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Details:
Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Abiraterone Acetate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 19, 2020
Details:
Strides Pharma's Prednisone Tablets USP, 10 mg and 20 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).
Lead Product(s): Prednisone
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
Prednisone is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co.
Lead Product(s): Prednisone
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (USFDA).
Lead Product(s): Prednisone
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
CYP-001 is Cynata's Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which is being evaluated for the treatment of acute graft versus host disease.
Lead Product(s): CYP-001,Prednisone
Therapeutic Area: Immunology Product Name: CYP-001
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2024
Details:
SAR439483 (ATSN-101) is a novel GUCY2D modulator which is currently being evaluated in phase 1/2 clinical development for the treatment of GUCY2D-associated leber congenital amaurosis (LCA1).
Lead Product(s): ATSN-101,Prednisone,Triamcinolone
Therapeutic Area: Rare Diseases and Disorders Product Name: SAR439483
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2024
Details:
VIP152 (enitociclib) is a highly selective CDK9 inhibitor that prevents activation of RNA polymerase II, resulting in reduction of known oncogenes MYC and MCL1. It is currently in Phase 1/2 trials combination with venetoclax and prednisone for the treatment of Lymphoma.
Lead Product(s): Enitociclib,Venetoclax,Prednisone
Therapeutic Area: Oncology Product Name: VIP152
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2024
Details:
Through the acquisition, Astellas has acquired PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer.
Lead Product(s): Abiraterone Decanoate,Dexamethasone,Prednisone
Therapeutic Area: Oncology Product Name: PRL-02
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $175.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 21, 2023
Details:
ATSN-101 is a LCA1 gene Transference Cell and Gene therapy drug candidate, which is currently being evaluated for the treatment of patients with GUCY2D-mutated Leber Congenital Amaurosis.
Lead Product(s): ATSN-101,Prednisone,Triamcinalone Acetonide
Therapeutic Area: Rare Diseases and Disorders Product Name: ATSN-101
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 04, 2023
Details:
Through the acquisition of Propella, Astellas will acquire PRL-02 (abiraterone decanoate), a next-generation androgen biosynthesis inhibitor being developed by Propella to treat prostate cancer.
Lead Product(s): Abiraterone Decanoate,Prednisone,Dexamethasone
Therapeutic Area: Oncology Product Name: PRL-02
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $175.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition November 15, 2023
Details:
JNJ-64091742 (niraparib) is an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that is currently being studied for the treatment of metastatic castrationresistant prostate cancer with BRCA alterations.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and approved in combination with abiraterone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2023
Details:
USFDA approves FoundationOne®CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate), the first-and-only dual action tablet, which was approved for deleterious BRCA-mutated metastatic castration-resistant prostate cancer in adults.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2023
Details:
KEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with BRCA-positive mCRPC.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
Details:
Lynparza (olaparib), a first-in-class PARP inhibitor, gets FDA approval for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. It is already approved in the US for HRR gene-mutated mCRPC.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2023
Details:
Lynparza® (olaparib), PARP inhibitor, in combination with abiraterone (an androgen biosynthesis inhibitor) and prednisone or prednisolone is being investigated in BRCA-mutated metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Details:
Akeega is a combination of niraparib, a highly selective poly (ADP ribose) polymerase (PARP) inhibitor and abiraterone acetate, an androgen biosynthesis inhibitor is being studied for adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Akeega
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2023
Details:
ESSA will conduct a Phase 1 trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetate plus prednisone in patients with prostate cancer.
Lead Product(s): Masofaniten,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 12, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2023
Details:
JNJ-64091742 is a combination of niraparib, an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor and abiraterone acetate, an androgen biosynthesis inhibitor, is currently being studied for the treatment of prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
PRL-02 (abiraterone decanoate) is routed through the lymph to target tissues where it releases the precise level of abiraterone needed to block CYP17 lyase for 12 weeks, thereby reducing interim tumor breakthrough risk.
Lead Product(s): Abiraterone Decanoate,Prednisone,Dexamethasone
Therapeutic Area: Oncology Product Name: PRL-02
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
TAVT-45 (abiraterone acetate) Granules for Oral Suspension (“TAVT-45”), is an enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. Abiraterone inhibits testosterone production, which can suppress tumor growth.
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: TAVT-45
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
Lynparza (olaparib) is first-in-class PARP inhibitor and first targeted treatment to block DNA damage response in cells/tumours harboring deficiency in HRR.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
LYNPARZA (Olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is being studied in men with castration-resistant prostate cancer ("CRPC") whose tumors have progressed on standard-of-care therapies.
Lead Product(s): Masofaniten,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA (pembrolizumab) in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of OS and radiographic progression-free survival for treatment of patients with mCRPC.
Lead Product(s): Pembrolizumab,Docetaxel,Prednisone
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
Abiraterone acetate 250 mg is indicated in combination with prednisone for the treatment of people with metastatic castration-resistant prostate cancer (CRPC) and those with metastatic high-risk castration-sensitive prostate cancer (CSPC).
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Abiraterone Acetate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
TAVT-45 is designed to provide an easy-to-consume oral suspension of abiraterone acetate, reconstituted in water or juice, for patients with difficulty taking large tablets.
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: TAVT-45
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
The primary endpoint of this prospective, multicenter, non-randomized study was the improvement of treatment response with Arscimed® (arsenic trioxide) in combination with prednisone, with or without cyclosporine.
Lead Product(s): Arsenic Trioxide,Prednisone,Cyclosporine
Therapeutic Area: Immunology Product Name: Arscimed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2022
Details:
The submission to the European Medicines Agency is based on results from the Phase 3 MAGNITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone for the treatment of patients with mCRPC who are positive for HRR gene alterations.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Niraparib is an orally administered, selective poly-ADP ribose polymerase (PARP) inhibitor, that is currently being studied by Janssen for the treatment of patients with prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: JNJ-64091742
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Niraparib is an orally administered, poly-ADP ribose polymerase inhibitor that is currently studied for the treatment of prostate cancer. ERLEADA (apalutamide), an androgen receptor inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
Initial results from Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone as a first-line therapy in patients with metastatic castration-resistant prostate cancer featured as an oral presentation.
Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
Cirtuvivint is a small-molecule inhibitor of the CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases that are emerging as key contributors to numerous forms of cancer.
Lead Product(s): Cirtuvivint,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: SM08502
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Masitinib is a tyrosine kinase inhibitor designed to selectively target mast cells (MCs) and macrophages. Masitinib in combination with docetaxel as first-line treatment of metastatic Castrate Refractory Prostate Cancer (mCRPC) eligible to chemotherapy.
Lead Product(s): Masitinib Mesylate,Docetaxel,Prednisone
Therapeutic Area: Oncology Product Name: AB12003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2021
Details:
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Final results of study AB12003 will be available in April 2021.
Lead Product(s): Masitinib Mesylate,Docetaxel,Prednisone
Therapeutic Area: Oncology Product Name: AB12003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
ACIS was a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA and ZYTIGA plus prednisone compared to placebo and ZYTIGA plus prednisone in 982 patients with chemotherapy-naïve mCRPC who received ADT.
Lead Product(s): Apalutamide,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2021
Details:
Two-fold increase (29% to 63%) in disease control rate at 12 weeks (the trial's primary efficacy endpoint) seen in patients receiving onvansertib for 14 days vs. 5 days in a 21-day cycle.
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Onvansertib
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2021
Details:
The ANDA is approved for its use in combination with Prednisone. Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, are the generic version of Zytiga® for treatment of metastatic prostate cancer.
Lead Product(s): Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2021
Details:
Safety demonstrated across all three dose/dose scheduling cohorts, including cohort C with onvansertib dosed over a longer period of time than cohorts A and B (onvansertib on Days 1 - 14 in a 21-day cycle).
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Treatment arms will be tapered to minimal OCS and an important secondary endpoint is reduction in cumulative OCS on nomacopan as high dose OCS are regarded as unsafe in this vulnerable patient population.
Lead Product(s): Nomacopan,Prednisone
Therapeutic Area: Dermatology Product Name: Coversin
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2020
Details:
Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care plus placebo met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with PTEN loss tumors.
Lead Product(s): Ipatasertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 19, 2020
Details:
Onvansertib demonstrates efficacy in Zytiga®-resistant metastatic castration-resistant prostate cancer (mCRPC) across known androgen receptor resistance mechanisms.
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
Phase 2b clinical trial will evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer.
Lead Product(s): Itraconazole,Docetaxel,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2020
Details:
Study AB12003 is a multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer eligible to chemotherapy.
Lead Product(s): Masitinib Mesylate,Docetaxel,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2020
Details:
GRAVITAS-301 results show that treatment with itacitinib-corticosteroids combo did not statistically improve overall response rate or non-relapse mortality compared to placebo plus corticosteroids.
Lead Product(s): Itacitinib,Prednisone,Methylprednisolone
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2020
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