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STAT+: Pharmalittle: We’re reading about FDA seeking new powers over DTC ads, an EU pledge to fight AMR, and more

Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is to … keep going. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup of stimulation. Our choice today is orange creme. Meanwhile, here are some items of interest to get you going. We hope you have a meaningful and productive day, and conquer the world. Best of luck…

Activist investor Shah Capital plans to vote against the re-election of board nominees and the executive ​compensation package at Novavax’s upcoming annual meeting, renewing pressure for ‌changes at the vaccine maker, Reuters writes. In a letter to the company, hedge fund founder Himanshu Shah said management has failed to implement aggressive cost-cutting measures ​and urged leadership to reduce costs and opportunistically buy back ​10 million to 20 million shares. Shah Capital, which owns 9% of Novavax and ⁠is its second-largest shareholder, has been pushing the board ​to pursue strategic changes, including a potential sale. The firm wants a like-minded ​strategic long-term investor to take a 10% to 20% ownership stake to reshape the company. In its letter, the firm said a partnership with Sanofi ​has not benefited Novavax.

The U.S. Food and Drug Administration is seeking  new powers to hold companies accountable for misleading direct-to-consumer ads, adding legislative weight to its pushback against deceptive drug advertising, Fierce Pharma explains. Last year, President Trump ordered the agency to ensure companies provide balanced information on the benefits and risks of drugs in DTC ads. Days later, the agency published letters alleging violations of federal pharma marketing rules by companies including Bristol Myers Squibb, Eli Lilly and Novartis. The FDA has continued to send letters to companies accused of breaking the rules. Now, the FDA has included its 2027 budget proposal to request new powers to regulate DTC ads. The agency said it “needs additional authorities to more effectively address DTC advertising that lacks fair balance and is frequently misleading and confusing to consumers and patients.”

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Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is to … keep going. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup of stimulation. Our choice today is orange creme. Meanwhile, here are some items of interest to get you going. We hope you have a meaningful and productive day, and conquer the world. Best of luck…

Activist investor Shah Capital plans to vote against the re-election of board nominees and the executive ​compensation package at Novavax’s upcoming annual meeting, renewing pressure for ‌changes at the vaccine maker, Reuters writes. In a letter to the company, hedge fund founder Himanshu Shah said management has failed to implement aggressive cost-cutting measures ​and urged leadership to reduce costs and opportunistically buy back ​10 million to 20 million shares. Shah Capital, which owns 9% of Novavax and ⁠is its second-largest shareholder, has been pushing the board ​to pursue strategic changes, including a potential sale. The firm wants a like-minded ​strategic long-term investor to take a 10% to 20% ownership stake to reshape the company. In its letter, the firm said a partnership with Sanofi ​has not benefited Novavax.

The U.S. Food and Drug Administration is seeking  new powers to hold companies accountable for misleading direct-to-consumer ads, adding legislative weight to its pushback against deceptive drug advertising, Fierce Pharma explains. Last year, President Trump ordered the agency to ensure companies provide balanced information on the benefits and risks of drugs in DTC ads. Days later, the agency published letters alleging violations of federal pharma marketing rules by companies including Bristol Myers Squibb, Eli Lilly and Novartis. The FDA has continued to send letters to companies accused of breaking the rules. Now, the FDA has included its 2027 budget proposal to request new powers to regulate DTC ads. The agency said it “needs additional authorities to more effectively address DTC advertising that lacks fair balance and is frequently misleading and confusing to consumers and patients.”

Continue to STAT+ to read the full story…

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Amgen shores up Tavneos’ FDA defense with Duke data analysis

Amgen shores up Tavneos’ FDA defense with Duke data analysis

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After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.​ ​Read More

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Chile offers new data on food warning label efficacy

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So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.

Read the rest…

Read More

Continue Reading

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Novartis’ $12B Avidity buy pays dividends with Phase 1/2 muscular dystrophy win

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The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.

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