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ESMT CA study: Cutting pharmaceutical prices will reduce number of new medications

Cutting pharmaceutical prices will severely reduce the number of new medications making it to market, according to a groundbreaking independent study from ESMT Competition Analysis. For the first time, the study on 'Pharmaceutical Innovation and Pricing Regulation' clearly models and quantifies the direct link between strict regulation and low innovation.

1 Jul 2010

Endo responds to FDA Complete Response letter for FORTESTA NDA

Endo Pharmaceuticals has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.

1 Jul 2010

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Arena Pharmaceuticals, Inc. today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

1 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

pSivida's licensee submits NDA to FDA for Iluvien

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a New Drug Application to the U.S. Food and Drug Administration for Iluvien for Diabetic Macular Edema.

1 Jul 2010

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent, or supportive care.

30 Jun 2010

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.

30 Jun 2010

InNexus develops IXS312 small protein fragment as topical therapy for AMD, diabetic retinal dysplasia

InNexus Biotechnology Inc., a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL™) technology, today announced that it has developed IXS312(VEGF), an antibody fragment with activity against the growth factor VEGF for planned use in ocular treatments.

30 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex® Tablets, a treatment for early breast cancer.

29 Jun 2010

FDA approves Teva's generic Effexor XR antidepressant

Teva Pharmaceutical Industries Ltd. announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.

29 Jun 2010

AFREZZA provides long-term glucose control in Type 2 diabetics: Study

AFREZZA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, as part of a diabetes treatment regimen, provides long-term glucose control comparable to usual insulin therapy but with a significantly reduced incidence of hypoglycemia and less weight gain in patients with Type 2 diabetes, according to a two-year study presented today at the American Diabetes Association's 70th Scientific Sessions.

29 Jun 2010

EpiCept requests FDA priority review of Ceplene NDA for AML

EpiCept Corporation announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission.

29 Jun 2010

FDA's acceptance for filing of DM-1796 NDA triggers $10M milestone payment to Depomed

Depomed, Inc. today announced that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration's acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.

29 Jun 2010

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

Zeria Pharmaceutical announced today positive results of their Japanese Phase III study of Z-338 (acotiamide hydrochloride hydrate; "acotiamide") for the treatment of functional dyspepsia (FD). FD is a gastrointestinal disease comprised of subjective symptoms including postprandial fullness, early satiation and epigastric pain without any organic abnormality on gastrointestinal tract.

28 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

The final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented today by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association. Dr. Rodbard was a principal investigator of this study, which was designed to evaluate the safety and efficacy of VIAject® versus regular human insulin when used in combination with insulin glargine.

28 Jun 2010

Arena's lorcaserin reduces body weight across patient subgroups

Arena Pharmaceuticals, Inc. today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

New Drug Application News and Research

ESMT CA study: Cutting pharmaceutical prices will reduce number of new medications

Endo responds to FDA Complete Response letter for FORTESTA NDA

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

pSivida's licensee submits NDA to FDA for Iluvien

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

InNexus develops IXS312 small protein fragment as topical therapy for AMD, diabetic retinal dysplasia

Alimera submits Iluvien NDA for DME to FDA

Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

FDA approves Teva's generic Effexor XR antidepressant

AFREZZA provides long-term glucose control in Type 2 diabetics: Study

EpiCept requests FDA priority review of Ceplene NDA for AML

FDA's acceptance for filing of DM-1796 NDA triggers $10M milestone payment to Depomed

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

Arena's lorcaserin reduces body weight across patient subgroups

FDA grants orphan drug designation for Chiasma's Octreolin

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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