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BioWorld - Wednesday, May 31, 2023
Home » Authors » Lee Landenberger

Lee Landenberger

Articles

ARTICLES

Pfizer posts positive phase III data for its hemophilia A/B treatment

May 30, 2023
By Lee Landenberger
No Comments
Pfizer Inc. has positive phase III data for its hemophilia treatment as it wades deeper into an indication that already has plenty of competition and at least one company with earnings of more than $1 billion. Pfizer’s marstacimab in treating hemophilia could lead to the first once-weekly subcutaneous treatment for hemophilia B and could end up being the first treatment administered as a flat dose for treating hemophilia A or B.
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Bioxcel has mixed phase III data and tough stock day

May 25, 2023
By Lee Landenberger
No Comments
Mixed phase III study results have Bioxcel Therapeutics Inc. moving ahead to complete the clinical trial while withstanding a hammering from investors. BXCL-501 (dexmedetomidine), a sublingual film being developed to treat bipolar disorders- or schizophrenia-associated agitation, produced clinically meaningful efficacy results in part 1 of the pivotal study with half of the approved dose, but the primary efficacy endpoint was not statistically significant at two hours (p=0.077). BXCL-501 separated from placebo at four hours (p=0.049).
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Xacduro

Entasis’ bacterial infection drug receives FDA approval

May 24, 2023
By Lee Landenberger
No Comments
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.
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Icosavax raises $67.8M and posts strong phase I RSV data

May 23, 2023
By Lee Landenberger
No Comments
While pricing a $67.8 million registered direct offering, Icosavax Inc. also released positive top-line interim data from a phase I study of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus in older adults.
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Weathering the storm? Rain’s cancer drug misses phase III goal

May 22, 2023
By Lee Landenberger
No Comments
Rain Oncology Inc.’s only asset failed a pivotal phase III study for treating dedifferentiated liposarcoma, casting shadows on the future of the small molecule and the company’s direction. Milademetan, an oral inhibitor of the MDM2-p53 complex that reactivates p53, missed the Mantra study’s primary endpoint of progression-free survival compared to the standard of care treatment, Yondelis (trabectedin, Johnson & Johnson/Pharmamar SA).
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Woman cooling off in front of fan

Nothing flashy: FDA approves Astellas’ menopause drug

May 16, 2023
By Lee Landenberger
No Comments
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
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Woman cooling off in front of fan

Nothing flashy: FDA approves Astellas’ menopause drug

May 15, 2023
By Lee Landenberger
No Comments
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
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Immunitybio’s bladder cancer candidate hit with a CRL

May 11, 2023
By Lee Landenberger
No Comments
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved.
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Kidneys

Bye bye, bardo: Reata halts development in kidney disease

May 10, 2023
By Lee Landenberger
No Comments
Despite hitting a phase III study’s primary and key secondary endpoints for treating diabetic kidney disease, Reata Pharmaceuticals Inc. is discontinuing its bardoxolone programs for the indication. The data that disappointed Reata were, after three years of treatment, finding no separation in end-stage renal disease events between the bardoxolone and placebo groups.
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Global handshake silhouette

In the ADC race, Eisai and Bliss enter one of the year’s biggest deals

May 9, 2023
By Lee Landenberger
No Comments
In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical (Hangzhou) Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. The massive collaboration is the eighth largest so far this year and one of three that involve ADCs in the year’s top 10 deals.
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View All Articles by Lee Landenberger

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