Counteroffers made by the 10 drugmakers from the first round of Medicare drug price negotiations have received a response from HHS and were invited to engage in further negotiations. The drugmakers, which include Bristol Myers Squibb, Eli Lilly and Co., Johnson & Johnson, Novartis and Pfizer, can meet with the CMS for further negotiations up to three times before the end of final price negotiations on Aug. 1.

The Center for Clinical Trial Innovation is a new hub launched by the FDA's Center for Drug Evaluation and Research that aims for clinical trial innovations to improve the design and conduct of such activities to "efficiently generate evidence on the safety and effectiveness of new therapies in ways that meet the growing demands of drug development," the CDER said. The C3TI's goal will be to expedite the sharing of learnings gained from the CDER's existing initiatives for clinical trial innovation with external parties.

European regulators have given IVDR Class C certification to Agilent Technologies for its GenetiSure Dx Postnatal Assay. The assay is used to evaluate genetic anomalies linked to dysmorphic features, developmental delay, congenital abnormalities and intellectual disability.

GSK announced on Tuesday that the FDA has accepted its five-in-one meningococcal vaccine candidate for review. A decision regarding the application is set for Feb. 14, 2025.

AstraZeneca disclosed positive data based on three years of survival follow-up for its immunotherapy Imfinzi, or durvalumab, combined with chemotherapy, consisting of gemcitabine plus cisplatin, tested as a first-line treatment on adults with advanced biliary tract cancer. Results found that the Imfinzi combination lowered mortality risk by 26% compared to chemotherapy plus placebo, and "(t)he latest data from TOPAZ-1 shows that twice as many patients with advanced BTC were still alive at three years with Imfinzi and chemotherapy, an especially meaningful advance in a setting where historically the prognosis has been poor," according to Do-Youn Oh, the trial's principal investigator.

A Phase 3 study showed that Genentech's glofitamab-gxbm plus chemotherapy were associated with a significant improvement in overall survival among patients with relapsed or refractory diffuse large B cell lymphoma who are not candidates for autologous stem cell transplant and who previously received at least one line of therapy, compared with rituximab plus chemotherapy.

A randomized controlled trial conducted by investigators found that an accelerated hepatitis B vaccination regimen for patients with advanced chronic kidney disease helped them achieve rapid seroconversion safely and effectively before hemodialysis initiation or undergoing a kidney transplant. Completion of the hepatitis B virus vaccination was done in eight weeks instead of the standard 24 weeks for this study.

Merck has launched a new educational campaign dubbed "Outnumber PAH" after its drug Winrevair gained the FDA's approval recently as a treatment for pulmonary arterial hypertension. The campaign aims to reach out to people diagnosed with PAH by offering information and resources to these patients and encouraging them to create a support system that would "outnumber" the disease, which would include family, friends, care teams and other patients with PAH based on the stories of seven patients whose stories are featured in the campaign.

Mexico has delayed implementation of a ban on genetically edited corn until 2025. The decision will give Mexican officials and industries more time to assess the ban's potential economic impacts and search for alternatives to glyphosate and other agricultural chemicals.

Fortera has opened a plant that produces low-carbon cement by capturing carbon dioxide from the flue of a CalPortland plant in California that produces conventional cement. Fortera expects to produce 15,000 tons annually of ReAct cement by capturing 6,600 tons of CO2.

Unifirst provides a range of apparel from traditional uniforms and industrial wear to protective clothing. Improve the safety of your facility, support infection control efforts with UHF chip technology, and enhance your business image – all at favorable rates and terms. Rent, lease, or purchase quality workwear today.