Industry News

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.

Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Vetter has become a participant of the UN Global Compact Network.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

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

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

Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.

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

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

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

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.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.

The kit is meant for use for the detection and quantitation of residual host cell protein.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

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

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

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

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