BioSpace

06/09/2024

Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.

Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.

06/09/2024

Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.

Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.

06/09/2024

Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics M**A-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.

Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ M**A-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.

06/09/2024

If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month— Sanofi and Regeneron’s blockbuster Dupixent.

If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month—Sanofi and Regeneron’s blockbuster Dupixent.

06/09/2024

With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.

With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.

06/09/2024

Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.

Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.

05/09/2024

BioMarin Pharmaceutical executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting.

BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting.

05/09/2024

Facing financial challenges, IN8bio is looking to preserve cash resources through a pipeline prioritization and layoffs at its New York City and Birmingham, Alabama, sites.

Facing financial challenges, IN8bio is looking to preserve cash resources through a pipeline prioritization and layoffs at its New York City and Birmingham, Alabama, sites.

05/09/2024

Eli Lilly and Company’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.

Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.

05/09/2024

A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following U.S. Food and Drug Administration approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.

A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.

05/09/2024

Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.

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Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.

05/09/2024

Novartis is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.

The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.

05/09/2024

Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.

Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.

05/09/2024

ImmunityBio will lay off 16 employees in El Segundo, California, and said it expects to need more funding to commercialize Anktiva, approved in April for non-muscle invasive bladder cancer.

ImmunityBio will lay off 16 employees in El Segundo, California, and said it expects to need more funding to commercialize Anktiva, approved in April for non-muscle invasive bladder cancer.

04/09/2024

Less than three months after filing for voluntary chapter 11 protection, DermTech is laying off 51 employees in San Diego, according to a Worker Adjustment and Retraining Notification Act notice. The layoffs are effective Sept. 6. Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.

Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.

04/09/2024

Under a multi-year agreement announced Wednesday, Eli Lilly and Company will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.

Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.

04/09/2024

Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.

Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.

04/09/2024

BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial.

BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial.

04/09/2024

The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.

The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.

04/09/2024

Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.

Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.

04/09/2024

Eli Lilly and Company offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.

Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.

04/09/2024

Getting caught between younger team members and older bosses can be stressful for millennial managers. A leadership expert and millennial manager share tips for bridging the gap between these groups.

Getting caught between younger team members and older bosses can be stressful for millennial managers. A leadership expert and millennial manager share tips for bridging the gap between these groups.

04/09/2024

There is still time to register for the upcoming live webinar, Embracing Agility: Critical for the role of QARA professional?. Join IQVIA Technologies and the BioSpace Insights team to explore strategies, best practices and the evolving landscape of QARA in today’s dynamic market.

Click here to learn more and register to join: https://hubs.li/Q02KPPpx0

04/09/2024

Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Company and Pfizer are leading the way.

Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way.

04/09/2024

Having difficult conversations with the right mindset can build trust and further develop your relationship with your team. Here is a peek inside our Manager’s Toolbox: How to Have Difficult Conversations.

Having difficult conversations with the right mindset can build trust and further develop your relationship with your team.

04/09/2024

The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.

The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.

04/09/2024

Analysts expect the companies’ Eylea HD and Vabysmo to generate $13.2 billion between them by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.

Analysts expect the companies’ Eylea HD and Vabysmo to generate $13.2 billion between them by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.

03/09/2024

Astellas Gene Therapies is closing its San Francisco biomanufacturing facility, shifting gene therapy manufacturing to North Carolina, cutting at least 17 employees and affecting dozens more.

Astellas Gene Therapies is closing its San Francisco biomanufacturing facility, shifting gene therapy manufacturing to North Carolina, cutting at least 17 employees and affecting dozens more.

03/09/2024

Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.

Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.

03/09/2024

On Friday, the FDA authorized the company’s updated COVID-19 vaccine as the third booster option for Americans this fall. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.

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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.