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The EU Biotech Act is expected to reduce clinical trial timelines, boost biomanufacturing, and most importantly, attract investments. The post “It’s time to Act”: EU biotech to und...
By Steven J. Gonzalez —
Policy designed to enhance agricultural output, adopt global farming practices
On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) seeking public input on the future regulation of genetically engineered (GE) or...
The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experie...
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...
A proposal to add biotechnology to the COINS Act follows two big deals involving Pfizer and Bristol Myers, and comes amid U.S. fears that China’s drugmaking progress may threaten n...
Historically, Indian pharmaceutical companies have focused on generics and services businesses, which carry lower risk and shorter development
The multipronged approach of Biotechnology Industry Research Assistance Council (BIRAC) encompassing funding, infrastructure, networks, market reach has led to expansion of biotech...
Several successful biotech startups trace their roots to BIRAC. Cleantech company GPS Renewables, for example, received funding under BIRAC’s Biotechnology Ignition Grant.
In 2024, China’s NMPA approved 83 new drugs, the FDA approved 50. China’s share of new commercial clinical trials jumped from 8% globally in 2013 to 30% in 2024, just behind the US...
America’s $150 billion per year private sector investment in biopharmaceutical research and development (R&D) does more than offer comfort. Increasingly, American innovators ar...
The U.S. International Trade Commission said it has opened an investigation into a U.S. biotechnology company's claim that a Chinese company is importing and selling kits and other...
The U.S. Senate Committee on Health, Education, Labor and Pensions on Wednesday cleared two bills for full Senate review, tackling the gap between health and patent oversight agenc...
Licencing agreement grants Ipca access to Bhami Research’s proprietary high-concentration subcutaneous biologics delivery platform for the development and commercialisation of mult...
Biotech’s effervescent activity has allowed it to overcome headwinds and sustain momentum into 2026, as the volume and value of licensing and M&A deals continues to increase. N...
The workflow pairs Bio-Techne’s MauriceFlex imaged capillary isoelectric focusing fractionation system with Refeyn's TwoMP mass photometry platform to connect charge heterogeneity...
An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes rev...
Distributed manufacturing establishments operate a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Reg...
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