LONDON – The CEOs of Pfizer Inc. and Astrazeneca plc both say they are on track to make their COVID-19 vaccines available for use before the end of the year and have promised to manufacture at risk, supply at cost and ensure equitable access.
New data show Johnson & Johnson’s Erleada (apalutamide) and Xtandi (enzalutamide) from Pfizer Inc. and Astellas Pharma Inc. both prolonged overall survival in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
DUBLIN – Shares in Valneva SE rose by as much as 32% during early trading April 30 on news that Pfizer Inc. is paying $130 million up front to in-license its Lyme disease candidate vaccine, VLA-15.
A little more than eight months after Pfizer Inc.'s $11.2 billion acquisition of Array Biopharma Inc., a combination of Array-developed Braftovi (encorafenib) and cetuximab has won FDA approval for the second-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC), becoming the first approved therapy specifically targeting that mutation.
One simple four-letter word can make a world of difference in how quickly biosimilars and interchangeables bring full competition to the U.S. marketplace of biologics, a handful of companies and industry groups told the FDA in comments on a draft guidance concerning the labeling of follow-ons that are licensed for fewer indications than the reference biologic.
After plunging dramatically at the beginning of the month, biopharmaceutical equities appear to be recovering some of the valuation they originally lost when the financial markets cratered. As the curtain closed on a very turbulent month that most investors will want to forget, the BioWorld Biopharmaceutical index finished up 0.75%, but down about 2% for the year.
LONDON – AM-Pharma BV raised a further $52 million for the phase III trial of its recombinant alkaline phosphatase product, Recap, in treating sepsis-associated acute kidney injury (AKI), but now faces a delay in starting the study, as the COVID-19 crisis takes up more and more clinical resources.
The importance of artificial intelligence and machine learning (AI/ML) has not been lost on drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been established to help deploy those tools.
The first wave of biosimilars began lapping at U.S. shores five years ago when the FDA approved Sandoz Inc.’s Zarxio on March 6, 2015, giving it a label identical to that of its reference biologic, Amgen Inc.’s Neupogen (filgrastim). But the tsunami of biosimilars, and the multibillion dollars of savings they were expected to bring, has yet to wash ashore.
Even as the volume of mergers and acquisitions in 2019 reached the highest level in the last 10 years, multiple big pharma companies are looking to get smaller, spinning off units into separate entities.
