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Kingfisher Healthcare (KFH) Receives FDA Clearance to Market KFH Energy in the USA And Raises EUR1 Million to Accelerate Market Penetration

Galderma Completes Acquisition of CollaGenex

ES Vascular Receives CE Mark for its First Aortic Stapler for End-to-End Anastomosis Between Synthetic Grafts and Aorta During Open Repair of Aortic Aneurysmal and Occlusive Disease

FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

Duska Therapeutics Plans 505(b) (2) NDA Filing Route for ATPace(TM)

More recent news

Simbionix Launches Innovative Patient-Specific Simulation
3rd October 2008 CLEVELAND, Ohio, October 3 /PRNewswire/ -- Simbionix, the world's leading developer of medical simulation systems, advances procedural simulation from theoretical promise to operating room reality. ...

ITGI Medical Received a CE Mark for its Second Pericardium Covered Stent - AneuGraft(R) - for Tortuous Vessels
30th September 2008 OR AKIVA, Israel, September 30 /PRNewswire/ -- ITGI Medical, Ltd. (TASE: ITGI) a company engaged with research, development, manufacturing and marketing of heterologous tissue covered stents,...

Sun Pharmaceutical Announces USFDA Approval to Market Generic Paraplatin(R) Injection
23rd September 2008 MUMBAI, India, September 23 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for the Abbreviated New Drug Application (ANDA) to market...

Sun Pharma Gets USFDA Approval for Generic Fosamax (R) Tablets
12th September 2008 MUMBAI, India, September 12 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for...

Positive SPA Reply From the FDA for TopoTarget's Pivotal Trial With Belinostat in PTCL
5th September 2008 COPENHAGEN, Denmark, September 5 /PRNewswire/ -- TopoTarget A/S (OMX: TOPO) announced that a positive reply from the FDA was received on a Special Protocol Assessment (SPA) for a phase III trial...

Neurotech Granted Fast Track Designations from the FDA for NT-501 in Two Indications - Retinitis Pigmentosa and Dry Age-Related Macular Degeneration
3rd September 2008 LINCOLN, Rhode Island, September 3 /PRNewswire/ -- Neurotech Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of sight-saving therapeutics for chronic...

Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA
27th August 2008 SAN DIEGO and INDIANAPOLIS, August 27 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call today provided context and...

Cambridge Laboratories Announces FDA Approval of XENAZINE(R) (tetrabenazine) in the US
18th August 2008 LONDON, August 18 /PRNewswire/ -- Cambridge Laboratories Group Limited ("Cambridge"), the privately owned specialty pharmaceutical company, announces today that XENAZINE(R) (tetrabenazine), the first...

Sun Pharma Gets USFDA Approval for Generic Depakote (R) Delayed Release Tablets
30th July 2008 MUMBAI, July 30 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for generic Depakote (R),...

Successful Inspection of Helsinn Birex Pharmaceuticals Dublin, Ireland by the US Food and Drug Administration
22nd July 2008 DUBLIN, Ireland, July 22 /PRNewswire/ -- Helsinn is pleased to announce that Helsinn Birex Pharmaceuticals, its drug facility in Dublin, Ireland, has undergone a successful inspection by the US Food...

Inion Receives 510(k) Marketing Clearance to Sell its Biodegradable Graft Containment Systems in the USA for Spinal Fusion Procedures
21st July 2008 TAMPERE, Finland and GUILDFORD, England, July 21 /PRNewswire/ -- Inion (LSE: IIN), the company focused on the development and commercialisation of novel biodegradable medical implants, today...

Bioheart, Inc. to Introduce At-Home Heart Failure Monitor for Congestive Heart Failure Patients
11th July 2008 SUNRISE, Florida, July 11 /PRNewswire/ -- Bioheart, Inc. (Nasdaq: BHRT), a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and...

FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent
2nd July 2008 ABBOTT PARK, Illinois, July 2 /PRNewswire/ -- Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for...

Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System
26th June 2008 PRINCETON, New Jersey, June 26 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities...

FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics' Unique Proprietary Chemistry
25th June 2008 LONDON, June 25 /PRNewswire/ -- Silence Therapeutics plc (London AIM: SLN) today announces that the U.S. Food and Drug Administration (FDA) has approved a Quark Pharmaceuticals Inc ("Quark")...

Stallergenes : Sublingual Desensitisation Tablets Oralair Grasses Approved in Germany
24th June 2008 ANTONY, France, June 24 /PRNewswire/ -- Today, Stallergenes has been granted with the marketing authorisation for its sublingual desensitisation tablet, Oralair(R) Grasses in adults, by PEI (Paul...

Merck Serono Announces Initiation of Second Phase II/III Clinical Study of Atacicept in Lupus
5th June 2008 GENEVA, Switzerland, June 5 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its development partner ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today the initiation of...

Simbionix Takes Non-Invasive GYN Surgical Training to the Next Level
2nd June 2008 CLEVELAND, Ohio, June 2 /PRNewswire/ -- Simbionix has announced the release of a new and exciting module for its LAP Mentor simulator that gives trainees hands-on experience with different techniques...

Over and Under(R) Pericardium Covered Stent is now in use in England and Proves Great Deliverability
2nd June 2008 OR AKIVA, Israel, June 2 /PRNewswire/ -- ITGI Medical, Ltd. (TASE: ITGI) announced today the first commercial use of the CE certified Over and Under(R) Pericardium Covered Stent (PCS) in the UK ...

First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA
29th May 2008 EDMONTON, Canada, May 29 /PRNewswire/ -- The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced today that, based on its study BCIRG 006,...

Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers
29th May 2008 COLLEGEVILLE, Pennsylvania, May 29 /PRNewswire/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast...

FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
28th May 2008 TIRAT CARMEL, Israel, May 28 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy...

Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
19th May 2008 PRINCETON, New Jersey, May 19 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) has nominated PSI-7851 as a lead development candidate for the treatment of chronic hepatitis C virus (HCV). PSI-7851 is...

Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension
15th May 2008 APPENZELL, Switzerland, May 15 /PRNewswire/ -- Ergonex Pharma today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the...

FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
12th May 2008 ST. DAVID'S, Bermuda and COPENHAGEN, Denmark, May 12 /PRNewswire/ -- Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration (FDA) has approved the New Drug...

Duska Therapeutics Plans 505(b) (2) NDA Filing Route for ATPace(TM)
25th April 2008 LA JOLLA, California, April 25 /PRNewswire/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska" or the "Company"), a biotechnology company developing medical products based on adenosine...

FDA Clears First Medical Product Made From Yulex(R) Natural Rubber
24th April 2008 MARICOPA, Arizona, April 24 /PRNewswire/ -- Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug...

FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
23rd April 2008 BASINGSTOKE, England and PHILADELPHIA, April 23 /PRNewswire/ -- Shire plc (LSE: SHP) (NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval...

ES Vascular Receives CE Mark for its First Aortic Stapler for End-to-End Anastomosis Between Synthetic Grafts and Aorta During Open Repair of Aortic Aneurysmal and Occlusive Disease
14th April 2008 HAIFA, Israel, April 14 /PRNewswire/ -- ES Vascular Ltd. announced today that it has received a CE Mark approval for its Open Aortic Stapler (OAS) system for mechanical suturing technology of aortic...

Galderma Completes Acquisition of CollaGenex
11th April 2008 LAUSANNE, Switzerland, April 11 /PRNewswire/ -- Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, today announced that its U.S. holding company,...

Kingfisher Healthcare (KFH) Receives FDA Clearance to Market KFH Energy in the USA And Raises EUR1 Million to Accelerate Market Penetration
31st March 2008 LEUVEN, Belgium, March 31 /PRNewswire/ -- Kingfisher Healthcare, a young healthcare company focused on improving patient quality of life, announced today that the U.S. Food and Drug Administration...