News
New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
AbbVie is off to a strong start for 2022 driven by success from Skyrizi and Rinvoq, as well as the company’s neuroscience platform. Abbvie also won FDA approval for a new indication for Rinvoq.
If you’re considering a career change from pharma to biotech, you’ll be happy to hear that according to industry experts, the transition is more common than you might think.
Genocea Biosciences and Solid Biosciences are undertaking a new strategic prioritization that includes reducing their headcount.
China’s proposed guidelines for bioethics say that organizations outside of China cannot collect and preserve Chinese human genetic resources inside China or take them out of the country.
Zymeworks received an unsolicited, non-binding acquisition offer from global investment firm All Blue Capital. All Blue is offering $10.50 per share for a total of $773 million in cash.
AstraZeneca topped off a very busy week with its first-quarter financial report, citing a total of $11.390 billion in revenue, a whopping increase of 60%.
The FDA approval was based on data from the Phase III Explorer-HCM trial that showed Bristol Myers Squibb’s Camzyos could decrease the heart’s contractility.
Finch Therapeutics has been given the green light to continue the Phase III Prism4 clinical trial, investigating the efficacy of CP101 in fighting recurrent C. difficile infections (CDI).
Alnylam announced another delay, this one caused by a much more sinister reason – the invasion of Ukraine, now heading into its third month and causing disruption on a multi-faceted and global scale.
The alliance will pair AbbVie’s neuroscience capabilities with Plexium’s comprehensive TPD platform.