A randomized, parallel controlled, double-blind, single-center phase I trial of recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) in people aged 18 years or older who have been immunized with COVID-19 vaccine for 3 months or more, or who have been infected with COVID-19 for 3 months or more

Start Date11 Mar 2023

Sponsor / Collaborator-

NCT05710289 / WithdrawnNot Applicable

A Prospective Blood Collection Study to Assess the Immunogenicity of Homologous Booster Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization Among Adults of 18 Years and Older.

The purpose of this study is to assess the immunogenicity of nationally available pre-defined homologous booster vaccination of a SARS-CoV-2 WHO EUA qualified vaccination in adults aged 18 years and older

Start Date01 Feb 2023

Sponsor / Collaborator

SK bioscience Co., Ltd.

[+1]

100 Clinical Results associated with COVID-19 Vaccine(Janssen)

100 Translational Medicine associated with COVID-19 Vaccine(Janssen)

100 Patents (Medical) associated with COVID-19 Vaccine(Janssen)

11,734

Literatures (Medical) associated with COVID-19 Vaccine(Janssen)

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Polysaccharide, Conjugate, and mRNA-based Vaccines are Immunogenic in Patients with Netherton Syndrome

Article

Author: Pasmans, Suzanne G M A ; Geers, Daryl ; Zaeck, Luca M ; Dalm, Virgil A S H ; de Vries, Rory D. ; Schappin, Renske ; GeurtsvanKessel, Corine H. ; Dik, Willem A. ; Zaeck, Luca M. ; Dik, Willem A ; Pasmans, Suzanne G. M. A. ; Bogers, Susanne ; Dalm, Virgil A. S. H. ; Gommers, Lennert ; Nouwen, Anouk E M ; GeurtsvanKessel, Corine H ; Nouwen, Anouk E. M. ; de Vries, Rory D

Abstract:

Background:

Netherton syndrome (NS) is a rare, severe genetic skin disorder, currently classified as an inborn error of immunity (IEI) due to previously reported immune dysregulation. We recently reported the results of an immunological evaluation showing no evidence for a relevant B- and/or T-cell mediated immunodeficiency, but immune responses after vaccination were not evaluated in that study. Therefore, we evaluated immune responses to three vaccine platforms in adult NS patients to further investigate the presence of a clinically relevant B- and/or T-cell immunodeficiency.

Methods:

Vaccination responses in eight adult NS patients were assessed in a cross-sectional study performed between January and August 2022. Clinical patient data were retrospectively retrieved from electronic patient files. Immune responses to a polysaccharide Streptococcus pneumoniae vaccine (PPV23) and conjugate Haemophilus influenzae type b vaccine (ActHiB) were measured. SARS-CoV-2-specific (functional) antibody and T-cell responses following booster vaccination with an mRNA-based COVID-19 vaccine were compared to controls.

Results:

None of the included patients suffered from recurrent and/or severe infections that could be attributed to a B- and/or T-cell immunodeficiency. ActHiB induced immune responses were normal in 7/7 NS patients. PPV23 induced responses were absent in 1/7, diminished in 2/7, and normal in 4/7 patients. Levels of SARS-CoV-2-specific binding and neutralizing antibodies after mRNA-based COVID-19 booster vaccination in NS patients were comparable to controls. SARS-CoV-2-specific CD4 + T-cell responses were detectable in all NS patients. In contrast, SARS-CoV-2-specific CD8 + T-cell responses were detectable in only 2/6 NS patients. T-cell responses to a positive control antigen pool were comparable to controls.

Conclusions:

Vaccine-induced immune responses were detectable after polysaccharide, conjugate and mRNA-based vaccination in our cohort of NS patients. A spectrum of responsiveness to vaccine challenges was found, with the ranges of vaccine responses overlapping those demonstrated in healthy control populations.

01 Dec 2025·Current Neurology and Neuroscience Reports

The Set up and the Triggers: An Update on the Risk Factors for Giant Cell Arteritis

Review

Author: Harnke, Ben ; Labowsky, Mary

PURPOSE OF REVIEW:

To describe recent research relevant to factors which predispose to giant cell arteritis (GCA) and those which trigger its manifestation, with particular emphasis on the more recent and controversial associations (COVID-19, vaccination, novel medications) which have changed the medical landscape and perhaps GCA prevalence.

RECENT FINDINGS:

GCA remains more prevalent in Caucasians but nevertheless affects other racial groups. Certain HLA haplotypes (i.e. DRB1*04) incurs risk of GCA. Polymyalgia rheumatica remains a strong association, and recent evidence also associates GCA with hematologic malignancy. COVID-19 infection may trigger GCA, in addition to vaccination (particularly the COVID-19 vaccine) and reactivated VZV infection, though the latter may be related to a common trigger. PD1-inhibitors may be associated with GCA. Previously establish patterns in geography and latitude are supported. A seasonal pattern of GCA in the summer/spring months is suggested but not proven. Controversy regarding GCA risk factors exists, as well as to whether the overall prevalence of GCA is rising. Given the growing aging population, the total number of cases of GCA will certainly increase, a challenge to which that our healthcare system must continue to rise to meet.

01 Mar 2025·AMERICAN HEART JOURNAL

Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study

Article

Author: de Luise, Cynthia ; Newburger, Jane W ; Russell, Mark W ; Taylor, Michael D ; Bainton, Jessica ; Dionne, Audrey ; Powell, Andrew J ; Jone, Pei-Ni ; Baker, Annette ; Graham, Emily ; Coleman, Julia ; Wheaton, Olivia ; Harty, Brian J ; Cai, Bing ; Portman, Michael A ; Sabati, Arash A ; Gayed, Juleen ; Friedman, Kevin ; Bradford, Tamara T ; Lanes, Stephan ; Truong, Dongngan T ; Pearson, Gail D

BACKGROUND:

Minimal data are available on mid- and long-term outcomes following COVID-19 vaccine-associated myocarditis/pericarditis. The COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) study aims to characterize the mid- and long-term sequelae of myocarditis/pericarditis following administration of any Pfizer-BioNTech COVID-19 vaccine (herein referred to as COMIRNATY®). Herein we describe the rationale and design of CAMP.

METHODS:

This ongoing and actively enrolling multicenter observational cohort study across 32 North American pediatric cardiac centers will include at least 200 patients <21 years-old who presented ≤21 days from COMIRNATY® vaccination and meet the Centers for Disease Control and Prevention (CDC) case definition of probable or confirmed myocarditis/pericarditis or isolated pericarditis. The comparison cohort will consist of 100 patients <21 years-old with COVID-19 associated myocarditis/pericarditis, including those who meet the contemporaneous CDC case definition of multisystem inflammatory syndrome (MIS-C). The study will collect detailed hospital and follow-up data for up to 5 years following illness onset. Electrocardiograms, echocardiograms, and cardiac magnetic resonance (CMR) examinations will be interpreted in core laboratories. The primary outcomes are 1) composite of left ventricular ejection fraction <55% by echocardiogram, findings of myocarditis by original or revised Lake Louise criteria on CMR, and/or the presence of high-grade arrhythmias or conduction system disturbances at 6 months after myocarditis/pericarditis onset; 2) complications, such as death, and non-cardiac morbidities; and 3) patient-reported outcomes of global health, functional status, and quality of life. Analyses will include descriptive statistics and regression modeling.

CURRENT STATUS:

Still enrolling, with 273 participants currently enrolled as of 10/16/2024 (173 vaccine-associated myocarditis/pericarditis, 100 COVID-19-associated myocarditis/pericarditis) CONCLUSIONS: With long-term follow-up and core laboratories for standardized assessments of cardiac testing, the CAMP study will make important contributions to our understanding of the mid- and long-term cardiac and non-cardiac sequelae of COVID-19 vaccine-associated myocarditis/pericarditis.

1,537

News (Medical) associated with COVID-19 Vaccine(Janssen)

13 Dec 2024

·www.prnewswire.com

Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement of First $50 Million Milestone

Novavax continues to progress Sanofi agreement by achieving first milestone, with additional milestones and ongoing tiered royalties to come, solidifying a strong model for future partnerships Novavax's COVID-19 vaccine included in Sanofi's two combination vaccine candidates for prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated and Fast Track designation recently granted in the U.S. GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi. "Novavax is steadily advancing our new corporate growth strategy. By achieving this milestone in our collaboration agreement with Sanofi, as well as the upcoming sale of our Czech Republic manufacturing site, we are strengthening our balance sheet as well as delivering significant cost reductions," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition, Sanofi recently announced it received U.S. FDA Fast Track designation for two vaccine candidates combining our proven COVID-19 vaccine with its market-leading influenza vaccines. These assets have progressed to Phase 1/2 clinical trials, with the potential for future Novavax milestone payments and royalties, if successful." The $50 million milestone is the first following the initial upfront payment at signing of the agreement with Sanofi in May 2024. Following this payment, there are additional potential milestones of up to $300 million related to Novavax's partnered COVID-19 vaccine that will be recognized in the periods when earned. In addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones. In addition, both stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties. Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant, and up to $210 million in milestone payments for each product including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M. Novavax's corporate growth strategy includes efforts to pursue additional partnerships for its late-stage and early-stage Research and Development assets and Matrix-M adjuvant alone. This growth strategy should position the Company for ongoing value creation as additional partnerships are secured under a similar contractual framework. About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes its COVID-19 vaccine and its pipeline includes its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, the possible achievement of additional milestones or receive royalties, and efforts to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024-2025 formula COVID-19 vaccine and the impact of its not having received a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Giovanna Chandler 240-720-7804 [email protected] SOURCE Novavax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccineFast TrackLicense out/inClinical StudyEmergency Use Authorization

12 Dec 2024

·pmlive.com

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

Sanofi has announced that its two combination vaccine candidates for COVID-19 and influenza (flu) have been granted fast track designation by the US Food and Drug Administration (FDA) for use in individuals aged 50 years and older. The regulator’s decision comes seven months after Sanofi gained a sole licence to Novavax’s adjuvanted COVID-19 vaccine for use in combination with its own licensed flu vaccines. It is hoped that the combined vaccine approach will alleviate the impact of both respiratory illnesses while simplifying immunisation practices for healthcare providers and patients, potentially leading to higher vaccine uptake. Sanofi’s first vaccine candidate combines its protein-based trivalent flu vaccine Fluzone High-Dose with Novavax’s adjuvanted recombinant COVID-19 vaccine, while the second consists of Sanofi’s recombinant protein-based trivalent flu vaccine Flublok and the Novavax vaccine. The combination vaccines will now benefit from the FDA’s fast-track process, which is designed to support the development and accelerate the review of products that address serious conditions. Clinical trials have shown that Fluzone and Flublok can prevent more flu infections in older adults than standard-dose flu vaccines, Sanofi said, adding that both vaccines have demonstrated significant and consistent reductions in flu-related hospitalisations in real-world evidence studies. Novavax’s COVID-19 vaccine has also been associated with a better tolerability profile than currently available mRNA COVID-19 vaccines when given as a booster dose, and has demonstrated high efficacy against COVID-19 as a primary vaccination in two late-stage studies, the company said. Sanofi has already initiated two separate phase 1/2 studies to evaluate the safety and immune response generated by the combination vaccines. Thomas Triomphe, executive vice president, vaccines at Sanofi, said: “Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the… levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Sanofi and Novavax’s licensing agreement announced in May, worth over $1.2bn, also gave Sanofi a co-exclusive licence to co-commercialise Novavax’s adjuvanted COVID-19 vaccine globally, except in countries that Novavax has existing partnership agreements with, as well as a non-exclusive licence to use the company’s Matrix-M adjuvant in vaccine products and a less than 5% stake in Novavax.

VaccineLicense out/inFast TrackClinical StudyEmergency Use Authorization

12 Dec 2024

·www.pharmaceutical-technology.com

Sanofi’s combo vaccines gain FDA fast track designation

The two candidates protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. Credit: fizkes/Shutterstock. Sanofi has announced that its two combination vaccine candidates, designed to prevent both influenza and Covid-19 infections in people aged 50 years and above, have received fast track designation from the US Food and Drug Administration (FDA). The candidates merge two existing vaccines that have demonstrated efficacy and favourable tolerability through randomised controlled studies. The first candidate combines the Fluzone high-dose influenza vaccine and the adjuvanted Novavax Covid-19 vaccine. The second merges Flublok, an influenza recombinant protein-based vaccine, with the Novavax vaccine. These influenza vaccines have significantly reduced flu-related hospitalisations in real-world evidence studies. The Novavax COVID-19 vaccine, when used as a booster dose, has a better tolerability profile than currently available mRNA vaccines and has shown high efficacy in two pivotal Phase III trials. Sanofi Vaccines executive vice-president Thomas Triomphe stated: “Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. “Our goal is to develop a combined flu and Covid-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry-leading levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.” Two separate Phase I/II trials (NCT06695117 and NCT06695130) to assess the immune response and safety of the combo candidates have been commenced by the company. These randomised, parallel, multi-arm, modified double-blind studies are set to provide further insights into the vaccines’ performance. The two candidates aim to protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections. The use of combination vaccines could simplify immunisation programmes, offering quicker administration, fewer injections, reduced errors and decreased syringe and vial disposal needs. This announcement follows the European Medicines Agency’s approval in November 2024 of Sanofi/Regeneron’s Dupixent for treating eosinophilic esophagitis.

Phase 3VaccineFast TrackClinical ResultDrug Approval

100 Deals associated with COVID-19 Vaccine(Janssen)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07B	DB15857

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	US	Janssen Pharmaceuticals, Inc.	27 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	US	Janssen Vaccines & Prevention BV	02 Nov 2021
Influenza, Human	Phase 3	BE	Janssen Vaccines & Prevention BV	02 Nov 2021
Influenza, Human	Phase 3	PL	Janssen Vaccines & Prevention BV	02 Nov 2021
Severe Acute Respiratory Syndrome	Phase 3	ZA	Janssen Vaccines & Prevention BV	17 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04765384 (HORIZON 1, CTgov)	Phase 2	COVID-19	51	messenger Ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine+COVID-19 mRNA vaccine (Group 1 (Adults): Ad26.COV2.S 5*10^10 vp)	lokrzttyac(dzusxrniwi) = mezptxofzo pjzdisbitz (pmunyxfvpr, pkcyxhlmev - nqhzdoiaso) View more	-	13 Nov 2024
				Ad26.COV2.S (Groups 2 and 3 (Adults): Ad26.COV2.S 5*10^10 vp)	lokrzttyac(dzusxrniwi) = vrrpcjmool pjzdisbitz (pmunyxfvpr, yjcfbpgaae - azmvoccvla) View more
NCT04614948 (ENSEMBLE2 \| ENSEMBLE 2, CTgov)	Phase 3	COVID-19	31,835	adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) (Double Blind Phase: Ad26.COV2.S)	bqpbgvlrnq(ueruyuuakq) = vvcetkkeog cnnyimkkku (xlefyvqtdy, aoomlndlmf - jupdzdkpck) View more	-	09 Oct 2024
				placebo+Ad26.COV2.S (Double Blind Phase: Placebo)	bqpbgvlrnq(ueruyuuakq) = lkylfqfkda cnnyimkkku (xlefyvqtdy, qqgnnzrrac - grcgymnisb) View more
NCT05007080 (HORIZON 2, CTgov)	Phase 2	COVID-19	304	Placebo (Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo)	skmqkegndg(kgtxknahpj) = ijzglqepbc djxjqhmccn (qfodwslrzf, vsatfkomop - txbcrnmxgv) View more	-	23 May 2024
				Placebo (Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo)	skmqkegndg(kgtxknahpj) = glfpowteav djxjqhmccn (qfodwslrzf, ojjqybdbwv - rupkqzjpot) View more
NCT04908722 (CTgov)	Phase 3	COVID-19	1,609	Ad26.COV2.S (Group 1: Ad26.COV2.S 9x10^10 vp)	jgjwmfzkfk(crsvyjivdw) = ndjjoqqzfl ciatsgxogn (pekcaabzsy, unpsmrnlly - pbaxtoceza) View more	-	23 May 2024
				Ad26.COV2.S (Group 2: Ad26.COV2.S 7x10^10 vp)	jgjwmfzkfk(crsvyjivdw) = gnskuwzrfh ciatsgxogn (pekcaabzsy, newbvjsijo - vjztvoluxp) View more
EHA2024	Not Applicable	Chronic Lymphocytic Leukemia	-	COVID-19 vaccine (Individuals diagnosed with CLL before the study start)	sbffugfder(uwojxmyjjc) = prvcjrkisn cruazeidsi (jgmiogrmwl ) View more	-	14 May 2024
AASLD2023	Not Applicable	Liver Diseases	211	COVID-19 vaccine	xkgnjosepj(fufvrltkux) = worsened after vaccination but hadn't clinical significance rjrwrjrotg (hkwshzryzj ) View more	-	10 Nov 2023
				COVID-19 vaccine
NCT05091307 (CTgov)	Phase 3	COVID-19 \| Influenza, Human	861	Placebo+Ad26.COV2.S (Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo)	mihriivoli(zvecfzwbdf) = bknvyqrfqh wcnlisgbsz (vikrdojlmy, nczlfauxst - jaggfgadet) View more	-	08 Aug 2023
				Placebo+Ad26.COV2.S (Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S)	mihriivoli(zvecfzwbdf) = waucnxycwc wcnlisgbsz (vikrdojlmy, nbcdfpkfar - qhiypqsdry) View more
NCT05047640 (CTgov)	Phase 3	COVID-19	58	BNT162b2 vaccine (BNT162b2 Vaccine Group)	mhxwfohhop(icatjrtbuw) = vxkwuhjngg sayujqvzkd (mezyjjvnah, hnykpvzzrr - joartrhdmf) View more	-	22 Jun 2023
				JNJ-78436735 Vaccine (JNJ-78436735 Vaccine Group)	mhxwfohhop(icatjrtbuw) = xbiyspwoiw sayujqvzkd (mezyjjvnah, wrtcxgfcuf - vpjitrlaqi) View more
EULAR2023	Not Applicable	Rheumatic Diseases	162	COVID-19 VACCINE (AIRD patients)	rsazgmnvtv(zknvqjtzoh) = cbsnsdyhag xuutiygxct (hqmmbvpnfa )	Positive	31 May 2023
COVAD (EULAR2023)	Not Applicable	Autoimmune Diseases	9,201	COVID-19 VACCINE (Pregnant with AID*)	qytudgbbcd(dbjlgaurpz) = Overall AE, minor AE, and major AE were reported significantly more frequently by pregnant than non-pregnant patients (45% vs. 26%, p=0.01; 40% vs. 25.9%, p=0.03; 17.5% vs. 4.6%, p<0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC. vhjgxsjgoe (jrkxnbvykl ) View more	-	31 May 2023
				COVID-19 VACCINE (Breastfeeding with AID*)

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