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• The Monday approval of the drug, baxdrostat, covers its use alongside other antihypertensive medications for adults whose blood pressure is not adequately controlled by currently available therapies.

• Baxfendy is a once-daily oral small molecule designed to inhibit aldosterone synthase, an enzyme that’s key to production of aldosterone by the adrenal gland.

• In the phase 3 clinical trial that supported Baxfendy’s FDA submission, results showed that the 1 mg and 2 mg doses of the drug both led to statistically significant reductions in blood pressure compared to placebo measured at 12 weeks. The study drug was well tolerated by patients. (MedCity News)

• The FDA simultaneously greenlighted Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvan and adjuvant treatment of patients with HER2-positive early breast cancer.

• The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.

  • While early, the adjuvant label comes with a catch: It precludes patients who’ve received Enhertu before surgery from continuing on the HER2-directed ADC in the post-operative setting.

  • Specifically, in the adjuvant setting, Enhertu is now approved for patients with HER2-positive breast cancer who have residual invasive disease following treatment with Herceptin (trastuzumab)—with or without Roche’s Perjeta—and taxane-based treatment.

  • When announcing an FDA priority review in March, Daiichi and AZ described the indication as for “after neoadjuvant HER2 targeted treatment,” which, if approved verbatim, would cover prior use of Enhertu. But apparently a broad label did not pan out.

• As for the neoadjuvant setting, Enhertu is cleared on top of the THP regimen (a taxane, Herceptin and Perjeta) for treating adults with HER2-positive stage 2 or stage 3 breast cancer. (Fierce Pharma)

• The dosing update to the prescribing information for Crysvita (burosumab-twza) introduces a new option for adults with X-linked hypophosphataemia (XLH).

• Affecting adults and children, this rare, progressive, genetic disorder impacts both bone and muscle health due to the body’s inability to retain sufficient phosphorus, a mineral essential for bone health.

• Following the update, healthcare providers can increase both the dose and frequency of the therapy for XLH patients whose serum phosphorus remains below normal after the initial treatment. (Pharmaceutical Technology)

• A vaccine for the Ebola strain driving the outbreak in the Democratic Republic of Congo and Uganda is likely months away from human trials, and there is no guarantee it would work, the World Health Organization said Wednesday.

• There are currently no approved vaccines for the Bundibugyo strain of the Ebola virus.

• There are two potential vaccine candidates, but neither is ready to move into human testing, Dr. Vasee Moorthy, the lead for the WHO’s research and development blueprint, said during a news conference.

• The more promising of the two could take six to nine months before enough doses are ready for trials, Moorthy said. The other may be available in two to three months but has not yet shown supporting results in animal studies.

• The timeline has pushed health officials to consider other options, including Merck’s Ebola vaccine, called Ervebo. (NBC News)

• A next-generation obesity drug from Eli Lilly reached a new level of weight loss in a late clinical trial, matching levels generally seen in those who've had bariatric surgery, company officials said today.

• The results challenge assumptions of how much the drugs can achieve and could help Lilly reinforce its position at the front of an increasingly competitive market.

• The phase 3 trial of retatrutide — a first-in-class injectable drug which includes GLP-1, GIP and glucagon hormones — found participants were able to achieve weight loss of about 28% over roughly 18 months.

• Nearly half (45%) were able to lose at least 30% or more of their body weight, a level associated with bariatric surgery.

• With a lower amount of the drug, trial participants lost roughly 19% of their body weight.

• Roughly 11% of patients on the top dose discontinued the drug due to adverse events, which Ken Custer, executive vice president and president at Lilly Cardiometabolic Health, said is "in line" with studies of anti-obesity drugs.

• Lilly's top-selling Zepbound delivered 21% average weight loss in late-stage trials, while Novo Nordisk's Wegovy produced about 15%. (Axios)

• A drug prospect from Relay Therapeutics has shown signs in a mid-stage clinical trial that it may be able to treat a cluster of conditions associated with the development of abnormal blood vessels.

• In 20 people with these vascular anomalies, a 12-week regimen of Relay’s therapy, zovegalisib, was associated with a 60% response rate across all doses tested, the company said Tuesday.

• Nearly all patients experienced an improvement in symptoms, and responses were observed in people with different disease subtypes and PIK3CA mutations driving their condition.

• Investigators did have to dial back dosing in 23% of people getting one of the doses Relay will take into further testing.

• But the company also said no patients discontinued treatment, the most common adverse events were “low-grade, manageable, and reversible” and the drug appeared safe enough to envision the kind of “chronic use” that’d be necessary for these conditions. (Biopharma Dive)

• Last week, a cadre of more than 100 biotech leaders were quick to recommend Pazdur for the job, penning a letter to President Trump himself following Marty Makary’s sudden resignation.

These deliverables include “concrete plans with timelines to restore confidence, preserve science-driven culture, and think outside the box bringing a bottoms up approach to the agency,” according to RBC.

“Decisional volatility, staff exodus, missed deadlines, and eroding scientific predictability at the FDA have created a crisis of confidence in America’s ability to remain a leader in biomedical progress,” the biotech execs wrote in their letter to Trump, which was posted by the advocacy group No Patient Left Behind.

“Solving it requires leadership with proven experience, unimpeachable scientific credibility, and a demonstrated track record of leadership and effectiveness—all qualities Dr. Pazdur has demonstrated throughout his time at the agency.” (Biospace)

• A physician in Italy observed the first one, the lymphatic system, which removes excess fluid from tissues, in 1622.

• Six years later, an English doctor described the second, the cardiovascular system, which pumps blood through our arteries, veins and capillaries. (It was a great decade for science.)

• After examining the skin of people with tattoos, researchers saw in their biopsies that ink particles had traveled deeper into the body than they expected, through the skin into an interstitial space beneath it — and from that space into the fascia, the connective material below.

• It has far-reaching implications for our understanding of the human body and for our health, because that interstitial space doesn’t just exist between the skin and the fascia, researchers discovered.

• There are spaces like it throughout the body, forming pathways between organs and allowing fluids, cells and molecules to move between them before re-entering the lymphatic and cardiovascular systems.

• Scientists call this large interconnected network the interstitium.