Mr. Cameron Groome reports: MICROBIX REPORTS RECORD THIRD QUARTER & NINE MONTH SALES

 

Microbix Biosystems Inc. has released its financial results for the fiscal third quarter and nine months ended June 30, 2017.

 

Third quarter financial results

Total third quarter revenue was $2,773,365, an increase of 23 per cent compared with the same quarter of fiscal 2016. Most revenues were derived from sales of antigen products, which are principally used in the manufacture of diagnostic tests for infectious diseases. Growth was driven by increased antigen orders from long-standing customers, with double-digit increases in sales of multiple products. The balance of revenue was derived from royalties on an out-licensed technology, which totalled $67,954.

First trial site qualified to start screening study patients

 

SOUTH SAN FRANCISCO, Calif., Aug. 24, 2017 -- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease. The Phase 1/2 clinical study in patients will commence shortly.

 

"New treatments that offer continuous delivery of medication providing non-pulsatile stimulation of dopamine receptors in the brain appear to have some advantages over oral formulations," said Dr. Aaron Ellenbogen of the Michigan Institute of Neurological Disorders, and the principal investigator at the first trial site, near Detroit, Michigan. "The ProNeura implants with ropinirole could potentially offer an important treatment option for continuous drug delivery that overcomes the fluctuating drug levels associated with oral administration of ropinirole, and we look forward to conducting this study."

GAITHERSBURG, Md., Aug. 23, 2017 -- Novavax, Inc., (Nasdaq:NVAX) today announced that data from a preclinical study of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M™ adjuvant (NanoFlu™) have been published in the journal Vaccine. Novavax is developing NanoFlu to protect older adults from seasonal influenza.

 

The manuscript describes the formulation of Novavax’ novel seasonal influenza vaccine candidate, NanoFlu, based on the 2017-2018 World Health Organization (WHO) recommended influenza strains. The study, conducted in ferrets, found that NanoFlu induced hemagglutination-inhibition (HAI) and microneutralizing (MN) antibodies against a broad range of influenza subtypes. In a head-to-head comparison against standard-dose and high-dose (HD) inactivated influenza vaccines in ferrets, NanoFlu elicited higher HAI and MN antibody responses exceeding those induced by the high-dose vaccine against recent (homologous) A(H3N2) by 7-fold, A(H1N1) by 26-fold, and B strain viruses by 2-fold. Additionally, NanoFlu induced superior protection in a ferret challenge model against a homologous and a 10-year old drifted influenza strain spanning over a decade.

NEW YORK, Aug. 23, 2017  -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the FDA (i) has completed its review of the Company’s responses to requests from the FDA for additional information relating to certain findings observed in nonclinical toxicology studies of lumateperone in an animal species and (ii) agrees that the Company has presented adequate data to support its position that the metabolic pathway in the animal species is distinctive from humans, which indicates that the toxicity observed in the animal species is not relevant to humans. 

 

Accordingly, the Company is moving forward with its long-term safety study of lumateperone and intends to submit a new drug application (NDA) for the treatment of schizophrenia by mid-2018.