Pharma
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Kyowa Kirin Buys Into Gene Therapy With Orchard Therapeutics Acquisition
The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.
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FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots
Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.
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Creating an Omnichannel Customer Journey in Healthcare
Improving Customer Experience and Conversion in Healthcare & Life Sciences
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Eli Lilly Jumps Into Radiopharmaceuticals via $1.4B Point Biopharma Acquisition
Acquiring Point Biopharma gives Eli Lilly a pipeline of radiopharmaceuticals, including one for prostate cancer that could rival Novartis’s Pluvicto. The deal comes ahead of an expected Phase 3 data readout for that Point therapeutic candidate.
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Novartis Kidney Disease Drug Hits First Goal of Study; 2024 FDA Filing Planned
Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.
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Structure Raises $300M as Oral GLP-1 Drug’s Data Keep Up With Pfizer, Eli Lilly
Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies. The data are from a small study and a short time frame, but Structure was able to leverage the encouraging preliminary results into a private placement of securities.
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Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod
Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.
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BrainStorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout
Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
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Pharma, Artificial Intelligence, BioPharma
Novo Nordisk Turns to Flagship’s Valo Health for AI-Driven Cardio Drug R&D
Novo Nordisk is paying Valo Health $60 million up front to gain three preclinical cardiovascular disease programs. Milestone payments for those programs and others covered under the artificial intelligence drug discovery pact could reach up to $2.7 billion.
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Contamination Risk Sparks a Recall of GSK, Scynexis Antifungal Drug
Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.
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Startup Syntax Bio Leverages CRISPR to Transform Cell Therapy Manufacturing
Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.
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Once a Blockbuster Prospect, Is Travere’s Kidney Drug on Track to Become a Bust?
Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.
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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.
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BeiGene, Novartis Drug Alliance Ends; It’s Their Second Terminated Deal This Year
BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.