The study met its primary endpoint, with tilrekimig showing a statistically significant increase in participants who saw a 75% or higher reduction in the eczema area and severity, across all doses tested, compared to placebo.

Tilrekimig is a potentially first-in-class, once-a-month antibody targeting multiple chronic Type 2 inflammatory conditions, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease.

Pfizer (PFE) plans to accelerate tilrekimig to Phase 3 development, with a pivotal study in atopic dermatitis set to start within 2026.

“We are encouraged by the topline Phase 2 results for tilrekimig, which show that combining the potent inhibition of IL-4/13 and TSLP pathways has the potential to deliver improved efficacy over the standard of care for atopic dermatitis,” said Mike Vincent, Chief Inflammation & Immunology Officer at Pfizer. “We plan to advance a broad clinical development program for tilrekimig, a potential first-in-class trispecific antibody discovered at Pfizer, in atopic dermatitis and other Th2-mediated inflammatory diseases including asthma and COPD.”

The Phase 2 study has two ongoing stages: one with participants who previously received biologic treatments and receiving either tilrekimig or placebo, and another with participants receiving either ompekimig or placebo.

Pfizer is also studying tilrekimig in a Phase 2 study in asthma and recently started a Phase 2b/3 study of the drug candidate in COPD.

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With its New Drug Application, the Durham, NC-based biotech seeks U.S. approval of brepocitinib as a treatment for dermatomyositis, a rare disease characterized by muscle weakness and skin rashes. The FDA has assigned a target action date in Q3 2026 for the NDA.

“We are committed to working closely with the FDA through their review to make this drug available for patients as quickly as possible,” Priovant CEO Ben Zimmer said.

The NDA is supported by data from the company’s 241-patient Phase 3 VALOR study, in which brepocitinib at 30 mg led to a statistically significant improvement in a clinical measure called the myositis Total Improvement Score, reaching the study’s main goal.

Priovant, which was established in 2021 as part of a transaction between Pfizer (PFE) and Roivant Sciences (ROIV), stated that if approved, brepocitinib will be the first FDA-approved targeted therapy for dermatomyositis.

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The California and Arizona attorneys general announced that 14 states and Pennsylvania Governor Josh Shapiro teamed up to file the lawsuit on Tuesday, which challenges the CDC’s move to recommend fewer shots for most American children earlier this year.

“Undermining confidence in vaccines will lead to lower vaccination rates and more infectious disease,” California Attorney General Rob Bonta said in a statement. “It will also drive up costs for states, including increased Medicaid spending and new expenses to combat misinformation and revise public health guidance.”

In addition to the California and Arizona attorneys general, plaintiffs in the suit include AGs in Colorado, Connecticut, Delaware, Maine, Maryland, Michigan, Minnesota, New Jersey, New Mexico, Oregon, Rhode Island, and Wisconsin, as well as the governor of Pennsylvania.

The lawsuit filed in a Northern California federal court named the U.S. Department of Health and Human Services and Health Secretary Robert F. Kennedy Jr. as defendants. It also named the CDC and its acting director, Dr. Jay Bhattacharya.

The lawsuit also challenges RFK Jr.’s decision to dismiss all members of the CDC’s Advisory Committee on Immunization Practices (ACIP) last year and replace them with his handpicked experts, some of whom have a history of criticizing messenger RNA-based COVID-19 shots.

The case is similar to another lawsuit filed by some of the leading medical groups, including the American Academy of Pediatrics and the American Public Health Association, against the Trump administration in a federal court in Massachusetts earlier this month.

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The decision, based on data from the company’s Phase 3 BREAKWATER trial, permits the marketing of the once-daily drug as part of a combination therapy for previously untreated mCRC patients with a BRAF V600E mutation in their cancers.

In December 2024, the FDA greenlighted Braftovi under its accelerated approval pathway for the same indication after BREAKWATER met one of its dual primary endpoints related to confirmed overall response rate.

Regarding its other dual primary endpoint of progression-free survival, the FDA said that Braftovi, with cancer therapy cetuximab, led to a median PFS of 12.8 months in the study for newly diagnosed BRAF V600E-mutant mCRC patients.

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On Thursday, multiple media outlets reported that the CDC has postponed the meeting of its Advisory Committee on Immunization Practices ((ACIP)), which was previously scheduled to take place from Feb. 25 to 27.

The decision came after several leading medical groups filed a lawsuit seeking a ruling to bar the CDC from holding the meeting, citing, among other things, HHS Secretary Robert F. Kennedy Jr.’s move to reconstitute the panel with his handpicked members last year.

The CDC’s ACIP panel issues non-binding recommendations to the agency regarding who should receive FDA-approved vaccines in the U.S., making their input critical for companies in receiving insurance coverage for their products.

Leading vaccine makers: GSK (GSK), Sanofi (SNY), Pfizer (PFE), Moderna (MRNA), BioNTech (BNTX), Novavax (NVAX), Merck (MRK), AstraZeneca (AZN)

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“Through this strategic collaboration with Pfizer China, we look forward to fully integrating Sciwind Biosciences’ innovative scientific achievements with Pfizer China’s best-in-class commercialization capabilities to accelerate the commercialization of Ecnoglutide.” said Sciwind Biosciences.

More on Pfizer

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• Q4 Healthcare Dividends: Johnson & Johnson Kept Outshining Pfizer (Rating Upgrades)
• Pfizer: Recovery Isn’t Over, Battered Valuation Still Discounts Its Turnaround Game
• CDC Deputy Director Ralph Abraham steps down
• Pharmaceutical tariffs still in play despite Supreme Court ruling

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German vaccine maker BioNTech (BNTX) sued the Cambridge, Massachusetts-based biotech company on Thursday, alleging that Moderna’s (MRNA) COVID-19 vaccine, mNEXSPIKE, violates a patent related to its rival shot, Comirnaty.

The lawsuit filed in Delaware federal court claimed that mNEXSPIKE, which was approved by the U.S. FDA in 2025, infringed upon BioNTech’s (BNTX) Patent No. 12,133,899.

The patent in question covers a streamlined messenger RNA-based vaccine design that BioNTech (BNTX) claimed it discovered while developing Comirnaty with its partner Pfizer (PFE). However, the New York-based pharma giant is not directly involved in the case.

The messenger RNA-based vaccine is expected to account for 55% of Moderna’s (MRNA) vaccine revenue during the 2025/26 respiratory virus season, according to the suit.

A Moderna (MRNA) spokesperson told Bloomberg that it is aware of the lawsuit and “will defend ourselves against these claims.” BioNTech (BNTX) wasn’t immediately available for requests for comments.

The lawsuit marked the latest patent row among the COVID-19 vaccine makers. Moderna (MRNA) filed lawsuits against Pfizer (PFE) and BioNTech (BNTX) in 2022, claiming their COVID-19 vaccine infringed upon its patent rights.

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