In opening today’s meeting of the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), the agency’s Peter Marks said, “We’re now in a reasonable place to reflect on the development” of the COVID-19 vaccines and consider how best to optimize their development going forward. While the FDA is asking the VRBPAC to vote on recommending the harmonization of the vaccine strain composition of all primary series and booster doses available in the U.S. to a bivalent vaccine targeting the original virus and omicron BA.4/5, it is looking toward next-generation vaccines that could prevent transmission of the SARS-CoV-2 virus, as well as asymptomatic infection. To get there, VRBPAC members said, researchers will need to look beyond neutralizing antibodies for other correlates of infection.

Grey Wolf raises $49M to advance tumor drug toward phase I/II

An anticancer approach that leads to improved tumor visibility edged closer to the clinic after Grey Wolf Therapeutics Ltd. scooped $49 million in a series B round. The immuno-oncology company plans to use the proceeds to move its lead candidate, GRWD-5769, into a phase I/II trial. GRWD-5769 is a targeted inhibitor of one of two homologues of endoplasmic reticulum aminopeptidase (ERAP), ERAP1, a key protein in the antigen presentation pathway. This results in an increased number and range of cancer antigens and certain other neoantigens on the surface of tumor cells, effectively flagging them for the body’s immune system.

Analysts positive, market not so much, on Aridis phase III MAb data for S. aureus VAP

Low enrollment in a phase III trial and a missed primary endpoint sent Aridis Pharmaceuticals Inc.’s shares (NASDAQ:ARDS) tumbling by 32.5% in early trading on Jan. 26., although the company’s AR-301 (tosatoxumab) showed superior efficacy over the control group in Staphylococcus aureus ventilator-associated pneumonia (VAP) patients. Aridis put out top-line AR-301-002 phase III data of the monoclonal antibody (MAb), showing the clinical cure rate with AR-301 plus standard-of-care (SOC) antibiotics reached 68.9% (42/61 patients) vs. 57.6% (34/59) with SOC antibiotics alone, missing statistical significance. Absolute efficacy was 11.3% (p=0.23). Treatment, however, reduced the duration of hospitalization by nine days, the time in the intensive care unit by seven days and the number of days on mechanical ventilation by two days. Analyst Carl Byrnes, of Northland Capital Markets, said the clinical cure rate of ≥10% “is considered clinically meaningful” but the smaller sample size – the company had intended to enroll 240 and ended up with only 120 evaluable patients – impeded AR-301’s ability to reach statistical significance.

Phase II miss in diabetic retinopathy fails to deter Ocuphire; FDA meeting ahead

Ocuphire Pharma Inc. rolled out top-line efficacy and safety data from the Zeta-1 phase II study testing oral APX-3330 in diabetic retinopathy. The trial missed its primary endpoint: percentage of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Score at week 24 in the study eye. Ocuphire plans to schedule an end-of-phase II meeting with the U.S. FDA. Shares of the Farmington Hills, Mich.-based firm (NASDAQ:OCUP) were trading midday at $3.28, down 48 cents, or 12%.

China adds 111 new drugs to NRDL, focus on innovation

Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. The negotiation and bidding process (including some renewal negotiations) comprised 147 drugs, out of which 121 negotiations concluded successfully. The newly added drugs include 56 drugs for chronic diseases such as hypertension, diabetes and mental health disorders; 23 drugs for oncology; 17 drugs for treating infections; seven drugs for rare diseases; 22 pediatrics drugs; two for COVID-19 treatment; and two designated as “national essential” drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.

China grapples with regulating online drug sales

China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time. Drugs that are prohibited from being sold online include vaccines, blood products, narcotics, psychotropic medications and radioactive drugs. According to China’s State Council, the measures are designed to make it easier for people to access drugs while at the same time focusing on ensuring the quality and safety of drugs by improving the quality management system for online drug sales. The regulations stipulate how online drug sales will be managed by all parties, including third-party platforms.

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