Boston
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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency
Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis. FDA approval of the Chiesi drug comes about five years after European regulators authorized the product.
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Karuna Picks Up Kidney Drugs for Chance to Challenge Boehringer Ingelheim in the Brain
Karuna Therapeutics has licensed two small molecules that shuttering Goldfinch Bio had developed for kidney disorders. These compounds target a pathway that could also treat neurological disorders, giving clinical-stage Karuna the opportunity to compete against a drug candidate from Boehringer Ingelheim.
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Cancer Biotech Elicio Finds Path to Public Markets Via Angion Reverse Merger
Elicio Therapeutics dipped its toe in the IPO waters but decided to go public by merging with publicly traded Angion Biomedica. Clinical-stage Elicio is developing immunotherapies, including cancer vaccines, that work by targeting immune cells located in the lymph nodes.
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Biotech Firm Slashes 75% of Staff After FDA Rejects Drug for Rare Lung Cancer
In rejecting Spectrum Pharmaceuticals drug poziotinib, the FDA said the biotech needs to generate more data from another clinical trial. Instead, Spectrum is turning the company’s focus to commercializing its recently approved product for treating a common cancer complication.
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Sea creature-inspired biotech Ascidian surfaces with $50M and a new way to edit RNA
Ascidian Therapeutics is developing therapies for inherited disorders that work by editing RNA with an approach that could offer advantages over currently available genetic medicines. The biotech’s lead program is in preclinical development for Stargardt disease, a rare eye disorder caused by multiple genetic mutations.
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Merck turns to biotech Cerevance to feed neuro pipeline with Alzheimer’s drugs
Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for new neurological disorder drugs. While Cerevance’s lead program is a Parkinson’s disease drug, Merck is wants to see if the startup’s technology can help it discover and develop new Alzheimer’s disease drugs.
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Devices & Diagnostics, BioPharma
Pear Therapeutics pares down its plans as restructuring cuts 9% of workforce
Pear Therapeutics is implementing a corporate restructuring projected to save about $28 million. The goal is to extend its available cash as the company presses on with commercialization efforts for its digital therapeutics.
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Harvard spinout lands $40M to bring in vivo drug discovery to cancer
Technological advances are moving drug discovery work to computers, but experimental medicines still must be tested in animals. Startup Manifold Bio is developing technology that enables the testing of hundreds of molecules in a single mouse, bringing drug hunters valuable in vivo data much earlier in the drug discovery process.
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Vertex builds up pipeline of type 1 diabetes cell therapies with $320M buyout
Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets and technologies. The two companies already share a partner in common: both have therapeutic candidates that use the gene-editing capabilities of CRISPR Therapeutics.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Biopharma firm Radius Health is going private in an $890M M&A deal
Two private equity firms have reached an $890 million deal to buy Radius Health, a company whose main asset is the commercialized osteoporosis drug Tymlos. In other M&A news, cancer biotech F-star Therapeutics is being acquired in a $161 million deal.
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How cell & gene therapy startups can warm up to investors in this “biotech nuclear winter”
Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World Medical Innovation Forum in Boston, a panel of venture capitalists discussed capital formation and what biotech firms need to do to win over investors and advance their research.
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BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.
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WMIF panel: How cell and gene therapy can overcome limitations of CAR T
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.
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HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda
Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.
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Artificial Intelligence, BioPharma
Biofourmis adds $300M to ramp up in virtual care, digital therapy clinical trials
The Series D round of funding makes Biofourmis a unicorn valued at $1.3 billion. CEO and founder Kuldeep Singh Rajput said that the new capital will be used to expand his company’s remote-monitoring technologies and continue development of digital therapeutics, both as companions to traditional drugs and as monotherapies.