Manufacturing

Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.

Testing by third-party lab accumulated 35,862 data points from 70 brands and 160 products as a benchmark for the study’s findings. Council for Responsible Nutrition criticized the study as lacking “critical context” and potentially “misleading consumers rather than empowering them.”

Glen Clova Scientific is galvanizing virus-like particle technology with disruptive advances in manufacturing to treat immune-related dermatology conditions in often overlooked senile populations.

Scrip picks five key themes that dominated biopharma developments in 2024 and look set to continue to influence the industry throughout this year.

The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.

In the first instalment of a three-part interview with Richard Saynor, the Sandoz CEO talks about the aftermath of the company’s spinoff from former parent Novartis and the work still left to do; the increasing prominence of biosimilars for Sandoz; the firm’s investments in manufacturing; thoughts on the potential for significant M&A; and future opportunities for the industry leader.

Merck’s India head for process solutions and Aragen Bioscience’s CEO talk about an incubator set-up and AI-led drug discovery to enable India’s research ecosystem, US tariffs on China, ADC and GLP-1 development, funding path for Goldman Sachs-investee Aragen and more in this video interview

Latest regulatory goals update also includes April as target date for final rule on exemptions from IND clearance for clinical trials to evaluate food, dietary supplements or cosmetics and May for an NPRM would recognize N-acetyl-L-cysteine as a lawful dietary ingredient.

Fitcrunch brand and CEO move to 1440 Foods; BBB National Programs expands leadership; Fighting Weight names CEO at launch; OmegaXL Sport connects with Model Elizabeth Gutiérrez; Board member moves to Natural Grocer helm; Quest Nutrition provides protein snacks for USA Rugby; Lionel Messi’s hydration beverage distribution spreads.

The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.