News

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.

Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.

The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.

The company opened its 62,000 square foot facility, called the BioProcess Innovation Center, in Triangle Park, NC.

The company opened a new sales office located in Seoul, South Korea.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Pharma has voiced strong opposition against Britain’s departure from the EU.

Jazz will acquire Celator for approximately $1.5 billion.

FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Lagarde will be based out of the company’s Boston office and will lead Patheon’s global corporate and cross-enterprise operations.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.

The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.

The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

The new 500-meter-square warehouse will hold incoming materials, including already micronized highly potent substances and cytotoxic products.

Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing to will collaborate on a project to test technology for T-cell stimulation and expansion.

The company will offer a standard serialization solution across 14 locations in Europe and more than 70 product lines.

In the largest-ever report of its kind, drugs entering clinical development in Phase I were found to have only a 1 in 10 chance of FDA approval.

Colorcon Acquired BASF’s Kollicoat IR Coating System product line, which includes currently customer business, and inventory.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).