PHARMACY MARKET

PCI Pharma Services Announces the Closing of Its Acquisition of LSNE

PCI Pharma Services | December 15, 2021

PCI Pharma Services Announces the Closing of Its Acquisition of LSNE
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.

Spotlight

Nanoparticle Tracking Analysis represents a rapid and information-rich multi-parameter nanoparticle characterization technique allowing the user to obtain number frequency particle size distributions of polydisperse nanoparticulate systems. It has resulted in its rapid adoption as an interesting new technique in a wide range of sectors within the pharmaceutical sciences.

Related News

PHARMA TECH

Angelini Pharma Selects AiDEA’s Artificial Intelligence to Boost Its Growth

Angelini Pharma | March 11, 2021

Trueblue, a main supplier of AI answers for Operational and Analytical CRM in the Life Science industry reports that Angelini Pharma, as a feature of a significant global computerized change measure, has picked AiDEA, the principal AI-Digital Cloud Pharma CRM arrangement dependent on Microsoft Dynamics 365. Angelini Pharma is a main pharmaceutical organization focused on aiding patients in the remedial zones of Central Nervous System (CNS) and Mental Health (including Pain), Rare Diseases and Consumer Healthcare. Angelini's new computerized vision is to reposition and lift its Customer Engagement abilities utilizing Artificial Intelligence by actualizing a creative AI-Driven CRM system. This layouts a make way towards Digital, yet in addition the eagerness to go worldwide through accepted procedures that empower connections with key customers while supporting the organization's global development, along these lines advancing its business and operational abilities. Angelini Pharma will execute the AiDEA CRM suite in excess of 24 subsidiaries around the world, offering its workers a wide scope of Artificial Intelligence applications. The main Pharma Company will accordingly exploit noteworthy bits of knowledge and omni-channel optimization algorithms intended to augment the utilization of assets, optimize Customer Engagement Activities on all channels and better address the issues of every stakeholder. After an intensive assessment interaction of the ideal accomplice and because of a previous fruitful Data Warehouse and Corporate Business Intelligence project, Angelini Pharma picked Trueblue's, which exhibited the abilities, advancement, adaptability and business benefit of its foundation dependent on Microsoft technologies. “We decided to boost the deployment of our Multichannel strategy to better support our ongoing transformation, and while advancing significantly, we realized the need to further accelerate also expanding to solutions based on the use of Artificial Intelligence," says Pierluigi Antonelli, Angelini Pharma’s CEO. "Trueblue's AiDEA Suite enables us to leverage our existing investments while accelerating our AI transformation to ensure our subsidiaries can better serve their customers". On a global level, organizations that are deliberately scaling artificial intelligence report a profit from investment almost multiple times more noteworthy than those that are merely experimenting. "We are excited about this relationship that has been lasting for several years and that makes Angelini Pharma the main player of a new paradigm, in this particularly important historical moment for the pharmaceutical context," says Marco Bonesini - CEO & Co-founder of Trueblue. "Our goal is to contribute to the growth of Angelini Pharma at international level with the strength of AiDEA and all the potential of an omni-channel AI-Driven solution based on Microsoft Dynamics 365, which is truly ready to change the CRM market in the pharmaceutical sector".

Read More

PRACTICE MANAGEMENT

AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance

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."

Read More

PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

Read More

Spotlight

Nanoparticle Tracking Analysis represents a rapid and information-rich multi-parameter nanoparticle characterization technique allowing the user to obtain number frequency particle size distributions of polydisperse nanoparticulate systems. It has resulted in its rapid adoption as an interesting new technique in a wide range of sectors within the pharmaceutical sciences.