European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
SEATTLE, July 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it had requested and the EMEA has agreed to an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA) in September, 2009 extending the review for the C...
United States Patent and Trademark Office Accepts CoolTouch's Re-examination Request for Cynosure '873 Patent
On May 22, 2009 the United States Patent & Trademark Office (USPTO) accepted CoolTouch's request
to re-examine the '873 Paolini laser lipolysis patent based on prior art by Dr. David Apfelberg and Mr. David Hennings.
Roseville, CA (PRWEB) June 2, 2009 -- On May 22,...
CoolTouch Inc. Settles Diomed Lawsuit, Files Re-examination Request for Cynosure '873 Patent
ROSEVILLE, Calif., April 13 /PRNewswire/ -- On April 7, 2009, the Boston District Court dismissed the "Diomed" lawsuit between Endolaser Associates, LLC and CoolTouch Inc. after CoolTouch signed a settlement agreement with Dr. Luis Navarro. This patent infringement suit was originally filed in ...
Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission
PLEASANTON, Calif., FRAMINGHAM, Mass. and SYDNEY, Australia, March 26 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, and HeartWare International, Inc. (Nasdaq: HTWR...
President's 2010 Budget Request Strongly Supports VA Programs
Funding Plan Improves Access, Modernizes Technology
WASHINGTON, Feb. 26 /PRNewswire-USNewswire/ -- President Obama's first proposed budget for the Department of Veterans Affairs (VA) expands eligibility for health care to an additional 500,000 deserving Veterans over the next five years, meet...
Medicsight PLC Receives Additional Information Request for FDA 510(k) Clearance
NEW YORK, Jan. 20 /PRNewswire-FirstCall/ -- Medicsight PLC, a subsidiary of MGT Capital Investments, Inc. (NYSE-A: MGT), and an industry leader in the development of Computer-Aided Detection (CAD) and image analysis software, which assists radiologists in the early detection of disease, announces ...
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Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
FDA Requests Enhancements to Risk Mitigation Strategies Consistent with Company's Recommendations
FRAZER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) announced today receipt of a complete response letter from the Food
and Drug Administration (FDA...
FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.
Agency Approves Expansion of Company's Phase 3 Study for Wet AMD after 90-day Review of Safety Data
FREMONT, Calif., April 17 /PRNewswire/ -- NeoVista, Inc. announced
today that the U.S. Food and Drug Administration (FDA) has granted the
to expand the nu...
Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
...scal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov , www.jnj.com or on request
from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertake to update any forward-looking statements as a result of new informatio...
FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
...sult in agreement in time to meet the PDUFA date.
The FDA did not identify safety concerns regarding INTUNIV in the
Complete Response letter or request
new clinical studies. Shire and the FDA
will continue to work together to resolve the remaining labeling language
over the next 4 to 8 weeks.
NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study
... risks and uncertainties, including, but not limited to; positive results in clinical trials may not be sufficient to obtain FDA approval; the FDA may request
additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ...
Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
... fiscal year ended December 31, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request
from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events o...
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Espion Visual Electrophysiology System
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NASA responds to California wildfire emergency imaging request
WASHINGTON -- A remotely piloted aircraft carrying a NASA sensor flew over much of California earlier this week, gathering information that will be used to help fight more than 300 wildfires burning within the state. Additional flights are planned for next week.
The flights by NASA's unmanned ...
High-tech vehicle design boosts emergency rescue capacity
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World Day to Combat Desertification focuses on human security
...n 8500 satellite-based products free of charge to African researchers working on water-related research activities and management projects.
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Comprehensive cardiogenetic testing for families of sudden unexplained death victims can save lives
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Conservationists seek to identify prime stopover sites for migrating birds
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UC Davis launches 'One Health' care for wild mountain gorillas and human neighbors
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Nasdaq Panel Grants Advanced Life Sciences Request for Continued Listing on Nasdaq Stock Market
CHICAGO, Feb. 5 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), today announced that on February 2, 2009 it received a letter from the Nasdaq Listing Qualifications Panel (the "Panel") informing the Company that the Panel has determined to grant the Company's r...
Cell Therapeutics to Request a Hearing With NASDAQ Following Receipt of Staff Determination Letter
SEATTLE, Oct. 10 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced today that the Company intends to
request a hearing with the NASDAQ Listing Qualifications Panel to present a
plan for regaining compliance with NASDAQ Marketplace Rule 4450(b)(1)(A),
Nasdaq Grants VirtualScopics' Request for Continued Listing
Extension until February 3, 2009 to meet continued listing criteria
ROCHESTER, N.Y., Oct. 9 /PRNewswire-FirstCall/ -- VirtualScopics, Inc.
(Nasdaq: VSCP ) today announced that the Nasdaq Hearings Panel has granted
the Company's request
to remain listed on the Nasdaq Capital Market and has
PharmAthene Response to DHHS Request for Proposals for Recombinant Protective Antigen Anthrax Vaccine Deemed Technically Acceptable and Within Competitive Range for Procurement Consideration
ANNAPOLIS, Md., Sept. 15 /PRNewswire-FirstCall/ -- PharmAthene, Inc.
(Amex: PIP ) a biodefense company specializing in the development and
commercialization of medical countermeasures against chemical and
biological threats, announced today that it has received notification from
Insmed to Request Hearing Before NASDAQ Panel to Review NASDAQ Staff Determination
RICHMOND, Va., June 20 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq:
INSM), a developer of follow-on biologics and biopharmaceuticals, today
announced that it intends to request
a hearing before The NASDAQ Listing
Qualifications Panel ('the Panel") to appeal an earlier Staff Determination
United States Patent Office Grants CryoCor's Request for Patent Interference
CryoCor Named Senior Party in Interference
SAN DIEGO, Feb. 13 /PRNewswire-FirstCall/ -- CryoCor, Inc. (Nasdaq:
CRYO), a medical device company focused on the treatment of cardiac
arrhythmias, announced today that the United States Patent and Trademark
Office (USPTO) has declared...
Request in Biological Products
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