Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
Akorn has filed a complaint in Delaware Chancery Court asking Fresenius to follow through on the pair's buyout agreement. A year after inking its $4.3 billion Akorn buyout agreement, Fresenius intends to scrap the deal. Akorn, though, isn’t having it, and analysts say a “legal battle royale” could be on the horizon.
On Tuesday, Bothell, Washington-based Steth IO announced the launch of its smartphone-based digital stethoscope.
Plymouth-based medical device maker Urotronic is ramping up clinical research on its Optilume drug-coated balloon to treat men with narrowed urethras, accelerating the data-gathering process for its novel device.
Recent doubts about traditional egg-based flu shots could mean more business for vaccines manufactured in cells. Protection against the dominant H3N2 flu strain offered by the coming season’s flu vaccine will still be far from optimal—putting it mildly. And that's thanks to the widely used manufacturing process based on eggs, a new study predicts.
GSK is shifting resources towards key therapeutic classes, including respiratory disease.
It's no secret that respiratory drugs make up a crowded field, and forthcoming generics will make the competition tougher still. AstraZeneca's Symbicort is no stranger to the fallout, either, what with payers pressing prices and new rivals grabbing share.
The LIBERTY Trial was Conducted in Patients who Have Tried Two to Four Therapies Without Success -- a Uniquely Difficult-to-Treat Population Often Excluded From Migraine Prevention Trials Patients Taking Aimovig had Nearly Three-Fold Higher Odds of Having Their Migraine Days cut by Half or More Compared to Placebo Safety and Tolerability Were Consistent With Results Seen in the Pivotal Clinical Program; Over 97 Percent of Those Taking Aimovig Completed the Double-Blind Treatment Phase Data Selected by the American Academy of Neurology Science Committee as one of the Most Noteworthy Presentations at 2018 Annual Meeting
Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
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