Moberg Pharma | November 06, 2020
The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") has today resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.
Gannex | December 14, 2020
Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42.
The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients.
Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed，novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature.
"We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."
PCI Pharma Services | December 15, 2021
PCI Pharma Services a leading global contract development and manufacturing organizatio announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.
This acquisition is a key step for PCI, as LSNE will expand PCI’s breadth of services as a global CDMO, building on its expertise in specialty manufacturing, clinical trial supply and pharmaceutical packaging. PCI is now able to offer integrated large and small molecule solutions for its clinical and commercial clients, including global manufacturing capabilities in complex formulations, high potency, sterile fill-finish, and lyophilization, an important manufacturing process commonly used with injectable and biologic therapies.
Founded in 1997, LSNE has an impressive history of serving global pharmaceutical, biotechnology and medical device companies. LSNE is differentiated by its high-quality cGMP aseptic fill-finish capabilities, and expertise in and ability to scale lyophilization. LSNE brings to PCI five FDA-approved facilities in the U.S. and Europe with a sixth expecting approval early in the new year. The closing of this acquisition, along with the capital commitments for significant capacity expansion and PCI’s recently announced construction of a New England Clinical Center of Excellence, will also help create a centralized hub for its Northeast clients.
The injectable CDMO market is a high-growth segment outpacing the overall pharmaceutical outsourcing market and PCI is making significant investments, like this acquisition, to respond to the evolving industry landscape. This is PCI’s fourth acquisition in three years, reinforcing the company’s commitment to add new capabilities and scale to help its clients continue bringing life-changing therapies to patients all over the world.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.