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Medigene Announces Pipeline Expansion Into Neoantigens With Programs Targeting Multiple KRAS Mutations & HLAs June 1, 2023
Medigene AG recently announced its pipeline expansion into neoantigens (also known as oncogenic driver mutations) with KRAS (Kirsten rat sarcoma...SPECIAL FEATURE - Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023
Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.
SPECIAL FEATURE - Excipients: Their Future Could Lie in Generics April 3, 2023
Contributor Cindy H. Dubin highlights the innovative work being done by several leading companies and exemplifies the importance of excipients to the future of drug development.
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame March 1, 2023
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
MARKET TRENDS - Emerging Trends in Injectable Drug Formulation & Delivery March 1, 2023
Martin Gonzalez, PhD, details current trends in sterile injectable formulations and delivery devices and highlights the challenges pharma and its CDMO partners are facing bringing emerging parenteral breakthroughs to patients.
EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis March 1, 2023
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
PAN-VARIANT INHIBITORS - How Pan-Variant Inhibition Can Outsmart Cancer Treatment Resistance March 1, 2023
Tim Clackson, PhD, says the goal in targeted oncology is to achieve pan-variant inhibition and, ideally, pan-variant inhibition should be accomplished with a single agent, avoiding the potential complications and toxicities of drug combinations.
IMUNON & Break Through Cancer Commence Enrollment in a Phase 1/2 Clinical Study of IMNN-001 in Combination With Avastin in Advanced Ovarian Cancer February 27, 2023
IMUNON, Inc. and Break Through Cancer recently announced the commencement of patient enrollment in a collaboration to evaluate IMUNON’s IMNN-001...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.
Gilead to Acquire All Remaining Rights to Potential First-In-Class Immunotherapy December 28, 2022
Gilead Sciences, Inc. and Jounce Therapeutics, Inc. amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buyout remaining contingent payments potentially due under….
MACHINE LEARNING - Applying Machine Learning Techniques: Gaining Meaningful Life Sciences Insights From Genomics Data November 30, 2022
Lucas Glass explains how the predictive capabilities offered by ML solutions can help pharmaceutical and biotech companies shift focus onto additional experiments — providing an opportunity to catch or generate potential options.
NANOPARTICLE ENGINEERING - Lighting the Way to a Patient-Centric Future October 3, 2022
Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.
SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
Agios Announces Publication of Phase 3 ACTIVATE-T Data Demonstrating Benefits of PYRUKYND for Adults With Pyruvate Kinase Deficiency August 19, 2022
Agios Pharmaceuticals, Inc. recently announced data from the core period of the pivotal Phase 3 ACTIVATE-T study of PYRUKYND (mitapivat) in adults with pyruvate kinase (PK) deficiency who receive regular….
Mitsubishi Gas Chemical & BD Have Signed LOI to Discuss Partnership Agreement to Explore New Ways to Advance Biologic Drug Delivery June 17, 2022
Mitsubishi Gas Chemical Company, Inc. and BD recently announced they have entered into an agreement to investigate further development of OXYCAPT – an innovation from MGC that integrates….
SPECIAL ROUNDTABLE - Which Trends Will Have the Most Impact on Drug Development in 2022? June 6, 2022
Drug Development & Delivery posed this question to life science leaders during a recent roundtable discussion. While their responses are varied, a common theme is that COVID-19 has left a lasting impact on the industry….
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
EXECUTIVE INTERVIEW - Catalent: Developing & Delivering Billions of Doses of Drugs Every Year June 1, 2022
Alessandro Maselli, President and Chief Operating Officer of Catalent, talks about his company’s unique approach to drug development partnerships as he prepares to become the company’s new President and Chief Executive Officer on July 1, 2022.
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.
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation April 4, 2022
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.