Featured Stories

Regulatory Editor Regulatory Editor

FDA Expands Label for Sarepta’s Duchenne Gene Therapy

The FDA has broadened the label for Sarepta Therapeutics’ Elevidys - a gene therapy for Duchenne muscular dystrophy (DMD). The therapy is now approved for all DMD patients aged 4 and older after the therapy showed meaningful clinical benefits in secondary measures, despite the trial missing its primary endpoint.

Read More
Strategy Editor Strategy Editor

Lupin Appoints CEO of New API CDMO Subsidiary

Indian multinational pharmaceutical company, Lupin, has expanded into the CDMO market.

The company has appointed Abdelaziz Toumi as the CEO of its newly established subsidiary, Lupin Manufacturing Solutions (LMS) which will focus on developing, manufacturing, and selling APIs while expanding into the CDMO market.

Read More
Strategy Editor Strategy Editor

Capitalizing on a Boom in Injectable Therapies

It wasn’t so very long ago that progress in delivering systemic treatments, via new oral technologies, inhalables and via a plethora of alternative routes of delivery suggested that the days were numbered for invasive injections, but recent reports now suggests injectables will remain a mainstay of drug delivery for some time to come.

Read More
Expansion Editor Expansion Editor

SCHOTT Pharma Opens Production Facility in Hungary

Since breaking ground in October 2022 and fresh from its IPO in September 2023, SCHOTT Pharma, the maker of drug containment solutions and delivery systems for injectable drugs, announced the culmination of a EUR 76 million investment with the opening of its new production facility in Lukácsháza, Hungary.

Read More
Regulatory Editor Regulatory Editor

WuXi Shares Surge Following BIOSECURE Act's Exclusion

WuXi AppTec and WuXi Biologics saw significant stock gains (7% and 14%, respectively) after the BIOSECURE Act was unexpectedly excluded from the National Defense Authorization Act (NDAA). The Act, which targets foreign biotech companies over U.S. national security concerns, proposed cutting ties with certain Chinese firms by 2032.

Read More
Strategy Editor Strategy Editor

BIO 2024: Adapting Payment Models for Gene Therapy

With plenty of panels happening at BIO 2024, one convention discussion highlighted the transformative potential of gene therapy and the challenges of funding these high-cost, one-time treatments. Experts from bluebird bio, Vertex Pharmaceuticals, and other stakeholders emphasized the need for innovative payment models that reflect the long-term value of gene therapies.

Read More
Strategy Editor Strategy Editor

Thermo Fisher Opens GMP-certified Ultra-cold Facility in Netherlands

Thermo Fisher Scientific has inaugurated a GMP-certified ultra-cold facility in Bleiswijk, Netherlands, to enhance its clinical trial network in Europe. This state-of-the-art facility supports the development of advanced therapies, including cell and gene therapies, biologics, and vaccines through comprehensive services, including ambient to cryogenic storage, clinical packaging, labeling, and distribution.

Read More
Strategy Editor Strategy Editor

Vetter Pharma Expands Manufacturing Capacity in the U.S. and Germany

The company will move its development services site from Skokie to Des Plaines, Illinois, where a construction project was announced to add new buildings for clinical manufacturing and related services. Vetter will also expand its commercial business at its 125-acre site in Saarland, Germany, to meet increasing customer demand for high quality injectables.

Read More