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Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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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Read our takes on the biggest stories happening in the industry.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
THE LATEST
The biotech is taking a synergistic approach to obesity with two muscle-preserving antibodies set to enter a Phase II study in mid-2024 in combination with existing incretin-based treatments.
Topline results from a mid-stage study show that 4D Molecular Therapeutics’ investigational gene therapy cut annual rates of Eylea injections by 85% and 89% for the low and high doses, respectively.
The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
The Japanese pharma’s financial numbers showed a drop in operating revenue as it signed a $300 million license and collaboration agreement with Protagonist Therapeutics.
The company’s blockbuster cancer treatment Keytruda continues to be a significant boon to its bottom line, according to Merck’s fourth quarter and full-year 2023 financial results.
With one disease-modifying therapy already reaching patients and another expected to soon, several biopharma companies anticipate key data for novel assets in the coming 12 months.
While AbbVie beat revenue expectations in the fourth quarter of 2023, the company reported Friday that its overall sales last year declined as it faced biosimilar competition for its blockbuster Humira.
The pharma Friday reported in-line and new product revenue growth of 9%, bringing in $9.8 billion for the fourth quarter of 2023. Eliquis and Opdivo remain top sellers but BMS is facing the loss of exclusivity.
The British pharma expects “meaningful” sales and earnings growth in 2024 and is upgrading its growth outlooks for 2026 and 2031, according to GSK CEO Emma Walmsley.
The U.S. Department of Health and Human Services on Thursday released new data showing that Americans pay three times more for prescription drugs than other developed countries and nearly 10 times more for insulin.