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Liquid Biopsy Startup Precede Sets Out to Make Precision Medicine More Precise
Precede Biosciences’ liquid biopsy platform yields insight into the genes and pathways in diseased tissue. Based on Dana-Farber Cancer Institute research, the startup aims to support biopharma drug R&D as it also develops the technology for clinical care applications.
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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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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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Artificial Intelligence, BioPharma
Already Partnered With Nvidia, Iambic Adds $100M for AI Drug Discovery
Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024.
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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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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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Invitae’s First of Its Kind Cancer Test Receives FDA Marketing Authorization
The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.
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Avalyn’s New Twist on Older Lung Disease Drugs Attracts $175M for Clinical Trials
Avalyn Pharma aims to improve treatment of idiopathic pulmonary fibrosis with inhalable versions of two older oral drugs and it’s now headed for mid-stage testing backed by a Series C financing. Other recent biotech industry financings raised money for research in cancer, immunology, and rare genetic diseases.
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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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Navigating Healthcare’s Data Revolution: Priorities, Opportunities, and Challenges for Health Systems
Arcadia recently partnered with HIMSS Market Insights to survey executives, IT, technology, and clinical leaders. Here’s what we found.
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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.