|Discovery Reports IND Submission for AEROSURF; Pfizer Receives European Approval For Label Update|
|By Staff and Wire Reports|
|Thursday, 17 October 2013 22:51|
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate its AEROSURF® phase 2 clinical program. The FDA has confirmed receipt of the IND and has indicated that, unless otherwise notified during its review, the Company may initiate the phase 2 clinical program after a 30-day period. Discovery Labs anticipates patient enrollment could begin in the fourth quarter of 2013. The Company will host a conference call this morning at 10:00 AM ET to discuss the AEROSURF program. Conference call details are below.
"The filing of our AEROSURF IND with the FDA represents an important milestone for our Company and a first step towards a potentially transformational medical advancement for the neonatology community and the infants they care for," said John G. Cooper, Chief Executive Officer at Discovery Labs.
AEROSURF is a novel investigational drug-device combination product being developed to deliver Discovery Labs' KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS). AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
"The AEROSURF program is leveraging important advancements in our novel technology platform," said Russell Clayton, DO, Senior Vice President, Research and Development, at Discovery Labs. "Our synthetic KL surfactant technology was recently validated with the FDA approval of SURFAXIN^® for the prevention of RDS in infants at high risk for RDS. We are now combining our KL4 surfactant with our proprietary drug delivery technologies to potentially deliver aerosolized KL surfactant to patients with respiratory disease, with an initial focus on the unmet medical needs in premature infants with RDS."
Conference Call and Webcast Details Discovery Labs will hold a conference call and webcast today at 10:00 AM EDT to discuss the foregoing. A live webcast of the conference call, including a slide presentation, is available at http://bit.ly/17KTf5r and www.discoverylabs.com. An archive of the webcast will be available on Discovery Labs' Investor Relations web site.
Pfizer Inc. (NYSE:PFE) announced the European Commission approved updates to the Summary of Product Characteristics (SmPC) for the company’s pneumococcal conjugate vaccine Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), regarding its use in certain populations at high risk of pneumococcal disease. The updated label now includes information describing the use of the vaccine in preterm infants, children and adolescents with sickle cell disease who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adults with human immunodeficiency virus (HIV) infection who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine.1
“People with conditions that compromise the immune system, such as HIV, those with sickle cell disease, and infants born prematurely are all at an increased risk of pneumococcal disease,2,3,4,5,6” said Luis Jodar, Ph.D., vice president, Vaccines, Global Medicines Development Group and Scientific Affairs, Pfizer. “The Prevenar 13 label in the European Union now includes important information about appropriate use of the vaccine for the prevention of pneumococcal disease for health care professionals who care for these patients.1”
The decision to approve the SmPC for Prevenar 13 followed the European Medicines Agency’s review of data submitted by Pfizer from several studies assessing immunogenicity and safety of vaccination with Prevenar 13 in these three risk groups.7,8,9 These data are under review by the U.S. Food and Drug Administration.
Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the third quarter ended September 30, 2013.
Amgen (NASDAQ: AMGN) today announced that it will report its third quarter financial results on Tuesday, Oct. 22, 2013, after the close of the U.S. financial markets.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based electronic health record (EHR), practice management, and care coordination services to medical groups and health systems, today announced financial and operational results for the third quarter of fiscal year 2013.
Cepheid (Nasdaq: CPHD) today reported revenues for the third quarter of 2013 of $100.1 million, representing growth of 24% from $80.5 million for the third quarter of 2012.
iMedicor (OTC Pink: VMCI) is pleased to announce that it has signed Ranger Networks to a reseller agreement to help penetrate the medical community with iMedicor's unique core product the iCore Exchange. The iCore Exchange is an interoperable, HIPAA-compliant exchange network where customers can send and receive secure emails within a HIPAA-compliant environment, as well as secure instant messaging and the ability to communicate with professionals outside the network with NwHIN Direct Protocol.
Intuitive Surgical, Inc. (Nasdaq:ISRG), the industry leader in robotic-assisted surgery, today reported third quarter of 2013 revenue of $499 million, down approximately 7% compared with $538 million for the third quarter of 2012.
Masimo (NASDAQ: MASI) announced today that four new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented at the largest gathering of anesthesiologists in the world, the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco.
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Food and Drug Administration ("FDA") has rescheduled its meeting with the Company to take place on October 28, 2013.
Omeros Corporation (NASDAQ: OMER) today announced that it has filed a replacement universal shelf registration statement (the "2013 Registration Statement") with the Securities and Exchange Commission (the "SEC").
SK3 Group, Inc.'s (OTC Pink: SKTO) Medical Greens announces the development of a new delivery system for large doses of phyto-cannabinoids, as used in the "Simpson" therapy, and a new licensed product line utilizing this delivery system.
Vaccinogen, Inc. (OTCQB:VGEN), a cancer vaccine company, today announced that it received notification from the U.S. Securities and Exchange Commission ("SEC") stating that the SEC had completed its review of the Company's Form 10 registration statement, effectively clearing comments with the SEC.