At least 9 of 14 ships in Strait of Hormuz linked to Iran after ceasefire - FT

 

Iran-linked vessels have accounted for the majority of recent transits through the Strait of Hormuz following a US-Iran ceasefire, the Financial Times reported on Friday.

At least nine of around 14 vessels that have passed through the strategic waterway since the pause in fighting were linked to Iran, including ships calling at Iranian ports, flying the Iranian flag or associated with Tehran’s maritime network, the FT said.

The report added that overall traffic through the Strait of Hormuz remains well below pre-conflict levels, with industry estimates suggesting commercial flows have yet to fully normalize.

Iran-linked ships dominate Hormuz traffic after ceasefire https://t.co/bHbZF4U7HK

— Financial Times (@FT) April 10, 2026

https://www.iranintl.com/en/liveblog/202604067622

'Axios: US said to have asked Israel to pause Hezbollah strikes'

 The United States and Lebanon asked Israel to pause its direct strikes on Hezbollah, Axios reported on Friday.

According to two sources familiar with the matter, Lebanon asked Israel for this "gesture" ahead of the two countries' negotiations on April 14. The US, which will act as a mediator in the talks, passed on Lebanon's message to Israel. The sources added that the US supports Lebanon's demand and urged Israel to agree to it.

Previously, it was reported that Israeli Prime Minister Benjamin Netanyahu agreed to make the process of approving further strikes on Lebanon more sophisticated after a conversation with US President Donald Trump. Moreover, Iran insisted that any fruition of the negotiations with the US must include a ceasefire in Lebanon.

https://breakingthenews.net/Article/US-said-to-have-asked-Israel-to-pause-Hezbollah-strikes/66048934

Lebanon confirms US will mediate talks with Israel

 The Lebanese Presidency announced in a statement on Friday that Lebanese and Israeli ambassadors to the United States concluded their first call.

The presidency shared that the two sides officially agreed to meet on April 14 in Washington, confirming that the US Department of State will act as a mediator during the process.

The two sides will discuss "the announcement of a ceasefire and the date for starting negotiations between Lebanon and Israel under American sponsorship," it was written in the statement.

https://breakingthenews.net/Article/Lebanon-confirms-US-will-mediate-talks-with-Israel/66048599

Replimune’s advanced melanoma drug rebuffed by FDA for second time

 

The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.

Replimune’s stock fell nearly 20% Friday after the FDA rejected its advanced melanoma drug for the second time.

The FDA’s first rejection of RP1, an oncolytic immunotherapy also known as vusolimogene oderparepvec, in July 2025 sparked months of controversy, including an open letter from 22 researchers involved with the drug’s trials urging the agency to “re-review” its decision. Replimune resubmitted the application for the drug in October with new analyses on RP1’s mechanism of action and on how patients fared relative to prior treatment with an approved immunotherapy, a Replimune spokesperson told STAT News at the time.

The review team members for Friday’s decision were different from those who reviewed the company’s initial biologics license application, according to the FDA’s Complete Response Letter (CRL), which was published Friday. This was intended to “maintain objectivity and account for potential bias,” the agency said. Despite this, the team found the data presented was “insufficient to conclude substantial evidence of effectiveness” of RP1 in unresectable advanced cutaneous melanoma. RP1 was being proposed in combination with Bristol Myers Squibb’s Opdivo to treat the rare skin cancer.

Replimune’s use of a single-arm trial appears to be the sticking point for the FDA, which wrote in the rejection letter that it “would not recommend” seeking approval based on results from a single-arm study. The use of alternative trial designs, such as single-arm trials, has been a hot-button issue that drew many biotech onlookers to the FDA’s decision regarding RP1.

The FDA added in the letter to Replimune that its advice “has remained consistent as evidenced by our communications dating back to March 2021 and subsequent interactions.”

There appears to be a disconnect between the agency and Replimune, however, as CEO Sushil Patel expressed surprise with the initial rejection. “The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews,” Patel said in a statement at the time. “Additionally, we had also aligned on the design of the confirmatory study.”

Analysts had given RP1 a 50/50 chance of approval this time around.

Replimune had been seeking accelerated approval for RP1. The company is currently conducting a randomized Phase 3 trial of the immunotherapy in combination with Opdivo, with an estimated completion date of January 2029.

https://www.biospace.com/fda/replimunes-advanced-melanoma-drug-rebuffed-by-fda-for-second-time

FDA probes abortion pill anew after court keeps mail access alive

 

A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.

The FDA is once again studying the safety of the abortion pill mifepristone just days after a federal Louisiana judge temporarily allowed the dispensing of the drug through mail.

“FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study,” the agency wrote in an April 8 update to its website. The analysis will help the regulator decide whether it needs to make “substantive” changes to its Risk Evaluation and Mitigation Strategies for mifepristone, though it is unclear what such changes could look like.

“The agency is taking care to do this study properly and in the right way,” the FDA wrote, nevertheless adding that it wants to wrap up the study “as soon as possible.” Analyses such as these take “approximately a year or more” in academic settings, the regulator claimed, noting that “the current agency plan is to have this study done sooner than that.”

This new safety study comes a day after a Louisiana court blocked an attempt by Liz Murrill, Louisiana’s Attorney General, to prevent mifepristone from being dispensed to patients by mail. In a 37-page ruling on April 7, Judge David Joseph granted the FDA’s motion to press pause on the case while it conducts an assessment of mifepristone’s safety.

“The equities and the public interest weigh heavily in favor of FDA completing the job that the law requires it to do,” Joseph wrote. “At this juncture, it is the completion of FDA’s promised good faith, evidence-based, and expeditious review [of mifepristone’s safety] that this court finds to be in the public interest.”

Joseph, who was appointed by President Donald Trump, gave the FDA six months to provide the court “with the status of its review . . . and any updated timeframe for completion.”

Mifepristone is a progesterone blocker that is used to terminate pregnancies alongside another drug called misoprostol. It can also be used to treat high blood sugar in Cushing’s syndrome. Because of its role in inducing abortion, mifepristone has attracted controversy, particularly since federal protection of abortion rights was eliminated by the Dobbs v. Jackson Women’s Health Organization Supreme Court decision in 2022. In November 2022, for instance, the Alliance for Hippocratic Medicine filed a lawsuit against the FDA, asking to agency to pull its approval of the pill.

Then, in April 2023, Texas judge Matthew Kacsmaryk issued a preliminary injunction that blocked sales of mifepristone. This order kicked off a legal back-and-forth, at one point drawing an open letter from more than 480 biopharma leaders, and made it all the way to the Supreme Court. The letter called Kacsmaryk’s decision an “act of judicial interference” made “without regard for science or evidence.”

In June 2024, the High Court ruled to keep mifepristone available.

The fight over abortion access continued into 2025. In April, advocacy group Ethics and Public Policy Center published a report alleging that serious adverse events have developed in more than 10% of women on mifepristone. The report led health secretary Robert F. Kennedy, Jr. in May to tell the FDA to review its safety policies around the drug.

The anti-abortion report was “fundamentally, fatally flawed,” according to an open letter from 53 biotech executives and investors that asked the FDA to maintain access to mifepristone.

https://www.biospace.com/fda/fda-probes-abortion-pill-anew-after-court-keeps-mail-access-alive

GSK again pulls application for leucovorin, touted by FDA as potential autism treatment

 

GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”

GSK has withdrawn an approval application for Wellcovorin, a decades-old drug that late last year gained renewed attention after the members of the Trump administration publicly suggested it has the potential to treat autism symptoms.

The pharma requested to terminate the new drug application because “the drug products were no longer marketed,” according to a Federal Register notice on Thursday. The withdrawal of the application was procedural and not linked to any safety or efficacy issues, a GSK spokesperson told The Wall Street Journal on Thursday, noting that the company had never intended to revive the drug.

Wellcovorin (generic name: leucovorin) was first approved in 1983 as a treatment to counter the toxic side effects of methotrexate, a common chemotherapeutic agent. GSK eventually discontinued the drug in 1997, though generic versions are on the market.

These generics will be unaffected by the pharma’s petition to pull the approval application for Wellcovorin, a spokesperson for the Department of Health and Human Services confirmed to WSJ. “GSK’s action does not affect the availability of generic leucovorin . . . or the labeling of leucovorin products,” the spokesperson said.

Wellcovorin re-entered the public’s consciousness in September 2025 after the FDA asked GSK to refile an application for the drug as a potential medicine for cerebral folate deficiency (CFD)—a highly unusual move for the regulator. At the time, the agency linked the rare disorder to “developmental delays with autistic features” and positioned leucovorin as a treatment.

Shortly after, GSK said that it would comply with the FDA’s request and file an application to update the drug’s label. This led to an approval last month, allowing the drug’s use in CFD caused by certain genetic anomalies.

In a press call, however, the agency admitted that there is not enough evidence to support the approval of leucovorin for autism more broadly, WSJ reported on Thursday. The American Academy of Pediatrics notes that “current evidence is insufficient to support prescribing leucovorin for autism in the absence of CFD.”

In September, alongside FDA Commissioner Marty Makary’s effort to paint leucovorin as an autism treatment, the agency also updated the label of products containing acetaminophen, such as Tylenol, to reflect a purported link to autism in children when used during pregnancy. These drugs, the FDA claimed at the time, could lead to “increased risk of neurological conditions such as autism and ADHD in children.”

However, the agency itself at the time conceded that “a causal relationship has not been established,” pointing to “contrary studies in the scientific literature.” Indeed, scientists have many times over rejected a causal link between acetaminophen during pregnancy and autism in children. As recently as 2024, a population study looking at 2.5 million children born from 1995 to 2019 found no such link.

https://www.biospace.com/business/gsk-again-pulls-application-for-leucovorin-touted-by-fda-as-potential-autism-treatment

Boehringer transfers schizophrenia DTx selling rights to Click

 Boehringer Ingelheim has amended its partnership with Click Therapeutics on a digital therapeutic (DTx) for schizophrenia, transferring commercial rights to the programme to the digital health specialist.

The changes to their longstanding alliance on the DTx, called CT-155, come a few months after it hit the target in the phase 3 CONVOKE schizophrenia trial, with the results showing that the smartphone app was able to help users achieve a reduction in negative symptoms when added to standard schizophrenia treatment.

Boehringer has sweetened the changes to the deal by making a $50 million Series D investment in Click, and has promised "dedicated commercial funding" to help the digital health company launch the DTx if it is approved by the FDA.

CT-155 is one of several DTx apps Boehringer and Click are working on under a $500 million partnership, first formed in 2020 and expanded two years later to include a second app for schizophrenia (CT-156), with an additional $460 million in potential milestones. The amendment signals that Boehringer may be shifting towards a more strategic investor role in DTx.

Boehringer is, however, continuing to take the lead on the phase 3 ENSPIRUS trial, which is putting the app through its paces in a real-world setting and also gauging how it can affect the use of healthcare services. Results from that are due later this year.

Click's chief executive, David Benshoof Klein, said the transfer of commercial rights is a "powerful validation of our vision and the capabilities we have spent over a decade building."

CT-155 has breakthrough device designation from the FDA, which reflects its potential to treat schizophrenia symptoms that are hard to address using pharmacological therapies for the disorder.

At the moment, there are no therapies approved by the FDA specifically to treat negative symptoms of schizophrenia, so CT-155 has a shot at becoming a first-in-class, adjunctive treatment with antipsychotics.

The app delivers interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioural therapy (CBT), which can often be hard to access even in countries with well-developed healthcare systems.

The CONVOKE results, presented at last year's European College of Neuropsychopharmacology (ECNP) congress, showed that CT-155 achieved a 4.2-point improvement in negative symptoms, measured using the CAINS-MAP scale from baseline to 16 weeks, compared with a control app.

According to the investigators, it was the first pivotal trial to show a statistically significant reduction in experiential negative symptoms of schizophrenia as an adjunct to standard of care.

https://pharmaphorum.com/news/boehringer-transfers-schizophrenia-dtx-selling-rights-click