News

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.

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.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

Takeda will pay approximately $400 million upfront for the exclusive worldwide rights to Hutchmed’s fruquintinib, a tyrosine kinase inhibitor, outside of China.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.