Pfizer’s inclacumab did not beat a placebo in a Phase 3 test in sickle cell disease. The trial failure comes nearly a year after Pfizer voluntarily withdrew Oxbryta from the market after tests showed higher rates of complications and deaths for that sickle cell disease drug.
Response Pharmaceuticals takes a new approach to weight loss with an oral small molecule designed to inhibit a protein called iMTP to reduce uptake of fats and cholesterol. While this drug’s lead indication is addressing weight gain in patients taking antipsychotics, the company is also exploring other metabolic indications such as patients who need a post-GLP-1 therapy.
In today’s healthcare landscape, your choice of medical billing partner directly impacts your bottom line. What are the best medical billing outsourcing companies, and which one is right for you?
Insmed’s Brinsupri is the first drug specifically approved for treating non-cystic fibrosis bronchiectasis, a progressive and potentially fatal lung disorder. The drug, licensed from AstraZeneca, inhibits activation of neutrophils, white blood cells that play a role in inflammatory and immune responses.
Boehringer-Ingelheim pill Hernexeos was awarded accelerated FDA approval for advanced cases of non-small cell lung cancer with HER2 mutations. But Bayer is on its heels with an oral small molecule currently under FDA review in the same indication.
Jazz Pharmaceuticals’ dordaviprone, brand name Modeyso, is now the first FDA-approved therapy for recurrent H3 K27M-mutant diffuse midline glioma. The drug came from Jazz’s $935 million acquisition of Chimerix earlier this year.
A next-generation Vertex Pharmaceuticals pain drug failed to beat a placebo in a Phase 2 clinical trial. Despite the disappointing outcome in bunionectomy pain, the company is continuing development of the oral drug in diabetic peripheral neuropathy.
At a time when AI is reshaping pharma, Reverba Global CEO Cheryl Lubbert explained in an interview why empathy, context, and ethics still require a human touch.
Hansa Biopharma has encouraging early clinical results showing its drug imlifidase, used as a pretreatment, enabled Duchenne muscular dystrophy patients to receive the gene therapy Elevidys. Sarepta is searching for ways to mitigate excessive immune responses to Elevidys that can lead to serious and potentially fatal liver injury.
Chronic hand eczema, which can develop from chemicals and cleansers that people use frequently for work, now has its first FDA-approved treatment. The new LEO Pharma drug, Anzupgo, is a topical cream designed to block four signaling proteins that drive inflammation.
Pharmaceutical tariffs are coming, part of President Trump’s stated goal of bringing drug manufacturing back to the U.S. Untangling the sprawling, global supply chain will be complicated and expensive, and could inadvertently compete with other administration goals regarding drug pricing and availability.
Roche’s astegolimab met the main goal of one pivotal COPD study but failed another, mirroring the mixed results recently posted by a Regeneron Pharmaceuticals COPD drug candidate that goes after the same target. Biologics are a new treatment option for COPD following approvals of antibodies from Sanofi and GSK.
Yusuf Qasim, President of Payments Optimization at Zelis, discussed how the company is transforming healthcare payments from a fragmented, patchwork system into a modern, digital infrastructure.
Sarepta Therapeutics knew about the death of a patient treated with its experimental gene therapy for a type of limb-girdle muscular dystrophy, but said nothing publicly for a month. Financial analysts lambasted Sarepta executives for failing to disclose the fatality when the company announced a restructuring that includes stopping work on this limb-girdle program.
Sarepta’s Elevidys will remain on the market with a black box warning. But this gene therapy for Duchenne muscular dystrophy still faces commercial headwinds and analysts say the company has work to do to win over patients and investors.
Though anselamimab failed its Phase 3 test in light chain amyloidosis, AstraZeneca points to encouraging results in a pre-defined patient subgroup — which may not be a winning strategy. Prothena resurrected its failed drug candidate for the disease based on a subgroup analysis, only to see that antibody fall short in a pivotal study.
The Phase 3 results in China are encouraging for Kailera Therapeutics, which holds rights to the molecule in the rest of the world. The startup is preparing a global clinical development program for this drug, a once-weekly injectable GLP-1 and GIP receptor agonist.
The FDA approved Bayer’s Kerendia for reducing the risk of heart failure in patients with mildly reduced ejection fraction, a measure of how much blood the organ can pump. The daily pill was first approved in 2021 for patients with chronic kidney disease associated with type 2 diabetes.