PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
Attributing recent reductions in certain U.S. prescription drug prices to intense congressional scrutiny rather than a biopharma industry commitment to affordability, Rep. John Sarbanes (D-Md.) said Congress must put more guardrails in place and restructure how the industry does business.
Rather than the in-your-face, blame-and-shame show that was expected, the Sept. 30 drug pricing hearing before the U.S. House Oversight Committee was more a reminder of the policy differences between Democrats and Republicans on how best to make prescription drugs more affordable.
CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
There are millions of fungal species, but it appears only a few hundred of them cause serious fungal infections that are responsible for an estimated 1.5 million deaths globally each year and are equally as dangerous as bacterial and viral infections. Last week, the U.S. CDC pointed the spotlight on this situation with its Fungal Disease Awareness Week.
The governor’s signature brought California a step closer to realizing state officials’ dream of having their own generic and biosimilar drug label. In signing the California Affordable Drug Manufacturing Act into law Sept. 28, Gov. Gavin Newsom touted the legislation as a way to break down market barriers to affordable prescription drug prices. “Our bill will help inject competition back into the generic drug marketplace – taking pricing power away from big pharmaceutical companies and returning it to consumers,” he said.
LONDON – As the last scheduled talks on the future EU/U.K. trading arrangements got underway on Sept. 29, the pharmaceutical industry across Europe issued an urgent plea for medicines to be spliced out of the contentious negotiations. In a joint statement, the U.K. and European industry organizations called for a mutual recognition agreement (MRA) to prevent the need for retesting of medicines imported from the EU to the U.K., in the event there is no deal.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen.
The always-busy American Society of Hematology meeting in December promises to include some especially intriguing datasets from the bispecific antibody space, as multiple players are likely to unveil findings related to their CD20xCD3 prospects.
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