Human Trials

01 Nov 2019
- Clinical Trials
- Human Trials
Daiichi Sankyo initiates clinical trial of DS-7300 in collaboration with Sarah Cannon Research Institute

By PBR Staff Writer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute (Sarah Cannon) announced today that the first patient has been dosed in a first-in-human phase 1/2 study evaluating DS-7300, an investigational B7-H3 targeting antibody drug conjugate (ADC), in patients with various advanced solid tumors that have progressed on standard treatments or for whom no standard treatment exists.
31 Oct 2019
Clinical Trials
Human Trials
ACADIA Pharmaceuticals initiates phase 3 pivotal study of trofinetide in Rett Syndrome

By PBR Staff Writer

ACADIA Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that it has initiated the Phase 3 LAVENDER placebo-controlled study to evaluate the efficacy and safety of trofinetide for girls and young women with Rett syndrome.
30 Oct 2019
Clinical Trials
Human Trials
Themis begins phase 1 trial of MV-LASV Lassa fever vaccine candidate

By PBR Staff Writer

Themis Bioscience said that it has initiated a phase 1 trial for its vaccine candidate MV-LASV against Lassa fever through the first administration to healthy volunteers.
30 Oct 2019
Clinical Trials
Human Trials
Boehringer Ingelheim advances first pan-KRAS inhibitor BI 1701963 into clinical testing

By PBR Staff Writer

Boehringer Ingelheim today presented promising preclinical data from its pan-KRAS program including the novel, oral inhibitor BI 1701963 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, USA.
30 Oct 2019
Clinical Trials
Human Trials
Femtogenix presents data on antibody drug conjugates containing reduced potency payloads in solid tumour models

By PBR Staff Writer

Femtogenix, a UK biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, announced data demonstrating the potent efficacy and favourable toxicity profile of a reduced potency analogue from its Pyridinobenzodiazepine (PDD) ADC payload platform in solid tumour models.
29 Oct 2019
Clinical Trials
Human Trials
Imfinzi and Imfinzi plus tremelimumab delayed disease progression in POSEIDON trial

By PBR Staff Writer

AstraZeneca announced positive progression-free survival (PFS) results for Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy, from the Phase III POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC).
28 Oct 2019
Clinical Trials
Human Trials
MacroGenics announces initiation of phase 2/3 MAHOGANY study of margetuximab in gastric or gastroesophageal junction cancer

By PBR Staff Writer

MacroGenics announced that the first patient has been dosed in the Phase 2/3 MAHOGANY clinical trial of margetuximab, an investigational, Fc-optimized monoclonal antibody targeting HER2, in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
28 Oct 2019
Clinical Trials
Human Trials
LIPAC Oncology announces successful completion of phase 1 bladder cancer clinical study and initiation of phase 2A study

By PBR Staff Writer

LIPAC Oncology LLC today announced the successful completion of a Phase 1 clinical study and progress in a Phase 2A study to further investigate TBC-1002 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).
24 Oct 2019
Clinical Trials
Human Trials
RAPT Therapeutics announces initiation of first-in-human phase 1 study of RPT193

By PBR Staff Writer

RAPT Therapeutics reported the initiation of its first-in-human Phase 1 clinical trial for RPT193, an orally-administered small molecule CCR4 antagonist that is designed to selectively inhibit the migration of type 2 T helper cells, or Th2 cells, into allergically-inflamed tissues.
24 Oct 2019
Clinical Trials
Human Trials
Talaris Therapeutics initiates phase 3 clinical trial of FCR001 in living donor kidney transplant recipients

By PBR Staff Writer

Talaris Therapeutics, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, announced the initiation of FREEDOM-1, the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

Drug Discovery

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Regulation

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Production & Sales

Manufacturing

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Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

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Human Trials

Daiichi Sankyo initiates clinical trial of DS-7300 in collaboration with Sarah Cannon Research Institute

ACADIA Pharmaceuticals initiates phase 3 pivotal study of trofinetide in Rett Syndrome

Themis begins phase 1 trial of MV-LASV Lassa fever vaccine candidate

Boehringer Ingelheim advances first pan-KRAS inhibitor BI 1701963 into clinical testing

Femtogenix presents data on antibody drug conjugates containing reduced potency payloads in solid tumour models

Imfinzi and Imfinzi plus tremelimumab delayed disease progression in POSEIDON trial

MacroGenics announces initiation of phase 2/3 MAHOGANY study of margetuximab in gastric or gastroesophageal junction cancer

LIPAC Oncology announces successful completion of phase 1 bladder cancer clinical study and initiation of phase 2A study

RAPT Therapeutics announces initiation of first-in-human phase 1 study of RPT193

Talaris Therapeutics initiates phase 3 clinical trial of FCR001 in living donor kidney transplant recipients

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