TOP Pharma & Biotech News #2?? February Edition

Welcome to the world of pharma news???

In February's edition, you will read about the most studied disease there is. In its recent responses to FAQs relating to Annex 1, EMA discusses bioburden guidelines. Last but not least, read about prescription drug prices in the U.S. that are significantly higher than in other nations.

Oncology research has gone on to attain priority status and has apparently been flush with pharma research dollars for years. The fact is that drug development companies went on to raise $7 billion in 2020 because of the disease’s heavy human toll, and cancer drug sales may almost double to $320.6 billion by 2026.

Last year, breast, solid tumors, and prostate cancers were among the top five most studied diseases, according to the Phesi Global Analysis report, examining over 65,000 trials with 100 million patients. Breast cancer, leading the list for the third consecutive year, is one of the most common cancers globally, affecting one in three American women.

Apart from breast cancer, research into solid tumors as well as prostate cancer also made Phesi’s top five, ranking at 2 and 5, respectively.

Apparently, the positive news is that there has been a surge in trial recruitment throughout all the top five indications in 2023, opined Phesi’s President, Dr. Gen Li.

The other two kinds in the top five most studied diseases in 2023 went to COVID-19 and stroke research.

Li adds that they have seen a major reduction in investment in COVID therapies last year, most likely because there were fewer patients.

But investments when it comes to stroke R&D leaped three spots from fifth in 2022 to second last year. It is well to be noted that the number of stroke-related deaths, especially in younger people, is anticipated to double by 2050, which may as well lead to more interest in this area.

In total, the clinical trial activity also scaled back due to the pandemic. The attrition rate in the phase 2 trial was down 1% since 2022, however still hovered at 28%, thereby marking a sizable leap from the 20% rate of attrition that was seen before the pandemic, as per Phesi.

Li says that ultimately, the clinical development sector is indeed beginning to recover from the pandemic, but one can expect the long-term effect to stretch into 2025.

This could as well slow the pace of novel drugs coming to market and may go on to put further pressure when it comes to future R&D costs.

Read more here .

Source: WORLD PHARMA TODAY

In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).

Last week, the European Medicines Agency (EMA) published four new Q&As to its catalogue of Annex 1 questions. These included two questions focusing specifically on bioburden level and bioburden sampling.

These are discussed in EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products.

What is the maximum bioburden level?

Update January 2019: This Q&A has been superseded by the Guideline on The Sterilisation of the medicinal product, active substance, excipient and primary container.

In its answer, when considering bioburden, EMA shared that the specification limits should be “NMT 10 CFU/100ml”, in line with the guideline sterilisation-medicinal-product and active-substance ref EMA/CHMP/CVMP/QWP/850374/2015.

From a good manufacturing practice (GMP) point of view, a bioburden limit of 10 CFUs/100ml before first filtration is not only “strongly recommended”, but achievable too, EMA asserted. This limit is applicable when a prefilter is installed, “unless otherwise justified”.

In relation to higher bioburden limits, these “should not be justified by the high capacity of two consecutive bacteria retaining filters”, EMA responded.

Yet for processes involving fermentation for instance, or the use of purified water for ophthalmic preparations, EMA stated that when appropriate justification is submitted “a bioburden limit of higher than 10 CFUs/100ml before prefiltration may be acceptable.” ?

EMA noted that in these cases, the first filter should show it can achieve a bioburden before the last filtration of NMT 10 CFUs/100ml. This is in line with the notes for guidance on manufacture of the finished dosage form (CPMP/QWP/486/95 and EMEA/CVMP/126/95).

What are the requirements for the bioburden sampling to support parametric release?

In its answer, the EMA highlighted that in Annex 1 point 10.4 “products authorised for parametric release, a supporting pre-sterilisation bioburden monitoring programme for the filled product prior to initiating the sterilisation cycle should be developed and the bioburden assay should be performed for each batch (sub batch)”.

The section also detailed steps for bioburden identification, stating that “any organisms found during bioburden testing should be identified and their impact on the effectiveness of the sterilising process determined.” EMA’s answer noted that the endotoxin/pyrogen level should be monitored, as appropriate.

In Annex 17 point 4.9, it states: “a pre-sterilisation bio-burden monitoring programme for the product and components should be developed to support parametric release.”

EMA also emphasised the importance of considering the time between sampling, sterilisation and testing.

Read more here .

Source: EPR

? Interested in ANNEX 1?

?? Join us on 19 – 21 March 2024 for our Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S) Online Training Course.

Prescription drug prices in the U.S. are significantly higher than in other nations, with prices in the U.S. averaging 2.78 times those seen in 33 other nations, according to a new RAND report.

The gap between prices in the U.S. and other countries is even larger for brand-named drugs, with U.S. prices averaging 4.22 times those in comparison nations.

The RAND study found that prices for unbranded generic drugs - which account for 90% of prescription volume in the U.S. - are about 67% of the average cost in the comparison nations.

The new report updates findings from earlier RAND analysis about U.S. drug prices. That analysis compared 2018 manufacturer gross drug prices in the U.S. with other nations using a price index approach.

The new report uses updated information through 2022. It also includes additional analysis that focuses on price comparisons for biosimilars and changes in price comparison results over time.

"These findings provide further evidence that manufacturers’ gross prices for prescription drugs are higher in the U.S. than in comparison countries," said Andrew Mulcahy, lead author of the study and a senior health economist at RAND, a nonprofit research organization."

The RAND analysis provides the most up-to-date estimates of how much higher drug prices are in the U.S. compared to other countries in the Organisation for Economic Co-operation and Development (OECD).

The analysis used manufacturer gross prices for drugs because net prices - the amounts ultimately retained by manufacturers after negotiated rebates and other discounts are applied - are not systematically available. Even after adjusting U.S. prices downward to account for these discounts, U.S. prices for brand name drugs remained more than three times higher than those in other countries.

RAND researchers compiled their estimates by examining industry standard IQVIA MIDAS data on drug sales and volume for 2022, comparing the U.S. to 33 OECD nations. The data include most prescription drugs sold in the U.S. and comparison countries.

Across all 33 comparison countries, U.S. drug prices ranged from 1.72 times the prices in Mexico to 10.28 times prices in Turkey.

Researchers estimated that across all of the OECD nations studied, total drug spending was $989 billion in 2022. The U.S. accounted for 62% of sales, but just 24% of the volume.

Recent estimates are that prescription drug spending in the U.S. accounts for more than 10% of all health care spending. Retail prescription drug spending in the U.S. increased by 91% between 2000 and 2020, and that spending is expected to increase by 5% annually through 2030.

The report, “International Prescription Drug Price Comparisons Estimates: Using 2022 Data,” is available on the website of the U.S. Department of Health and Human Services and on www.rand.org .

Read more here .

Source: WORLD PHARMA NEWS

Want to boost your career in pharma and biotech? ??

Check all of our online training courses led by leading industry professionals:

Thank you for reading! ??

If you are interested in the most relevant pharma news,?don’t forget to follow this newsletter so you won’t miss any more hot topics.