BioSpace

BioSpace stands out as the top online hub for life science professionals, offering the latest industry news and career opportunities. With a rich history spanning more than 30 years, BioSpace has been dedicated to connecting talented individuals with job openings in the biotechnology and pharmaceutical sectors. Moreover, it has fostered better communication and collaboration among leaders in the biopharmaceutical field, enhancing discovery and innovation.

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Sangamo's ‘Positive’ Phase I/II Data for Fabry Gene Therapy Opens Path to FDA

4 days ago | biospace.com | Tristan Mañalac

Sangamo Therapeutics’ investigational gene therapy isaralgagene civaparvovec improved kidney function in patients with Fabry disease, according to a Phase I/II readout from the company on Tuesday. Sangamo plans to use these results to build a case for an accelerated approval of the gene therapy. This news comes after an earlier data release, slim on details, from the biotech last month, announcing that it had met a “key milestone” for a regulatory filing for isaralgagene civaparvovec.
In latest AI Play, Sanofi Bets $630M+ for Formation Bio’s JAK/SYK Blocker

4 days ago | biospace.com | Tristan Mañalac

Sanofi has licensed gusacitinib, an oral JAK/SYK dual inhibitor from the “AI-native” drug development company Formation Bio, marking the pharma’s latest investment in AI-focused drug development. Terms of the deal, announced Monday, were sparse. The licensing agreement will involve upfront and milestone payments worth up to €545 million, or approximately $632 million, though the companies did not provide a specific breakdown of these numbers.
Lilly Antibody Protects Patients From Losing Muscle While Taking Novo's Wegovy

4 days ago | biospace.com | Tristan Mañalac

Eli Lilly’s antibody bimagrumab, when used alongside Novo Nordisk’s semaglutide, marketed as Wegovy, helps patients lose weight while also preserving their muscle mass. These results come from the placebo-controlled Phase IIb BELIEVE study, which enrolled more than 500 patients who were given subcutaneous semaglutide weekly and intravenous bimagrumab at weeks 4, 16, 28 and 40.
Exelixis Beats Bayer in Colorectal Cancer as Zanzalintinib Delivers ‘First Pivotal Success’

5 days ago | biospace.com | Tristan Mañalac

Exelixis’ third-generation tyrosine kinase inhibitor zanzalintinib, when used in combination with Roche’s PD-L1 blocker Tecentriq, outperforms Bayer’s Stivarga for the treatment of certain patients with colorectal cancer, according to a release from Exelixis. These findings, announced Sunday, mark “the first pivotal success from the zanzalintinib program,” William Blair analysts wrote in a Monday note.
Novo Leans on CagriSema’s Safety as Amycretin Moves Forward to Phase III

5 days ago | biospace.com | Tristan Mañalac

After the underwhelming readout for CagriSema last December, Novo Nordisk came to the American Diabetes Association’s 85th scientific congress with new safety data for the drug, possibly hoping to rebuild investor confidence. Also over the weekend, Novo revealed mid-stage data for its GLP-1- and amylin-targeting drug amycretin, leading to dose-related questions.
Compass Plots Path to FDA With ‘Meaningful’ Phase III Data for Psilocybin Drug in Depression

5 days ago | biospace.com | Tristan Mañalac

Compass Pathway’s investigational psilocybin therapy COMP360 significantly eases symptoms in patients with treatment-resistant depression, clearing the way for regulatory discussions. A release from the company on Monday was light on specifics, without any data on how a placebo arm performed.
Vertex’s Cell Therapy Could Be ‘Functional Cure’ for Diabetes, but Market Prospects Uncertain

5 days ago | biospace.com | Tristan Mañalac

Vertex Pharmaceuticals’ investigational, off-the-shelf cell therapy zimislecel helps control blood sugar levels in patients with type 1 diabetes, according to a readout from the Phase I/II FORWARD trial presented Friday at the American Diabetes Association meeting in Chicago. Data, which were published simultaneously in The New England Journal of Medicine, showed that 10 of the 12 treated patients who had at least one year’s worth of follow-up did not need insulin treatment.
Zealand’s GLP-1/GLP-2 Drug Elicits Over 11% Weight-Loss-With the Potential for More

1 week ago | biospace.com | Tristan Mañalac

Zealand Pharma’s investigational obesity therapy dapiglutide reduced body weight by more than 11% after 28 weeks of treatment in an early-stage study. That’s an effect analysts say might even be an “underrepresentation” of its true weight-loss potential. Writing to investors on Wednesday, William Blair analysts flagged the “atypical patient characteristics” in Zealand’s study: that 93% of its participants were male.
Cycle Wins First FDA Nod for Ultra-Rare Genetic Disease

1 week ago | biospace.com | Tristan Mañalac

The FDA approved the use of Cycle Pharmaceuticals’ oral drug nitisinone on Thursday. The product will be marketed under the brand name Harliku, for use in adult patients with alkaptonuria. Affecting one in 100,000 to 250,000 people worldwide, alkaptonuria (AKU) is an ultrarare genetic disease caused by a deficiency in the HGD an enzyme.
FDA Freezes Trials Shipping Cells to China, ‘Other Hostile Countries’

1 week ago | biospace.com | Tristan Mañalac

The FDA suspended clinical trials that send living cells and other biological materials overseas for genetic engineering in what the agency branded as “hostile countries.”According to the agency’s announcement of the move on Wednesday, it has accrued “mounting evidence” of studies failing to inform their participants of how biological material, such as DNA, collected during a trial, will be treated.