News
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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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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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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The company’s three-drug combination met all primary and key secondary endpoints in two randomized controlled trials in cystic fibrosis patients, paving the way for an application to regulators.
The antibody-drug conjugate, in combination with Takeda’s Velcade and the steroid dexamethasone, reduced the risk of death and disease progression by 59% versus a similar Darzalex-based regimen.
The Swiss pharma’s dealmaking momentum continues in early 2024 with the acquisition of German biotech MorphoSys in an effort to strengthen its oncology portfolio.
Academic and industry jobs are distinguished by their approaches to collaboration and exploratory research, among other factors.
Metagenomi could potentially raise over $100 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $16 per share.
Phase I results published Monday suggest Amgen’s investigational weight-loss drug MariTide produces longer-lasting effects than GLP-1s currently on the market.
The investment arm of the Novo Nordisk Foundation is acquiring contract development and manufacturing organization Catalent to help meet high demand for Ozempic and Wegovy.
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.