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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.
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.
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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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The Swiss pharma is looking to leverage Voyager Therapeutics’ capsid technology for gene therapies aimed at treating Huntington’s disease and spinal muscular atrophy.
All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
Biopharmas of varying sizes—including larger companies like Amgen, Gilead and Pfizer—cut employees in 2023 to stay afloat.
Eli Lilly has signed a multi-year contract with animal genomics biotech Fauna Bio to use its artificial intelligence platform to discover drug targets for obesity in a deal worth nearly half a billion dollars.
Under the companies’ agreement, a previously disclosed option exercise fee of $75 million has been reduced to $10 million and the remaining pre-option development milestone has been removed.
GSK withdrew three patents related to its asthma inhalers while Impax delisted both of its patents for Adrenaclick and Kaléo delisted eight patents covering Auvi-Q—the companies’ respective epinephrine auto-injectors.
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.
In a Phase II study, Jazz Pharmaceuticals’ investigational fatty acid amide hydrolase inhibitor JZP150 did not significantly improve post-traumatic stress disorder symptoms compared to placebo.
FDA
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
Microgravity offers unique advantages when investigating cells and proteins, but collaboration and a strong ethical framework are needed to fully realize its benefits.