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Adding oleclumab and monalizumab to the PD-L1 inhibitor improved PFS, while another study showed improved real-world outcomes.
In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.
Amgen’s KRAS G12C inhibitor in combination with the company’s Vectibix generated a 27% overall response rate, nearly tripling the responses seen with Lumakras monotherapy in colorectal cancer.
AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.
Phase III sub-analyses presented at ESMO show the drug providing a survival benefit in a complex subpopulation, as well as improvements to quality of life.
Moderna is hot on the heels of Pfizer with booster data for its COVID-19 vaccine, and could benefit from its rival being first to face potential skepticism from the US FDA over booster data for its vaccine.
France’s Provepharm Life Solutions, which finds new uses for known mature molecules, in particular antidotes and surgical dyes, by improving their efficacy and maximizing their therapeutic potential, has fresh funds to expand its portfolio.
With big oncology losses largely in the rearview mirror, Roche is trying to sell investors on its next wave of cancer drugs; R&D overview pushes message of pipeline renewal.
The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.
The UK’s choice of the mRNA vaccines as COVID-19 boosters is no surprise – but not releasing the key study data behind the decision is.
Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
While Viatris says it has sufficient capacity to meet current and future demand for tuberculosis drug pretomanid, TB Alliance has signed a non-exclusive license with Lupin. This is the second tie-up with an Indian manufacturer but the local restricted use approval means countries other than India are likely to benefit for now.
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