Societal CDMO has received service contracts for three new customers. The agreements cover a range of manufacturing services for clinical trials, analytical methods, formulation development and cGMP manufacturing.
For the first contract, Societal will support the initiation of a Phase II clinical trial of an antidepressant that is already approved in Europe and Australia. Societal will be responsible for the procurement, preparation, packaging and labeling of both the study drug and matching placebo for use in the study. These activities are conducted in collaboration at its Georgia and California facilities.
In addition, Societal will help develop a liquid oral formulation and then produce and package a first batch of an investigational treatment for pediatric patients with dietary restrictions who also suffer from neurological and neuropsychiatric disorders.
And in the third contract, Societal will support another clinical trial — a Phase II trial of an antisense oligonucleotide being tested in multiple types of cancer. Societal will tag, store and distribute the candidate under the terms of the agreement.
“These new agreements underscore the full range of services that Societal CDMO offers to its customers, beginning with efforts in analytical methods and process development and formulation design, and progressing to cGMP manufacturing, packaging, labeling and distribution. Importantly, two of these new agreements relate to our clinical trials services business, which we see as a key growth driver for the company,” said David Enloe, CEO of Societal CDMO, in a statement.
Chime Biologics receives a Chinese manufacturing license
Chime Biologics, which raised investor funds for a 15-fold production expansion in 2021, has received a commercial manufacturing license from the National Medical Products Administration (NMPA) in China.
According to the company, after an 18-month product development and manufacturing collaboration with LEPU Biopharma, the company passed a pre-approval inspection, including an on-site inspection and a GMP compliance inspection.
As part of the partnership with LEPU Biopharma, Chime will manufacture an anti-PD-1 monoclonal antibody called Puyouheng, which has been conditionally approved for commercialization in China. The drug is approved for patients with inoperable or metastatic advanced solid tumors with high microsatellite instability or mismatch repair deficiency (dMMR).
“This also marks Chime Biologics’ official entry into the commercial production service era. Chime Biologics will work side-by-side with Lepu to bring alternative medical solutions to cancer patients in China and the rest of the world,” Chime CEO John Zeng said in a statement.
Teva runs into supply difficulties for its ADHD drug Adderall
Teva has struck a chord with its popular ADHD drug Adderall.
According to the American Society of Health-System Pharmacists (ASHP), both 20 mg and 30 mg Adderall tablets are currently on backorder in the US as the company targets a release date later this month. The FDA drug deficiency tracker does not identify a current Adderall deficiency. An Adderall bug has already been fixed, but the site also warns that its database is experiencing technical difficulties and may be outdated.
The ASHP said Teva is also having backorder issues with its generic version of Adderall. However, the company is expected to launch more generic 10mg tablets in August, followed by 15mg and 30mg tablets.
For Adderall, Teva is aiming to launch additional 20 mg and 30 mg tablets in early to mid-August, ASHP said.