FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Aerie Pharmaceuticals Rocklatan (netarsudil and latanoprost ophthalmic solution) to decrease elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension.
Medical device company receives second FDA clearance, adding blood flow monitoring technology to portfolio
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
Evaluate recently published the Vantage Pharma, Biotech and Medtech 2018 in review report. The annual report offers insights into the previous year’s activities in biopharma and the medical device industry.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC, has reported that the U.S. Food and Drug Administration has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis.
FDA Approval Allows Interventional Cardiologists Access to Resolute DES Technology to Treat De Novo CTO