News

Improving Gender Diversity

February 02, 2023

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

The Commercial Message mRNA Products Send

February 02, 2023

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

Proportion, Balance, and Restraint

February 02, 2023

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

Bioequivalence for Immediate-Release Solid Oral Dosage Forms

February 01, 2023

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

FDA Grants Accelerated Approval to Lilly Cancer Drug

February 01, 2023

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

FDA Approves Novel Breast Cancer Treatment

February 01, 2023

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

Gerresheimer Presents New Clinical Trial Kit at Pharmapack

February 01, 2023

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

FDA Resumes In-Person Meetings with Industry … Sort Of

January 31, 2023

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 Experts Predict Increased Packaging Consolidations in 2023

January 31, 2023

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

AstraZeneca and ThermoFisher to Collaborate on Companion Diagnostic Test

January 31, 2023

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