FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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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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An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety.
Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
As insulin prices skyrocket, pharmas and PBMs faced pointed critique from the Senate HELP Committee, led by Sen. Bernie Sanders (I-VT).
The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.
Colchicine, a drug used to treat gout, saw a 16-fold price increase since the FDA changed its policy toward single-ingredient oral colchicine products, which had previously been available generically.
A federal judge compelled Merck to release confidential information on its HPV vaccine as a part of discovery in a series of lawsuits spanning states dating back to 2020.
Elfabrio’s label contains a boxed warning for hypersensitivity reactions, such as anaphylaxis, and recommends that medical support measures should be on standby when administering the treatment.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.