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USPTO grants Collegium second patent for tamper-resistant DETERx formulation platform

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that a new patent has been issued by the U.S. Patent and Trademark Office (USPTO) relating to its tamper-resistant DETERx™ formulation platform. US Patent Number 7,771,707 contains claims that cover Collegium's proprietary extended-release formulations, which are designed to resist dose dumping when subjected to a variety of physical methods of tampering.

18 Aug 2010

Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

Cumberland Pharmaceuticals Inc. ,a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announces financial results for the second quarter ending June 30, 2010, and provides revenue guidance for full year 2010.

17 Aug 2010

A.P. Pharma second quarter 2010 net loss decreases to $0.09 per share

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2010.“We are working expeditiously to complete the work needed to prepare for a meeting with the FDA. Once the necessary information is available, we will request an End of Review meeting to discuss the next steps for the APF530 New Drug Application.”

16 Aug 2010

KemPharm receives patent for LAT prodrug technology for Attention Deficit – Hyperactivity Disorder treatment

KemPharm, Inc. announced today that it has received a Notice of Issuance from the United States Patent and Trademark Office (USPTO) for its patent application entitled "Polar Hydrophilic Prodrugs of Amphetamine and Other Stimulants and Processes for Making and Using the Same", U.S. Patent No. 7,772,222. This patent protects broad aspects of the Company's core Ligand Activated Therapy (LAT) prodrug technology platform and its application to the treatment of Attention Deficit – Hyperactivity Disorder.

16 Aug 2010

Adeona reports $979,782 net income for second-quarter 2010 vs. $879,550 net loss for same period in 2009

Adeona Pharmaceuticals, Inc. announced its second quarter 2010 financial results and recent achievements.

16 Aug 2010

Neurologix second-quarter net loss increases to $4.5 million

Neurologix, Inc., a biotechnology company developing innovative gene therapies for the brain and central nervous system, today reported its financial results for the three and six months ended June 30, 2010.

13 Aug 2010

BioSante second-quarter net loss increases to $10.8 million

BioSante Pharmaceuticals, Inc. today announced its financial results for the second quarter of 2010.

13 Aug 2010

Alimera Sciences second-quarter net loss decreases to $4.8 million

Alimera Sciences, Inc., today announced financial results for the second quarter ended June 30, 2010 and provided an update on progress toward achieving its 2010 goals.

13 Aug 2010

Antares Pharma second-quarter total revenue increases 78% to $3.1 million

Antares Pharma, Inc. today reported financial and operating results for the second quarter ended June 30, 2010.

13 Aug 2010

FDA grants LifeCycle Pharma SPA for LCP-Tacro pivotal Phase 3 study in 'de novo' kidney transplant patients

LifeCycle Pharma A/S today announced receipt of agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment of its pivotal Phase 3 study, Study 3002, for LCP-Tacro in patients, who have just received a kidney transplant.

12 Aug 2010

Gentium second-quarter total revenues increase to EUR 7.55 million

Gentium S.p.A. today reported financial results for the first half of 2010 and for the quarter ended June 30, 2010. The Company reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency.

12 Aug 2010

Perrigo fourth-quarter fiscal 2010 net sales up 22%

Perrigo Company today announced results for its fourth quarter and full year ended June 26, 2010.

12 Aug 2010

FDA grants BioMimetic Therapeutics orphan drug designation for rhPDGF-BB in treatment of OCD

BioMimetic Therapeutics, Inc. today announced that it has received orphan drug designation from the Food and Drug Administration for its protein therapeutic, recombinant human platelet derived growth factor, to be used in conjunction with autograft and/or commercially available osteochondral allograft for the treatment of osteochondritis dissecans of the knee, elbow or ankle.

12 Aug 2010

Depomed announces SPA agreement with FDA for Serada Phase 3 trial for menopausal hot flashes

Depomed, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design and analysis of Breeze 3, a Phase 3 trial evaluating Serada® (extended release gabapentin tablets) for menopausal hot flashes.

11 Aug 2010

Tamir Biotechnology's three compounds effective show potential for yellow fever

Tamir Biotechnology, Inc.(formerly Alfacell Corporation) announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that testing of three of our company's compounds showed in vitro results rarely seen before by the U.S. government for yellow fever.

11 Aug 2010

Jazz Pharmaceuticals second-quarter net product sales increase 49% to $39.5 million

Jazz Pharmaceuticals, Inc. announced financial results for the second quarter ended June 30, 2010 and updated financial guidance for 2010. The company's updated financial guidance reflects higher expected sales of XYREM® (sodium oxybate) and the effects of recent financing activities.

11 Aug 2010

Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of its novel once-daily oral antibiotic Restanza to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.

11 Aug 2010

Noven enters agreement to acquire global rights to ADHD drug Daytrana from Shire

Noven Pharmaceuticals, Inc. today announced that it has entered into a Product and Trademark Acquisition Agreement with affiliates of Shire plc pursuant to which Noven will acquire global rights to Daytrana® (methylphenidate transdermal system) from Shire.

11 Aug 2010

Vertex reports results from Phase 3 ILLUMINATE study of telaprevir-based therapy for hepatitis C

Vertex Pharmaceuticals Incorporated today announced results from the Phase 3 ILLUMINATE study, which was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus (HCV) was undetectable at weeks 4 and 12 of treatment (extended rapid viral response or eRVR).

10 Aug 2010

Inhibitex reports net loss of $5.6 million for second-quarter 2010

Inhibitex, Inc. today announced its financial results for the second quarter ended June 30, 2010.

10 Aug 2010

New Drug Application News and Research

USPTO grants Collegium second patent for tamper-resistant DETERx formulation platform

Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

A.P. Pharma second quarter 2010 net loss decreases to $0.09 per share

KemPharm receives patent for LAT prodrug technology for Attention Deficit – Hyperactivity Disorder treatment

Adeona reports $979,782 net income for second-quarter 2010 vs. $879,550 net loss for same period in 2009

Neurologix second-quarter net loss increases to $4.5 million

BioSante second-quarter net loss increases to $10.8 million

Alimera Sciences second-quarter net loss decreases to $4.8 million

Antares Pharma second-quarter total revenue increases 78% to $3.1 million

FDA grants LifeCycle Pharma SPA for LCP-Tacro pivotal Phase 3 study in 'de novo' kidney transplant patients

Gentium second-quarter total revenues increase to EUR 7.55 million

Perrigo fourth-quarter fiscal 2010 net sales up 22%

FDA grants BioMimetic Therapeutics orphan drug designation for rhPDGF-BB in treatment of OCD

Depomed announces SPA agreement with FDA for Serada Phase 3 trial for menopausal hot flashes

Tamir Biotechnology's three compounds effective show potential for yellow fever

Jazz Pharmaceuticals second-quarter net product sales increase 49% to $39.5 million

Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

Noven enters agreement to acquire global rights to ADHD drug Daytrana from Shire

Vertex reports results from Phase 3 ILLUMINATE study of telaprevir-based therapy for hepatitis C

Inhibitex reports net loss of $5.6 million for second-quarter 2010

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