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Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments.
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The industry remains unwavering in the commitment to increased clinical trial accessibility and representation.
Price-negotiation provisions that are out of step with reality are discouraging funders and Big Pharma partners from investing in potentially transformative therapies. Fixing some of the unintended consequences of the IRA will clear the way for innovative medicines to reach patients in need.
Non-opioid pain therapies are entering an unprecedented era, marked by the landmark FDA approval of Vertex’s Journavx and a growing number of alternative approaches. Their ultimate uptake, however, remains to be seen.
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Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab’s efficacy and safety profile before making its final decision on whether to grant the drug approval.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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The deal comes three months after Pfizer inked a PD-1/VEGF partnership with Summit Therapeutics, leading BMO Capital Markets to express confusion regarding the pharma’s overall strategy.
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Govorestat failed to meet its primary endpoint in a Phase II/III trial for a rare form of Charcot-Marie-Tooth disease, a few months after the FDA rebuffed the same drug in a similar indication.
Regeneron promised to comply with 23andMe’s consumer privacy policies and related data security laws.
Taking center stage at the American Society of Gene and Cell Therapy meeting was the first-ever reported case of a personalized in vivo CRISPR editing therapy, which substantially eased the symptom burden in an infant.
The restrictions on Novavax’s vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”
Analysts at BMO Capital Markets said in a weekend note that a non-invasive blood test could help boost uptake of Alzheimer’s disease therapies.
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.