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Following a Type A meeting with the FDA, Mesoblast claims it has a better understanding of what the regulator needs in order to consider approving remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease, the company announced Thursday.

FDA

Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.

pills, drug manufacturing

A new study provides the first empirical evidence that the not-for-profit manufacturer’s business model can lead to robust drug supplies and lower medicine costs.

Sam Srivastava, WCG

Srivastava discusses how his personal upbringing eventually intersected with a team that works to deliver over 90% of FDA-approved therapeutic drugs onto the global market.

Valneva

Today French vaccine maker Valneva reported a smaller half-year loss, as a rebound in global tourism boosted sales of its travel vaccines Ixiario and Dukoral.

handshake gloves

While a particular target was not disclosed, PeptiDream CEO Patrick Reid said in a statement that the company hopes to “bring innovative first-in-class peptide radiopharmaceuticals to patients worldwide.” 

FDA

The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.

HHS also announced an investment of $600 million in 12 domestic COVID-19 test manufacturers.

data

To enable their science to change the world, pharma companies need an in-depth understanding of their market, including doctors, potential patients, and payers, as well as a plan on how to navigate it most effectively. This includes understanding their target audience, as well as the relevant channels they need to utilize in order to engage with that audience.

U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk’s main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.