The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
Although inflammatory arthritis can be treated systemically, drugs are often injected directly into affected areas, particularly when the disease affects just one or a few joints. Problem is, injectable drugs are usually cleared quickly from the joint, limiting their effectiveness. A new delivery system could improve the efficacy and durability of arthritis treatments, as well as cut down on nasty side effects caused by systemic therapy.
In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.
Macrolide Pharmaceuticals, a next-generation antibiotics company developing macrolides that are first-in-class with Gram-negative activity for a broad range of multi-drug resistant bacterial infections, announced that Mahesh Karande has joined the company as President and CEO. The company is also pleased to announce the completion of a $20 million financing led by current investors Advent Life Sciences, Gurnet Point Capital, Novartis Venture Fund, Roche Venture Fund and SR One.
Researchers have developed an "injectable bandage" that quickly stops bleeding and allows wounds to heal faster than traditional dressings. Biomedical engineers at Texas A&M University in College Stations have invented the "injectable bandage," which is composed of a seaweed-derived gelling agent and two-dimensional clay nanoparticles.
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
According to a piece by Bloomberg, Allergan is looking at options to divest its women’s health unit in a move that could potentially reap about $5 billion.
The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.
Such alerts remind clinicians about everything from a patient's drug allergies, to possible drug interactions, to dosing guidelines, to lab testing guidance. Clinicians can either follow the alerts' recommendations, override them, or ignore them.
Aslan wants to list on the U.S. exchange under the ASLN symbol.
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