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 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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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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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. 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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Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface
Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.
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Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development1/26/2022
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
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High-Volume Manufacture Of Thin-Wall Medical Device Components With LCP3/2/2022
The advantages of Liquid Crystal Polymer (LCP) thermoplastics are translatable to precision combination drug delivery devices which incorporate complex mechanisms and wireless connected electronics.
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Modern Containment Solutions In OSD Processes12/14/2021
In the containment world for OSD processing we see smaller batch sizes and more changeover, which require greater levels of efficacy, efficiency, and speed. Here we consider the pros and cons between a hard-wall system and a flexible-wall containment systems.
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New Technologies For Safe Powder Handling In The Bulk Pharma Industry8/7/2020
The increasing toxicity and reactivity of API products and more demanding production standards have made closed powder handling an unavoidable factor and manual handling obsolete.
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It Hasn’t Been Easy For Pharma To Be Green10/2/2020
Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Selecting A Reversed-Phase Column For The Peptide Mapping Analysis Of A Biotherapeutic Protein
- Speed To Market – API Large Scale Commercial Manufacturing
- Boost Performance With A Chromatography Resin Update
- Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions
- Do Small Outsourcing Partners Benefit Small And Emerging Biotechs?
NEWSLETTER ARCHIVE
- 07.01.22 -- Simplify And Accelerate The Development Pathway For APIs With Low Solubility
- 07.01.22 -- How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems
- 06.30.22 -- Insights On Outsourcing Highly Potent API Manufacturing
- 06.30.22 -- De-Risking Your Pharma Supply Chain
- 06.29.22 -- Optimizing Formulations And Drug Delivery For Novel Therapeutics
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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