Switzerland
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FDA Approves Blood Thinner Reversal Drug, But Requires More Tests to Assess Serious Risk
While Octapharma drug Balfaxar met the goal of its pivotal clinical trial, more deaths and blood clot problems were reported in the study drug arm versus the comparator group. The FDA is requiring a post-marketing study to further assess the drug’s risks.
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Here’s Why Novartis Is Paying $500M to Acquire a Preclinical RNA Startup
Novartis’s acquisition of DTx Pharma brings a lead program for a rare disease with no FDA-approved therapies. But the deal could also help the pharma giant bring new RNA therapies to new places in the body, a top Novartis executive explained.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Ironwood Places $1B Bet on Biotech That Could Bring Its Next Blockbuster GI Drug
Ironwood Pharmaceuticals is paying $1 billion to acquire VectivBio, a biotech whose lead program could become a blockbuster treatment for a gastrointestinal disorder. Preliminary Phase 3 data are expected by the end of 2023.
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Roche Forks Over $70M for Brain-Penetrating Cancer Drug Candidate
Roche is acquiring global rights to a Zion Pharma Limited drug candidate with potential applications treating breast cancer that has metastasized to the brain. The small molecule, currently in Phase 1 testing, is designed to penetrate the blood-brain barrier.
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New FDA Nod for Roche Drug Moves It to the Front Line in Treating Blood Cancer
Roche’s Polivy is now approved as an earlier line of treatment for patients who have diffuse large B-cell lymphoma. Accelerated approval of the drug in 2019 had made the drug a third treatment option for patients with advanced cases of this type of blood cancer.
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Alentis Therapeutics Lands $105M for Clinical Trials in Fibrosis and Cancer
Three months after Alentis Therapeutics’ lead program posted positive Phase 1 data, the biotech has raised cash to advance that program to mid-stage testing in fibrosis. The Series C financing will also support a cancer drug candidate ready to start human testing.
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Roche Drug for Rare Blood Disorder Hits Phase 3 Goals; Regulatory Filings Are Next
AstraZeneca dominates the market for drugs that treat rare blood disorder paroxysmal nocturnal hemoglobinuria. Roche drug crovalimab met the two main goals of its pivotal test, and if approved, would offer a dosing edge compared to AstraZeneca’s two blockbuster PNH medicines.
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Devices & Diagnostics, BioPharma
Tumor-Zapping Device Scores in Pivotal Study, Sends Shares of Novocure Soaring
Novocure’s electrical field-producing medical device, in combination with standard drug therapies, improved overall survival in a pivotal study that enrolled patients with advanced non-small cell lung cancer. The medtech company now plans to seek regulatory approvals.
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FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer
A Ferring Pharmaceuticals gene therapy is now FDA approved for treating bladder cancer that does not respond to an immunotherapy used to treat the cancer in its early stages. The Ferring gene therapy, Adstiladrin, turns bladder wall cells into tiny factories churning out a cancer-fighting therapeutic protein.
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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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European approval of Novartis cancer drug puts a new STAMP on leukemia
Novartis drug Scemblix is the first in a new class of drugs known as STAMP inhibitors. European Commission approval of the small molecule provides a new treatment option for chronic myeloid leukemia that is resistant to earlier treatments, as well as those cases in which patients cannot tolerate the other therapies for this blood cancer.
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Alcon ups its glaucoma game again with $770M Aerie Pharma acquisition
The Aerie Pharma acquisition brings Alcon two commercialized glaucoma products, as well as a pipeline of programs in various stages of development for other eye diseases. Alcon has been an active dealmaker, turning to M&A as a way to bolster its eye products portfolio and pipeline.
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Novartis warns of two patient deaths after dosing with gene therapy Zolgensma
The two deaths reported following treatment with Novartis’s Zolgensma mark the first fatal cases of acute liver failure associated with the gene therapy. Liver complications are a known side effect risk of Zolgensma and other genetic medicines that are delivered by engineered viruses.
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New Versant Ventures startup goes ‘gutless’ for next-generation gene delivery
Vector BioPharma has launched from the biotech startup incubator of Versant Ventures, which is backing the company with a $30 million Series A financing. Vector is developing virus-like particles with the capability to deliver large payloads of genetic medicines to a wide range of tissues.
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FDA setback leads women’s health biotech ObsEva to give up on uterine fibroids drug
ObsEva’s uterine fibroids drug linzagolix has hit a snag at the FDA, portending a likely delayed regulatory decision. Rather than stick it out and see if its small molecule can match up against commercialized products from AbbVie and Myovant, ObsEva plans to give up rights to the drug as part of a corporate restructuring.
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Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for these vouchers, which grant a company a shorter regulatory review timeline for a drug that addresses a rare or neglected disease.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
