This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
The research compared patient care metrics at hospitals that had experienced a data breach and those that had not. For instance, the study examined the proportion of heart attack patients that die within 30 days of being admitted to a health system.
Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet.
The two sessions (NPC & CPPCC) this year have received much attention from China and outside China, wherein, the most-watched theme is “reform”. Regarding pharmaceuticals, the event that attracts the highest attention is CFDA reform, followed by policy moves of the TCM issue and bio-medicine, etc. that China has been strongly supporting in recent years.
AbbVies stock $ABBV is getting hammered this morning after its $10 billion Rova-T program posted poor mid-stage results for third-line small cell lung cancer, forcing the company to scuttle any plans to seek an accelerated approval for the closely-watched drug after talks with skeptical regulators.
The EU medicines regulator has started its review of Astellas and Pfizer’s prostate cancer drug Xtandi in what looks likely to become a hotly contested indication - non-metastatic castration-resistant prostate cancer (nmCRPC).
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