Aeglea begins dosing in Phase I/II trial of AEB1102 for arginase 1 deficiency
Aeglea BioTherapeutics has begun dosing patients in the repeat dose part of its Phase I/II clinical trial of AEB1102 (pegzilarginase) to treat arginase 1 deficiency. (Source: Drug Development Technology)
Source: Drug Development Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Electronic Submission for Changes to OTC Monographs?
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review process and finalise pending monographs as quickly as possible. To that end, they are seeking passage by Congress of The OTC Monograph User Fee Progr … (Source: Drug Development Technology)
Source: Drug Development Technology - September 6, 2017 Category: Pharmaceuticals Source Type: news
Bial ’s epilepsy drug shows clinical efficacy in real-life study
Bial and its licensee Eisai have reported positive real-life data of Zebinix (eslicarbazepine acetate) from the Euro-Esli study in patients with partial-onset seizures (POS). (Source: Drug Development Technology)
Source: Drug Development Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
Faron receives IDMC recommendation to continue Phase III ARDS trial
Finland-based biopharmaceutical firm Faron Pharmaceuticals has received recommendation from the Independent Data Monitoring Committee (IDMC) to continue its Phase III clinical trial (INTEREST) of Traumakine (FP-1201-lyo) to treat moderate-to-severe a … (Source: Drug Development Technology)
Source: Drug Development Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
H3 Biomedicine initiates dosing in Phase I trial of breast cancer drug
H3 Biomedicine, a member of Eisai ’s Oncology business group, has started dosing patients in a Phase I clinical trial of H3B-6545 as a monotherapy to treat breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
A Guide Accross the Regulatory and Scientific Terrain
Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration (FDA). (Source: Drug Development Technology)
Source: Drug Development Technology - September 5, 2017 Category: Pharmaceuticals Source Type: news
FDA initiates clinical hold on Cellectis ’ UCART123 trials
The US Food and Drug Administration (FDA) has initiated a clinical hold on Phase I trials of biopharmaceutical firm Cellectis ’ universal chimeric antingen receptor T-cells (UCARTs) product candidate UCART123. (Source: Drug Development Technology)
Source: Drug Development Technology - September 4, 2017 Category: Pharmaceuticals Source Type: news
Eisai to highlight data from lenvatinib trials for uHCC and RCC
Japanese pharmaceutical company Eisai is planning to present data from the clinical trials of its drug candidate lenvatinib at the European Society for Medical Oncology (ESMO) 2017 Congress to be held in Madrid, Spain, between 8-12 September. (Source: Drug Development Technology)
Source: Drug Development Technology - September 4, 2017 Category: Pharmaceuticals Source Type: news
Midatech files CTA for MTD201 ’s carcinoid cancer and acromegaly trial
UK-based specialist pharmaceutical firm Midatech Pharma has submitted a clinical trial application (CTA) for its drug candidate MTD201 to treat carcinoid cancer and acromegaly. (Source: Drug Development Technology)
Source: Drug Development Technology - September 4, 2017 Category: Pharmaceuticals Source Type: news
AstraZeneca to report data from multiple oncology trials at ESMO 2017
AstraZeneca and its global biologics research and development arm MedImmune are set to report results of more than 40 clinical trial presentations at the European Society of Medical Oncology (ESMO) 2017 Congress to be held in Madrid, Spain, from 8-12 … (Source: Drug Development Technology)
Source: Drug Development Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news
Heptares starts dosing in Phase I trial of Alzheimer ’s drug
UK-based Heptares Therapeutics has started dosing subjects in a Phase I clinical trial of HTL0016878 being developed for the treatment of neurobehavioural symptoms in Alzheimer ’s disease patients. (Source: Drug Development Technology)
Source: Drug Development Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news
OncBioMune to investigate new prostate cancer drug in Phase II trial
OncBioMune Pharmaceuticals has reported an ongoing review of its Phase II clinical trial protocol by the regulatory committee at Beth Israel Deaconess Medical Centre / Harvard Medical School in the US for evaluation of ProscaVax to treat early stage … (Source: Drug Development Technology)
Source: Drug Development Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news
M & As this week: Gilead Sciences, RegenxBio
Gilead Sciences and its subsidiary Dodgers Merger Sub plan to acquire Kite Pharma for $11.9bn. (Source: Drug Development Technology)
Source: Drug Development Technology - August 31, 2017 Category: Pharmaceuticals Source Type: news
Incyte reports positive data from Phase I/II combination trial for melanoma
Incyte has reported additional positive data from a Phase I/II clinical trial (ECHO-202) of its product candidate epacadostat in combination with Merck ’s anti-PD-1 drug Keytruda (pembrolizumab) to treat advanced melanoma. (Source: Drug Development Technology)
Source: Drug Development Technology - August 31, 2017 Category: Pharmaceuticals Source Type: news
Deals this week: CF PharmaTech, Aurealis Pharma, aTyr Pharma
CF PharmaTech has secured $65m in a series D financing round led by SDIC. The Chinese respiratory drug developer plans to use the funds for the development of inhalation products. (Source: Drug Development Technology)
Source: Drug Development Technology - August 31, 2017 Category: Pharmaceuticals Source Type: news
