There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
Four biopharma companies are pooling some of their chemical data and making it public for the first time as part of the pioneering stage of a European effort to reduce the need for animal testing in drug development.
Roche Holding AG’s attempt to find a next-generation cancer immunotherapy has suffered a setback after the first phase III readout for an anti-TIGIT drug, tiragolumab, turned out negative. With big pharma investing heavily in TIGIT (T-cell immunoreceptor with immunoglobulin and ITIM domains), results from the company’s Skyscraper-02 trial were closely watched.
The challenging financial environment of 2022 will lead to an increase in partnerships, according to representatives of the two big Swiss biopharma companies, Roche Holding AG and Novartis AG.
Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. As revealed by BioWorld last week, hundreds of clinical trials were being conducted in the two countries at the time Russian President Vladimir Putin gave orders to invade Ukraine on Feb. 20.
Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."
South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa.
PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
