New Drug Application News and Research

RSS

Phase III CLL14 study evaluating Venclexta plus Gazyva to treat CLL meets its primary endpoint

Genentech, a member of the Roche Group , announced today that the randomized Phase III CLL14 study, which evaluated fixed-duration Venclexta® in combination with Gazyva® in people with previously untreated chronic lymphocytic leukemia and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death compared to standard-of-care Gazyva plus chlorambucil.

1 Nov 2018

IU Philanthropic Venture Fund commits to invest $500,000 to NERx Biosciences company

The Indiana University Philanthropic Venture Fund, which provides capital to faculty, students, alumni and staff at all IU campuses to help them further develop their research and innovations into startup companies, has committed to invest $500,000 in Indianapolis-based NERx Biosciences Inc. as part of a $2.2 million bridge round.

1 Nov 2018

The Lancet Infectious Diseases journal publishes clinical trial results for Shionogi’s cefiderocol

Shionogi & Co., Ltd. announced today that The Lancet Infectious Diseases journal has published clinical results from the pivotal randomized controlled trial evaluating cefiderocol for the treatment of complicated urinary tract infection in patients at risk of multidrug-resistant Gram-negative infections.

26 Oct 2018

Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma

Incyte Corporation announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment.

22 Oct 2018

Scientists receive $5.1 million grant to develop stem cell-based therapy for blinding retinal conditions

Scientists at the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions.

19 Oct 2018

FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T

Immusoft Corporation, a Seattle-Wash.-based cell therapy company, announced today that the U.S. Food and Drug Administration (FDA) has granted it Rare Pediatric Disease Designation (RPDD) for Iduronicrin genleukocel-T, Immusoft's Sleeping Beauty transposon-engineered autologous plasmablasts for the expression and delivery of alpha-L-iduronidase (IDUA) to treat Mucopolysaccharidosis type I (MPS I).

17 Oct 2018

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

Novartis today announced that both the US Food and Drug Administration and European Medicines Agency have accepted the company's New Drug Application and Marketing Authorization Application respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis in adults.

8 Oct 2018

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Genentech, a member of the Roche Group, today announced that the Phase III CAPSTONE-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo in people at high risk of serious complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease.

4 Oct 2018

Cidara initiates Phase 3 clinical trial to evaluate efficacy, safety of rezafungin to treat invasive candidiasis

Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the first trial site has been activated for ReSTORE, a Phase 3 clinical trial evaluating the efficacy and safety of the company's lead antifungal, rezafungin, to treat candidemia and invasive candidiasis.

27 Sep 2018

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today positive topline results from the interim analysis of the ENVISION Phase 3 Study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria.

27 Sep 2018

FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome

Myelo Therapeutics GmbH announced today that the US Food and Drug Administration has granted an Orphan Drug Designation to its orally applied new chemical entity Myelo001 for the treatment of Acute Radiation Syndrome.

25 Sep 2018

FDA approves Cassipa sublingual film for maintenance treatment of opioid dependence

The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

7 Sep 2018

NCCN updates Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets

Exelixis, Inc. today announced that the National Comprehensive Cancer Network updated its Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets.

7 Sep 2018

Verastem doses first patient in Phase I/II clinical trial of duvelisib in combination with venetoclax

Verastem, Inc., operating as Verastem Oncology, a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced dosing of the first patient in a multicenter Phase I/II clinical trial at the Dana-Farber/Harvard Cancer Center of duvelisib in combination with venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

6 Sep 2018

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration issued a Complete Response Letter for the New Drug Application for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor, for the treatment of attention-deficit hyperactivity disorder.

3 Sep 2018

Researchers publish new paper on developing vaccine candidates for Helminthic parasites

Helminthic parasites, like hookworm and liver flukes (schistosomiasis), affect an estimated 1 billion people worldwide. Infection from hookworm and schistosomiasis result in a combined loss of as much as 92 million disability-adjusted life years annually.

17 Aug 2018

FDA grants approval for first generic version of epinephrine auto-injector

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.

16 Aug 2018

CFDA accepts Ascletis’ NDA for first all-oral HCV treatment

Ascletis announced today it has received the acceptance letter from the China Food and Drug Administration for Ravidasvir new drug application.

1 Aug 2018

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Sunovion Pharmaceuticals Inc. today announced that a study evaluating the efficacy and safety of dasotraline in adults with moderate to severe binge eating disorder met its primary endpoint, demonstrating a statistically significant decrease in number of binge days per week from baseline to Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group.

25 Jul 2018

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for the treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.

20 Jul 2018