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Actavis seeks FDA marketing approval for Ambrisentan Tablets, 5 mg and 10 mg

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg.

6 Apr 2015

Columbia Laboratories to adopt Juniper Pharmaceuticals brand marks

Columbia Laboratories, Inc., today announced that it will adopt Juniper Pharmaceuticals, Inc. as its new corporate brand. The name change will become effective Friday, April 10, 2015, and the Company's common stock will begin trading on the Nasdaq Stock Exchange under the new ticker symbol — "JNP" — on Monday, April 13, 2015.

2 Apr 2015

Mylan announces U.S. launch of Amlodipine and Valsartan Tablets

Mylan N.V. today announced the U.S. launch of Amlodipine and Valsartan Tablets, 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg, which is the generic version of Novartis' Exforge Tablets.

31 Mar 2015

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

30 Mar 2015

LEO Pharma A/S announces regulatory submission of ENSTILAR® for psoriasis in Europe

ENSTILAR® has the potential to be the first cutaneous foam approved for the treatment of psoriasis vulgaris.

26 Mar 2015

TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

Teikoku Pharma USA announced today that it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration for Docetaxel Injection Concentrate, Non-Alcohol Formula on February 26, 2015 and received an acknowledgment of the receipt from FDA.

25 Mar 2015

Mast plans to develop vepoloxamer for chronic heart failure treatment

Mast Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, today announced its plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure.

23 Mar 2015

Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen today announced that an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan.

21 Mar 2015

Columbia Laboratories' revenues increase 11% to $32.5 million in 2014

Columbia Laboratories, Inc., today announced financial results for the three- and twelve-month periods ended December 31, 2014.

18 Mar 2015

Mylan releases Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr in U.S.

Mylan N.V. and Mylan Inc. today announced the U.S. launch of its Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering of Fentanyl Transdermal System 12, 25, 50, 75 and 100 mcg/hr.

11 Mar 2015

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

10 Mar 2015

Pacritinib for myelofibrosis meets primary endpoint in Phase 3 PERSIST-1 trial

CTI BioPharma Corp. and Baxter International Inc. today announced positive top-line results for the primary endpoint from PERSIST-1, the randomized, controlled Phase 3 registration clinical trial examining pacritinib, a next generation oral JAK2/FLT3 multikinase inhibitor, for the treatment of patients with primary or secondary myelofibrosis.

From Baxter International Inc. 9 Mar 2015

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).

8 Mar 2015

ANI acquires approved ANDA for Flecainide Acetate tablets USP

ANI Pharmaceuticals, Inc. today announced that it has acquired the approved abbreviated new drug application ("ANDA") for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals.

5 Mar 2015

Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration.

4 Mar 2015

Rigel Pharmaceuticals reports net loss of $22.3 million for fourth quarter 2014

Rigel Pharmaceuticals, Inc. today reported financial results for the fourth quarter and year ended December 31, 2014. For the fourth quarter of 2014, Rigel reported a net loss of $22.3 million, or $0.25 per share, compared to a net loss of $16.9 million, or $0.19 per share, in the fourth quarter of 2013.

3 Mar 2015

Taiho announces submission of TAS-102 MAA to EMA for treatment of mCRC

Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC).

2 Mar 2015

Neuroprotective compounds can limit damage to the brain during ischemic stroke

In the 1990s, neuroscientists identified a class of drugs that showed promise in the area of stroke. NMDA receptor antagonists could limit damage to the brain in animal models of stroke. But one problem complicated testing the drugs in a clinical setting: the side effects included disorientation and hallucinations.

28 Feb 2015

Chiasma closes $70 million Series E financing round

Chiasma, Inc., a U.S. privately-held biopharma company developing octreotide capsules, its lead product for the orphan condition acromegaly, today announced the closing of a $70 million Series E financing round.

27 Feb 2015

Actavis files ANDA to market Budesonide Extended-release Tablets

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Budesonide Extended-release Tablets, 9 mg.

25 Feb 2015