Trump Hits Drugmakers With 100% Tariff but Carve-outs Soften the Blow

 

While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.

The Trump administration has imposed a 100% tariff on imports of patented pharmaceutical products and ingredients. However, analysts predicted the action will have a limited effect on many companies.

One year after proposing its “Liberation Day” tariffs, the Trump administration has completed a Section 232 investigation into the pharma industry and imposed tariffs in response to the findings. Aiming to bolster national security and public health, the administration will impose a 100% tariff on imports from 17 large companies in 120 days. The tariffs will apply to smaller companies in 180 days.

Most large companies have already mitigated the risk by striking deals with the Trump administration. A 0% tariff rate will apply to companies with Most Favored Nation (MFN) and onshoring agreements with the administration through January 20, 2029. Companies that only have onshoring agreements face a 20% tariff rate.

But not all of those deals have resulted in exemptions. Despite being the first Big Pharma to appear at the White House announcing an agreement and specifically agreeing to MFN pricing, Pfizer is on the list of businesses subject to the 120-day deadline but absent from the list of firms with company-specific tariff agreements.

Johnson & Johnson and GSK have all disclosed deals with the Trump administration but are nonetheless listed as companies facing near-term tariffs and missing from the list of drugmakers with White House agreements.

Regeneron, which has yet to strike a deal, is also listed as being required to pay the levies in 120 days, although BMO Capital Markets analysts said in a note to investors that the company has indicated it expects to be exempt from tariffs. The analysts expect Regeneron to disclose a deal soon.

Indeed, companies without deals will have pathways to reaching agreements, the administration said. Jefferies analysts said in a note to investors that existing deals set precedents for others to follow.

Companies may incur tariffs significantly below 100% even if they fail to reach agreements. Under the terms of trade deals, imports from the European Union, Japan, Korea, Switzerland and Liechtenstein will incur a 15% tariff. The United Kingdom has secured a 0% tariff on exports to the U.S. as part of a deal that lowers a reimbursement threshold.

A 0% tariff rate applies to products including orphan drugs, cell and gene therapies and antibody-drug conjugates. BMO analysts said the carve-outs likely lower the broader impact to the industry if tariffs are implemented against small, more specialized biotech companies.

Yet BIO, the trade group that represents smaller biotechs, warned the tariffs could cause harm. Tariffs “will raise costs, impede domestic manufacturing and delay the development of new treatments,” BIO CEO John Crowley said in a statement. Crowley added that tariffs, the uncertain policy environment and MFN schemes “work directly against” the goal of increasing biotech’s investments in the U.S.

Generic and biosimilar medicines are completely exempt from the tariffs, although the administration pledged to review the decision in one year. The Association for Accessible Medicine, a trade group for off-patent drugmakers, applauded the exemption of generic and biosimilar drugs and ingredients from the tariffs.

https://www.biospace.com/business/trump-hits-drugmakers-with-100-tariff-but-carve-outs-soften-the-blow

BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline

 

After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.

BioNTech and Moderna were two of the big winners of the COVID-19 pandemic. Having gone into 2020 as leaders in the promising but unproven mRNA space, the biotechs quickly made vaccines that validated the modality, generated billions of dollars and further extended their leads over rivals such as CureVac. Both companies looked set for bright futures.

A few years later, their fortunes have diverged, with BioNTech building an expansive pipeline beyond mRNA as Moderna has grappled with challenges. BioNTech commands a market cap north of $20 billion, making the company more than twice as valuable as Moderna. The valuations reflect Moderna’s decline over the past two years, with the company shedding value as BioNTech has held steady.

Before the recent shift, Moderna and BioNTech followed seemingly similar trajectories. Equipped with mRNA platforms, the companies attracted mega-rounds and partnerships with top pharma companies before seeing their valuations skyrocket as they changed the course of the pandemic. Yet the similarities masked differences that sowed the seeds of the recent divergence in the biotechs’ fortunes.

BioNTech Buys Bumper Pipeline

While mRNA put BioNTech on the map, even early in the company’s history the modality was just one of a range of technologies at its disposal. This is a core difference between the companies. BioNTech applied an array of modalities to one therapeutic area, with some exceptions that took the company beyond its focus on cancer. Moderna applied one modality, mRNA, to a wide range of therapeutic areas.

That difference has shaped the post-pandemic trajectories of BioNTech and Moderna. Flush with money from its Pfizer-partnered COVID-19 shot, BioNTech doubled down on its multi-modality cancer strategy. BioNTech supported its in-house mRNA pipeline with deals for assets including the anti-CTLA-4 antibody gotistobart, HER2-directed antibody-drug conjugate (ADC) BNT323 and PD-L1xVEGF-A bispecific BNT327. The pipeline’s potential has analysts excited.

“All eyes are now on whether BioNTech can move fast and execute on this impressive pipeline in a way that drives value, as they are playing in competitive spaces,” TD Cowen analysts said in a note to investors. “There is a lot here to drive interest, but we note that the company has historically had some slippage of timelines ... or outright attrition for pipeline assets.”

BNT327, now known as pumitamig, is the main event. BioNTech secured rights to the asset before the surge in interest in PD-1/L1xVEGF bispecifics, allowing it to acquire the program for a relatively small sum. Bristol Myers Squibb paid BioNTech $3.5 billion to co-develop the asset, reflecting pumitamig’s potential to replace Keytruda as the backbone of immuno-oncology combinations.

Pumitamig is one of several BioNTech assets that are in Phase III trials. BioNTech is on course to report Phase III results for gotistobart, pumitamig and BNT323, plus mRNA vaccine BNT113, next year. While pumitamig has the highest sales ceiling, TD Cowen analysts said gotistobart is “a nice commercial opportunity.” The analysts were writing after seeing non-pivotal Phase III data.

Moderna’s mRNA Moves Miss the Mark

The deal-driven creation of a pipeline stacked with promising late-phase cancer candidates has enabled BioNTech to move beyond the COVID-19 vaccine that transformed its fortunes. Phase III failures could cause the strategy to unravel but to date BioNTech has performed better than Moderna with investors in the post-pandemic era.

As BioNTech diversified, Moderna bet big on its internal pipeline, seeking to replicate its COVID-19 success by developing mRNA vaccines against an array of respiratory diseases. The biotech’s R&D budget rose from $2 billion in 2021 to $4.8 billion in 2023. With a broad late-phase push planned, Moderna told investors in its 2023 annual report that it aimed to launch up to 15 products in five years.

Multiple factors derailed Moderna’s plans. The contraction of the COVID-19 market and loss of share to Pfizer and BioNTech caused the company’s product sales to fall from $18.4 billion in 2022 to $3.1 billion in 2024. Moderna responded by cutting costs and dropping R&D programs in a push for profitability.

At the same time, the biotech’s efforts to ease reliance on its COVID-19 vaccines suffered setbacks. The FDA approved Moderna’s RSV vaccine mRESVIA in 2024. The timing meant Moderna missed out on the bumper first year of the market. Moderna has struggled to win market share from GSK and Pfizer, with a Guggenheim Securities review of prescriptions for the week ended November 21 putting its stake at just 2%.

Moderna’s plans to launch a third product were delayed when the FDA requested efficacy data from a Phase III trial of its flu vaccine. The request prompted Moderna to withdraw a request for FDA approval of its flu/COVID combination vaccine. Moderna now sees the flu shot as a growth driver for 2027 onward and the combination vaccine as a product that will start to move the needle in 2028.

A norovirus shot, which Moderna sees as a growth driver for 2028 onward, rounds out the biotech’s near-term seasonal vaccine strategy. The oncology candidates intismeran and mRNA-4359, plus the rare disease prospect mRNA-3927, give Moderna more shots on goal that could add to growth in the coming years.

One concern is how the candidates, all of which are based on mRNA, will be received by regulators and patients. Piper Sandler analyst Ted Tenthoff said at an event with Moderna in December 2025 that “under the FDA and [Health Secretary] RFK Jr., it really feels like they’ve declared war on mRNA vaccines.”

Moderna has now bowed to that pressure, with CEO Stéphane Bancel announcing at the World Economic Forum in Davos, Switzerland, last month that the famed biotech would scale down investment in late-stage vaccines as the U.S. market snaps shut.

“You cannot make a return on investment if you don’t have access to the U.S. market,” Bancel said, according to a report from Bloomberg.

Bancel’s remarks were vague, and the company has yet to clarify the future direction of the vaccine programs, and whether the shift will apply to just the infectious disease portfolio or all. Nevertheless, investors were happy with a change in direction. The company’s shares have risen 50% since the year began—but BioNTech’s are climbing too.

Moderna will continue to face the challenge of executing its late-phase strategy while contending with an FDA that recently linked the deaths of children to COVID-19 vaccines and vowed to tighten regulations. Having moved beyond mRNA vaccines, BioNTech’s headaches are largely limited to the R&D uncertainties and operational challenges that are common to all drug development.

https://www.biospace.com/business/biontechs-multi-modality-play-outpaces-modernas-mrna-focused-pipeline

BioNTech Starts Shuttering Singapore mRNA Manufacturing Site Amid Pipeline Pivot

 

BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.

BioNTech is closing a Singapore production plant less than four years after buying the site from Novartis to supply mRNA vaccines and therapies in the Asia-Pacific region.

When BioNTech bought the facility in November 2022, the company expected the facility to be fully operational in late 2023 and create more than 100 jobs. This week, BioNTech told The Straits Times that the planned Singapore site will close by the end of February. The company employs 85 people at the plant.

BioNTech framed the shuttering of the facility as part of efforts to align capacity with its pipeline and long-term strategic direction. The company bought the plant to support clinical and commercial supply of its mRNA vaccines and therapeutics across the Asia-Pacific region. However, BioNTech’s R&D pipeline subsequently diversified beyond mRNA, setting the company up for growth even as Health Secretary Robert F. Kennedy Jr. came down hard on the technology over the past year. In August, Kennedy canceled around $500 million in BARDA contracts associated with mRNA vaccine development, for example.

“Under the FDA and [Health Secretary] RFK Jr., it really feels like they’ve declared war on mRNA vaccines,” Piper Sandler analyst Ted Tenthoff said at an event with Moderna in December 2025.

BioNTech’s initial plans for the Singapore site included potential expansions to support production of other drug classes, such as cell therapies. However, the primary purpose of the facility was to establish the capacity to make several hundred million doses of mRNA-based vaccines a year. With vaccine sales falling and BioNTech’s pipeline evolving, the company’s need for that level of capacity has diminished.

In 2022, BioNTech reported €17.3 billion ($20 billion) in sales driven by Comirnaty, the mRNA COVID-19 vaccine it developed with Pfizer. Last year, BioNTech’s sales totaled €2.9 billion ($3.3 billion). The company expects COVID-19 vaccine sales to fall this year. BioNTech and Pfizer recently stopped a COVID-19 vaccine study over slow enrollment.

The company’s chances of returning to growth lie outside mRNA. BioNTech’s pipeline prospects include the anti-CTLA-4 antibody gotistobart, HER2-directed antibody-drug conjugate BNT323 and PD-L1xVEGF-A bispecific BNT327. Amid the shift, BioNTech’s founders and top executives Ugur Sahin and Özlem Türeci are leaving the biotech to start a new company focused on mRNA.

BioNTech shared plans for the mRNA manufacturing facility in Singapore in 2021. At the time, the biotech planned to start building a plant that year and bring it online in 2023, Ryan Richardson, then the company’s chief strategy officer, said on an earnings call. Richardson envisioned the site providing mRNA products for regional and global markets and supporting rapid responses to pandemic threats in Asia.

The company invested in the site after choosing to buy from Novartis rather than start from scratch. In its 2025 annual report, BioNTech named investments in Singapore as a contributor to the €307.1 million ($355 million) in capital expenditures incurred last year.

https://www.biospace.com/business/biontech-starts-shuttering-singapore-mrna-manufacturing-site-amid-pipeline-pivot

French and Japanese-Owned Ships Make First Hormuz Crossings

 

A French container ship and a Japanese-owned tanker have crossed the Strait of Hormuz, in what appear to be the first such transits since the war in Iran shuttered the crucial waterway.

The CMA CGM Kribi container ship exited the strait on Friday, according to ship tracking data compiled by Bloomberg and two people familiar with the situation. That’s the first ship linked to Western Europe that’s known to have made it through since the war began more than a month ago. Japan’s Mitsui OSK Lines confirmed on Friday that the liquefied natural gas tanker it part-owns also crossed — another first.

https://www.bloomberg.com/news/articles/2026-04-03/french-owned-container-ship-exits-hormuz-in-first-since-iran-war

Senior Iranian Official Involved In Reaching Out To Vance Severely Wounded In Airstrike

 A top Iranian official who was involved in diplomatic outreach and indirect talks or messaging with the United States and Pakistani mediators was reportedly critically wounded in a US-Israeli strike. Kamal Kharazi, an 81-year-old senior adviser to Tehran and former foreign minister, lost his wife in the Wednesday strike on his home, state media has said.

Kharazi chairs Iran's Strategic Council on Foreign Relations and has been viewed as a potential backchannel negotiator involving Islamabad, but now he's been hospitalized with serious injuries, state media has also said.

"We have seen what looks like an assassination attempt against the former foreign minister, Kamal Kharazi … We don’t know why he’s been targeted. He has been gravely wounded, and his wife was killed," said an Al Jazeera correspondent in Tehran.

Iranian officials described to Mehr News Agency that Kharazi was overseeing outreach to Pakistan tied to a possible meeting with US Vice President JD Vance. A potential Vance trip to Pakistan was initially reported as possibly being in the works late last month.

But Middle East Eye has reported that Kharazi was not seeing much room for diplomacy as US-Israeli actions escalate to attacks on Iranian infrastructure and energy:

He told CNN in March, "I don’t see any room for diplomacy anymore. Because Donald Trump had been deceiving others and not keeping with his promises, and we experienced this in two times of negotiations – that while we were engaged in negotiation, they struck us."

If he succumbs to his wounds, Kharrazi would be the latest senior Iranian official killed since the war began.

In addition to Khamenei, top security adviser Ali Shamkhani, Revolutionary Guard commander Mohammad Pakpour, Armed Forces Chief of Staff Abdolrahim Mousavi, and Defence Minister Aziz Nasirzadeh were all killed on the first day of the war.

Ali Larijani, secretary of the Supreme National Security Council, was killed on 17 March, along with his son and one of his ⁠deputies. Intelligence minister and head of civilian monitoring, Esmail Khatib, was killed in an Israeli strike a day later.

Some analysts and pundits have accused Israel in particular of trying to sabotage any US-Iran talks, as the Netanyahu government wants to see complete regime collapse in the Islamic Republic.

Israel has also stood accused of seeking to create the conditions to lure the White House into authorizing 'limited' strikes which would inevitably become an open-ended war with no timeline.

https://www.zerohedge.com/geopolitical/senior-iranian-official-involved-reaching-out-vance-severely-wounded-airstrike

Iran state TV warns public against disclosing officials’ hiding places

 Iranian state television has escalated its messaging by warning citizens not to reveal the locations of officials hiding among civilians.

As the regional conflict involving Iran, Israel, and the United States escalates, Iran’s state broadcaster, Islamic Republic of Iran Broadcasting (IRIB), has undergone a marked transformation in tone and language.

In a segment of a program on Iran’s state broadcaster, presenter Mohammad Jafar Khosravi acknowledged that officials are hiding in safe houses among ordinary citizens and urged the public not to reveal their locations, warning that otherwise they would be “finished” and targeted.

Alongside this shift, dehumanizing language toward foreign adversaries has become increasingly common. Following intensified strikes in late February, IRIB hosts and commentators repeatedly described Israeli officials as “rabid dogs,” portraying them as threats that must be eliminated.

The escalation in tone extends beyond broadcast television. On social media platform X, IRIB presenters have engaged in increasingly personal exchanges with Israeli officials.

Figures such as Ameneh Saadat Zabihpour and Ali Rezvani, both sanctioned by the United States in 2022 as "Interrogator Journalists", have traded insults with Israeli spokespersons, with some interactions descending into personal attacks, religious provocation, and inflammatory rhetoric.

"After blunt death threats by the Revolutionary Guard, aired on State TV and the televised intimidation of the women's football team, State TV presenters are openly calling for the murder of the people of Iran," the Iranian Independent Filmmakers Association (IIFMA) said in a post on its Instagram.

"The recent calls for 'shoot-to-kill' verdicts make the broadcaster an instrument of direct attack on a population already reeling from the violent suppression of January uprising," the Association said last month.

https://www.iranintl.com/en/202604020258

Iran’s Pezeshkian faces hardline backlash over conditional war-end offer

 Iranian President Masoud Pezeshkian is facing a fierce political backlash after signaling a conditional willingness to end the war, exposing deep divisions within Iran’s political and military establishment over diplomacy versus continued conflict.

In a phone call on Tuesday with European Council President Antonio Costa, Pezeshkian said Iran has the “necessary will” to bring the conflict to an end - provided that “essential conditions, especially guarantees to prevent renewed aggression, are met.”

Following Pezeshkian’s remarks, US President Donald Trump wrote on Truth Social that the “president of the new Iranian regime” had requested a ceasefire. Oil prices dipped slightly after the comments.

Iranian officials swiftly rejected Trump’s characterization. Mehdi Tabatabaei, the deputy for communications and information at the president’s office, responded on X:

“The position of the Islamic Republic of Iran regarding the defense of the nation against the aggression of evildoers and the conditions for ending the imposed war has not changed, and there is no regard for the delusions and lies of criminals.”

In a letter addressed to the American public published on Wednesday, Pezeshkian reiterated that Iran’s military actions were “purely a response and defense, not the initiation of war and aggression.” He described continued confrontation as “costly and fruitless,” signaling a more pragmatic tone from parts of the political establishment.

Hardliners and figures aligned with the security establishment have set stricter conditions for ending the war. Mohsen Rezaei, now a military adviser to Mojtaba Khamenei, has said the conflict should only end with reparations and guarantees, including the removal of US bases from the region.

Hardliner backlash intensifies

Pezeshkian’s comments triggered strong criticism from conservative and hardline figures. Lawmaker Hamid Rasaei described the remarks as evidence of a “wavering personality” and “passivity in the face of the enemy,” arguing that such positions could embolden further attacks.

Rasaei has previously compared Pezeshkian to Iran’s first president, Abolhassan Banisadr, who was removed from office by parliament for “political incompetence”. Similar comparisons have circulated widely on social media in recent days.

Some critics framed the conflict as a struggle between “truth and falsehood” and opposed any negotiated settlement short of total victory.

Calls for deterrence over diplomacy

In an open letter published on X, hardline activist Mohammad Shirakvand criticized Pezeshkian’s appeal for European guarantees, writing: “When you yourself state that the United States does not believe in diplomacy, what does speaking of guarantees for ending the war mean other than repeating a costly mistake?”

“This war is a battle of truth against falsehood and an arena of clashing wills. The government must play on this field, not on promises that have repeatedly proven unreliable,” he added.

Shirakvand argued that “real guarantees are not built through diplomacy, but through power and deterrence on the battlefield.”

Another widely shared post by a conservative account, Rah-e Dialameh, described Pezeshkian’s remarks as “sending a signal of weakness to the enemy,” linking them to the drop in oil prices and warning that such a strategy “must be stopped before it causes further damage.”

Some hardline users accused Pezeshkian of “sending ceasefire signals” and weakening Iran’s military posture, demanding that security authorities “control” him.

One user appeared to issue an implicit threat, suggesting authorities should restrict his public appearances “to protect his life,” claiming the country “is better managed on autopilot.”

Son defends the president’s stance

Amid escalating criticism, Pezeshkian’s son and adviser, Yousef Pezeshkian, publicly defended his father. He challenged critics’ logic, asking: “I do not understand the meaning of these criticisms; are we not seeking to meet conditions and obtain guarantees? Or are we seeking war until the complete destruction of America and Israel?”

He framed the president’s position as a realistic attempt at conditional de-escalation, contrasting it with what he implied were unrealistic or maximalist goals.

He also defended his father’s earlier apology to neighboring countries affected by Iranian strikes, calling it an “ethical duty” and highlighting efforts to maintain regional relations despite the conflict.

https://www.iranintl.com/en/202604026228