New Drug Application News and Research

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FDA accepts EffRx NDA for EX101 to treat osteoporosis

EffRx Pharmaceuticals SA, an Epalinges/Lausanne, Switzerland based drug delivery company announces that the New Drug Application for the company's lead development program EX101 has been accepted for filing by the US Food and Drug Administration.

12 May 2011

FDA accepts Insys NDA for Fentanyl SL Spray to treat breakthrough cancer pain

Insys Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Fentanyl SL Spray. The FDA will notify Insys of its PDUFA date in the 74-day letter which is expected in the upcoming weeks.

12 May 2011

Pacira Pharmaceuticals reports net loss of $9.8 million for first quarter 2011

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL, and reiterated 2011 financial guidance.

11 May 2011

Impax Pharmaceuticals initiates IPX159 Phase I study in Restless Legs Syndrome

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., announced the successful filing of an Investigational New Drug Application for IPX159 in Restless Legs Syndrome and initiated a Phase I study.

11 May 2011

Genentech submits vemurafenib NDA for BRAF V600 mutation-positive metastatic melanoma

Genentech, a member of the Roche Group, today announced that the company submitted a New Drug Application for vemurafenib to the U.S. Food and Drug Administration for people with BRAF V600 mutation-positive metastatic melanoma, and that Roche submitted a Marketing Authorization Application to the European Medicines Agency for vemurafenib in the same indication.

11 May 2011

Independent investigator begins pump trial of Biodel's two ultra-rapid human insulin formulations

Biodel Inc. announced today that an independent investigator initiated a pump trial of Biodel's two ultra-rapid-acting formulations of recombinant human insulin.

10 May 2011

Inspire reports net loss of $17.6 million for first quarter 2011

Inspire Pharmaceuticals, Inc. announced today financial results for the first quarter ended March 31, 2011, reporting a net loss of $17.6 million or per common share, as compared to a net loss of $14.8 million, or per common share, for the same period in 2010.

10 May 2011

Unigene first quarter net loss decreases 58% to $6.6 million

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced first quarter financial results for the period ended March 31, 2011. The Company highlighted significant progress achieved in the first quarter with the execution of its turnaround strategy.

9 May 2011

Antares Pharma first quarter total revenues increase to $3.6 million

Antares Pharma, Inc. today reported financial and operating results for the first quarter ended March 31, 2011.

9 May 2011

Pacira to present EXPAREL data in postsurgical pain at two medical meetings

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that clinical and preclinical data highlighting the safety and efficacy of EXPAREL™ will be presented at two medical meetings.

6 May 2011

POZEN reports revenue of $4.5 million for first quarter 2011

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the first quarter ended March 31, 2011.

5 May 2011

ZIOPHARM reports net loss of $39.0 million for first quarter 2011

ZIOPHARM Oncology, Inc, an oncology small molecule and synthetic biology drug development company, today reported its financial results for the three months ended March 31, 2011, and provided an update on the Company's activities in the first quarter.

5 May 2011

Columbia Laboratories net revenues increase 74% to $12.5 million

Columbia Laboratories, Inc. today reported financial results for the three-month period ended March 31, 2011.

5 May 2011

FTC, FDA take action on unproven STD drug products

The U.S. Food and Drug Administration and the Federal Trade Commission today announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases.

4 May 2011

pSivida presents data of ILUVIEN Phase 3 trial in Diabetic Macular Edema at ARVO 2011

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the presentation of new data from the completed 36-month FAME Study of ILUVIEN for the treatment of Diabetic Macular Edema at the 2011 ARVO Annual Meeting.

4 May 2011

Top-line results from Lymphoseek NEO3-09 Phase 3 study in breast cancer, melanoma

Neoprobe Corporation, a diversified developer of innovative oncology diagnostic products, today announced top-line results from its Lymphoseek NEO3-09 study.

4 May 2011

CTI to re-submit pixantrone NDA to FDA's Office of New Drugs for re-review

Cell Therapeutics, today announced that the Office of New Drugs of the U.S. Food and Drug Administration after carefully reviewing the materials CTI submitted in support of its appeal, the reviews of the New Drug Application for pixantrone prepared by the FDA staff, the transcript of the March 22, 2010 Oncology Drugs Advisory Committee meeting and consulting with the Center for Drug Evaluation and Research's Deputy Director of Clinical Science and the Office of Biostatistics, concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved.

3 May 2011

Merck's Phase III study shows efficacy results of tafluprost to treat ocular hypertension

Merck, known as MSD outside the United States and Canada, announced today that new Phase III data showed that patients with open-angle glaucoma or ocular hypertension, who were dosed once-daily with tafluprost, Merck's investigational, preservative-free prostaglandin analogue ophthalmic solution, experienced a reduction in intraocular pressure comparable to patients taking twice-daily preservative-free timolol maleate, a beta-adrenergic antagonist.

3 May 2011

FDA approves Perrigo's Minoxidil Foam, a generic version of Men's Rogaine Foam

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter Minoxidil Foam, a generic version of Men's Rogaine Foam.

3 May 2011

Watson introduces generic version of Concerta

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., has launched an authorized generic version of Concerta as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc.

2 May 2011