Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021
Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation.
The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments.
According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients."
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.
About Piramal Pharma Limited
Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.
Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
Yangtze River Pharmaceutical, TraceLink | May 06, 2021
TraceLink Inc., the leading digital network platform company, today announced that Yangtze River Pharmaceutical Group has selected TraceLink's global compliance solution to aid its plans for global growth. As the company gears up for international market expansion this year, Yangtze River Pharmaceutical Group (YRPG) will use TraceLink's multienterprise compliance applications and industry-leading digital supply network to comply with track and trace requirements in multiple markets, including the United States and Europe.
"As we approach our 50th anniversary this year, we are preparing to deliver our innovations to global markets beyond China," said Mr. Luo Bai Gui GM's Executive Assistant, International Projects from YRPG. "Given the broad scope of our portfolio and diverse business model, TraceLink' s integrated network, global compliance solutions and low total cost of ownership are crucial for us to achieve commercial success in multiple markets."
"Global commercialization has become a top priority during this special milestone year for YRPG and serialization compliance is a necessary step in their preparation for global expansion," said Shabbir Dahod, President and CEO, TraceLink. "As one of the top pharmaceutical enterprises in China, YRPG is highly esteemed for its relentless innovation and TraceLink is proud to be their serialization partner of record as they embark on their journey of continued global growth."
With more than 16,000 employees and over 20 subsidiaries located across China, YRPG has established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCMs) and biological medicines. Yangtze River Pharmaceutical Group's products include Chinese, Western medicines and APIs, covering ten fields, nearly 20 dosage forms and over 300 types of medicines and strengths. Nearly 100 innovative drugs for major diseases are currently under research & development.
About Yangtze River Pharmaceutical Group
With a total manufacturing footprint of more than 3 million square meters, Yangtze River Pharmaceutical Group employs 16,000 and owns 11 manufacturing subsidiaries located in Beijing, Shanghai, Nanjing, Guangzhou, etc. The company fields established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCM) and biological medicines. Currently, Yangtze River Pharmaceutical Group exports part of its portfolio assortment to 30 countries including Europe, Asia and Africa.
TraceLink is the only business network creation platform for building integrated business ecosystems with multienterprise applications. Business networks are the foundation of an Industry 4.0 digitalization strategy that delivers customer-centric agility and resiliency of the end-to-end supply network leveraging the collective intelligence of an industry. TraceLink's Opus Digital Network Platform enables speed of open innovation and implementation with a partner ecosystem for no-code and low-code development of solutions and applications.
Farxiga | January 07, 2021
Pushing for another endorsement for SGLT2 prescription Farxiga in persistent kidney illness (CKD), AstraZeneca a year ago posted amazing information in its critical preliminary. Presently, the FDA has acknowledged its CKD application and granted a need survey, setting up a choice for the subsequent quarter—and putting Farxiga significantly farther in front of its future adversaries.
In that preliminary, named Dapa-CKD, AZ's Farxiga in addition to standard of care cut the joined danger of deteriorating kidney capacity or demise brought about via cardiovascular or kidney issues by 39% over fake treatment in certain CKD patients. Furthermore, the medication cut the danger of death from any reason by 31%.
Initially endorsed to control glucose, Farxiga a year ago scored a class-first FDA gesture to lessen the danger of major cardiovascular occasions in patients with cardiovascular breakdown—regardless of whether they have diabetes. Presently, AstraZeneca is planning to change the therapy worldview in persistent kidney sickness. Johnson and Johnson's Invokana conveys a FDA endorsement in diabetic kidney infection, however Farxiga is gunning for a gesture in ongoing kidney sickness with or without type 2 diabetes.
At the point when AZ introduced its definite stage 3 Dapa-CKD results back in August, an executive said the information "truly can possibly modify" clinical course readings. Before that, the organization halted its preliminary early last March after break information "demonstrated Farxiga's advantages sooner than initially envisioned."
The FDA's Wednesday move "presents to us a bit nearer to conveying this new therapy choice for the large numbers of patients living with ongoing kidney illness in the U.S.," AZ's chief VP of biopharma R&D, Mene Pangalos, said in an assertion. "Farxiga can possibly be a really groundbreaking medication across an expansiveness of illnesses, including type 2 diabetes, cardiovascular breakdown with diminished discharge division and, whenever endorsed, constant kidney infection."