FTC order could ease biopharma competition
In Amgen’s consent order with the US Federal Trade Commission (FTC) addressing the intended acquisition of Horizon Therapeutics, once finalised, some requirements will be effective for 15 years.
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In Amgen’s consent order with the US Federal Trade Commission (FTC) addressing the intended acquisition of Horizon Therapeutics, once finalised, some requirements will be effective for 15 years.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
As the pharmaceutical industry awaits the first regulatory approval of an mRNA-based oncology therapy, research predicts BioNTech will lead the market by 2029, which by then, is anticipated to value $2 billion.
IMA Pharma showcases its extensive, all-in-one vaccine production solutions, including the design and development of complete aseptic lines and secondary packaging, all facilitated by the latest advanced technologies.
Key recommendations highlighted in a recent report by the Access to Medicine Foundation offer pharmaceutical manufacturers ways to effectively manage the release of antibiotic waste into the environment, and thus contribute to the reduction of antimicrobial resistance (AMR).
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to support implementation of new requirements for medicine packaging in 2025 under the Windsor Framework.
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
Subin Baral, EY Global Deals Leader for Life Sciences, a partner at Ernst & Young LLP, shares exclusive insight on how strategies such as specialisation can help life science companies secure future growth and the key role divestments and spin-outs have on ensuring this strategic focus.
The first randomised trial comparing efficacy of a highly selective RET-kinase inhibitor with multikinase inhibitors (MKIs) in advanced medullary thyroid cancer (MTC) has delivered promising results.
The biopharma industry will see more customisation in the design of bioprocess containers in the next five years, a market report has predicted.
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
Research states that the rising success rate of RNA-based COVID-19 vaccines and demand for personalised medicines is driving the global RNA therapy clinical trials market.