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 The Patenting Challenges Of AI-Assisted Drug Discovery
- How To Navigate Drug Repurposing And Bridging Studies
- 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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Enabling Fast, Appropriate Drug Product Supply For Phase 1 Trials
Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.
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A Guide to Annex 1 Requirements For Particle Monitoring1/15/2021
The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
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Liposomal And Nanoparticle Technology At Pfizer Melbourne4/20/2022
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
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Software Tools For Pharmaceutical Lyophilization Process Development1/11/2022
Highlights from a webinar describing a software modeling tool developed to optimize conditions for the primary drying cycle while accounting for heterogeneity within and between batches of drug products.
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Evaluating Your Research Equipment's Cost of Ownership3/22/2022
In this paper we review how lifespan, reliability, technical support, maintenance costs and workflow efficiency factor in to calculating the cost of ownership of your research equipment.
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A Guide To Pharmaceutical Quality Management6/16/2022
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Robust Process Development For cGMP Manufacturing Of Cell Therapies
- Importance Of Chain Of Custody For Commercial Pharma Distribution
- Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate Risk
- Successful Scale Up From Trial Stage Lab Mixer To Industrial Process
- Updating The Economics Of Biologics Manufacturing
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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