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Merck has FDA approval for a new combination drug for HIV, giving patients a new treatment option and an alternative to a blockbuster Gilead Sciences pill that comes with tolerability and side effect problems, some of them serious.

The Merck drug, brand name Idvynso, is specifically approved for adults who have reduced the virus to very low levels in the blood by taking antiretroviral drugs. For these patients, Merck’s new once-daily pill can be a replacement for those antiretrovirals.

Merck said Idvynso will be available in pharmacies after May 11. (MedCity News)

BioAge Labs released a new set of positive early results for its entry into the NLRP3 inhibitor class, a highly anticipated group of medicines. 

The new data follows a readout in January that showed a 120-milligram daily dose of BioAge’s BGE-102 had “best-in-class” potential for lowering inflammation implicated in cardiovascular risk in obesity patients. Now, the company has released comparable Phase 1 data for the 60-milligram dose of the pill.

Previous research has shown that the drug is well tolerated and can cross the blood-brain barrier, which could enable it to better attack a range of diseases. (BioPharma Dive)

Roche presented further positive efficacy results on its multiple sclerosis (MS) therapy hopeful fenebrutinib at the American Academy of Neurology (AAN) annual meeting, but the BTK inhibitor’s safety profile remains a key focus, particularly an imbalance in deaths. 

Last month, the company announced that a third phase 3 study of fenebrutinib had met its primary endpoint, adding to two earlier wins. At the time, Roche noted that a number of deaths in patients given fenebrutinib was being analyzed in more detail.

At the AAN meeting this week, the drugmaker said that across the FENhance 1 and 2 studies, which focused on patients with relapsing multiple sclerosis (RMS), there was one death in participants given Sanofi's Aubagio (teriflunomide), and seven in the fenebrutinib group; a further death was reported at a later date. (FirstWord Pharma)

And while a couple of these raises have broken years-long records—Eikon Therapeutics’ $380 million plan, for instance, and Generate:Biomedicines’ $400 million offering—none have excited industry observers more than Kailera Therapeutics.

The biotech went well over that mark, clocking the largest IPO in biopharma’s history.

Here, we look at the other record-smashers—the biotechs that have brought in staggering amounts of money in their IPOs—and where they are now.

The Trump administration is indefinitely delaying a Medicare pilot program to cover weight-loss drugs after health insurance companies voiced concerns about participating.

It’s a blow to the administration after Trump last year touted deals with Eli Lilly and Novo Nordisk to cut prices on GLP-1 drugs in exchange for access to a new pool of patients.

Medicare will still cover the drugs for weight loss through a transitional program starting in July and running through the end of 2027, but it will foot the bill on its own.

The administration will shelve plans for a five-year experiment known as BALANCE, in which participating private Medicare insurers would have paid for drugs like Zepbound and Wegovy as a regular benefit.

Medicare is barred by law from covering weight-loss drugs. The BALANCE program was intended as a workaround, allowing Medicare beneficiaries to access the drugs for just the $50 co-pay. (Axios)

Trump endorsed the potential of psychedelic treatments and vowed to expedite their research and development as remedies for severe mental health conditions, a seminal moment for a field long shunned by the US government.

But how impactful his latest executive order is, and whether it actually benefits a therapeutic class trying to break into mainstream prescribing, remains to be seen.

The April 18 announcement sent the world of psychedelics ablaze, in a good way, with companies and researchers heralding the president’s actions as a breakthrough.

The executive order directs the FDA to hasten review of psychedelic drug applications using the Commissioner’s National Priority Voucher (CNPV) and to work with the Drug Enforcement Administration to allow eligible patients to receive the drugs under the Right to Try law.

FDA Commissioner Marty Makary said Saturday that three companies would receive vouchers this week, though he did not name them. (Endpoints)

From vaccines to herbicides and transparency, health secretary Robert F. Kennedy Jr. is singing a different tune these days.

The same guy who once said no vaccine is safe was on Capitol Hill this week touting what he’s done to encourage vaccination, including funding the development of new vaccines, approving new shots for patients, and urging parents to get their kids inoculated against measles, mumps, and rubella.

He also portrayed the administration’s secret deals with drugmakers as standard practice and defended the administration’s plans to boost production of an herbicide that MAHA followers hate.

But Kennedy was still at times up to his old moves on vaccines. (STAT)

Researchers presented some of the promising data this week at a cancer conference in San Diego.

The data was collected from a small number of patients and has not yet been published in a medical journal or reviewed by regulators. Neither drug has been approved for use.

A gain of six months of life is virtually unheard-of in the field. The company also said the drug’s side effects were “manageable.”

Unlike vaccines for infectious diseases, which aim to prevent people from contracting an illness, there is hope that vaccines could be used to treat cancer that has already been diagnosed, though the approach is not widely used for most cancers.