Pharma News

Shire plc submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse® (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule. Vyvanse capsules can be swallowed whole or consumed by opening and mixing the entire contents into water, orange juice or yogurt. Vyvanse chewable tablets will offer an additional administration option for patients.

Bristol-Myers Squibb’s announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma (cHL) after prior therapies.

AbbVie announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta™ (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells.Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is marketed collaboratively by the companies in the U.S. and by AbbVie outside of the U.S.

ALK’s partner for North America, MSD (known as Merck in the United States and Canada), announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for review. MSD submitted the BLA, for a tablet against HDM allergy, to the FDA in February 2016. 

Clovis Oncology, Inc. Announced That The U.S. Food And Drug Administration (Fda) Oncologic Drugs Advisory Committee (Odac) Met To Discuss Approval Of The New Drug Application (Nda) For Rociletinib.

Data from a new study presented today may help reduce the waiting time for a liver transplant for people with the Hepatitis C virus (HCV). The study, presented at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrated that the medium to long-term outcomes for people with HCV who have received a HCV-positive liver were no different from those who were given a healthy liver.

New research in monkeys exposed to SIV, the animal equivalent of HIV, reveals what happens in the very earliest stages of infection, before virus is even detectable in the blood, which is a critical but difficult period to study in humans. The findings, published online today in the journal Cell, have important implications for vaccine development and other strategies to prevent infection.

Scientists at the Centers for Disease Control and Prevention (CDC) have concluded, after careful review of existing evidence, that Zika virus is a cause of microcephaly and other severe fetal brain defects. In the report published in the New England Journal of Medicine, the CDC authors describe a rigorous weighing of evidence using established scientific criteria.

Addex Therapeutics announced the results of the mGlu5 receptor occupancy study with dipraglurant in healthy volunteers. The study was conducted under the direction of lead investigator professor of neurology, Dean F. Wong, MD, PhD of the Departments of Radiology, Psychiatry and Neuroscience at Johns Hopkins University.

Mylan N.V. announced the U.S. launch of Metoprolol Tartrate Tablets USP, 37.5 mg and 75 mg, which is the generic version of Novartis' Lopressor® Tablets. These strengths are the first and only available intermediate dosage strengths between the existing Metoprolol Tartrate Tablets USP strengths of 25 mg, 50 mg and 100 mg. Mylan currently is the only manufacturer that offers Metoprolol Tartrate Tablets in five strengths.