PFIZER INC.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1849-01-01
- Employees
- 88K
- Market Cap
- $163.3B
- Website
- http://www.pfizer.com
Samsung Biologics to Spin Off Biosimilar Business to Focus on Core CDMO Services
• Samsung Biologics announced plans to establish Samsung Epis Holdings, which will incorporate Samsung Bioepis as a wholly owned subsidiary, separating its biosimilar development from CDMO operations.
• The strategic spinoff aims to streamline operations by allowing each business to focus on their different revenue models, with final shareholder approval scheduled for September 16.
• As one of the world's leading CDMO firms, Samsung Biologics reported impressive financial performance with $3.3 billion in sales and $1 billion in net profit in 2024.
FDA Expands Warning for mRNA COVID-19 Vaccines Due to Heart Side Effect Risk in Young Males
• The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses.
• New warnings cite data from the FDA's safety surveillance system and a 2023 study showing that while clinical courses were generally mild, myocardial injury was common among affected individuals.
• Health officials maintain that these heart conditions remain rare complications, with CDC data indicating they typically resolve quickly, though studies are ongoing to determine potential long-term effects.
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
• The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010.
• Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.
Dementia Discovery Fund Secures $269M in Second Fund to Accelerate Novel Therapeutics Development
• The Dementia Discovery Fund (DDF), managed by SV Health Investors, has closed its second fund with $269 million in commitments, bringing its total raised capital to over $550 million for dementia therapeutics development.
• The fund has secured backing from previous cornerstone investors including AARP, British Business Bank, Gates Frontier, pharmaceutical giants Bristol Myers Squibb, Eli Lilly, and Pfizer, with the Alzheimer's Association joining as a new investor.
• DDF-2 has already invested in four companies and aims to build a portfolio of 10-15 innovative biotech ventures across the UK, Europe, and US, addressing the urgent global challenge of dementia affecting over 50 million people worldwide.
SK Bioscience Wins Patent Dispute Against Pfizer Over Pneumococcal Vaccine Components
• South Korea's Supreme Court ruled that SK bioscience's PCV13 components do not infringe on Pfizer's patent claims, allowing the company to export vaccine components to high-demand markets.
• Despite the victory, SK bioscience remains restricted from selling its domestically developed SKYPneumo vaccine in South Korea until 2027 due to a separate patent dispute with Pfizer.
• SK bioscience is simultaneously developing a more advanced 21-valent pneumococcal conjugate vaccine in collaboration with Sanofi, which entered global Phase 3 clinical trials in late 2024.
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
FDA Advisory Committee Rejects New Indications for Genentech's Columvi and Pfizer's Talzenna Combination
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against approving Genentech's Columvi for a new indication, citing concerns about the pivotal trial's applicability to US patients.
• In a separate decision, the same committee unanimously rejected (8-0) Pfizer's application for Talzenna in combination with Xtandi for first-line treatment in adults with prostate cancer.
• These negative recommendations highlight the FDA's increasing scrutiny of oncology drug applications and may signal stricter requirements for clinical trial design and population representation.
CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025
• CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
• The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
• CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.
FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children
• The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups.
• Under the new framework, COVID-19 vaccines will remain readily available through streamlined approvals only for adults 65 and older and those with health conditions that increase risk of severe COVID-19.
• The policy shift, spearheaded by FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, represents a significant departure from the previous "one-size-fits-all" approach to COVID-19 vaccination recommendations.
Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
FDA Advisory Committee Rejects Pfizer's Talzenna Expansion for Broader Prostate Cancer Population
• Pfizer's application to expand Talzenna's indication to all castration-resistant prostate cancer (CRPC) patients was rejected by FDA's advisory committee due to insufficient data in biomarker-negative patients.
• The company sought to broaden Talzenna's current approval beyond patients with HRR gene mutations, but FDA questioned the reliance on an "incompletely defined" subgroup analysis.
• FDA oncology chief Richard Pazdur emphasized that chance effects could not be ruled out due to the lack of a formal efficacy analysis in patients without HRR mutations.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Sanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma
• Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.
• The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026.
• Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.
CureVac Wins Key Patent Validity Decision in Ongoing mRNA Litigation Against BioNTech
• European Patent Office largely upholds CureVac's patent EP 3 708 668 B1 for split poly-A tail technology, a foundational mRNA innovation, dismissing BioNTech's opposition challenge.
• The ruling represents a significant milestone in the broader patent dispute between the two companies, with an infringement hearing scheduled for July 1, 2025, at the Regional Court Düsseldorf.
• CureVac seeks recognition and compensation for its pioneering contributions to mRNA technology that enabled the development of COVID-19 vaccines.
Roche Expands Molecular Glue Portfolio with $2 Billion Monte Rosa Partnership
• Roche has signed a $2 billion partnership with Monte Rosa Therapeutics, including a $50 million upfront payment, to develop molecular glue therapies targeting previously "undruggable" proteins in cancer and neurological diseases.
• This marks Roche's second major molecular glue deal in a month, following a similar $2 billion alliance with Orionis Biosciences, demonstrating the company's strategic push to establish leadership in this emerging therapeutic category.
• Monte Rosa will lead discovery and preclinical activities using its QuEEN platform, with Roche taking over late-stage development of candidates that can potentially address the 80% of human proteins currently inaccessible to traditional drug development approaches.
TALAPRO-2 Trial: Talazoparib-Enzalutamide Combo Shows Significant Survival Benefit in Metastatic Prostate Cancer
• The combination of talazoparib and enzalutamide demonstrated an 8.8-month improvement in overall survival compared to enzalutamide alone in metastatic castration-resistant prostate cancer patients.
• Patients with homologous recombination repair-deficient tumors showed an even more pronounced benefit, with a 14-month survival improvement and 38% reduction in death risk.
• The phase 3 TALAPRO-2 trial revealed manageable safety profiles with no new concerns, despite grade 3/4 anemia occurring in 49% of patients, which was effectively managed through dose adjustments.
FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment
• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment.
• The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s.
• STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations.
• The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.
FDA Approves Pfizer's Hympavzi (Marstacimab) for Hemophilia A and B
• The FDA has approved Hympavzi (marstacimab) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B.
• Hympavzi is the first anti-tissue factor pathway inhibitor approved in the U.S. for hemophilia A or B, offering a novel mechanism of action.
• Clinical trials demonstrated Hympavzi significantly reduced annualized bleeding rates compared to both on-demand and routine prophylactic treatments.
• The drug is administered via a convenient once-weekly subcutaneous injection, providing an alternative to frequent intravenous infusions.
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