Trump says pharma tariffs may touch 250% in 18 months; FDA okays Jazz Pharma’s rare brain tumor drug

By PharmaCompass

2025-08-07

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The US Food and Drug Administration (FDA) has granted an accelerated approval to Jazz Pharmaceuticals’ Modeyso, a drug that treats diffuse midline glioma, a rare and aggressive brain tumor. The agency has also approved an expanded indication for Teva Pharma’s Ajovy to help prevent migraines in children.

A Financial Times report says Novartis has expressed interest in acquiring San Diego-based Avidity Biosciences. Novo Nordisk has cut its 2025 sales outlook due to lower growth expectations in the second half for its obesity drug Wegovy and diabetes med Ozempic in the US.

The week saw two clinical trial failures. Vertex Pharmaceuticals said it will stop developing its experimental non-opioid painkiller — VX-993 — after a phase 2 trial failure. And Spine BioPharma’s chronic low back pain candidate — SB-01 — has missed its primary endpoint in a phase 3 trial.

After three deaths in Sarepta’s trials earlier this year, there was news of a death of a male patient enrolled in Allogene’s CAR-T therapy trial. And FDA’s Adverse Event Reporting System has revealed four deaths of patients who had taken Agios’ anemia med Pyrukynd.

In geopolitical news, the US President Donald Trump has said tariffs on drugs imported into the US could reach up to 250 percent within the next 18 months.

A US Senate committee has turned down Trump’s plan to cut the budget of the National Institutes of Health (NIH) by 40 percent. Meanwhile, the US Department of Health and Human Services (HHS) is ending the mRNA vaccine work being funded by Biomedical Advanced Research and Development Authority (BARDA), thereby impacting 22 projects, collectively valued at around US$ 500 million.

Trump says pharma tariffs may touch 250% in 18 months, sends letters to 17 firms to cut prices

The US President Donald Trump has said the planned tariffs on drugs imported into the US could reach up to 250 percent over the next one year to 18 months. This is the highest tariff he has spoken of so far. He said he plans to initially impose a “small tariff” on pharmaceuticals, which will then be raised to 150 percent, and then to 250 percent in a year to a year and a half “maximum.” He said the new drug tariff will be announced within the next week.

Meanwhile, Trump has sent letters to the leaders of 17 major pharmaceutical companies, asking them to reduce US prescription drug prices to match those paid overseas. They have been asked to take action by September 29.

Senators protect NIH budget: A US Senate committee has rejected Trump’s plan to cut the budget of the National Institutes of Health (NIH) by 40 percent. Instead, the panel has endorsed maintaining the agency’s structure and increasing its funding for 2026 by US$ 400 million.

HHS to end BARDA-funded mRNA vaccine work: The US Department of Health and Human Services (HHS) has said it plans to end mRNA vaccine work funded by BARDA. This is being viewed as a major escalation of Health Secretary Robert F. Kennedy Jr.’s campaign against vaccines in general and mRNA vaccines in particular. The decision affects 22 projects valued at around US$ 500 million collectively.

FDA grants accelerated approval to Jazz Pharma’s drug for ultra rare brain tumor

FDA has granted an accelerated approval to Jazz Pharmaceuticals’ drug — Modeyso (dordaviprone) — to treat diffuse midline glioma, a rare and aggressive brain tumor, in adults and children aged one year and older. This is the first FDA-approved systemic therapy for this condition. Jazz had acquired the drug through its US$ 935 million Chimerix buyout earlier this year.

Greenlights Teva’s Ajovy for migraine in children: FDA has approved an expanded indication for Teva Pharma’s Ajovy (fremanezumab-vfrm) to help prevent migraines in children aged six to 17 years who weigh 45 kilograms or more. This is the first time a drug has been approved for preventing migraines in children.

Novartis plans to acquire Avidity Biosciences, says Financial Times report

Novartis has expressed interest in buying out San Diego-based Avidity Biosciences, and is currently evaluating a bid for the company, a Financial Times report has said. Avidity has a market value of about US$ 5.8 billion, and has three medicines in clinical trials, “which could be approved as early as 2027,” the report said. Avidity is working with advisers to assess options, it added.

Novo cuts 2025 outlook as Wegovy, Ozempic sales shrink; appoints new CEO

Novo Nordisk has cut its 2025 sales outlook due to lower growth expectations in the second half of 2025 for its obesity drug Wegovy and diabetes med Ozempic (both semaglutide) in the US.

Novo is facing rising pressure from its rival Eli Lilly, and is expecting increased competition from generic versions of Wegovy. The company has named Maziar Mike Doustdar as its new CEO.

Lilly plans to sell NJ plant: Eli Lilly is selling its Branchburg, New Jersey facility, even as it is going ahead with its US$ 27 billion investment to set up four new manufacturing facilities in the US. Lilly is reportedly in late-stage talks with one buyer and hopes to close the deal by the year-end, a company official has said.

Patient dies in Allogene’s CAR-T therapy trial; FDA reports deaths of four patients on Agios’ anemia med

After three deaths in Sarepta’s trials for two separate gene therapies, Allogene Therapeutics and Agios Pharmaceuticals have reported patient deaths.

In the case of Allogene, a male patient enrolled in a pivotal phase 2 study testing Allogene’s CAR-T candidate cema-cel (cemacabtagene ansegedleucel) for large B-cell lymphoma passed away. However, the mortality wasn’t linked with cema-cel, and Allogene has attributed the death to ALL-647, a monoclonal antibody that was being used as a lymphodepletion therapy to prepare patients for the cema-cel treatment.

In the case of Agios, FDA’s Adverse Event Reporting System has revealed four deaths of patients who had taken its anemia med Pyrukynd (mitapivat). However, in an SEC filing, Agios has said that the drug’s risk-benefit profile remains unchanged.

Vertex’s non-opioid painkiller, Spine BioPharma’s back pain med fail trials

Vertex Pharmaceuticals will stop developing its experimental non-opioid painkiller — VX-993 — as a monotherapy in acute pain after a phase 2 trial failure. The painkiller was being tested for treating acute pain after bunionectomy surgery.

Meanwhile, Spine BioPharma’s chronic low back pain candidate — SB-01 — has missed its primary endpoint in a phase 3 trial performed on 417 patients with chronic low back pain associated with degenerative disc diseases.

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