Dapagliflozin

Novartis is now the sixth drugmaker to bring its Inflation Reduction Act challenge to the Supreme Court as the pharma industry’s yearslong court battle comes to a head. Novartis was the last drugmaker expected to file a petition, at least for now. A decision to take any of the cases could give the justices a chance to shed light on the constitutionality of the negotiation program, or on how the government can negotiate drug prices under the law. A Novartis spokesperson told Endpoints News that the company filed its petition on Friday. The petition wasn’t immediately available. CMS negotiated a 53% discount from the list price of Novartis’ heart drug Entresto. AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, Novo Nordisk and Boehringer Ingelheim have also filed petitions. Whether the high court takes up any of the cases remains to be seen. The Supreme Court was initially slated to discuss AstraZeneca’s petition last Friday, but a notice posted on the docket last week said it was rescheduled. Boehringer Ingelheim argued in its petition that the program’s “scope and scale alone make this case worthy of review,” claiming that negotiations will affect hundreds of billions of dollars in the US pharma market. AstraZeneca urged in court documents that “time is of the essence.” Prices reached under the first round of IRA negotiations took effect on Jan. 1, including for AstraZeneca’s type 2 diabetes drug Farxiga. So far, drugmakers have lost every case where a court has ruled on the merits, with just a handful of cases pending in the lower courts. Two opposing rulings at the appellate level — also known as a circuit split — would make the high court more likely to take one or more of the cases, but that has yet to occur. Merck — the first company to bring a lawsuit in 2023 — is still waiting on a district court ruling. Appeals court decisions are still pending in cases brought by Teva and industry trade group PhRMA. In November, CMS announced the prices reached during the second round of negotiations, including for Novo’s Ozempic and Wegovy. The government is expected to announce 15 additional drugs selected for the third round of negotiations this week. HHS declined to comment on Monday.

The number of new molecules or in-market drugs with late-stage label expansion programs has grown to 37 at AstraZeneca in 2025, compared with 27 in 2021. AstraZeneca’s $80 billion revenue target for 2030 is “very much within reach,” Chief Financial Officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference Tuesday.“If we have the same success rate this year as we had last year of our phase 3s, then I think the confidence increases even further,” she said.Within the drugmaker's oncology portfolio alone, AZ had 10 positive phase 3 readouts last year, which gave the company “a lot of cards that we get to play between now and 2030,” oncology business chief Dave Fredrickson said at the event.The number of new molecules or in-market drugs with late-stage label expansion opportunities at AstraZeneca grew to 37 in 2025 compared with 27 in 2021, according to a presentation by Sarin. At the same time, the non-risk-adjusted value per indication of those meds has also increased to about $1.3 billion in 2025 from about $700 million previously.As Sarin noted, analysts’ projections for AZ in 2030 have risen to match that $80 billion target, versus a consensus estimate of $67 billion when the company first floated the goal in May 2024.Within the oncology portfolio, Fredrickson suggested the PD-L1 inhibitor Imfinzi will likely be AZ’s largest oncology medicine by sales “in the midterm period” thanks to a series of new indications such as perioperative gastric cancer. But perhaps more important is the upcoming phase 3 Avanza readout for AZ and Daiichi Sankyo’s TROP2 ADC Datroway and Imfinzi in first-line metastatic non-small cell lung cancer (NSCLC).“We have very little sales of Imfinzi in stage 4 lung cancer, so this would be a really nice opportunity to grow into that setting,” Fredrickson said.If that effort is successful, Imfinzi would supplant Tagrisso, which has been AZ’s largest oncology product for a long time. In the first nine months of 2025, Tagrisso’s sales grew 10% year over year to nearly $5.4 billion, while Imfinzi’s haul jumped 25%, reaching $4.3 billion.“That doesn’t mean Tagrisso is not going to be doing well,” Fredrickson added. “It’s just because I think Imfinzi has got more engines to grow off of.” As the longtime EGFR inhibitor king, Tagrisso is facing a threat from Johnson & Johnson’s combination of Rybrevant and Lazcluze, which beat the AZ med in a head-to-head phase 3 in first-line EGFR-mutant NSCLC.“We’re continuously looking for opportunities to raise the bar and beat Tagrisso right now,” Fredrickson said. “The near- and mid-term opportunities to do that are through Tagrisso combinations.”The phase 3 Flaura2 trial recently showed that Tagrisso’s combination with chemo could help first-line patients live longer than Tagrisso alone. The readout spurred an interest among doctors to favor the combo, instead of Tagrisso monotherapy, for most patients, according to Fredrickson.Beyond chemotherapy, AZ is weighing whether to add Datroway to Tagrisso in the front-line setting.“Ideally, we’d like to be able to bring in other ADC combos with Tagrisso into the space as well,” Fredrickson said.Outside of oncology, analysts have high hopes for AZ’s Ionis-partnered transthyretin amyloidosis (ATTR) drug Wainua, which is expected to read out phase 3 ATTR-cardiomyopathy data in the second half of 2026. The Cardio-TTRansform trial is the largest ever done in ATTR-CM, and, perhaps more importantly, it could have data on whether Wainua works on top of Pfizer’s blockbuster Vyndamax (tafamidis).AZ boasts a strong presence in cardiovascular disease, including with Farxiga, and its experimental hypertension drug baxdrostat is under FDA priority review with a decision expected in the second quarter. AZ was among the first large pharma companies to have signed a most-favored-nation drug pricing deal with the Trump administration.“I think one of the things that we were encouraged by with the administration [is] that the administration understood the nuanced aspects of ensuring that life sciences continue to be competitive and robust within the United States,” Sarin said, “and that meant a phased approach to the work that we're doing.”That phased approach lies in the fact that beginning in 2026, MFN is going to first touch Medicaid, which according to Sarin represents only a low-single-digit percentage of global sales for AZ over time.“It will grow to represent multiple channels of business and multiple medicines, but it gives us the opportunity to plan to get towards that and to offset by increasing funding for innovation across the globe as the U.S. prices come down,” Sarin said.