News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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
Emalex Biosciences closed a Series D funding round Thursday counting $250 million in earnings, much of which will bankroll a Phase III trial of ecopipam for Tourette syndrome.
Exelixis has inked a licensing agreement with Catalent to gain access to three of Catalent’s target programs with antibody and ADC candidates, the companies announced Thursday.
Moderna is dropping an IL-12 program in autoimmune disorders after AstraZeneca returned the rights, the mRNA leader announced Thursday in its third quarter filing.
Alkermes is exploring the potential spin-out of its cancer business into an independent, publicly traded company. Alkermes offered further details during an investor call Wednesday.
San Diego-based Arcturus Therapeutics signed a strategic collaboration and licensing deal with CSL Seqirus to help develop and commercialize vaccines.
Q1 is the time when many employers are actively recruiting new talent. Because it takes an average of 60 days to fill a job opening, Q4 might be the best time to apply for jobs in the life sciences.
Flush with cash from the growing success of its chemotherapy drug, Exelixis dropped $100M on two collaboration deals this week to invest in promising early clinical assets.
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
A Data Safety Monitoring Board overseeing the Phase Ib/II trial assessing UniQure’s gene therapy for Huntington’s disease recommended that enrollment in the higher-dose cohort could resume.
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.