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Vaccine Development Builds on COVID-19 Breakthroughs

March 02, 2023

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Subsurface Currents

March 02, 2023

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

AbbVie Receives Positive CHMP Opinion for Crohn’s Disease Treatment

March 01, 2023

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

February 28, 2023

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

WHO Calls for Increased Funding to Aid Yemen’s Health Crisis

February 27, 2023

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden

February 27, 2023

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

FDA Approves Sanofi Hemophilia Treatment

February 24, 2023

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

IRBs Need More Monitoring

February 23, 2023

GAO calls for more oversight of institutional review boards in clinical trials.

FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination

February 22, 2023

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

FDA Approves First Treatment for Geographic Atrophy

February 22, 2023

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.