Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

BioMarin’s investigational therapy failed to elicit clinical improvements in patients with ENPP1 deficiency, while also missing key secondary endpoints of rickets severity and growth.
Despite having no definitive data, Sen. Ron Johnson (R-WI) in a letter to health secretary Robert F. Kennedy, Jr. suggested there was a conscious effort by the Biden administration’s FDA to cover up the safety risks of COVID-19 vaccines.
Merck and Kelun-Biotech’s antibody-drug conjugate significantly improved progression-free and overall survival in a pivotal endometrial cancer study, though the companies have yet to specify when they plan to file for approval.
Baxfendy, the first aldosterone synthase inhibitor to be approved by the FDA for high blood pressure, is among the products AstraZeneca is relying on to hit its 2030 goal of $80 billion in revenue.
The FDA has previously linked eight deaths in the U.S. to Tavneos and has alleged that doctored data were used to support its 2021 approval.
After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.
The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease.
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.
CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data.
Degron Therapeutics will have stiff competition in immunology, as Novartis inked a $5.7 billion agreement with Monte Rosa Therapeutics last year to develop molecular glues for undisclosed immune-mediated conditions.
Beqalzi is the first BCL2 inhibitor approved for relapsed or refractory mantle cell lymphoma.
While Takeda is eliminating 4,500 roles across its global operations, the company has some 2,200 jobs currently open for hiring, for which internal candidates will be prioritized.
Despite seeing some regain, patients in two trials maintained most of their weight loss after switching to either Foundayo or lower-dose Zepbound from other injectable incretin therapies.
FDA
With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins.