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.
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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Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
Although the COVID-19 pandemic is waning in the U.S., there is still plenty of research and news about the disease. Here’s a look.
The new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
Pfizer says it expects the U.S. CDC’s ACI to meet in October to recommend the appropriate and safe use of pneumococcal vaccines, including PREVNAR 20, in adults.
Bharat will conduct Phase IV studies to check real-world efficacy against the virus, while Ocugen says Covaxin will be a valuable tool in helping to end the COVID-19 pandemic.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
Results from the Phase III TULIP® study show an antibody-drug conjugate from Byondis significantly prolonged PFS in patients with pretreated HER2-positive metastatic breast cancer.