Medvedev tells EU to 'shut up' over Romania incident

 Russian Security Council Deputy Chairman Dmitry Medvedev dismissed European outrage over a drone strike in Romania, asserting that EU nations are direct participants in the Ukraine conflict.

Following an incident where a drone struck a residential building in Galati, injuring two people, Medvedev stated on social media on Friday that while the drone's origin must be determined, "all EU countries need to shut up on this topic." He labeled European states as "direct participants in the war with Russia," claiming they fight using Ukrainian proxies.

He stated that the "imbecile-like EU leaders" know "perfectly well how to end the war" and concluded that accountability rests with them, adding, "So demand answers from them."

https://breakingthenews.net/Article/Medvedev-tells-EU-to-'shut-up'-over-Romania-incident/66397398

JNJ TECVAYLI ups survival in Phase 3 multiple myeloma trial, FDA and EMA filings for earlier-line use

 

Johnson & Johnson's TECVAYLI improves survival in Phase 3 MajesTEC-9 multiple myeloma trial, with FDA and EMA filings for earlier-line use

• MajesTEC-9 showed TECVAYLI significantly improves progression-free and overall survival versus standard of care in earlier-line disease.
• Johnson & Johnson submitted applications to expand TECVAYLI use as early as second-line therapy in multiple myeloma.
• FDA approved an expanded TREMFYA label adding structural joint damage data for active psoriatic arthritis.

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

UnitedHealthcare Eliminates Nearly 2/3 of Peds Prior Authorization

 UnitedHealthcare is removing two-thirds of authorization requirements for members under age 18 by year’s end. This move is the latest in a series of initiatives to simplify the healthcare system for providers and patients.

The company is eliminating prior authorizations for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.

UnitedHealthcare is also introducing authorization waivers for certain procedures performed at leading comprehensive pediatric hospitals, reflecting these facilities’ consistent use of well-established care practices. These hospitals represent a broad network of nationally recognized pediatric centers spanning medical and surgical specialties.

“Parents should be able to spend less time having to navigate the health system and more time focusing on their children as they get the care they need,” said Tim Noel, CEO of UnitedHealthcare. “These changes are part of our broader efforts to simplify healthcare and allow families — and their doctors and nurses — to pursue routine care with far fewer administrative steps, while higher-risk procedures continue to undergo reviews.”

UnitedHealthcare is conducting a rigorous, data-driven review of all pediatric prior authorization requirements to determine which services can be safely removed while maintaining high standards of clinical quality and patient safety. The company will eliminate pre-approval for certain pediatric services, including some diagnostic imaging; reviews of where care is provided; sleep studies; routine outpatient testing; and select surgical and therapeutic procedures that are consistently approved. UnitedHealthcare will continue to require pre-approval for services with higher clinical complexity or variability, including experimental treatments, specialty drugs and when required by government regulation.

The changes apply to UnitedHealthcare’s commercial and Medicaid plans.

https://www.unitedhealthgroup.com/newsroom/2026/2026-05-29-uhc-eliminates-nearly-two-thirds-of-prior-authorization-requirements-for-pediatric-care.html

Agios to discontinue tebapivat development in lower-risk myelodysplastic syndromes as Phase 2b misses

 

Agios to discontinue tebapivat development in lower-risk myelodysplastic syndromes after Phase 2b trial misses efficacy threshold

• Phase 2b study failed its predefined efficacy threshold but identified no new safety issues for tebapivat.

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

Apogee investors riled by $1.3B royalty deal, as eczema drug matches Lilly’s Ebglyss

 

Apogee’s pipeline in a product drug zumilokibart achieved significant disease clearance in a mid-stage atopic dermatitis trial, but investors were miffed by a royalty financing deal with Blackstone.

Apogee Therapeutics has irked investors who were hoping for an M&A deal by securing $1.3 billion in royalty financing from the private equity firm Blackstone Life Sciences.

The biotech’s shares dipped about 11% before market open on Wednesday despite delivering data for the atopic dermatitis (AD) candidate zumilokibart that Truist Securities said “looks competitive.”

Even so, the analysts weren’t surprised that the readout—which showed strong performance for the mid-dose—didn’t move the needle.

“We suspect this morning’s stock reaction … is being driven in part by the synthetic royalty agreement with Blackstone announced alongside the data,” Truist wrote in a note to clients. “Given that many investors view APGE as a potential M&A candidate, today’s transaction may signal that an acquisition is not imminent.”

CEO Michael Henderson justified the funding, however, by saying that the deal includes a provision for change of control, allowing a buyback of significant portions of the royalty.

“We felt that they were a great partner that provided us a bespoke capital structure and an attractive cost of capital that gives us a path to commercialization and even profitability without needing to rely on the equity markets anymore,” Henderson explained on an investor call Wednesday morning.

Blackstone will provide up to $1.3 billion in funding, which makes the deal the largest ever royalty financing for a pre-Phase 3 program, according to Apogee. The biotech currently has $1.3 billion in cash on hand, with the Blackstone deal adding $800 million in synthetic royalties and $500 million in a future senior debt option.

Blackstone has been granted a maximum 6.25% royalty rate on up to $5 billion in worldwide annual sales of zumilokibart, which drops to as low as 1.7% at $20 billion in sales.

With Blackstone’s backing, Apogee now has funds to commercialize zumilokibart for AD, asthma and eosinophilic esophagitis (EoE). “That was something we had heard from investors in the past, right? How will you fund this through launch and even profitability? And we have that now,” Henderson said.

Apogee wanted to preserve strategic optionality and flexibility coming out of the zumilokibart readout, and Blackstone was able to do that.

“They met us where we were on that,” Henderson said. “So, it was kind of a no-brainer from us, because it gives us a clear path forward while keeping all optionality clearly on the table.”

Alongside the financing announcement, Apogee also revealed data from part B of the Phase 2 APEX trial of zumilokibart. The results show higher performance for the mid dose as compared to the high dose, which Truist said may be disappointing to investors.

The anti-IL-13 antibody had comparable efficacy at both the mid- and high-doses, according to Apogee. The main goal was the percentage of patients who achieved at least a 75% improvement in eczema severity. The high dose saw 61.6% achievement, and the mid dose was 65.9% at 16 weeks.

“The dose‑ranging study failed to demonstrate incremental efficacy at higher doses versus current standard of care, Ebglyss,” Truist wrote. “Notably, the mid‑dose (consistent with the dose studied in Part A) outperformed the high dose across all efficacy measures.”

On safety, there was also a higher rate of non–infective conjunctivitis–related adverse events depending on the concentration of the dose.

With that said, Truist believes the mid-dose data is “broadly comparable” to Eli Lilly’s Ebglyss.

Apogee is preparing zumilokibart as a pipeline in a product, with an initial focus on AD, which the company said is a $50 billion market opportunity. A Phase 3 program is set to launch in the second half of the year, which could mean a launch in 2029, according to the investor presentation.

A Phase 2a clinical trial for EoE is also expected to begin in the second half of this year with a readout expected in the second half 2027. Apogee is also planning a Phase 2b in asthma to initiate in the first half of 2027.

https://www.biospace.com/drug-development/apogee-investors-riled-by-1-3b-royalty-deal-as-eczema-drug-matches-lillys-ebglyss

Pfizer bets up to $10.5B in 12-candidate cancer collab with China’s Innovent

 

Pfizer continues its dealmaking spree by striking a back-heavy partnership with China’s Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer.

Pfizer is teaming up with China’s Innovent Biologics to advance a broad pipeline of cancer therapies, continuing the New York pharma’s recent dealmaking spree.

Under the terms of the agreement, announced late on Thursday, Pfizer will make a $650 million upfront payment and offer up to $9.85 billion in development, regulatory and commercial milestones. The companies expect to close the deal in the third quarter.

Pfizer and Innovent will advance a pipeline of 12 novel therapies across a wide range of oncology indications, though the partners haven’t yet specified what types of cancer they plan to target.

Innovent will contribute eight assets. Pfizer will have an exclusive worldwide license to four, while its ownership over the other four will apply only outside the Greater China region. The pharma will be the major funder of all eight programs.

For its part, Pfizer will throw four of its own assets into the pot. The companies will co-develop and co-commercialize these molecules, splitting development costs. U.S. and Europe profits from these products will be shared between the companies, while Innovent will have Greater China rights to these programs.

All 12 programs are early-stage therapies based on antibodies, including antibody-drug conjugates (ADCs) and multi-specific antibodies that can engage the immune system, according to Thursday’s announcement.

The Innovent partnership presents “an opportunity not only to strengthen our pipeline, but to accelerate the delivery of breakthroughs that can redefine standards of care,” Pfizer’s Chief Oncology Officer Jeff Legos said in a statement.

Pfizer is looking out to 2029 as a key turning point. In the interim, the pharma is investing heavily into its pipeline through big-ticket deals, not unlike the Innovent commitment.

Perhaps most notable of these deals, however, is the pharma’s recent $9.8 billion pickup of obesity star Metsera, gaining entry into the lucrative and increasingly competitive weight-loss arena. Pfizer in February released the first readout from Metsera’s pipeline since the buyout, touting a 12.3% placebo-adjusted weight reduction at 28 weeks.

Leading up to the Metsera acquisition, the pharma in May last year entered into a licensing agreement with 3SBio, fronting $1.25 billion and promising up to $4.8 billion in milestones. This deal gave Pfizer an investigational PD-1/VEGF bispecific antibody for cancer.

Other recent Pfizer partnerships include Sciwind Biosciences, YaoPharma and Novavax.

https://www.biospace.com/business/pfizer-bets-up-to-10-5b-in-12-candidate-cancer-collab-with-chinas-innovent

https://breakingthenews.net/Article/OpenAI-launches-tool-for-pandemic-detection/66396802