At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate. For instance, while imported pharmaceuticals won’t be hit with tariffs, the imported supplies, equipment, and services U.S. manufacturers need to produce their drugs, devices and medical supplies likely will go up in price because of the tariffs.
Tariffs pressure industry markets; uncertainty remains
President Donald Trump’s tariffs announcement pushed stocks of biopharma and med-tech companies downward in early trading, even though there may not be an immediate impact to either industry. Pharmaceuticals were specifically excluded from the 10% baseline tariff, noted analyst Umer Raffat, of Evercore ISI, and his colleague suggested there was readthrough to the med-tech industry. “Then we get into what exactly is going on with counter tariffs. Is it never or is it not for now? And the short answer is, it’s not for now.” Raffat said, adding that they are coming in the next few weeks. Still, the uncertainty caused the Nasdaq Biotech Index (NBI) to fall about 2% in early trading April 3, and the XBI index, which is an S&P biotech select industry index, dropped as much as 3.8%. As for medical technology and equipment stocks, the DJSMDQ, which is a Dow Jones select industry index, fell as much as 2.9%.
Asia in firing line of Trump tariffs, but health care escapes largely unscathed
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange (ASX) shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
With ‘wholesale assault’ on research, bipartisan alarm at institutional failure
Biomedical research seems like it should be the ultimate bipartisan issue. But under the Trump administration, unless and until Congress regains its will to make use of its constitutional powers, bipartisan support for research seems to be a thing of the past. On March 3, members of the National Academies of Science, Engineering and Medicine warned that the second Trump administration has been waging a “wholesale assault” on American research.
Shares of Aldeyra plunge on reproxalap CRL
Aldeyra Therapeutics Inc. took receipt of another complete response letter (CRL) from the U.S. FDA related to the NDA for reproxalap in dry eye disease (DED). Regulators want at least one more study with the RASP modulator in DED. Shares of the firm (NASDAQ:ALDX) were trading at $1.39, down $3.93, or 73%. The first CRL landed on Aldeyra’s desk in late November 2023. In the latest letter, regulators identified concerns related to data submitted with the NDA, which the FDA said may be related to methodological issues, including a difference in baseline scores across treatment arms.
IgAN again: Novartis gets second approval in the kidney disease
The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. In August 2024, the FDA has granted accelerated approval to Novartis’ Fabhalta (iptacopan) for reducing proteinuria in adults with IgAN at risk of rapid disease progression. There was no risk evaluation and mitigation strategy safety program included in the approval for the selective endothelin A receptor antagonist as there was for Travere Therapeutics Inc.’s dual endothelin angiotensin receptor antagonist Filspari (sparsentan) for IgAN.
Sumitomo Pharma offloads two more subsidiaries
Sumitomo Pharma Co. Ltd. announced that it will sell off two more of its subsidiaries, Sumitomo Pharma (China) Co. Ltd. and Sumitomo Pharma Asia Pacific Pte. Ltd. (and their subsidiaries), to Marubeni Global Pharma Corp. April 1, as the Japanese pharma continues restructuring efforts from last year.
Newco news: Antag aiming to fill therapeutic gaps in obesity space
The latest obesity contender, Antag Therapeutics A/S, has dosed the first participants in a phase I trial of a glucose-dependent insulinotrophic polypeptide (GIP) agonist it said will address key gaps in the current treatment options, not least the gastrointestinal side effects seen with GLP-1 agonists. Fresh from raising a €80 million (US$84.1 million) series A in December 2024, Antag has the phase I placebo-controlled, double-blind trial of AT-7686 underway in healthy lean volunteers and healthy obese volunteers.
BioWorld Insider Podcast: As biopharma investments stumble, med tech surges
The biopharma sector is still trying to get its wind and resume its once-powerful investment ways. Medical technology has sidestepped much of biopharma’s issues by being more flexible along the development path, according to BioWorld MedTech Editor Annette Boyle in this edition of the podcast. This year’s med-tech investment numbers have improved over those from last year and the year before by bringing in $2.76 billion by financing 56 transactions in January alone. Boyle described the current financing climate on the newest BioWorld Insider podcast and explained why the sector is performing well year to date.
Also in the news
AC Immune, Accord, Allakos, Alloy, Arctic, Atsena, Aura, Averoa, Biogen, Biomarin, Concentra, Connect, Denali, Desentum, Edgewise, Ena Respiratory, Endeavor, Greenwich, Helsinn, Inhibrx, Intra-Cellular Therapies, Jaguar, Johnson & Johnson, Journey, Multiomic Health, Novadip, Nurix, Quoin, Rycarma, Sanofi, Senhwa, Sensorion, Tenaya, Valneva, Yingli