drug-development
12 stories tagged "drug-development"
Drugs Aimed at This Week's Brain-Inflammation Target Have Already Failed in Patients
AstraZeneca and Pfizer each took a P2X7 blocker into rheumatoid arthritis trials, and neither beat placebo. A Birmingham lab now says the same receptor could tame inflammation in Alzheimer's and Parkinson's.
Brain & AgingIn Lab Tests, the Alzheimer's Fragment Labeled 'Non-Amyloidogenic' Builds Amyloid Faster Than Amyloid Beta
For decades the alpha pathway was billed as the safe way to cut the Alzheimer's precursor protein. Its leftover fragment, p3, builds fibrils in less than half the time amyloid beta needs in lab tests, forms ring-shaped pores, and turns up in plaques where a common antibody stain can't tell the two a
CancerCancer Wasting Was Hiding in Two Million Routine Weigh-Ins
At Memorial Sloan Kettering, 48.8% of 59,493 tumor-sequenced cancer patients had at least one cachectic weight-loss episode over about five years. No drug is approved for it, and a French hospital coded it in under 1% of its cancer patients.
Metabolic & WeightThe 'Self-Destruct' Fat Shot Billed as Obesity Medicine Faces Its Pivotal Trial Below the Obesity Line
Caliway's CBL-514 shrank belly fat in small trials and drew obesity headlines at EASD, but its phase 3 caps enrollment below a BMI of 30 and grades flatter stomachs, not weight.
Drugs & FDAThe FDA's New Fast Lane for Experimental Drugs Is Run by a Lawyer Who Defended the Food and Tobacco Industries
Operation TrialBlazer lets drug sponsors feed their first-in-human safety data to the FDA in pieces, on a rolling clock, to shave months off the wait. The review it speeds is the one that decides whether an untested drug can go into a person at all.
Drugs & FDAFour Years After Congress Dropped the Animal-Testing Requirement for New Drugs, the FDA Finally Updated Its Rulebook to Match
The FDA's direct final rule swaps 'animal studies' for 'nonclinical studies' across its regulations. It eliminates no animal testing, moves no evidentiary bar, and sets up no program to prove the alternatives it now invites actually work.
Drugs & FDAThe FDA's New Pilot Lets a Drug Sponsor Choose the Institution Helping Build Its First-in-Human Application, and Reviews the Pieces as They Arrive
The agency will select 8 to 10 sponsor-QRI pairs to co-develop first-in-human trial applications it reviews on a rolling basis, and its stated reason is that China and Australia get there faster.
Drugs & FDAThe 'Bone-Building Switch' Is Back in the Headlines. It Was Tested in Mice, and Only Mice
A publicly funded Leipzig compound rebuilt bone in ovariectomized mice, 8 per treated group. More than a year later the same experiment is still being sold to readers as a way to keep their bones strong for life.
Brain & AgingThis Week's Autism 'Breakthrough': A Rare Mutation, an Injection Into Mice, and Not One Human Patient
An injection that silences one gene rescued social behavior in mutant mice and a dish of human cells. The headlines called it an autism therapy. No autistic person has received it, and the gene it targets is mutated in a small fraction of cases.
Infectious DiseaseDavid Ho's Lab Built an Antibody to Neutralize Nearly Every Strain of HIV. Its First Test in People With the Virus Held for Two Weeks.
Fifty-four volunteers, nine with HIV, and just three with virus still in their blood. The engineered antibody drove their viral load down as much as ninetyfold, then lost the ground within a week as it drained away.
Brain & AgingThe amyloid-versus-tau war in Alzheimer's might be the wrong fight
A four-person UC Riverside chemistry group argues amyloid beta and tau compete for the same microtubule binding sites, a unifying mechanism that cuts under Alzheimer's research's three-decade amyloid-versus-tau fight.
Brain & AgingThe Alzheimer's Drug That Bets the Plaques Are a Symptom
An ETH Zurich team spent nearly twenty years tracing why Alzheimer's nerve cells run out of energy, and the answer points to a protein the amyloid-clearing drugs never touched.