Search Results for: BIOSIMILARS The US Biosimilar Approval
Articles
MARKET REPORT - Survey Suggests Global Innovation to Recover Much More Quickly Than Expected in 2023 February 9, 2023
After a brief fall in 2022 to a score of 6.5 – the first decline since its inception in 2018 – the index has surged to a record score of 7.4. This sudden recovery in scores over a little more than 8 months bodes extremely well for device and packaging manufacturers in the year ahead, suggesting a strong global recovery in industry outlook and confidence.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina December 14, 2022
Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research...SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
Biogen & Eisai Amend Collaboration Agreements on Alzheimer's Disease Treatments March 15, 2022
Biogen Inc. and Eisai Co., Ltd. recently announced the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the US as ADUHELM (aducanumab-avwa)…..
Biogen Exercises Option to Participate in the Development & Commercialization of a Late-Stage Bispecific Antibody February 1, 2022
Biogen Inc. recently announced it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay...2021 Analytical Testing eBook - Bioanalytical Testing is Fastest Growing Sector September 20, 2021
In this annual Drug Development & Delivery analytical ebook, we present best practices in stability studies as well as the benefits of UPLC optimization…..
SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
Dyadic Announces Technology Transfer & Licensing Agreement With South Africa’s Rubic Consortium July 28, 2021
Dyadic International, Inc. recently announced it signed a COVID-19 vaccine technology transfer and licensing agreement with the Rubic Consortium, a...SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market May 3, 2021
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
EXECUTIVE INTERVIEW - Celanese: Better Therapeutic Outcomes From Better Drug Delivery March 29, 2021
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
SPECIAL FEATURE - Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis January 14, 2021
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market? September 1, 2020
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions May 5, 2020
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 2 March 2, 2020
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review March 2, 2020
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2019 product approvals.