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Pfizer granted priority review for new multiple myeloma therapy

High Priority

The FDA has granted priority review for Pfizer's novel BCMA-targeted therapy for relapsed/refractory multiple myeloma. The PDUFA date is set for October 15, 2025.

Implications:

This priority review could accelerate Pfizer's entry into the multiple myeloma market with a potential approval 4 months ahead of schedule. If approved, this would be the third BCMA-targeted therapy on the market, increasing competition in this space.

Recommendations:

Consider accelerating development timelines for competing multiple myeloma assets. Prepare market access strategy to differentiate from Pfizer's offering.

Multiple Myeloma Regulatory
May 28, 2025 - 10:30 AM

AstraZeneca reports positive Phase 3 results for IL-13 inhibitor in severe asthma

Medium Priority

AstraZeneca announced positive topline results from their Phase 3 trial of their IL-13 inhibitor in severe asthma. The study met its primary endpoint of reduction in exacerbation rate.

Implications:

These results strengthen AstraZeneca's position in the severe asthma market. The data showed a 56% reduction in exacerbation rate compared to placebo, which is comparable to existing biologics in this space.

Recommendations:

Monitor for full data presentation at upcoming respiratory conferences. Consider conducting a comparative analysis against our pipeline assets in development for severe asthma.

Severe Asthma Clinical Trial
May 27, 2025 - 2:15 PM

Roche announces collaboration with biotech for novel multiple myeloma target

Medium Priority

Roche has announced a strategic collaboration with a biotech company to develop a novel target for multiple myeloma. The deal includes $40M upfront with potential milestone payments of up to $1.5B.

Implications:

This collaboration signals Roche's continued interest in expanding their presence in multiple myeloma. The novel target appears to be complementary to existing BCMA-targeted approaches.

Recommendations:

Investigate the specific target and mechanism of action. Consider similar partnership opportunities with other biotechs working on novel multiple myeloma targets.

Multiple Myeloma Business Development
May 26, 2025 - 9:45 AM

New publication on long-term safety of IL-23 inhibitors in psoriasis

Low Priority

A new meta-analysis published in JAMA Dermatology examined the long-term safety profile of IL-23 inhibitors in moderate-to-severe plaque psoriasis, showing favorable safety outcomes over 5 years.

Implications:

This publication strengthens the overall safety profile of the IL-23 inhibitor class. The meta-analysis included data from multiple products across different manufacturers.

Recommendations:

Consider incorporating these findings into medical communications for our IL-23 inhibitor. The long-term safety data could be valuable for discussions with healthcare providers.

Psoriasis Publication
May 25, 2025 - 11:20 AM

BMS submits sNDA for psoriasis indication expansion

Medium Priority

Bristol Myers Squibb has submitted a supplemental New Drug Application (sNDA) to expand the indication of their IL-17 inhibitor to include moderate-to-severe plaque psoriasis in adolescents.

Implications:

If approved, this would be the second IL-17 inhibitor approved for adolescent psoriasis, expanding BMS's addressable market. The pediatric psoriasis market remains relatively underserved.

Recommendations:

Evaluate the potential for pediatric studies with our psoriasis assets. Consider market research to understand the size and needs of the adolescent psoriasis population.

Psoriasis Regulatory
May 24, 2025 - 3:40 PM
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