Catalent is the global leader in enabling pharmaceutical, biotechnology, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients globally. With broad scale and deep expertise, Catalent is a preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
How can sponsors navigate the rapid shift to decentralization in clinical trials? There are pitfalls to avoid and key elements to keep front and center.
Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.
Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
State-of-the-art R&D lab at Florence, KY site expands technical feasibility capabilities for long-acting delivery of small molecules, biologics and nucleotides.
Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location
Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.
New product, Corning Valor RTU Vials with SG EZ-fill Technology, offers a unique combination of Corning Valor Glass vial attributes with SG EZ-fill integration.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.
Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.
Lonza exits both softgels and liquid-filled hard capsules and NextPharma plans to broaden its technology offering into lipid based finished dosage forms.
Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.
Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.
35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
From discovery to intermediates, APIs & drug products, a CDMO needs expertise across multiple elements of the pharma process to deliver an integrated experience
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA11.13.20
Single-dose intranasal vaccine for COVID-19 designed to generate a broad immune response with nasal mucosal immunity to prevent infection and transmission.
As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
Leverages Fusion's Targeted Alpha Therapies platform and radiopharmaceuticals expertise and AstraZeneca's portfolio of antibodies and cancer therapies.
ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.
Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.
Adds 258,000 sq.-ft. to current Cookeville footprint and represents expansion into biologics, cold chain storage and third-party logistics distribution.
LAU-7b has shown potent antiviral effects against SARS-CoV-2 and MERS-CoV coronaviruses, and is also being developed for its anti-inflammatory properties.
Kodak Pharmaceuticals will produce critical pharmaceutical components that have been identified as essential but have lapsed into chronic national shortage.
Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation
Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patients
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.
Mike Grippo will serve as senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer
JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.
A look at landmark changes in the management of data in the life sciences over the last 20 years and how the industry has addressed the challenges these develop
Guy J. Dewil, M.D. brings significant life sciences and clinical trial leadership experience across operations, business development and product management
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge
Ryan Carpentier, Executive Director of Business Development, Cryoport09.23.19
Vicki Barbur of Battelle discusses real-time microbiology, critical factors determining the rapid method of choice, and accessibility to new technologies
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards
The chief executive talks industry trends, challenges and what’s in store for PCI Pharma Services as it continues its rapid growth and global expansion strategy
The use of electronic tongue technology helps firms reduce development times and costs by overcoming challenges associated with traditional testing panels.
Detlev Haack & Martin Koeberle, Hermes Pharma03.06.19
IDDI, BMS Consortium aims to establish that the GPC statistical method can complement the design, analysis and interpretation of clinical trial results
To drive patient enrollment in CBT’s ongoing Phase 1/2 trial of CBT-101 in patients with c-Met dysregulated malignancies including non-small cell lung cancer
Catalent Pharma Solutions and CEVEC Pharmaceuticals have entered a joint commercial cell line development service for pharma and biotech customers worldwide.
Catalent Pharma Solutions celebrates the 50th anniversary of its Schorndorf, Germany facility, which specializes in modified release technologies and clinical supply services.
Catalent Pharma Solutions has entered into a license agreement with Pantec AG for the exclusive worldwide development rights to the Lyopan fast-dissolve technology for healthcare products.
Catalent Pharma Solutions is adding to its global network of sourcing specialists to supply comparator drugs directly from manufacturers in an effort to reduce customer costs and ensure timely initiation and reliability of product supply.
David Duffield, director of Global Security for Catalent Pharma Solutions has been awarded membership in the American Society for Industrial Security (ASIS), Pharmaceutical Security Council.
Catalent Pharma Solutions has appointed Scott Neilson as vice president of Operations Development, Elaine Dymond as vice president of Quality, Ronald Overhiser as vice president of Innovation Operations, and Evjatar Cohen as vice president of Portfolio Ma
Catalent Pharma Solutions has released its Optiform compound optimization platform, a solid-state and highly-automated analysis platform for salt, crystal-form, and co-crystal screening.
Stephen Tindal, director, Softgel Formulation and Operations for Catalent Pharma Solutions, has been accepted as a member of the United States Pharmacopoeia (USP) advisory panel focusing on liquid filled gelatin capsules.
TraceLink, Inc. and Catalent Pharma Solutions have entered a partnership aimed at improving production visibility for Catalent customers across their entire manufacturing and packaging product lifecycle.
Catalent Pharma Solutions has joined the Business Ethics Leadership Alliance (BELA), a new initiative founded by The Ethisphere Institute to promote ethical business practices.
Lois Johnson has been appointed vice president of Quality, Development and Clinical Services, and Alex Eslava has been named vice president of Quality, Sterile Technologies, at Catalent Pharma Solutions.
Catalent Pharma Solutions has expanded its packaging capacity with the installation and qualification of a ZED in-line blister card sealer at its Clinical Supply Services facility in Philadelphia, PA.
The Almac Group has completed a 67,000-sq.-ft. expansion to its facility in Durham, NC, which now houses the company’s Clinical Services and Diagnostics Divisions.
Will Downie has been appointed group president, Sterile Technologies and senior vice president of Global Sales and Marketing, Catalent Pharma Solutions, effective October 12, 2009.
Catalent Pharma Solutions and GlaxoSmithKline (GSK) have extended their contract under which Catalent will continue to supply GSK with its trade requirements of Lovaza omega-3 acid ethyl esters in soft gelatin capsules.
Steve Leonard has been appointed senior vice president of Global Operations, Catalent Pharma Solutions. Mr. Leonard will be located at the company’s corporate headquarters in Somerset, NJ.
John Kay has been appointed to the position of director of operations for the printed components business of Catalent Pharma Solutions Packaging Services segment.
Catalent Pharma Solutions will close its folding carton printing facility in Pennsauken, NJ in August 2009 and will expand capabilities at its Moorestown, NJ facility.