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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Artificial intelligence won’t replace people in biopharma, but it is infiltrating every step of drug development, including in some ways that aren’t so obvious.
Wave Life Sciences in a Tuesday filing with the SEC said Takeda has elected to terminate its option to continue work on Wave’s WVE-003 clinical-stage Huntington’s disease program—a potential $5 billion commercial opportunity, according to the biotech.
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market.
Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq.
Learn how to craft a resume that stands out by exploring 10 common resume mistakes and how to avoid them.
J&J beat expectations this week to launch the Q3 earnings season; a study about children treated with bluebird bio’s Skysona comes at a bad time for the company; Sen. Warren calls for scrutiny of Novo’s purchase of Catalent; and other news.
Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion.
At 52 weeks of follow-up, more patients on Eli Lilly’s monoclonal antibody Omvoh demonstrated histologic response, suggesting better long-term outcomes than Johnson & Johnson’s blockbuster therapy Stelara.