This is a multi-center, single arm open label phase 1b/2 study of pembrolizumab in combination with 177Lu-PNT2002 (also known as 177Lu-PSMA I&T) radiopharmaceutical therapy in patients with metastatic clear cell renal cell carcinoma (RCC) who have progressed after prior treatment with anti-programmed cell death protein 1 (PD1) or PD-L1 immune-checkpoint inhibitors (ICIs). The study comprises 2 phases: an open-label Phase 1b dose escalation portion followed by a Phase 2 dose expansion portion. Investigators hypothesize that pembrolizumab in combination with 177Lu-PNT2002 in in patients with metastatic clear cell RCC at a biologically active dose will result in tolerable safety profile and it will lead to improved radiological objective responses in patients who have progressed after prior treatment with standard anti-PD1 or anti- Programmed Cell Death Ligand 1 (PDL1) immune-checkpoint inhibitor containing regimen when compared to historic controls. Patients in both phases will have prostate-specific membrane antigen (PSMA), positron emission tomography (PET) imaging with the radiotracer (F-18)-DCFPyl, to help detect any spread of the cancer.

Start Date01 May 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06604442 / RecruitingPhase 4

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Start Date01 Nov 2024

Sponsor / Collaborator

Blue Earth Diagnostics Ltd.Startup

[+1]

NCT05568537 / Not yet recruitingPhase 4IIT

Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)

This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) [whichever comes first].

Start Date01 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with [18F]DCFPyL

100 Translational Medicine associated with [18F]DCFPyL

100 Patents (Medical) associated with [18F]DCFPyL

Literatures (Medical) associated with [18F]DCFPyL

01 Dec 2024·Clinical Genitourinary Cancer

Impact of Baseline Renal Insufficiency on Piflufolastat F-18 Performance and Investigation of Changes in Renal Function Following Piflufolastat F-18 Administration: Results From the OSPREY Trial

Article

Author: Lin, Daniel W. ; Lin, Daniel W ; Denes, Bela S ; DiPippo, Vincent A. ; DiPippo, Vincent A ; Iravani, Amir ; Chappidi, Meera R. ; Stambler, Nancy ; Denes, Bela S. ; Chappidi, Meera R ; Baskaran, Saradha

INTRODUCTIONPiflufolastat F-18, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical, is predominantly eliminated via urinary excretion, and the kidneys have one of the highest absorbed doses. Therefore, this subgroup analysis aimed to investigate the impact of piflufolastat F-18 on renal function and its diagnostic performance in patients stratified by baseline renal function.PATIENTS AND METHODSThe OSPREY clinical trial enrolled 2 cohorts: A-high-risk patients undergoing radical prostatectomy with pelvic lymphadenectomy, and B-patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Baseline estimated glomerular filtration rates were calculated, and patients were stratified by baseline chronic kidney disease (CKD) stage. Changes in serum creatinine within 28 days postdose and diagnostic performance of piflufolastat F-18 were assessed for each CKD stage group in both cohorts.RESULTS385 patients (cohort A, n = 268; cohort B, n = 117) underwent piflufolastat F-18-PET/CT. Baseline and postpiflufolastat F-18 median creatinine levels (mg/dL) were similar for patients in cohort A (0.95 [n = 264] vs. 0.95 [n = 252], respectively) and cohort B (0.93 [n = 116] vs. 0.96 [n = 84], respectively). Among 332 men (cohort A, n = 249; cohort B, n = 83) with baseline and postpiflufolastat creatinine measurements, there were minimal changes in creatinine across all baseline CKD stage groups (median change ranged from -0.02 to 0.023 in groups with >1 patient). The diagnostic performance of piflufolastat F-18 showed no meaningful differences when stratified by baseline CKD stage.CONCLUSIONPiflufolastat F-18 appears to be safe and effective for imaging prostate cancer, including men with mild/moderate renal insufficiency.

01 Oct 2024·European Journal of Nuclear Medicine and Molecular Imaging

The Homunculus of unspecific bone uptakes associated with PSMA-targeted tracers: a systematic review-based definition

Review

Author: Bauckneht, Matteo ; Morbelli, Silvia ; Bertagna, Francesco ; Rizzo, Alessio ; Fornarini, Giuseppe ; Dondi, Francesco ; Grimaldi, Serena ; Racca, Manuela ; Laudicella, Riccardo ; Albano, Domenico ; Treglia, Giorgio ; Cioffi, Martina

AbstractPurposeProstate-Specific Membrane Antigen (PSMA)-targeted Positron Emission Tomography (PET) has revolutionised prostate cancer (PCa) diagnosis and treatment, offering superior diagnostic accuracy over traditional methods and enabling theragnostic applications. However, a significant diagnostic challenge has emerged with identifying unspecific bone uptakes (UBUs), which could lead to over-staging and inappropriate treatment decisions if misinterpreted. This systematic review explores the phenomenon of UBUs in PCa patients undergoing PSMA-PET imaging.MethodsStudies assessing the prevalence, topographical distribution, and potential clinical implications of UBUs were selected according to the Preferred Reporting Items for a Systematic Review and Meta-Analysis (PRISMA) method and evaluated with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.ResultsThe percentage of PCa patients with UBUs on PSMA-PET scans ranged from 0 to 71.7%, depending on the radiopharmaceutical used, with [18F]PSMA-1007 showing the highest incidence. The ribs are the primary site of UBUs across all PSMA-targeted radiopharmaceuticals. The spine is the second most frequent UBU site for [68Ga]Ga-PSMA-11, [18F]DCFPyL, [18F]rhPSMA-7, while the pelvic girdle represents the second most frequent site for [18F]PSMA-1007. The average maximum Standardized Uptake Value (SUVmax) of UBUs varied from 3.4 to 7.7 and was generally lower than that of bone metastases.ConclusionsOur findings underscore the need for heightened awareness and precise interpretation of UBUs to avoid potential over-staging and subsequent inappropriate treatment decisions. Considering the radiopharmaceutical used, PET-derived semiquantitative parameters, the topographical distribution of UBUs, and accurately evaluating the pre-test probability based on clinical and laboratory parameters may aid nuclear medicine physicians in interpreting PSMA-PET findings.

01 Jun 2024·International Journal of Biological Macromolecules

Unlocking the potential of phenolated kraft lignin as a versatile feed additive

Article

Author: Wang, Wen-Lei ; Wei, Hai-Lin ; Yang, Xiao-Hui ; Zhang, Ping-Hu ; Jing, Fei ; Li, Long ; Zhou, Yong-Hong

Lignin, a renewable natural antioxidant and bacteriostat, holds promise as a versatile, cost-effective feed additive. However, traditional industrial lignin faces limitations, including low reactivity, poor uniformity, and unstable properties, necessitating chemical modification. Complex modification methods pose economic and toxicity challenges, so this study adopted a relatively simple alkali-catalyzed phenolization approach, using phenol, catechol, and pyrogallol to modify kraft lignin, and characterized the resulting products using various techniques. Subsequently, their antioxidant, antibacterial, adsorption properties for heavy metal ions and mycotoxins, growth-promoting properties, and antiviral abilities were assessed. The phenolation process led to lignin depolymerization and a notable increase in phenolic hydroxyl content, particularly in pyrogallol-phenolated lignin (Py-L), rising from 3.08 to 4.68 mmol/g. These modified lignins exhibited enhanced antioxidant activity, with over 99 % inhibition against E. coli and S. aureus, and remarkable adsorption capacities for heavy metal ions and mycotoxins. Importantly, Py-L improved the growth performance of mice and reduced influenza mortality. Furthermore, density functional theory calculations elucidated the mechanism behind the enhanced antioxidant properties. This study presents a promising avenue for developing versatile feed additives to address challenges related to animal feed antioxidant supplementation, bacterial control, and growth promotion.

News (Medical) associated with [18F]DCFPyL

10 Sep 2024

·www.globenewswire.com

Curium Announces PYLCLARI® – An Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer – Is Now Available in Spain

PARIS, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that in Spain, PYLCLARI® is now available for patients with prostate cancer. PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Benoit Woessmer, PET Europe CEO at Curium commented, “The availability of PYLCLARI® in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI® continues to grow and now covers seven countries including Austria, France, Germany, Greece, Italy, the Netherlands, and Spain.” In Spain, prostate cancer is one of the most common cancers among men with around 30,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced by Curium at two sites in Madrid and one site in Sevilla, ensuring timely and efficient distribution across the country. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com

Drug ApprovalRadiation Therapy

17 Jun 2024

·www.globenewswire.com

Curium Continues to Make Strong Progress in European Roll-Out Of PYLCLARI® – 18F-PSMA PET Diagnostics of Patients With Prostate Cancer

First doses of PYLCLARI® administered in Austria in early May 2024PYLCLARI® now available in France, Germany, Greece, Italy, and the Netherlands PARIS, June 17, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that with first doses in Austria administered in May 2024, it is making strong progress in the European roll-out of PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Benoit Woessmer, PET Europe CEO at Curium commented, “Today’s news that PYLCLARI® is now available to patients with prostate cancer in Austria is a testament to Curium's dedication to and ambition for the country and health care professionals in Austria. PYLCLARI® is currently available in six European countries – with more countries planned for first doses in 2024. We are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose prostate cancer.” In Austria, prostate cancer is one of the most common cancers among men with around 7,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced in Austria by Curium at its Linz premises, with first doses administered at KABEG Klinikum Klagenfurt and a hospital in Linz. Authorization to produce PYLCLARI® at Curium’s Linz site was granted by Austria’s Österreichische Agentur für Gesundheit und Ernährungssicherheit in October 2023. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com

Drug ApprovalRadiation Therapy

30 May 2024

·www.globenewswire.com

Curium Announces First Commercial Doses in France of Pylclari® – an Innovative 18F-Psma Pet Tracer Indicated in Patients With Prostate Cancer

PARIS, May 30, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that earlier this month patients in France received the first doses of PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Today’s news follows earlier announcements by Curium of the first doses for Greece in November 2023, and for 2024 first doses for Italy in February, for the Netherlands in March, and for Germany in May. Benoit Woessmer, PET Europe CEO at Curium commented, “We are extremely pleased with today’s news that PYLCLARI® is now available to patients with prostate cancer in France. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, the growing availability of PYLCLARI® in Europe is improving the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose and monitor prostate cancer – ultimately for the benefit of patients with prostate cancer.” In France, prostate cancer is one of the most common cancers among men with around 60,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced in France at Curium’s facilities in Bordeaux, Lyon, Nancy, Marseille, Paris, and Tours. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com

Drug ApprovalRadiation Therapy

100 Deals associated with [18F]DCFPyL

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09	DB14805

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diagnostic agents	NO	Curium PET France	27 Nov 2023
Diagnostic agents	EU	Curium PET France	27 Nov 2023
Diagnostic agents	IS	Curium PET France	27 Nov 2023
Diagnostic agents	LI	Curium PET France	27 Nov 2023
PSMA-Positive Prostatic Cancer	NO	Curium PET France	27 Nov 2023
PSMA-Positive Prostatic Cancer	IS	Curium PET France	27 Nov 2023
PSMA-Positive Prostatic Cancer	LI	Curium PET France	27 Nov 2023
PSMA-Positive Prostatic Cancer	EU	Curium PET France	27 Nov 2023
Prostatic Cancer	US	Progenics Pharmaceuticals, Inc.	26 May 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
PSMA-Positive Prostatic Cancer	NDA/BLA	CH	Curium PET France	22 Feb 2024
Recurrent Prostate Carcinoma	Phase 1	FR	Curium PET France	07 Jul 2020
Renal Cell Carcinoma	Phase 1	-	Sidney Kimmel Cancer Center	-
Renal Cell Carcinoma	Phase 1	-	The Johns Hopkins University	-
Renal Cell Carcinoma	Phase 1	-	Progenics Pharmaceuticals, Inc.	-
Recurrent Prostate Carcinoma	Discovery	FR	Curium PET France	07 Jul 2020
Prostatic Cancer	Discovery	CA	Progenics Pharmaceuticals, Inc.	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2024	Not Applicable	PSMA-Positive Tumor	-	18F-DCFPyL PET/CT	zfnensiwfz(gfkovhhsos) = ehorcfsonj zuimueiunx (uyssrjsbyl, 82% - 100%)	-	09 Jun 2024
MP18-18 (AUA2024)	Phase 2	Prostatic Cancer 18F-DCFPyL PSMA PET \| mpMRI	100	18F-DCFPYL	rqtpxtfegu(fwgxmeuvgw) = kvamotqfgy ymxevqakgl (uokwwuvctv ) View more	Positive	01 May 2024
NCT04727736 (CTgov)	Phase 2	Recurrent Prostate Carcinoma	47	18F-DCFPyL	(oswzcbpxrp) = medjjlvumn hbjlkggfaz (hhvtnsrtyd, yxidrupakm - hahacgjiwc) View more	-	15 Feb 2024
F18-DCFPyL PSMA-PET/CT vs. mpMRI (ASTRO)	Not Applicable	Prostatic Cancer	47	F18-DCFPyL (PSMA-PET/CT)	lvjvmimcfs(evsynnhhvb) = mqbslisoal oxbhieepoz (ltfnnrirvt )	Negative	01 Oct 2023
				F18-DCFPyL (mpMRI)	lvjvmimcfs(evsynnhhvb) = flowoplfjf oxbhieepoz (ltfnnrirvt )
SNMMI2023	Not Applicable	Metastatic Prostate Carcinoma	-	18F-DCFPyL PET/CT	xwvtmhetex(upirggtgxl) = ohxkkwvoks pwwkblfgqr (vavawhogpb, 1 - 0-2)	-	28 Aug 2023
SNMMI2023	Not Applicable	-	-	68Ga-PSMA-11	xbcgpivsll(jnlnlaemcq) = ilbylpadmn aukydlkgug (yummkhdymo )	-	28 Aug 2023
				18F-DCFPyL	xbcgpivsll(jnlnlaemcq) = cpvgxizydh aukydlkgug (yummkhdymo )
SNMMI2023	Not Applicable	Recurrent Prostate Carcinoma	-	18F-DCFPyL18F-DCFPyL PET/CT (18F-DCFPyL-PET/CT)	idfxpfgazu(iwxejvtjaf) = quzyvoyigo iceevcrcpy (zlttynuczh )	-	28 Aug 2023
				18F-DCFPyL PET/CT (Multiparametric MRI)	idfxpfgazu(iwxejvtjaf) = gpvxicxbox iceevcrcpy (zlttynuczh )
PREP protocol (ASCO_GU2023)	Not Applicable	Prostatic Cancer Adjuvant	-	<sup>18</sup>F-DCFPyL PSMA-PET (Primary RT (pRT))	(ttorlqpbhu) = irehdvmxls zqvdmravra (jguyftrmbc, 3.1 - 8.9) View more	-	21 Feb 2023
				<sup>18</sup>F-DCFPyL PSMA-PET (Salvage/Adjuvant RT (sRT))	(ttorlqpbhu) = myllwpskss zqvdmravra (jguyftrmbc, 0.6 - 3.4) View more
PSMA-PET Registry for Recurrent Prostate Cancer (PREP) (ASCO_GU2023)	Not Applicable	-	177	<sup>18</sup>F-DCFPyL PSMA PET/CT (Node positive)	(tftpuzrpgb) = axcqyexvvo ciwhvhlrpg (fdhskicfcg )	-	21 Feb 2023
				<sup>18</sup>F-DCFPyL PSMA PET/CT (Persistently detectable PSA after initial radical prostatectomy)	(tftpuzrpgb) = prpddlmmbm ciwhvhlrpg (fdhskicfcg )
NCT02981368 (OSPREY, ASCO_GU2022) Manual	Phase 2/3	Prostatic Cancer	345	18F-DCFPyL (Cohort A)	eslwjcvqlp(uvsdrmddey) = Cohort A: 0(GS ≤6), 0(GS 3+4), 2.4(GS 4+3), 2.5(GS 8), 1.8(GS 9-10); Cohort B: 1.3ng/mL(PSA 0 to < 0.2), 5.43ng/mL(PSA 0.2 to < 4), 11.3ng/mL(PSA 4 to < 20), 9.7ng/mL(PSA 20 to < 50), 9.4ng/mL(PSA ≥50) jziighlgic (mxmxhnpcpp ) View more	Positive	16 Feb 2022
				18F-DCFPyL (Cohort B)

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