FEATURE ARTICLES
Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
- How To Navigate Drug Repurposing And Bridging Studies
- How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
- 2022 Outsourcing Trends In Biopharmaceutical Manufacturing
- The Coming Wave Of Radio(bio)pharmaceuticals
- FDA Publishes Guidance For Biopharma Container And Carton Label Design
GUEST COLUMNISTS
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Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
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FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
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How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
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How To Navigate Drug Repurposing And Bridging Studies
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Based on BioPlan Associates’ 2022 Annual Report/Survey, biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
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FDA Publishes Guidance For Biopharma Container And Carton Label Design
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
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Assessing Extractables & Leachables In Parenteral Drug Products
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.
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FDA Finds Drug Shortages Are Mostly Caused By Quality Issues
New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
PHARMA ONLINE WHITE PAPERS
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Why Form Follows Function For Cell Culture Science
Configurability builds cell culture equipment around processes, so you don’t need to build your processes around your equipment.
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QbD And Weighing: Ensuring Accurate Measurements4/25/2022
This paper explains how you can proactively build sound weighing processes, based on Quality by Design, to ensure consistent quality of your products, improve productivity and reduce costs.
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Assembling The Right Team For A Successful Nonclinical Program11/18/2021
Discover insight into the importance of nonclinical studies and review recommendations for assembling a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.
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Adapting To Pharma’s Next Normal8/26/2021
To survive in a competitive and unrelenting industry, pharmaceutical and biotech companies must continually focus on improvement. But when the pace and magnitude of change renders traditional improvement approaches ineffective, companies must evolve to survive. That’s the crisis facing all organizations throughout the global pharma industry, and those who implement new operational models and technologies sooner will be far better positioned for adaptability and success.
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Considerations For Pre-Filled Syringes For 503(b) Compounding Facilities3/4/2022
Industry experts weigh in on how to help 503(b) compounding facilities bring acute care drugs to market more quickly, provide a safer drug administration process and minimize health care and hospital costs.
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High Potency Drug Manufacturing: Molecule To Market8/5/2020
The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialized medicines. As the biological activity and specificity of the API increases, dosage strengths decrease – resulting in increased potency of the APIs in terms of occupational handling for drug product manufacture. This paper examines the process of successful high potency drug manufacturing and delivery to market.
PHARMA ONLINE APP NOTES & CASE STUDIES
- R&D Services Company Implements A Collaborative Electronic Lab Notebook
- bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches
- Accelerating Discovery With Improved IP Management - Streamlining Lab Execution With BIOVIA
- Overcoming Obstacles In AAV Viral Vector Manufacturing
- A New Way Of Looking At De-Nesting And Re-Nesting Solutions
NEWSLETTER ARCHIVE
- 06.29.22 -- Optimizing Formulations And Drug Delivery For Novel Therapeutics
- 06.29.22 -- Clinical Supply Optimization And Comparator Local Sourcing Strategies
- 06.28.22 -- Efficient Pediatric Formulation Development Through Clinical Partnerships And Taste Masking
- 06.28.22 -- FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
- 06.27.22 -- Protecting Drug Products With Freeze/Thaw Technology
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.
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