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The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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FDA
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
FDA
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
Amid high rates of U.S. obesity, a bipartisan bill has been reintroduced in the Senate and House of Representatives with backing from Eli Lilly, Novo Nordisk and Boehringer Ingelheim.
The company’s sales guidance for 2023 has been raised to $98.8 billion to $99.8 billion, driven by cancer drugs and medical devices. J&J’s stock rose about 5% in early trading Thursday.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
The company is handing back a multivalent Shigella vaccine candidate to LimmaTech Biologics, which spun out in 2015 after GSK’s acquisition of GlycoVaxyn for $190 million.
Illumina is laying off 79 workers in San Diego, and according to an internal email, more layoffs will be announced soon.
At almost 80,000 square feet, the addition will allow the Japan-based to create jobs for in-office and hybrid workers in the region.