Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
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The U.S. Department of Health and Human Services (HHS) is being criticized for its quick headlong plunge awarding $21M to two companies testing heartburn drug famotidine, the active ingredient in Pepcid, in COVID-19 patients.
The study, since suspended due to a shortage of patients, was being conducted by Florida-based Alchem Laboratories and its subcontractor Northwell Health in New York.
HHS outlined a long list of concerns in a June 8 letter, including the absence of a system to track safety, no independent data monitor to ensure the integrity of results and no proper FDA documentation, concluding that there was a “high probability” that the companies would fail to honor the terms of the agreement.
In a June 19 written response to the letter, Alchem CEO James Talton stated that the trial needed to be redesigned due to frequent changes in standards of care treatment.
A whistleblower, former BARDA director Rick Bright, cited the contract as an example of unethical conduct by agency leadership.
President Trump has signed four executive orders aimed at cutting drug prices including tying Medicare drug payment levels to those of other countries (targeted to take effect August 24).
Under Priority Review status, the FDA approves Gilead Sciences (GILD -2.5%) unit Kite Pharma’s CAR T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of mantle cell lymphoma, a rare and aggressive type of non-Hodgkin lymphoma.
The product’s labeling has a Boxed Warning regarding the risks of cytokine release syndrome (CRS) and neurotoxicities. The Risk Evaluation and Mitigation Strategy (REMS) has been combined with the REMS for Yescarta (axicabtagene ciloleucel).
The FDA is warning consumers to avoid “dozens” of imported hand sanitizers due to the presence of toxic wood alcohol (methanol) which can lead to methanol poisoning when applied to the skin or death if ingested.
The agency says it is concerned about brands making false claims that their products protect against coronavirus and increasing numbers of users who are getting sick from ingesting the products, including people who were hospitalized or blinded.
Most of the questionable brands were made from ~six companies in Mexico. Several were sold by major retailers like Walmart (NYSE:WMT).
Hand sanitizers remain one of the most sought-after products amid the pandemic.
The FDA recommends only those containing at least 80% ethanol or 75% isopropyl alcohol.
Hutchison China MediTech (NASDAQ:HCM) has initiated a Phase I study of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase 1 and 2 mutations, in patients with hematological malignancies in China. The first patient was dosed today.
The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL‑306 to determine the maximum tolerated dose and/or the recommended Phase II dose (“RP2D”).
The second stage is a dose expansion phase where three cohorts of patients will receive HMPL‑306 to further evaluate the safety and clinical activity at the RP2D.
