Inotek Pharmaceuticals Corporation

Fiercepharma | June 16, 2020

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or it...

Business Insights

BioMarin Pharmaceutical Inc. | November 24, 2022

BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an...

BioSpace: | February 27, 2020

Gilead Sciences, based in Foster City, California, announced it will launch two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19, the disease caused by the novel coronavirus. The outbreak began in China in December and has since spread through much of the rest of the world, with most cases concentrated in Asia. The current number of confirmed cases worldwide is greater than 81,400 with a total death count of 2,770. The first cases of co...

Pharma Tech

AstraZeneca | November 13, 2020

Months after drugmakers launched an unprecedented COVID-19 research effort, some existing medicines have turned in promising results—but more of them have failed against the virus. And AstraZeneca’s blood cancer med Calquence just became one of them, falling short in two tests in hospitalized patients. AstraZeneca said Thursday that the medicine—already approved in mantle cell lymphoma—didn't help patients survive the virus and reduce respiratory failure any better th...