will explore collaborative opportunities to support further development of VX-787.
“There is an urgent need for new medicines targeting influenza that work more quickly, address resistant and pandemic strains, and are effective when taken more than two days after symptoms appear,” said Chris Wright, M.D., Ph.D., Vertex's Senior Vice President, Global Medicines Development and Medical Affairs. “Further development of VX-787 may offer an opportunity to address these needs. The data from this proof-of-concept study validate VX-787's new mechanism of action, and underscore its potential to significantly reduce the severity and duration of influenza.”
Alexandria Real Estate Equities, Inc. (NYSE: ARE), the largest and leading owner, operator, and developer of high-quality, sustainable real estate for the broad and diverse life science industry, is pleased to announce that Onyx Pharmaceuticals, Inc., a global commercial-stage oncology company, has executed a 10-year lease with an affiliate of Alexandria for a new, single tenant, ground-up development at 269 East Grand Avenue in South San Francisco.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Cowen and Company 33rd Annual Global Healthcare Conference to be held March 4-6, 2013 at the Marriott Copley Place in Boston. Mr. Adrian Adams, Chief Executive Officer and President, is scheduled to present an overview of the Company and its product pipeline at 11:20 a.m. ET on Wednesday, March 6, 2013.
Biocell Labs Inc., a wholly owned subsidiary of Abattis Bioceuticals Corp. (OTC PINK: ATTBF) (CNSX: FLU), announces the engagement of Dr. Paula Brown to provide the Company with the expertise and assistance needed to expand its capacity into the production of novel bio-pharmaceutical products.
Deaf-Talk, Inc. (PINKSHEETS: MGQG), dba DT Interpreting (DTI) (www.dtinterpreting.com), the industry leader in on-demand video sign language interpreting, today announced that it has entered into a management agreement with Conley & Associates (C&A), a well established medical sales firm.
Depomed, Inc. (NASDAQ: DEPO) announced that NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's (FDA) Reproductive Health Drugs Advisory Committee is meeting this morning to discuss the company's New Drug Application (NDA) for SEFELSA™, Depomed's investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause.
Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the bioenergy, bio-based chemicals, biopharmaceutical and industrial enzyme industries, announced today that its President and CEO, Mark Emalfarb, will be making a presentation at the World Biofuels Markets exhibition at the Beurs-World Trade Center in Rotterdam, The Netherlands during its Advanced Biofuels Session: Transformative Technologies, at 4:00 p.m. local time on March 13, 2013.
The Board of Elan Corporation, plc (NYSE:ELN) (the Company) has approved the decision to initiate a unique cash dividend policy enabling its shareholders to benefit directly from the long term cash flow generated by Tysabri.
iBio, Inc. (NYSE MKT: IBIO) today announced that it has been notified by the NYSE MKT (the "Exchange") Staff that the Company is currently not in compliance with the listing standard set forth in Section 1003(a)(ii) of the NYSE MKT Company Guide.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the Company will release results for its third quarter of Fiscal Year 2013 ended January 31, 2013, prior to the market opening on Thursday March 7, 2013 and will hold a conference call to discuss its financial results at 10 a.m. Eastern Time.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC) announced that the US Patent and Trademark Office (USPTO) has issued a key patent application covering ICT-121, an immunotherapeutic vaccine targeting CD133, an important cancer stem cell marker that is commonly overexpressed on a broad range of solid tumors.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced an underwritten public offering of 5,375,000 of its ordinary shares held by certain of its existing shareholders. Jazz Pharmaceuticals will not receive any proceeds from the sale of ordinary shares by the selling shareholders in the offering, and its total number of ordinary shares outstanding will not change as a result of the offering.
Life Technologies Corporation (NASDAQ: LIFE) announced today that it has signed a collaborative research agreement and related license with Harvard University under which it has acquired exclusive rights to develop a panel of characterization assays designed to rapidly evaluate human pluripotent stem (hPS) cells for their utility in a variety of discovery and translational research applications.
iBio, Inc. (NYSE MKT: IBIO) announced it is proceeding with development of an antibody candidate as a therapeutic against influenza, including highly pathogenic H5N1 strains resistant to drugs such as oseltamivir (marketed as Tamiflu®).
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the Cowen & Company 33rd Annual Health Care Conference on Tuesday, March 5, 2013, at 9:20 a.m. Eastern Time.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will receive an additional potential royalty stream now that the European Commission (EC) has approved Novartis' llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.
SurgiCount Medical, Inc., the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB: PSTX), today announced it is introducing a new proprietary surgical sponge at the upcoming Association of periOperative Registered Nurses (AORN) 60th Congress March 3-7 in San Diego, California.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) announces that it intends to complete a non-brokered private placement of up to 20,000,000 units ("Units") of the Corporation at a price of $0.10 per Unit for gross proceeds of up to $2,000,000 (the "Private Placement").
XenoPort, Inc. (Nasdaq: XNPT) announced today that it will release its fourth quarter financial results on March 11, 2013 at approximately 4:30 p.m. Eastern Time.
Z Trim Holdings, Inc. (OTC Markets: ZTHO), a bio-technology company providing value-added ingredients to a variety of industries, today announced that it recorded, in the month of February 2013, sales growth of 75% over sales in February 2012.