Pharminent

FDA expands Camzyos label to include pediatric patients

The FDA expanded the approved indication for Bristol Myers Squibb’s Camzyos to treat symptomatic obstructive hypertrophic cardiomyopathy in adults and pediatric patients weighing at least 30 kg.

FDA accepts Roche’s application for MS pill fenebrutinib

The FDA has accepted Roche’s application for fenebrutinib, an oral BTK inhibitor, in two major forms of multiple sclerosis. Safety questions remain over the program, according to the report.

ICMRA urges alternatives to animal testing across medicine lifecycle

EMA endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities calling on medicine developers, manufacturers and regulators to advance alternatives to animal testing across the medicine lifecycle.

FDA recruits scientific and consumer members for advisory committees

The FDA is recruiting to fill vacancies on its advisory committees, seeking new scientific and consumer representatives. The committees have met less frequently during the Trump administration, with more meetings scheduled since former Commissioner Marty Makary left the agency in May.

Lilly’s EloraTZP beats tirzepatide in Phase 2b obesity, diabetes trial

In a 48-week Phase 2b study in adults with obesity and type 2 diabetes, Lilly’s EloraTZP (eloralintide plus tirzepatide) produced average weight loss of up to 54.1 lbs (23.3%) versus 34.4 lbs (14.8%) with tirzepatide 15 mg, and A1C reductions of up to 2.9% versus 2.4%. Lilly said it plans to begin Phase 3 trials of the combination regimen at the end of the year.

Lilly’s orforglipron meets cardiovascular non-inferiority objective in ACHIEVE-4

In the ACHIEVE-4 type 2 diabetes trial, Lilly’s oral GLP-1 Foundayo (orforglipron) met the primary objective of non-inferiority versus insulin glargine, with a 16% lower risk of MACE-4 and a 23% lower risk of MACE-3. Pre-planned analyses showed a 53% lower risk of cardiovascular death and a 57% lower risk, alongside sustained A1C reduction and weight loss.

Bristol Myers revises admilparant fibrosis trial after safety events

Bristol Myers Squibb amended its ALOFT study of the LPA1 receptor antagonist admilparant, with a spokesperson confirming a “limited number” of liver-related safety events, including one patient death, were observed in testing of the drug. It is unclear whether the drug was responsible, according to the report.

Lilly post-hoc analyses project lower diabetes, cardiovascular risk with Foundayo

In post-hoc analyses of the ATTAIN-1 trial, Lilly’s Foundayo (orforglipron) 17.2 mg was associated with a predicted 57% reduction in long-term risk of type 2 diabetes and an 18% reduction in predicted cardiovascular disease risk versus placebo.

Novo reports real-world weight loss data for oral semaglutide

Novo reported real-world data showing weight loss among patients who switched to its oral semaglutide pill.

Sanofi and Regeneron expand immunology alliance in $8B deal

Sanofi and Regeneron expanded their R&D alliance with a roughly $8 billion agreement, including a $1 billion upfront payment, covering four new long-acting antibodies. The companies will co-develop and co-commercialize the four immunology candidates.

Varda raises $251M for space-based pharmaceutical processing

Varda secured $251 million in funding to support its space-based pharmaceutical processing mission, which uses microgravity conditions for drug manufacturing.

AbbVie UK report estimates £870M migraine burden in Greater Manchester

A report from Health Innovation Manchester and AbbVie UK estimates migraine affects about 280,000 people across Greater Manchester and creates an annual economic and quality-of-life burden of around £870 million. The report drew on linked healthcare data, health economic modeling, pathway analysis and patient and healthcare professional insights.