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Investigational compound for treating indolent lymphomas shows positive results in phase II clinical study

Bayer today announced positive data on its investigational compound copanlisib, an intravenous pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.

31 Mar 2017

Research highlights threat of Zika virus to donated blood supplies in the U.S

Investigators have shown that certain screening methods that detect the genetic material of Zika virus can be used to ensure that donated blood supplies remain free of the virus.

28 Mar 2017

GUMC launches phase II clinical study to examine safety of cancer drug for Parkinson's disease

Georgetown University Medical Center today announces the launch of a phase II clinical trial to study the safety of the cancer drug nilotinib and its effects on clinical outcomes and biomarkers in people with Parkinson's disease.

27 Feb 2017

Plant-based drug for hemophilia shows promise in animal models

People with hemophilia require regular infusions of clotting factor to prevent them from experiencing uncontrolled bleeding. But a significant fraction develop antibodies against the clotting factor, essentially experiencing an allergic reaction to the very treatment that can prolong their lives.

13 Feb 2017

Mylan announces U.S. launch of generic Zovia Tablets

Mylan N.V., today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan's product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Zovia® 1/50E-28 Tablets (Watson).

30 Dec 2016

Mylan announces U.S. launch of generic Concerta Tablets

Mylan N.V., today announced the U.S. launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a generic version of Janssen's Concerta Tablets.

30 Dec 2016

MDA celebrates FDA approval of new spinal muscular atrophy drug

The Muscular Dystrophy Association today celebrated news of the U.S. Food and Drug Administration's decision to grant approval for nusinersen (brand name Spinraza), the first disease-modifying drug to treat the most common genetic cause of death in infants.

23 Dec 2016

GUMC receives FDA clearance to begin clinical study of cancer drug in patients with Alzheimer's disease

Georgetown University Medical Center today announces the U.S. Food and Drug Administration has completed its review of an investigational new drug application (IND) for the use of nilotinib in a phase II clinical trial for patients with mild to moderate Alzheimer's disease.

30 Sep 2016

Researchers make successful vaccine formulation that targets proteins linked to Alzheimer’s disease

With more than 7.5 million new cases of Alzheimer’s disease a year, the race to find a vaccine and effective treatment for dementia is growing by the day.

12 Jul 2016

European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients

Amgen has announced that the European Commission (EC) has approved a variation to the marketing authorization for Kyprolis® (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Kyprolis by the EC in less than a year.

6 Jul 2016

FDA approves additional indication for Eisai's anticancer agent Lenvima in combo with Everolimus for advanced renal cell carcinoma

Eisai Co., Ltd. has announced that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for an additional indication for Eisai's in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

16 May 2016

NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system disorders, today announced the start of patient enrollment in a long-term safety study (trial 012) of the company’s continuously administered subcutaneous levodopa/carbidopa formulation used in both ND0612H and ND0612L.

13 May 2016

FDA announces availability of investigational test to screen donated blood for Zika virus

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

31 Mar 2016

Breckenridge Pharmaceutical announces final FDA approval for Gabapentin Oral Solution

Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Gabapentin Oral Solution 250 mg per 5 mL, which is AA rated to Neurontin, a drug marketed by Pfizer.

18 Mar 2016

Aralez resubmits NDA package for YOSPRALA to FDA

Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, today announced that it has resubmitted to the U.S. Food and Drug Administration the New Drug Application ("NDA") for its investigational candidate, YOSPRALA (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

15 Mar 2016

WRAIR researchers publish results from Plasmodium vivax malaria vaccine study

Walter Reed Army Institute of Research researchers recently published the results of testing a Plasmodium vivax malaria vaccine candidate in a human challenge model.

27 Feb 2016

Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration of Desoximetasone Ointment USP 0.25%, the generic equivalent of Topicort Ointment, 0.25%, of Taro Pharmaceuticals U.S.A., Inc.

26 Feb 2016

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy.

23 Feb 2016

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas Pharma Inc. and Medivation, Inc. today announced that the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication.

22 Feb 2016

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug Imitrex Nasal Spray, of GlaxoSmithKline.