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Matrix receives FDA's tentative approval for novel co-packaged version of HIV/AIDS therapy

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg.

21 Sep 2011

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

Santarus, Inc., a specialty biopharmaceutical company, today announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis.

20 Sep 2011

FDA approves Amphastar's ANDA for Enoxaparin Sodium Injection

Watson Pharmaceuticals, Inc. today announced that Amphastar Pharmaceuticals, Inc., has received U.S. Food and Drug Administration approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection in the 100mg/mL and 150mg/mL strengths.

20 Sep 2011

Keryx completes enrollment in Zerenex Phase 3 long-term study for hyperphosphatemia

Keryx Biopharmaceuticals today announced completion of patient enrollment in the long-term study component of its Phase 3 registration program of Zerenex, the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

20 Sep 2011

NanoViricides acquires light industrial building for laboratory facilities and cGMP production

NanoViricides, Inc. announced that Inno-Haven LLC has completed acquisition of a light industrial building. The Company anticipates that it will be leasing a portion of this space, in the near future, for laboratory facilities and cGMP production of its nanoviricides® drug candidates against various viral diseases.

19 Sep 2011

Tarsa reports positive data from OSTORA Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

19 Sep 2011

Positive data from Tarsa's OSTORA Phase III trial on postmenopausal osteoporosis

Tarsa Therapeutics today presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA-, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

19 Sep 2011

ODAC recommends ApoPharma's Ferriprox for FDA approval to treat transfusional iron overload

ApoPharma Inc. today announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10 - 2 to recommend that the FDA grant accelerated approval of Ferriprox (deferiprone), an oral iron chelator, for the treatment of patients with transfusional iron overload when current chelation therapy is inadequate.

15 Sep 2011

Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

Kremers Urban Pharmaceuticals Inc. is pleased to announce that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product, for which Concerta is the reference listed drug product. The ANDA is currently under review with FDA.

14 Sep 2011

Impax confirms JALYN patent challenge

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in connection with JALYN capsules.

13 Sep 2011

BioSante reports top-line results from LibiGel PK study for HSDD in postmenopausal women

BioSante Pharmaceuticals, Inc., today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study.

12 Sep 2011

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking sales and marketing approval for vismodegib to treat people with advanced basal cell carcinoma (BCC), which includes metastatic and locally advanced BCC for whom surgery is inappropriate.

12 Sep 2011

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

Genentech, a member of the Roche Group, today announced that the company has submitted a New Drug Application for vismodegib to the U.S. Food and Drug Administration (FDA) for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.

12 Sep 2011

EpiCept announces FDA's feedback on Ceplene clinical development for AML

EpiCept Corporation today announced that at a recent meeting with the U.S. Food and Drug Administration (FDA) the Company was provided more definitive guidance regarding the clinical development of Ceplene, the Company's lead product administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission.

12 Sep 2011

Diamyd receives NIH grant to develop NTDDS for Chemotherapy Induced Peripheral Neuropathy

Diamyd Medical AB with collaborators has received a three million dollar grant from the US National Institutes of Health to develop the Company's patented Nerve Targeting Drug Delivery System (NTDDS) for prevention of Chemotherapy Induced Peripheral Neuropathy.

12 Sep 2011

FDA grants final approval for Mylan's Promethazine HCl Tablets

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 Promethazine Hydrochloride (HCl) Tablets USP, 12.5 mg, 25 mg and 50 mg. Promethazine HCl Tablets are used to relieve the symptoms of certain allergic reactions, such as perennial and seasonal allergic rhinitis.

9 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.

6 Sep 2011

Discovery Labs files Complete Response to FDA for SURFAXIN to treat RDS in premature infants

Discovery Labs, Inc. today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the U.S. Food and Drug Administration (FDA) for SURFAXIN(lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.

6 Sep 2011

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

DURECT Corporation announced today the dosing of the last patient in the U.S. pivotal Phase III clinical study for POSIDUR known as BESST.

6 Sep 2011

New Drug Application News and Research

Matrix receives FDA's tentative approval for novel co-packaged version of HIV/AIDS therapy

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

FDA approves Amphastar's ANDA for Enoxaparin Sodium Injection

Keryx completes enrollment in Zerenex Phase 3 long-term study for hyperphosphatemia

NanoViricides acquires light industrial building for laboratory facilities and cGMP production

Tarsa reports positive data from OSTORA Phase III ORACAL trial for postmenopausal osteoporosis

Positive data from Tarsa's OSTORA Phase III trial on postmenopausal osteoporosis

ODAC recommends ApoPharma's Ferriprox for FDA approval to treat transfusional iron overload

Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

Impax confirms JALYN patent challenge

BioSante reports top-line results from LibiGel PK study for HSDD in postmenopausal women

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

EpiCept announces FDA's feedback on Ceplene clinical development for AML

Diamyd receives NIH grant to develop NTDDS for Chemotherapy Induced Peripheral Neuropathy

FDA grants final approval for Mylan's Promethazine HCl Tablets

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

Discovery Labs files Complete Response to FDA for SURFAXIN to treat RDS in premature infants

Enrollment complete in DURECT's POSIDUR Phase III study for post-surgical pain

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