opioids

The long-awaited review of problematic prescribing of opioids is taking longer than observers had hoped. Studies of this extended use of the pain medications have lagged for years beyond their expected completion, said FDA Commissioner Robert Califf to the Associated Press.

FDA sign

On Tuesday, Curis, Inc. announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.

Outlook Therapeutics logo

Outlook Therapeutics, Inc., a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

U.S. Supreme Court Justice Sonia Sotomayor on Monday declined to block New York City from enforcing its mandate that all municipal workers be vaccinated against COVID-19, rebuffing a police detective who challenged the public health policy.

Bayer

On Monday, Bayer revealed data from a Phase III trial of Kerendia (finerenone), showing the drug’s potential to reduce the risk of all-cause and cardiovascular mortality in type 2 

monkeypox

The U.S. government said on Monday it would provide about $11 million to support the packaging of Bavarian Nordic’s Jynneos monkeypox vaccine at a U.S.-based manufacturer’s facility.

Japan’s health ministry said on Monday that its panel of experts had agreed to approve manufacturing and sales of AstraZeneca’s COVID-19 preventive treatment Evusheld.

Novartis

Novartis said on Monday its Scemblix was approved by the European Commission for adult patients with chronic myeloid leukemia (CML), offering a new treatment approach for patients with intolerance to other therapies.

Germany’s Bayer said on Sunday it was starting a Phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor.

Farxiga

AstraZeneca’s blockbuster diabetes drug Farxiga led to significant reductions in the risk of hospitalization and death in people with all types of heart failure, according to study data released on Saturday, opening the door to a substantial increase in patients who could benefit.