Pfizer Inc.
American multinational pharmaceutical and biotechnology corporation, develops medications and vaccines across immunology, oncology, cardiology, endocrinology, and neurology.
Clinical Trials
5236
1758 active
Approvals
91
Total approvals
Agencies
2
Regulatory bodies
Founded
1849
Not yet recruiting
62
1.2%
No Longer Available
14
0.3%
Terminated
454
8.7%
Recruiting
280
5.3%
Suspended
1
0.0%
Approved For Marketing
4
0.1%
Available
4
0.1%
Withdrawn
126
2.4%
Active, not recruiting
1696
32.4%
Unknown
4
0.1%
Completed
2590
49.5%
- Adding tucatinib to trastuzumab and pertuzumab maintenance after first-line induction chemotherapy extended median investigator-assessed PFS to 24.9 months versus 16.3 months with placebo in the phase III HER2CLIMB-05 trial. - The hazard ratio was 0.641 (95% CI, 0.514-0.799; P<0.0001), an 8.6-month median gain and a 36% relative reduction in progression or death across 654 randomized patients. - PFS benefit was consistent across prespecified subgroups including hormone receptor status, baseline brain metastases and induction response, while overall survival and CNS outcomes remain immature. - Tucatinib increased toxicity, with diarrhea in 67% versus 47% of controls and serious treatment-emergent adverse events in 16.9% versus 8.0%.
- The Trump administration said all 50 state Medicaid programs have agreed to participate in the GENEROUS international reference-pricing model, which launched in January as a five-year voluntary program. - CMS calculates a most-favored-nation price from manufacturer-reported data in eight countries, using the second-lowest net international price adjusted for purchasing power parity. - A White House analysis estimated a Medicaid MFN framework could save about $64.3 billion over 10 years, though KFF says savings depend on participation and confidential pricing data. - Documents obtained by Public Citizen show Pfizer agreed to share part of net increased foreign revenue with HHS from January 2026 through January 2029 under its MFN contract.
- The EPO Boards of Appeal revoked EP 3 590 949, a Moderna mRNA vaccine patent that had been upheld at first instance. - Board of Appeal 3.3.08 issued the decision after a two-day oral hearing, with added matter cited as a likely factor. - The ruling removes patent grounds Moderna had used against BioNTech and Pfizer, though divisional applications and further litigation remain.
- The US Treasury is drafting rules that would likely let pharmaceutical companies keep striking most licensing deals for Chinese-developed drugs, according to three people briefed on the process. - The rules would permit investment in promising Chinese drugs unless they involve pathogens or biotechnology that could be weaponized, and remain unfinalized and subject to change. - Outside licensing deals in Chinese biotech reached $115 billion last year, and almost half of US deals to license drugs from abroad in 2025 were with Chinese companies. - Pfizer and other large drugmakers have lobbied against broad restrictions, while some smaller biotechs and lawmakers are pushing for tighter Treasury oversight of China biotech transactions.
- The EMA's CHMP adopted a positive opinion recommending KEYTRUDA plus Padcev as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer. - The recommendation is based on the Phase 3 KEYNOTE-B15 trial, which reduced event-free survival events by 47% versus neoadjuvant chemotherapy and surgery. - KEYNOTE-B15 also showed a 35% reduction in risk of death and a pathologic complete response rate of 55.8% versus 32.5% with chemotherapy. - The European Commission will review the opinion, with a final decision on marketing authorization in the EU expected by the fourth quarter of 2026.
- The CHMP has adopted a positive opinion recommending enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer in the EU. - The opinion rests on Phase 3 EV-304 data showing a 47% reduction in risk of recurrence, progression or death and a 35% reduction in risk of death versus gemcitabine-cisplatin. - If the European Commission approves, the MIBC indication would extend from cisplatin-ineligible patients to all adults with resectable disease regardless of cisplatin eligibility.
- Health Canada has authorized an XFG variant-adapted COMIRNATY vaccine for active immunization against COVID-19 in individuals aged 6 months and older. - The 2026-2027 formula targets the Omicron XFG lineage, aligning with public health recommendations to more closely match currently circulating variants. - Pfizer Canada says it has secured sufficient inventory for federal and provincial vaccination programs, with doses reaching distribution channels in the coming days and weeks.
- Genentech reported that Lunsumio plus lenalidomide significantly improved progression-free survival versus rituximab plus lenalidomide in relapsed or refractory follicular lymphoma. - The Phase III CELESTIMO trial met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful reduction in disease progression risk. - CELESTIMO is a confirmatory study intended to convert Lunsumio's accelerated third-line approval to full approval and secure a second-line or later indication. - Overall survival data were immature, no new safety signals emerged, and full results including the hazard ratio are awaited at an upcoming medical meeting.
- Pfizer withdrew its EU marketing authorization application for subcutaneous anti-PD-1 antibody Zumrad (sasanlimab) in BCG-naive, high-risk non-muscle invasive bladder cancer on 13 February 2026. - The EMA's CHMP provisionally concluded the drug could not be authorized, citing protocol changes during the pivotal CREST trial and a statistical analysis method altered to favor a positive result. - Regulators also flagged the unblinded investigator-assessed event-free survival endpoint as potentially biased and noted overall survival data did not support the primary finding.
- A modeling study in The Lancet projects Medicare's most-favored-nation pricing policy would cut spending by $5.2 billion under GLOBE and $6.4 billion under GUARD in its initial phase. - For roughly three in four medicines studied, Medicare savings would approach four times that drug's entire annual sales in the reference country, creating incentives to alter pricing abroad. - Reported confidential agreements with 17 manufacturers could reduce the policy's projected Medicare savings by 71 percent, according to the analysis. - The White House separately announced that all 50 state Medicaid programs will receive most-favored-nation rebates on brand-name drugs, with taxpayer savings estimated at $64.3 billion over a decade.
