FDA approves Roche drug for rare autoimmune disorder NMOSD
The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.
Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
Navigating The Right Steps For Your Healthcare Startup
This webinar will explore how a banking platform approach could be the resource for your company.
Phase III study of Roche anti-inflammatory drug in Covid-19 fails
The company said that the COVACTA trial of Actemra in Covid-19 pneumonia had failed to meet its primary endpoint. Earlier this month, Regeneron and Sanofi announced that their study of a similar anti-inflammatory drug had also not met its primary endpoint.
Roche pays Blueprint $675M upfront for ex-U.S. development, commercialization rights to cancer drug
Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.
Novartis agrees to pay $729M to settle kickback lawsuit
The payments include $678 million related to speaker and promotional programs that took place between 2002-2011 and $51.25 million related to support for a charitable co-pay foundation. The lawsuit originated as a whistleblower suit in 2011.
Novartis halts its trial of hydroxychloroquine in Covid-19, citing poor enrollment
The drugmaker said an "acute" recruitment challenge made it unlikely the trial would be able to collect meaningful data on efficacy. More than a dozen hydroxychloroquine or chloroquine trials on ClinicalTrials.gov have been suspended, terminated or withdrawn.
presented by
The Best Options for Diagnostic Imaging Covered by Medicare
Health care professionals can refer patients to the best options for diagnostic imaging covered by Medicare to give more people the medical assistance they need without extra financial stress.
Novartis to test autoimmune disease drug in Covid-19 pneumonia patients
The Swiss drugmaker said Tuesday it would initiate a Phase III trial of 450 patients to test Ilaris as a treatment for cytokine release syndrome in Covid-19 pneumonia patients.
Novartis to acquire digital therapeutics maker Amblyotech
Financial terms of the deal were kept confidential. Novartis will work with Ubisoft and McGill University to accelerate development of a digital therapeutic for amblyopia, also known as lazy eye.
Regulatory speed bump gets in way of Roche spinal muscular atrophy drug approval
An analyst wrote that while the delay for risdiplam - prompted by Roche's submission of additional data - is unfortunate, the timing of the pivotal trials and the patient population guarantee a broad label for the drug, making the company's decision prudent.
Roche starts Phase III study of arthritis drug in Covid-19 pneumonia
The company said the trial had been launched last week, comparing Actemra against placebo in patients hospitalized with pneumonia due to Covid-19. Other trials looking at the drug are underway in Italy and China.
presented by
How to Optimize Your Phlebotomy Setup for Efficient Patient Care
The layout of your phlebotomy station can significantly impact efficiency. A well-thought-out setup ensures that every tool is within reach, minimizing unnecessary movement and reducing patient wait times.
Roche gets special FDA nod for Covid-19 diagnostic test
The agency gave the Swiss drug and diagnostics maker an emergency use authorization, or EUA, for a test to detect the novel coronavirus, known as SARS-CoV-2, designed to run on its Cobas 6800 and 8800 testing systems.
Another blow to Alzheimer’s field as two drugs fail in study of early-onset disease
Lilly and Roche said that the Phase II/III DIAN-TU trial of their amyloid beta-targeting drugs - gantenerumab and solanezumab - failed to meet its primary endpoint in patients genetically predisposed to early-onset Alzheimer's disease.
Novartis wraps up $9.7B Medicines Company buyout
The deal was originally announced in November. The Medicines Co.'s lead product candidate is inclisiran, an RNAi drug for reducing cholesterol, for which it submitted an FDA approval application in December.
Roche, Sarepta Therapeutics sign $1.15B deal for ex-US rights to gene therapy for Duchenne’s
An analyst wrote that the deal would create value for Sarepta, which has a gene therapy in Phase II development for Duchenne muscular dystrophy, SRP-9001, but lacks the resources to commercialize it abroad.
Roche completes acquisition of Spark Therapeutics as regulators give go-ahead
The Federal Trade Commission and its U.K. counterpart concluded that Roche would not likely have an incentive to delay or discontinue development of Spark's hemophilia A gene therapy. Roche markets a monoclonal antibody for the same disease.