BioPharma
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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.
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Bristol Myers Squibb Bolsters Its Cancer Presence With $4.8B Mirati Acquisition
Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study
Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.
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MedCity Influencers, BioPharma
Fostering the Next Generation of Antisense Oligonucleotide Therapies
Antisense oligonucleotides (ASOs) have faced their share of challenges, but a combination of research advances and a market ripe for innovation is setting this drug class up for a resurgence. Antisense oligonucleotide (ASO)—a class of drugs that works by targeting RNA to alter gene expression and control aberrant proteins in ways that traditional drugs can’t.
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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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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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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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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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MedCity Influencers, Artificial Intelligence
Health Equity Begins with Increasing Diversity in Clinical Research: AI Can Help
It’s critical that we address these examples of institutionalized bias and racism in how we approach clinical trials for drugs and devices. While it’s a daunting task, the path forward is surprisingly clear, and AI can be instrumental in the next step of overcoming unconscious biases inherent in clinical trial processes.
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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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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.