India‘s drug regulator has sought comments from pharma industry stakeholders on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials and have an easier path to obtaining approvals for a product launch. Experts, however, believe that instead of making drugs cheaper, the move…
Boehringer Ingelheim and Click Therapeutics have revealed the data from their pivotal trial of digital therapeutic (DTx) CT-155 for schizophrenia, which has shown efficacy against some of the symptoms that are hardest to address with drug therapies. At the European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam this week, the two partners presented data from…
A year ago, Astellas was celebrating the first-in-class approval of its claudin 18.2-targeting cancer drug Vyloy for gastric cancers. Now, a bid to expand its label into pancreatic cancer has hit the buffers. The 393-patient phase 2 GLEAM study compared the combination of Vyloy (zolbetuximab) with chemotherapy (gemcitabine and nab-paclitaxel) to chemotherapy alone, but failed…
AMC Flags Human Trial Violations, Refers Case to Gujarat FDCA We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
Unequal Trials in New Drug Approvals: CDSCO Seeks Feedback for Policy Reform We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
Ahmedabad: The Ahmedabad Municipal Corporation has written to the Gujarat Food and Drug Control Administration (FDCA) after receiving complaints about “lapses” in clinical trials on humans being conducted by some city-based laboratories, said an official on Wednesday. According to the corporation’s medical officer of health, Dr Bhavin Solanki, the complaints mostly concern the lack of…
AstraZeneca’s baxdrostat has hit the mark in another phase 3 trial involving people who struggle to control their blood pressure with current therapies, keeping the would-be blockbuster on track for regulatory filings this year. The latest top-line readout from the Bax24 study in patients with resistant hypertension showed that baxdrostat achieved a statistically significant reduction…
Researchers have shut pregnant women out of gold-standard clinical trials in order to protect them and their babies. But the practice has had the opposite effect. Instead, women have to wade through a chaotic data landscape, and many may choose to suffer through untreated illnesses. Besides sowing confusion, the lack of data makes it easier…
Bristol Myers Squibb has said it hopes to be ready soon to file for approval of its multiple myeloma drug iberdomide after reporting positive results in a phase 3 trial. Full data from the EXCALIBER-RRMM study in relapse/refractory multiple myeloma is not ready to be disclosed, but BMS said the trial showed that the cereblon…
Roche has staked a claim to use its oral selective oestrogen receptor degrader (SERD) giredestrant as a second-line therapy for breast cancer, regardless of a patient’s ESR1 mutation status. Top-line results from the evERA study showed that the combination of giredestrant with everolimus improved progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast cancer…