EMA Streamlines Medicine Approval Process to Accelerate Access to New Treatments in the EU
Key TakeawaysThe European Medicines Agency (EMA) is implementing measures to improve the efficiency of the approval process for new medicines, targeting faster assessments...
FDA Clarifies Compounding Rules as National GLP-1 Drug Supply Stabilizes
Key TakeawaysThe FDA announces that the national shortage of tirzepatide injection, a GLP-1 medication, has been resolved.
The agency reminds compounders of legal...
NICE Seeks to Address Evidence Uncertainty for Elacestrant in Advanced Breast Cancer Treatment
Key TakeawaysNICE is consulting on draft guidance that currently does not recommend elacestrant for advanced breast cancer due to uncertainty in clinical evidence.
...
Gilead Secures Future of HIV Prevention with Bold Royalty-Free Agreements for Lenacapavir in High-Risk Countries
Key TakeawaysGilead signs royalty-free agreements with six global manufacturers to produce low-cost versions of Lenacapavir for HIV prevention and treatment.
The initiative targets...
Boehringer Ingelheim Partners with NCD Alliance to Improve Care for Non-Communicable Diseases
Key TakeawaysBoehringer Ingelheim partners with NCD Alliance to address global inequities in non-communicable disease (NCD) care, particularly in underserved communities.
The partnership will...
La La Anthony Partners with Amgen to Raise Awareness on Plaque Psoriasis
Key TakeawaysLa La Anthony opens up about her personal journey with plaque psoriasis and encourages open communication with doctors about treatment needs.
The...
Enhertu Granted US Priority Review for HER2-Low Breast Cancer
Key TakeawaysEnhertu received Priority Review for HER2-low and HER2-ultralow metastatic breast cancer after endocrine therapy.
Phase 3 trial showed Enhertu improved progression-free survival...
Calquence Receives US Priority Review for Untreated Mantle Cell Lymphoma
Key TakeawaysCalquence granted Priority Review by the FDA for first-line treatment of mantle cell lymphoma (MCL).
Phase 3 trial data showed a 27%...
Merck Presents Long-Term Data for Tulisokibart in IBD
Key TakeawaysMerck showcases long-term efficacy of tulisokibart in ulcerative colitis and Crohn’s disease at UEG Week 2024.
Phase 2 data show sustained treatment...
Merck Expands Pipeline with CN201 B-Cell Therapy Acquisition
Key TakeawaysMerck acquires CN201, a bispecific antibody targeting B-cell malignancies and autoimmune diseases.
CN201 shows promise in treating relapsed B-cell hematologic malignancies, such...
