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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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FDA
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.
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While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings.
The vaccine maker is prepared to cut another $300 million in operating expenses in 2024 to keep the company afloat as it works to get its combination COVID-19/flu vaccine into Phase III.
In a bid to join Eli Lilly and Novo Nordisk in the lucrative, high-growth obesity market, AstraZeneca is investing in a Phase I oral GLP-1RA candidate from Shanghai-based biotech Eccogene.
FDA
The oral targeted therapy, now sold under the brand name Fruzaqla, is approved for adults with metastatic colorectal cancer who have received certain previous treatments for the disease.
FDA
Lilly’s Zepbound (tirzepatide) injection is the first and only approved treatment that activates two incretin hormone receptors, GIP and GLP-1, to treat obesity and excess weight.
Research associates are always in demand. Check out these top companies currently hiring RAs.
With headwinds in the wider biotech sphere, the third quarter showed continuing vulnerabilities in the COVID space while the weight-loss drugs drove blockbuster sales.
The company on Wednesday reported nearly 50 billion euros, or $53.3 billion, in revenue with zero cash flow. Several layers of management will be eliminated as structural split-off strategies are considered.
This week, in (our inaugural episode!) BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma’s reported Q3 earnings. They also tackle what’s going on at Pfizer, ADCs, deals and more.
The third-quarter growth of Gilead’s HIV, oncology and cell therapy businesses was completely offset by declining COVID-19 and liver disease sales, with revenue flat compared to the same period last year.