Drugmakers to Maryland affordability board: Capping list prices may not help...
Drugmakers are pushing back against Maryland’s Prescription Drug Affordability Board and its list of six medicines that will be reviewed for potential price caps. The board is conducting studies of six...
View ArticleCHMP recommends 14 new approvals, seven label expansions
The European Medicines Agency’s human medicines committee recommended 14 new drugs for approval this week, including Pfizer’s gene therapy for hemophilia B. The approval recommendations include: →...
View ArticleNovartis sues Maryland over state law banning limits on discounts to 340B...
Novartis is suing the state of Maryland to block a state law that will ban drugmakers from placing limits on discounts to pharmacies that supply drugs to hospitals serving low-income and uninsured...
View ArticleFDA questions data on MDMA-based therapy in PTSD ahead of advisory committee
The FDA questioned data around Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder on Friday, less than a week before its advisory committee meets to discuss what could be the...
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#ASCO24: Immunocore unveils early-stage data of skin cancer treatment that...
CHICAGO — Immunocore reported Friday that in an early-stage study, 56% of melanoma patients who received its experimental drug achieved disease control — a measurement that’s not typically touted by...
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Merck CEO says Keytruda is ‘not a repeatable model’
CHICAGO — Can there be another Keytruda? Merck CEO Rob Davis, whose company makes the $25 billion-a-year cancer medicine, says it’s a “once-in-a-lifetime drug” whose success won’t be repeated. “I can...
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#ASCO24: Iovance's TIL therapy plus Keytruda show durable treatment effect in...
CHICAGO — Iovance Biotherapeutics said Friday that adding its melanoma cell therapy on top of an immunotherapy — the current go-to for advanced skin cancer — resulted in cancer disappearing in seven...
View ArticleMerck’s $3B return to eye disease; J&J’s $1.25B tuck-in; Keytruda challenger...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
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#ASCO24: BMS details confirmatory trial win for KRAS inhibitor Krazati
Bristol Myers Squibb said its KRAS cancer drug Krazati met the primary endpoint in a Phase 3 confirmatory trial in patients with non-small cell lung cancer, according to new data shared at the American...
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#ASCO24: GenFleet highlights Phase 2 data on KRAS/EGFR combo in lung cancer
As companies increasingly look to combinations to boost the efficacy of KRAS therapies, a Phase 2 study is offering some of the first clinical evidence for combining KRAS and EGFR in frontline lung...
View ArticleIntellia’s CRISPR therapy cuts swelling attacks by 98% in two-year study
Intellia Therapeutics has revealed that a single infusion of its experimental CRISPR therapy, called NTLA-2002, almost entirely eliminated swelling attacks in 10 people with hereditary angioedema....
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#ASCO24: GSK plots Blenrep’s return with more data on its ADC for multiple...
CHICAGO — GSK said its multiple myeloma drug Blenrep combined with other treatments helped reduce the risk of disease progression or death by almost 50% compared to standard of care. The data further...
View Article#ASCO24: AstraZeneca, J&J share new data in bids to expand reach of lung...
CHICAGO — This weekend, AstraZeneca cancer R&D chief Susan Galbraith is wearing a lapel pin with the number six, marking the years AstraZeneca has sponsored studies presented at the plenary session...
View Article#ASCO24: Daiichi Sankyo, AstraZeneca say Enhertu works better than chemo in...
CHICAGO — Daiichi Sankyo and AstraZeneca’s antibody-drug conjugate Enhertu gave HER2-low breast cancer patients a median of 5 more months without cancer progression or death compared to chemotherapy,...
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#ASCO24: With a promising new Keytruda contender, Summit prepares to spar...
CHICAGO — Summit Therapeutics is prepared to take on the world’s best-selling drug. On Thursday, the biotech’s stock nearly tripled after reporting that its cancer drug ivonescimab beat Merck’s...
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#ASCO24: A small group of melanoma patients may need far less immunotherapy...
Interim results from a clinical trial conducted by researchers in the Netherlands and Australia suggest that some melanoma patients may need far less immunotherapy than they’re currently prescribed....
View ArticleIsotope shortage forces pause of Bristol Myers Phase 3 radiopharmaceutical trial
The development of the lead drug behind Bristol Myers Squibb’s recent $4.1 billion acquisition of RayzeBio has hit delays, because of supply issues of a rare radioactive isotope crucial to the...
View ArticleEli Lilly licenses preclinical antisense program designed to treat ALS, dementia
Eli Lilly added another neuroscience program to its pipeline, licensing an antisense oligonucleotide from the ALS biotech QurAlis. The deal, announced Monday, is the latest indicator that Lilly is...
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Rapport Therapeutics sets out for $122M Nasdaq debut as IPO backlog seeks...
Clinical-stage neuroscience biotech Rapport Therapeutics will seek about $122 million in net proceeds from its initial public offering, according to new securities paperwork outlining its Nasdaq...
View ArticleDelaware court lets Zantac lawsuits go ahead, wiping $8B+ from GSK market cap
GSK shares were down more than 9% premarket on Monday after a Delaware court allowed more than 70,000 Zantac-related cases against the drugmaker to go ahead. Judge Vivian Medinilla concluded on Friday...
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