gene therapy
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Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions
Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.
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Eli Lilly Turns to Startup Capsida to Bring Gene Therapy Into the Brain
Eli Lilly is paying $55 million up front to begin an alliance with Capsida Biotherapeutics pursuing gene therapies for central nervous system disorders. Capsida’s technology enables the delivery of a gene therapy to a single organ or multiple organs, a capability that could bring such treatments to a wider range of diseases.
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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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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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2023 Likely To Be a Crucial Year for Pharma—and Insurers
2023 is shaping up to be a crucial year for everyone involved – and affected – by the pharmaceutical industry. It’s likely to be a year of experimentation for payers – and defensiveness for drug makers.
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MedCity Influencers, BioPharma
A Dose of Innovation
As gene sequencing, machine learning, powerful imaging, sensors, gene and cell therapies make their way out of academic labs into everyday healthcare, our approach to healthcare is changing. For the first time, not only can we pinpoint the molecular and genetic causes of disease, but we also have the technologies to access them. On the back of this, prevention and cures are becoming possible. Can we afford them?
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CSL’s Gene Therapy Approval Marks First for Hemophilia B and New High in Pricing
CSL Behring’s hemophilia B gene therapy, Hemgenix, carries a $3.5 million list price. But the company contends that by reducing economic burdens associated with bleeding and prophylactic infusions, the one-time treatment will save money over time.
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New Gene Therapy Biotech Telaria Launches With Rare Skin Disease Focus
Telaria is developing a gene therapy for the rare skin disorder recessive dystrophic epidermolysis bullosa. The company was formed by Replay, a gene therapy biotech that forms subsidiaries that leverage its platform technologies for writing and delivering genetic medicines.
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Cell and Gene Therapies Push Payers to New Strategies to Assess Outcomes
Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.
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Astellas takes a stake in Taysha and gets a chance at next big gene therapy buyout
Astellas has purchased an equity stake in Taysha Gene Therapies in a $50 million deal that gives it an option to license the company’s two lead gene therapy candidates. The Japanese pharmaceutical giant also gains the option to buy its new partner outright depending on clinical and regulatory developments expected in the coming year.
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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.
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MedCity Influencers, BioPharma
Meeting the needs of rare disease patients: Improved access to specialty pharmaceuticals, gene and cell therapies
Specialty carve outs that move specialty drugs away from traditional prescription drug management to a pharmacy benefit administrator (PBA) or specialty administrator will continue and likely to provide cost savings.
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MedCity Influencers, BioPharma
Gene therapy is saving lives; There are still key challenges to realize its full potential
Gene therapy can offer hope to patients with previously untreatable diseases, but there’s more work to be done to improve both the safety and efficacy of this therapeutic modality.
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Eli Lilly’s $487M Akouos buyout expands its gene therapy scope to hearing loss
Eli Lilly is acquiring Akouos on the heels of the biotech receiving FDA permission to begin a clinical trial testing its gene therapy for an inherited form of hearing loss. The deal is Lilly’s second gene therapy acquisition following the 2021 buyout of Prevail Therapeutics.
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BioMarin layoffs to save $50M a year; cash will go to pipeline, gene therapy launch prep
BioMarin Pharmaceutical said the layoffs will improve efficiency across the company as it prepares for the potential U.S. launch of Roctavian, a gene therapy for severe hemophilia A. The one-time treatment was approved in Europe in August.
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AstraZeneca throws lifeline to gene-editing biotech LogicBio with $68M buyout
AstraZeneca’s LogicBio acquisition comes at a critical time for the biotech. Though LogicBio has encouraging early clinical data for its lead gene-editing therapeutic candidate, the company’s cash woes include a flagging stock price that is set to lose its listing on the Nasdaq.
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Rejuvenate Bio CEO highlights ambitious approach of using gene therapy to reverse aging
CEO and Co-founder Daniel Oliver share how he and his co-founder started the company and their vision for treating age-related conditions.