Pharma News

PTC Therapeutics, Inc. announced that it received yesterday evening a Refuse to File letter from the United States Food and Drug Administration (FDA) regarding PTC's New Drug Application (NDA) for Translarna™ (ataluren), an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

A form of natural sugar that triggers liver cells to clean up excess fat may help tackle nonalcoholic fatty liver disease (NFLD) in the near future, researchers have found after conducting a key research on mice.

Researchers have discovered that copper has the properties to destroy the “superbug” methicillin-resistant Staphylococcus aureus (MRSA) - a bacteria that is resistant to many antibiotics.

Researchers have developed a novel therapeutic approach that could lead to nanomedicines tailored to maintain cancer cells in a dormant state.

Influenza commonly known as "flu” can hide itself undetected in an individual's body by the person's immune system, reveals a study. The influenza virus that affects mainly the nose, throat, bronchi and occasionally lungs contains a protein that helps in outsmarting the immune system which can track viruses and alert the body of the entry of foreign virus into the human cells to multiply.

A single dose of the drug zoledronic acid was found to inhibit bone loss that is common in HIV-infected patients on antiretroviral therapy (ART), according to results of a phase two clinical trial.

South Asian countries should jointly tackle anti-microbial resistance that has arisen due to overuse and misuse of antibiotics, Union Health Minister J.P. Nadda said on Tuesday.

Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.

formulation approved dose, tolerability and immunologic efficacy, investigational new formulation Astellas Pharma Inc. and Medivation, Inc. announced that the U.S. Food and Drug Administration (FDA) 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. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC.

Merck, known as MSD outside the United States and Canada, announced top-line results from the company’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults.