Frank Vinluan

1 week ago | medcitynews.com | Frank Vinluan

A Gilead Sciences drug that protects against HIV infection has won a highly anticipated FDA approval, becoming the first medication for HIV prevention available as a twice-yearly injection. The regulatory decision announced Wednesday covers use of the antiviral drug, lenacapavir, for HIV-1 pre-exposure prophylaxis (PrEP). The approval is for adults and adolescents weighing at least 35 kg (about 77.1 pounds) who are at risk of sexually acquired HIV-1.

1 week ago | medcitynews.com | Frank Vinluan

The FDA is implementing a new pilot program that could incentivize development of certain new drugs by dramatically shortening their regulatory reviews. But to qualify, a drug must address specified national health interests. The FDA already has a program that speeds up regulatory review of rare disease drugs. This priority review voucher program (PRV) was created by Congress, initially for rare and neglected diseases, then later expanded to include rare pediatric diseases.

1 week ago | dealbreaker.com | Frank Vinluan

BioNTech, a biotech company best known for its successful development of a messenger RNA Covid-19 vaccine, is acquiring fellow mRNA company CureVac in a $1.25 billion stock deal that brings together firms applying their respective technologies to the development of new treatments for cancer.

1 week ago | medcitynews.com | Frank Vinluan

A patient has died after receiving Sarepta Therapeutics’ approved gene therapy for Duchenne muscular dystrophy — the second fatality reported by the company in the past three months. Like the first patient, the latest death followed a case of acute liver failure. Along with disclosing the latest patient death on Sunday, Sarepta said it is developing new safety measures to mitigate the liver injury risk to patients treated with the gene therapy, Elevidys.

1 week ago | medcitynews.com | Frank Vinluan

Bispecific antibodies are one of the most active areas of cancer research, and pharmaceutical companies are busy striking deals to add them to their pipelines. One of the most talked about drugs at this year’s annual meeting of the American Society of Clinical Oncology was a bispecific antibody that did not even have data presented at the conference. Summit Therapeutics announced preliminary Phase 3 data for ivonescimab, which is designed to target the proteins EGFR and VEGF.