Industry News

Novartis announced data from the Phase IV Multiple Sclerosis and clinical outcome and MRI in the US (MS-MRIUS) study, which confirmed the effectiveness of Gilenya® (fingolimod) in the real-world setting, supporting previous findings from Phase III trials. Results show that Gilenya impacted four key measures of MS disease activity (relapses, MRI lesions, disability progression and brain shrinkage), in people with relapsing-remitting multiple sclerosis (RRMS) for up to 16 months. This is also the first time a multicenter study has evaluated and shown that routine magnetic resonance imaging (MRI) scans taken in the every-day clinical setting can reliably be used to measure brain shrinkage, a key measure of disease progression, in people with RRMS. Full results are presented at the 69th American Academy of Neurology (AAN) Annual Meeting, in Boston, Massachusetts, USA.

Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, announced the receipt of a preclinical milestone in connection with the advancement of a Bicycle into preclinical development for the treatment of diabetic macular edema, under its ophthalmology alliance with ThromboGenics, a biopharmaceutical company focused on developing treatments for back of the eye disease.

Aptose Biosciences Inc  a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, announced that preclinical data for its pan-FLT3/BTK inhibitor CG’806 will be presented in two separate posters at the 2017 American Association for Cancer Research (AACR) Conference Hematologic Malignancies: Translating Discoveries to Novel Therapies, being held May 6-9 in Boston, MA.

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AstraZeneca announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

Cipla Ltd, a global pharmaceutical company, today announced that its wholly owned subsidiary in USA — Cipla USA Inc. has signed a worldwide licensing agreement (except for East Asia) with MEDRx Company Limited (MEDRx) to further develop and commercialize MRX-4TZT, a Tizanidine1 patch for the management of Spasticity.

Hallstar, a specialty chemical company based in Chicago, has been awarded the 2017 Global in-cosmetics^® Innovation Silver Prize for its revolutionary new anti-aging ingredient, Micah. Winners were announced at the in-cosmetics^® conference in London on April 4th. The awards are given to honor the development of a novel active or functional ingredient combining innovative science and product features in a way that demonstrates substantial benefits to manufacturers and end-users.

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Intellia Therapeutics a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR technology, announced that the European Patent Office (EPO) has decided to grant a patent broadly covering the CRISPR/Cas9 genome editing technology. The patent includes claims covering compositions of the widely adopted CRISPR single guide RNA technology for use in any non-cellular and cellular setting, including eukaryotic cells such as human or mammalian cells, as well as for use in human therapeutics.

Takeda Pharmaceutical Company Limited announced a strategic collaboration with NuBiyota LLC for the development of Microbial Ecosystem Therapeutic products for gastroenterology (GI) indications with a high unmet medical need.

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Roche announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff). Countries accepting CE mark are the first to receive access to the cobas® Cdiff test, which detects C. diff in stool specimens from symptomatic patients1 and provides rapid and definitive results in under 20 minutes. Timely and accurate diagnosis of this infection is important because it can quickly become life threatening, especially to high-risk patients such as the elderly, immuno-compromised and those undergoing antibiotic treatment.

Cipla Ltd, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA).