New Drug Application News and Research

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Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid

Immune Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for its first in class lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP).

7 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute and breakthrough pain, today announced the initiation of an open-label Phase 3 study (SAP302) of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury.

6 Oct 2015

FDA accepts Braeburn's resubmission of Probuphine NDA for review

Braeburn Pharmaceuticals, an Apple Tree Partners company, today announced that the U.S. Food and Drug Administration has accepted Braeburn's resubmission of the Probuphine New Drug Application (NDA) for review and set February 27, 2016 as the target date for Agency action.

28 Sep 2015

Mylan releases generic version of Invega in the U.S.

Mylan N.V. today announced the U.S. launch of Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg, the generic version of Janssen's Invega.

28 Sep 2015

Kolltan announces presentation of data from KTN0158 preclinical study in mast cell tumors at ESMO 2015

Kolltan Pharmaceuticals, Inc. today announced the presentation of data from a preclinical study evaluating KTN0158 in dogs with spontaneous mast cell tumors. KTN0158 is a proprietary, humanized anti-KIT IgG1 monoclonal antibody drug candidate being developed as a potential therapy for cancer and mast cell-related diseases.

28 Sep 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration approved the new drug application for Tresiba (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba provides a long duration of action beyond 42 hours.

From Novo Nordisk 26 Sep 2015

Study explores effectiveness of frontline treatments for couples with unexplained infertility

A breast cancer drug with promise for improving the chance that couples with unexplained infertility can have a baby without increasing their risk of multiple births apparently does not deliver, according to a comparative study.

24 Sep 2015

FDA approves Impax Laboratories' generic version of Testred Capsules 10 mg

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has approved its generic version of Testred Capsules 10 mg.

22 Sep 2015

Mylan releases Fluvastatin Sodium Extended-release Tablets in the U.S.

Mylan N.V. today announced the U.S. launch of Fluvastatin Sodium Extended-release Tablets, 80 mg, which is the generic version of Novartis' Lescol XL Tablets.

18 Sep 2015

Allergan settles patent litigation with Amneal related to NAMENDA XR extended release capsules

Allergan plc, today announced that its subsidiaries Forest Laboratories, LLC and Forest Laboratories Holdings, Ltd., along with Adamas Pharmaceuticals, Inc., have entered into a settlement agreement with Amneal Pharmaceuticals LLC and related companies and subsidiaries.

10 Sep 2015

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that ARX-04 (sufentanil sublingual tablet, 30 mcg) met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery.

9 Sep 2015

FDA grants Orphan Drug designation to Rigel's Fostamatinib for treatment of patients with ITP

Rigel Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug designation to Fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor which is currently in Phase 3 clinical studies in patients with chronic immune thrombocytopenic purpura (ITP).

8 Sep 2015

Mylan releases generic version of Yasmin Tablets in the U.S.

Mylan N.V. today announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, which is the generic version of Bayer's Yasmin Tablets. Mylan's partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy.

8 Sep 2015

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

Allergan plc. today announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis.

2 Sep 2015

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Allergan plc today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

2 Sep 2015

Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today it has completed enrollment of the additional subjects, as directed by the Data Review Committee (DRC) earlier this year, into the company's Phase 2 study for SGX942.

31 Aug 2015

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

HedgePath Pharmaceuticals, Inc., a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today enrollment has commenced in its Phase II(b) SCORING (SUBA-Cap Objective Response in Gorlin's) clinical trial.

23 Aug 2015

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant Pharmaceuticals International, Inc. and Sprout Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a wholly-owned subsidiary of Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones.

20 Aug 2015

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

United Therapeutics Corporation announced today that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc.

19 Aug 2015

New Drug Application News and Research

Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid

First patients screened in Axovant's phase 3 study of RVT-101

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

FDA accepts Braeburn's resubmission of Probuphine NDA for review

Mylan releases generic version of Invega in the U.S.

Kolltan announces presentation of data from KTN0158 preclinical study in mast cell tumors at ESMO 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Study explores effectiveness of frontline treatments for couples with unexplained infertility

FDA approves Impax Laboratories' generic version of Testred Capsules 10 mg

Mylan releases Fluvastatin Sodium Extended-release Tablets in the U.S.

Allergan settles patent litigation with Amneal related to NAMENDA XR extended release capsules

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

FDA grants Orphan Drug designation to Rigel's Fostamatinib for treatment of patients with ITP

Mylan releases generic version of Yasmin Tablets in the U.S.

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

Drug Discovery - Second Edition eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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