www.fdanews.com/articles/198759-week-in-review
Week In Review
August 28, 2020
Clinical Trials
Merck said its blockbuster cancer drug Keytruda (pembrolizumab) in combination with chemotherapy significantly improved survival in patients with locally advanced or first-line metastatic esophageal cancer in a phase 3 clinical trial.
The FDA has updated its information on the surrogate endpoints it has accepted in clinical trials for drug approvals and biologics licenses.
Trials of drugs to treat cancer in the central nervous system (CNS) that has metastasized from solid tumors outside the CNS should examine whether the treatment controls the cancer at all disease sites, according to an FDA draft guidance released Wednesday.
Complete Response Letters
The FDA has turned down Tricida’s new drug application for veverimer (TRC101) as a treatment for metabolic acidosis in patients with chronic kidney disease and said it needs to see more supporting data.
COVID-19
Johnson & Johnson (J&J) expects to begin the largest late-stage trial for a COVID-19 vaccine candidate to date early next month if results from its early-stage studies pan out.
President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients.
German vaccine maker CureVac and the European Union (EU) are close to finalizing a supply deal for the company’s COVID-19 vaccine candidate that will stock the EU with hundreds of millions of doses.
Sinopharm has announced that it will launch another phase 3 trial of its experimental COVID-19 vaccine candidate, this time in Peru, following a greenlight from the Peruvian health regulator.
Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial.
In a surprise U-turn, the FDA on Sunday authorized the emergency use of convalescent plasma for treating COVID-19, following accusations by President Trump that the agency was holding off on issuing an Emergency Use Authorization (EUA) for political reasons.
New data from Gilead Sciences’ late-stage trial of its antiviral remdesivir showed that a five-day course of the drug helped patients with moderate COVID-19 pneumonia, but the finding was of “uncertain clinical importance,” according to researchers.
Russia will begin a phase 3 trial of its Sputnik V COVID-19 vaccine on 40,000 volunteers this week, Russia’s state news agency Tass announced Friday.
AstraZeneca has denied claims that it is in talks with the U.S. government about receiving a potential Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate.
The World Health Organization (WHO) has expressed doubts about the FDA’s decision to grant an Emergency Use Authorization (EUA) for convalescent plasma as a COVID-19 treatment, claiming that the supporting evidence is weak.
Novavax announced yesterday that it has enrolled its first volunteers in a phase 2 trial of its COVID-19 vaccine candidate NVX-CoV2373.
Moderna announced that it has concluded exploratory talks with the European Commission for a deal to supply up to 160 million doses of its COVID-19 vaccine.
FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure.
AstraZeneca has dosed the first participants in a phase 1 trial of its investigational monoclonal antibody product AZD7442 for preventing and treating COVID-19.
The National Institutes of Health (NIH) said it plans to study an investigational antiviral from Gilead Sciences that proponents believe may offer significant advantages over remdesivir as a possible COVID-19 treatment.
Moderna’s coronavirus vaccine candidate was well-tolerated and worked well in elderly COVID-19 patients in a small, early-stage trial, the company said Wednesday, following promising results announced in July for younger patients.
Three ranking Democrats have asked a Virginia-based consulting firm to reveal details of its government contract for Operation Warp Speed’s chief adviser Moncef Slaoui, citing concerns that the contract allows the former pharma executive to skirt ethics rules and avoid disclosing potential conflicts of interest.
Partner Therapeutics has enrolled the first patient in a phase 2 trial evaluating its inhaled Leukine (sargramostim) for hospitalized COVID-19 patients.
Inspections
The FDA rapped an AbbVie manufacturing facility in Barceloneta, Puerto Rico, for good manufacturing practice failures, including missing written procedures.
Labeling
The FDA has rapped Chicago, Ill.-based drugmaker Xeris Pharmaceuticals for a misleading television ad for its diabetes drug Gvoke (glucagon injection).
Pricing
As of Friday evening, the pharma industry had still not put forward a price-cutting strategy that could sway the president into discarding a drug pricing executive order he has threatened to enforce.
Several drug manufacturers are threatening to end discounts to hospitals that they pass on to patients under the federal government’s 340B drug pricing program.
The Trump administration’s Aug. 24 deadline has come and gone for the pharma industry to come up with a drug pricing strategy that would prevent a threatened executive order by President Trump from going into effect — but the White House and big pharma have remained silent.
The Department of Justice (DOJ) has charged a Teva Pharmaceuticals subsidiary with allegedly conspiring to rig prices for generic drugs, making it the seventh drugmaker to be indicted as part of an ongoing probe.
Recalls
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have.
Warning Letters
A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility.
Briefs/Columns