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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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CNS innovator oligonucleotide licensing value up 339% from £2bn in 2024

Pharmaceutical Technology

Large pharmaceutical companies such as AbbVie, Lilly, Roche and Takeda have demonstrated strong interest in licensing innovator oligonucleotides for CNS indications, accounting for 63% of licensing deals between 2021 and 2025 year-to-date. ASOs accounted for more than half ($3.54 billion), while siRNAs made up more than a third ($2.51

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Responsible antibiotic use: How the industry can lead the way for evidence-backed guidelines

Express Pharma

According to ICMR, infections that were once easily treatable are now becoming resistant to widely used antibiotics, leading to prolonged hospital stays, higher mortality rates, and rising healthcare costs. This creates little financial incentive for pharmaceutical companies to invest in antibiotic research.

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TekniPlex Healthcare Unveils New Barrier Protection Systems Plant

Pharmaceutical Commerce

Supporting sterile barrier packaging and supply chain resilience The Madison plant reinforces the TekniPlex Healthcare’s goal of assisting pharma and medical companies, which indirectly includes its downstream partners as well. How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing. Pharmaceutical Commerce.

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Trump’s push to onshore pharma manufacturing clouded by ‘lack of clarity’

Pharmaceutical Technology

Robert Barrie June 11, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Drugmakers have poured billions of dollars into pharma manufacturing facilities across the US as they adapt to macroeconomic pressures. Conversely, foreign manufacturing plants will be subject to increased inspection fees.

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Regulatory measures for cybersecurity in India’s pharmaceutical industry

Express Pharma

Pharmaceutical companies face unique challenges due to their rapid digital transformation, adopting Internet of Things (IoT), Artificial Intelligence (AI), and blockchain technologies. Cybersecurity Challenges Intellectual Property Theft: Pharmaceutical companies invest heavily in research and development. With over 1.9

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Curbing AMR through sustainable antibiotic manufacturing

European Pharmaceutical Review

[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.