Formulation Development
Incyte & Zai Lab Announce Collaboration & License Agreement
Incyte and Zai Lab Ltd. recently announced that the companies have entered into a collaboration and license agreement for the development and commercialization of
Amicus Therapeutics & Catalent Biologics Enter Strategic Partnership
Amicus Therapeutics, Inc. has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity for….
Calithera Biosciences Initiates Phase 1/2 Trial
Calithera Biosciences, Inc. recently announced treatment of the first patient in a Phase 1/2 open-label clinical trial of the glutaminase inhibitor telaglenastat (CB-839) in combination…
Appili Therapeutics Signs $3-Million Grant to Develop Antibiotics That Target Superbugs
Appili Therapeutics Inc. recently announced the United States Department of Defense, (DOD) Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program (PRMRP) has completed…
Amicus Therapeutics & Brammer Bio Enter Strategic Development & Manufacturing Collaboration
Amicus Therapeutics, Inc. has entered into a strategic manufacturing collaboration with Thermo Fisher Scientific. Thermo Fisher, a best-in-class contract development and manufacturing organization (CDMO) with…
Therapeutic Solutions International Obtains Exclusive License for Patented Clinical Stage Adult Stem Cell
Therapeutics Solutions International, Inc. recently announced signing of a license agreement providing exclusive rights to a patented adult stem cell for development of therapeutics in…
Y-mAbs Announces Recruitment Status for Pivotal Trials
Y-mAbs Therapeutics, Inc. recently announced the status of patient recruitment for the company’s two pivotal Phase 2 trials, one for omburtamab for the treatment of…
Verrica Pharmaceuticals Enrolls First Patient in Phase 2 Trial
Verrica Pharmaceuticals Inc. recently announced that the first patient has been enrolled in the company’s Phase 2 ‘CARE’ clinical trial evaluating the optimal dose regimen,…
Arcturus Therapeutics Receives Orphan Drug Designation
Arcturus Therapeutics Holdings Inc. recently announced the US FDA has granted Orphan Drug Designation for the company’s lead product candidate………
Athenex Announces Strategic Global Initiatives
Athenex, Inc. recently announced it has strategically expanded its presence in Europe and Latin America to grow its global……
Esperion & Oberland Capital Announce $200-Million Agreement
Esperion recently announced a $200 million capped, tiered, revenue-based funding agreement on net revenues of bempedoic acid and the bempedoic acid / ezetimibe combination tablet.…
Seelos Therapeutics Announces Acquisition of Exclusive Worldwide License of Gene Therapy Program
Seelos Therapeutics, Inc. recently announced the exclusive worldwide licensing of a gene therapy program targeting the regulation of the SNCA gene, which encodes alpha-synuclein expression, …
SunGen Pharma Announces Partnership With Athenex Pharmaceutical
SunGen Pharma recently announced to launch Bivalirudin for Injection in the near future through their joint venture Peterson Athenex with Athenex Pharmaceuticals. This tentatively approved…
Wave Life Sciences Announces Initiation of Phase 2/3 Clinical Trial
Wave Life Sciences Ltd. recently announced the initiation of DYSTANCE 51, the Phase 2/3 efficacy and safety clinical trial of suvodirsen, an investigational stereopure oligonucleotide…
Atossa Genetics Preliminary Phase 2 Study Achieves Primary Endpoint
Atossa Genetics Inc. recently announced that a preliminary analysis from its recently completed Phase 2 study of the company’s proprietary 20-mg daily topical Z Endoxifen…
Novavax Confirms Accelerated Approval Pathway Available for Licensure of NanoFlu
Novavax, Inc. recently announced it will utilize the accelerated approval pathway for licensure for NanoFlu, its nanoparticle seasonal influenza vaccine candidate. The US FDA acknowledged…
Novavax & Catalent Biologics Enter Strategic Partnership
Novavax, Inc. and Catalent Biologics’ Paragon Gene Therapy unit recently announced an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax product development and manufacturing facilities, giving it immediate access to……..
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
2019 Respiratory Drug Development eBook - Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
Innate Pharma Announces Publication of Phase I Clinical Trial Results
Innate Pharma SA recently announced the online publication in The Lancet Oncology of the results from the completed Phase 1 dose-escalation and expansion clinical trial…
