News

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

Pharmapack Europe has announced the winners of the 2023 Pharmapack Awards spanning five categories across two dedicated awards.

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

The change would impact every package and hundreds of systems.

Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.

Naoki Okamura, Astellas’ current chief strategy officer, will take over the role from Kenji Yasukawa.

CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.

iotaSciences isoPick is designed to expand handling solutions for cell biology and gene therapy applications.

The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.

Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.

Improvements to Fluid Air’s Magnaflo filter blowback system are intended to increase powder yield in PolarDry Models 001 and 004.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

The European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical‑grade manufacturing of cannabis-based medicines.

Although some headway is being made into more gender-diverse executive levels in pharma, much more work is still needed.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.