ENP Newswire- 22 April 2013. Release date- 19042013- Basel,- Alcon, the global leader in eye care and a division of Novartis, announces US FDA approval for Simbrinza Suspension, indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. 'Alcon is the global leader in providing b
By a News Reporter-Staff News Editor at Respiratory Therapeutics Week- Bayer HealthCare announced that the New Drug Application for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration for the treatment of inoperable chronic thromboembolic pulmonary...
By a News Reporter-Staff News Editor at Pharma Business Week BD Medical, a segment of BD, a leading global medical technology company, announced the commercial launch of a new passive needle guard technology, BD UltraSafe PLUS?. The BD UltraSafe PLUS? Passive Needle Guard has received 510 clearance as an anti-needlestick safety device. This p
RALEIGH, NC and LUGANO, SWITZERLAND 04/22/13 DARA BioSciences, Inc., a specialty pharmaceutical company focused on oncology and oncology supportive care products, and the Swiss pharmaceutical Helsinn Group, a leading player in the cancer supportive care arena, announced today that DARA has reintroduced Gelclair into the U.S. market.
Neuralstem, Inc. announced that it has received approval from the Food and Drug Administration to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder. NSI-189, the lead compound in Neuralstem' s neurogenic small molecule platform, is a proprietary ne
This is how it might pan out: the FDA has sought $4.7 billion. For, a higher budget this fiscal would help the FDA to hire more inspectors. And from drug-makers' perspective, higher FDA staff could mean quicker regulatory clearances.
The Swiss pharmaceutical Helsinn Group, a leading player in the cancer supportive care arena, announced today that DARA BioSciences, Inc., a U.S. specialty pharmaceutical company focused on oncology and oncology supportive care products, has launched Gelclair (R) into the U.S. market. Gelclair (R) is manufactured by the Helsinn Group and is an FDA-
By a News Reporter-Staff News Editor at Pharma Business Week MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced that it has received 510 clearance from the U.S. Food and Drug Administration and European CE mark approval for its new AIR-BAND? Radial Compression Device. AIR-BAND will be commercially available
On April 17, 2013, Neuralstem, Inc. announced that it received approval from the United States Food and Drug Administration to commence a Phase II clinical trial using NSI-566 in the treatment of amyotrophic lateral sclerosis or ALS. On April 18, 2013, the Company announced that CEO and President, Richard Garr, will take part in a comprehensive Bio
By a News Reporter-Staff News Editor at Clinical Trials Week Spencer Trask, a venture capital firm focused on developing big ideas into world-changing companies, congratulates InVivo Therapeutics, for its recent approvals from the U.S. Food and Drug Administration. On the heels of FDA approval for Humanitarian Use Device designation, InVivo has r
DUBLIN, Ireland, April 22, 2013 Warner Chilcott plc today announced that the United States Food and Drug Administration has approved MINASTRIN TM 24 FE for the prevention of pregnancy. MINASTRIN 24 FE is manufactured for Warner Chilcott by a third party. Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women'
Warner Chilcott plc today announced that the United States Food and Drug Administration has approved MINASTRIN^TM 24 FE for the prevention of pregnancy. MINASTRIN 24 FE is manufactured for Warner Chilcott by a third party. The Company does not expect to be in a position to commercially launch MINASTRIN 24 FE during 2013..
FDA Approves New Drug Application NDA for Teva's Quartette? levonorgestrel/ethinyl estradiol and ethinyl estradiol Tablets for the Prevention of Pregnancy. By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has approved Quartette? tabl
MADISON, N.J. and TIGARD, Ore., April 19, 2013/ PRNewswire/ Bausch+ Lomb, the global eye health company and Paragon BioTeck, Inc. today announced that the companies have entered into a license agreement for Bausch+ Lomb to commercialize and distribute Paragon's phenylephrine in the United States on an exclusive basis beginning this month. "This
Alcon, the global leader in eye care and a division of Novartis, announces US FDA approval for Simbrinza (TM) Suspension, indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Elevated IOP is the only modifiable risk factor for glaucoma. "Alcon is the global leader in prov
Release date- 18042013- Abbott Park, Illinois- Abbott today announced that the TECNIS Toric 1- Piece intraocular lens has received U.S. Food and Drug Administration approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism. The average age for the cataract surgery patient in the Unit
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and Listing. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Electronic Submission of Medical Device Registration and Listing" has been approved b
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health Care Professional Survey of Prescription Drug Promotion. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled " Health Care Professional Survey of Prescription Drug Promotion" has been approved by t
Novartis International AG/ Alcon announces FDA approval of Simbrinza (TM) Suspension, a new beta blocker-free, fixed-combination therapy for glaucoma patients. *Simbrinza offers a wide range of treatment possibilities due to its strong efficacy, providing sustained control and a 21%-35% reduction in intraocular pressure,,* Combines Brinzolamide 1.0
-Clinical studies on point-of-care wrist imaging planned at UCLA. "The clearance for our M2 compact wrist MRI system by the FDA is an exciting step for Aspect Imaging. With this FDA clearance, we will begin to provide this system to clinicians interested in diagnostic-quality imaging of the wrist in an affordable, flexible product at a fraction of
Clinical studies on point-of-care wrist imaging planned at UCLA Using this novel compact MRI platform. SALT LAKE CITY, UT, April 19, 2013/ PRNewswire/- Aspect Imaging, the world leading developer of compact high-performance magnets, today announced that the U.S. Food and Drug Administration has cleared the Company's M2? compact MRI system for dia
MADISON, N.J. and TIGARD, Ore., April 19, 2013/ PRNewswire/ Bausch+ Lomb, the global eye health company, and Paragon BioTeck, Inc. today announced that the companies have entered into a license agreement for Bausch+ Lomb to commercialize and distribute Paragon's phenylephrine in the United States on an exclusive basis beginning this month. "This
SHARES in GLAXOSMITHKLINE gained 3.2 per cent yesterday after a US panel recommended approval of new lung drug Breo Ellipta. The inhaled drug to treat smoking-related lung damage has been developed with GSK's partner Theravance. The green light came from an advisory panel to the US Food and Drug Administration.
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 18, 2013.{ nfg} Targacept, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics?, announced it has completed recruitment of patients in the Phase 2 b study of TC-5619 as a treatment for negative symptoms and cognitive dy
Abbott today announced that the TECNIS Toric 1- Piece intraocular lens has received U.S. Food and Drug Administration approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism. The average age for the cataract surgery patient in the United States is approximately 68 years with more t
