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PTC Therapeutics’ Waylivra receives Brazilian regulatory approval

Waylivra has been approved as the first treatment for familial partial lipodystrophy in Brazil.

India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

The BBV154 vaccine is approved for the first two-dose schedule and homologous booster doses.

How an innovative new bioreactor is using ultra-fine filters to increase T-cell production

Cell therapies and regenerative medicine have enormous potential to change the way we treat patients and deliver health care, but the production of cells on a reproducible commercial scale poses a challenge.

How to cut drug supply costs with seamless forecasting and IRT systems

Cut drug wastage, reduce risk, and optimise supply with advanced, integrated technologies designed to deliver increased visibility, flexibility and accuracy.

Roche to supply Actemra IV courses to Canada for Covid-19

The Canadian Government will receive 15,000 courses of Actemra IV from Roche.

Liminatus Pharma enters SPAC merger deal with Iris Acquisition

The boards of directors of both companies have granted approval for the merger.

US FDA approves Ferring’s Rebyota for Clostridioides difficile infection

The approval is based on the findings from the clinical programme including data from the Phase III PUNCH CD3 trial.

UTMB and HDT Bio receive US funding for vaccine development

The funds are intended to advance the vaccines to the successful conclusion of Phase I clinical trials.

CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology analyzes recent regulatory decisions by several authorities that will likely impact therapy manufacturing plans.

What’s next for Container Closure Integrity Testing?

Driven by changing regulations and an increased need for quality, traceability, and efficiency, the pharmaceutical industry is upgrading how it performs container closure integrity tests.

Current pipeline developments could bring new hope for patients with PPMS

The current MS pipeline offers new hope for pre-progressive MS (PPMS) patients, with three late-stage agents in development.

The “Medical Bypass”: new drugs to strike obesity

The FDA has granted Mounjaro a Fast Track designation to treat obesity, as it has shown comparable potential to gastric bypass surgery.

Biocon Biologics acquires biosimilars business of Viatris for $3bn

Following the closing of the deal, Viatris president Rajiv Malik has joined Biocon Biologics’ board of directors.

Gilead receives EC marketing authorisation for HIV treatment in children

The latest approval in the EU is based on data from an open-label clinical trial of Biktarvy.

City of Hope researchers develop new brain cancer therapy

In addition to removing tumour cells at the injection site, the treatment demonstrated an abscopal effect.