Drugmakers asked to defend Chinese trials; reports

 Members of the China Select Committee in the US House have launched a national security investigation into a number of big pharma companies, asking for details of their use of clinical trial sites in China.

Letters to the companies – which include MSD and AbbVie according to Reuters and Bristol Myers Squibb according to Endpoints – are asking whether trials in China have involved sites linked to the Chinese military and particularly locations in Xinjiang, where there has been persecution of the mainly Muslim population of Uyghurs and other Turkic minorities.

The letters are signed by China Select Committee chair John Moolenaar (R-MI), who has asked the pharma companies whether they can guarantee that subjects recruited in the trials are "participating voluntarily and with informed consent." They ask for the companies to respond by 17th July.

"Through a combination of regulatory reforms, state subsidies, and (at best) questionable ethics, China has transformed itself into the cheapest and fastest place in the world to ​run early-stage human drug trials," the letters read. And while they do not accuse the drugmakers of wrongdoing, they suggest that running studies in China "exposes American ​companies to ethical and security ⁠risks."

The move is part of a concerted effort by lawmakers in the US to defend US biopharma interests at a time when China is emerging as a major player on the world stage, and increasingly a source of new medicines licensed by US companies and a location for clinical trials.

Last week, HHS said it will introduce a series of measures – under the Operation Trailblazer banner – to speed up drug research by reducing unnecessary delays to studies, increase participation in clinical research, and strengthen domestic research capacity.

Meanwhile, Moolenaar and Congresswoman Debbie Dingell (D-MI) earlier this month introduced the Biotech Investment National Security Act (BINSA), which would add biotechnology, and specifically pharmaceutical and biological product development, to the list of sectors subject to outbound investment screening.

That would make US companies' licensing deals, joint ventures, and equity investments involving Chinese organisations subject to review by the US Treasury Department. 

And, in May, Moolenaar wrote to Treasury Secretary Scott Bessent to call for restrictions on US investment in Chinese biotech companies, in the wake of BMS's $15.2 billion alliance with Hengrui Pharma, which he said involved the transfer of intellectual property to the Chinese company.

https://pharmaphorum.com/news/drugmakers-asked-defend-chinese-trials-reports

Mamdani, NYC Council reach handshake deal on colossal $125B budget — without NYPD expand

 Mayor Zohran Mamdani struck a last-minute handshake deal on Tuesday morning with City Council Speaker Julie Menin on the Big Apple’s colossal, roughly $125 billion budget for next year — but the agreement notably leaves out an expanded headcount for the NYPD.

The final deal comes right before a July 1 deadline to pass a budget for the 2027 fiscal year — and after a tense, protracted negotiation that nearly fell apart at the eleventh hour over Mamdani backtracking on a campaign promise to fund the expansion of a housing voucher program.

However, Mamdani and the council came to a last-minute agreement Monday night to expand voucher access that will see the council voting to establish a new rental assistance program aimed at helping New Yorkers facing eviction or in the shelter system who aren’t eligible for the City Fighting Homelessness and Eviction Prevention Supplement program.

Once the legislation passes, the Mamdani administration has agreed to drop its appeal of a lawsuit brought by the City Council after former Mayor Eric Adams’ veto of the expansion was overridden in 2024 and he refused to enact the approved reforms.

“Every New Yorker deserves a safe, affordable home, and this agreement will help more families avoid eviction and homelessness,” said Speaker Julie Menin.

“Our historic announcement includes the administration dropping their lawsuit against the council and a new bill which addresses some of the fiscal concerns. Housing vouchers are a smart investment that save taxpayers money by preventing homelessness before it happens,” Menin added.

The spending plan’s contours are expected to closely match Mamdani’s $124.7 billion executive budget unveiled in May, but with more spending earmarked for council members — and without the promised NYPD headcount boost after the mayor caved to activists who protested the increase, sources said.

Mamdani allies and activists slammed Hizzoner for proposing to swell the police department’s ranks by 580 officers after he made a campaign pledge to freeze the NYPD’s staffing levels. Around 50 elected officials and advocates, including the local Democratic Socialists of America chapter, gathered around City Hall last Thursday to protest his about-face.

City Council leadership, however, has pushed to expand New York’s Finest. They were at first successful, getting Mamdani’s executive budget proposal to boost the ranks from the current 33,861 to 35,370 in the 2027 fiscal year.

But ultimately, Mamdani sided with the protesters.

Meanwhile, the city’s Department of Education will likely draw the biggest portion of funding, with $37.9 billion outlined in the executive budget.

Other anticipated outlays include $14.6 billion for the city’s Department of Social Services and $6.59 billion in NYPD funding.

The young, untested socialist Mamdani quickly turned the focus to the budget after taking office by sounding the alarm about a supposed $12 billion upcoming shortfall, blaming his predecessor, Adams, for the crunch.

He has since revised the estimate to $5.4 billion — a still-dire gap that he argued could be bridged either by taxing the rich or hiking property taxes nearly 10% across the board.

Critics argued that Mamdani’s ultimatum was a tactic to push a tax on the wealthy through the state Legislature.

Ultimately, Gov. Kathy Hochul helped serve up $4 billion in largely kick-the-can measures to delay massive spending.

The governor also paved the way for a pied-à-terre tax on luxury second homes that she and Mamdani claimed would raise $500 million a year, a figure that city Comptroller Mark Levine argued was roughly $200 million too high.

The Post has reached out to the mayor’s office and City Council for comment.

https://nypost.com/2026/06/30/us-news/mamdani-nyc-council-reach-handshake-deal-on-colossal-125b-budget-without-nypd-expansion/

Users in US report issues with X, Grok

 Users in the United States reported issues on Tuesday with x.AI LLC's X and Grok, according to Downdetector.

Users of both the social media platforms and the chatbot mostly reported issues with the applications, followed by the website.

The problems were reported mostly in the areas around New York City, Boston, Chicago, Washington, Dallas, and Los Angeles.

https://breakingthenews.net/Article/Users-in-US-report-issues-with-X-Grok/66602428

Qatar: No direct US-Iran talks planned

 Qatar's Foreign Ministry stated on Tuesday that there are currently no plans for a high-level meeting between the United States and Iran. The disclosure seems to confirm Tehran's statement, which denied direct talks with Washington.

Still, the ministry confirmed that US presidential envoys Steve Witkoff and Jared Kushner are expected to arrive in Qatar to meet mediators to discuss negotiations.

US President Donald Trump yesterday claimed Tehran requested the negotiations to take place in Doha, and the White House later revealed that both Witkoff and Kushner would represent the American side.

https://breakingthenews.net/Article/Qatar:-No-direct-US-Iran-talks-planned/66601785

Iran: IAEA without access to damaged nuclear sites

 The Iranian Foreign Ministry's spokesperson Esmail Baghaei stated on Tuesday that the International Atomic Energy Agency (IAEA) remains blocked from inspecting the damaged nuclear sites in his country.

Speaking at a press conference, Baghaei urged IAEA Director General Rafael Grossi to "stop issuing political statements" and focus on his job instead.

Earlier, Grossi noted that the IAEA's inspections of Iran's nuclear sites was necessary to provide credibility to the memorandum of understanding Tehran and Washington signed recently.

https://breakingthenews.net/Article/Iran:-IAEA-without-access-to-damaged-nuclear-sites/66602919

BioCryst to end internal discovery, cuts 2026 non-GAAP opex guidance

 

BioCryst to end internal discovery, close Birmingham research site, cuts 2026 non-GAAP opex guidance to $420–$440 million

• Strategic shift emphasizes external innovation after ending internal discovery programs and Birmingham, Alabama research facility operations.
• Company reaffirmed its revenue guidance while lowering 2026 non-GAAP operating expense guidance to $420–$440 million.

https://finviz.com/stock?t=BCRX&p=d

FDA hits Praxis with 3-month delay for epilepsy drug verdict

 

The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.

Praxis Precision Medicines will have to wait up to three more months for the FDA’s decision on its epilepsy therapy.

Monday, the Boston biotech announced that the agency has delayed its target decision date for the investigational sodium channel blocker relutrigine after classifying data from additional analyses as a major amendment to the original application. Relutrigine’s original target action date of Sept. 27 has now been pushed back to Dec. 27. The company is seeking approval for relutrigine in patients with developmental epileptic encephalopathies (DEE) linked to SCN8A and SCN2A mutations.

The FDA hasn’t asked for any additional trials, nor did it point out any safety or manufacturing concerns, according to Praxis’ Monday announcement.

Jefferies took this lack of flags as good news, calling the review extension a “fairly benign delay” in a Monday note.

“Importantly, the FDA did not cite any safety or manufacturing concerns, and no new clinical studies were requested, so we continue to believe approval prospects are favorable,” the analysts wrote. “Said another way, the FDA could have issued a CRL [complete response letter] if it was not inclined to approve.” Jefferies’ historical analysis of review extensions indicates that more than 80% end up getting the regulator’s greenlight.

Relutrigine is an oral drug that blocks the persistent flow of current across sodium channels, which when otherwise left unchecked is a key driver of seizures in patients with DEE. In December 2025, Praxis announced that a mid-stage study for relutrigine in this indication would be terminated ahead of schedule because of the drug’s strong performance, in accordance with the recommendations of an independent data committee.

Data released that same month showed a 53% placebo-adjusted reduction in seizures over 16 weeks. Treated patients also saw 66% more motor seizure-free days. Jefferies called these results “impressive” in its Monday note, “especially given the lack of effective options” for the DEE population.

Praxis “is comfortable with relutrigine reaching $1B+ peak sales in SCN2A/8A alone,” the analysts added.

Outside of relutrigine, Praxis is also advancing the antisense oligonucleotide elsunersen to reduce seizures in SCN2A DEE. The FDA granted the asset breakthrough therapy designation last week. Elsunersen is in the pivotal single-arm EMBRAVE3 trial, which is currently enrolling patients.

https://www.biospace.com/fda/fda-hits-praxis-with-3-month-delay-for-epilepsy-drug-verdict