Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

FDA

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

FDA

European Pharmaceutical Review

NOVEMBER 4, 2022

These are identical to doses used in human trials for FDA approval. Co-principal investigator on the study, Dr Jeffrey Petrella, Professor of Radiology and Director of the Alzheimer Imaging Research Laboratory at Duke University added: “It often takes tens of millions of dollars and many years to do a head-to-head comparison of drugs.”.

Research Laboratories

European Pharmaceutical Review

AUGUST 12, 2024

Progress in immunotherapy drug development In June, the US Food and Drug Administration (FDA) authorised an immunotherapy combination to treat endometrial cancer. The bispecific antibody has shown potential to generate “significant and sustained reductions in B-cell populations”. The deal is anticipated to be finalised in Q3 of 2024.

Research Laboratories

Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). 12% experienced a complete response and 55% a partial response.

Research Laboratories

pharmaphorum

SEPTEMBER 28, 2021

Merck & Co’s FDA approval for Keytruda in advanced liver cancer looks secure, after an Asian clinical trial found that the cancer immunotherapy improved survival in these patients. Keytruda (pembrolizumab) was cleared by the FDA as a second-line therapy for the hepatocellular carcinoma (HCC) form of liver cancer in 2018.

Research Laboratories

pharmaphorum

AUGUST 5, 2020

Intercept was previously the front runner but its obeticholic acid has run into trouble with the FDA , which rejected a filing at the end of June. Non-alcoholic steatohepatitis, as the disease is also known, has been a target for pharma for years but is proving a tough nut to crack as there are no drugs yet approved to treat it.

Research Laboratories

European Pharmaceutical Review

JUNE 18, 2024

The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status.

Chemotherapy

pharmaphorum

APRIL 9, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said in a statement that the data marked the first time an anti-PD-1 therapy showed potential adjuvant treatment for patients with RCC.

Research Laboratories

Pharmaceutical Technology

AUGUST 5, 2022

The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.

Research Laboratories

pharmaphorum

OCTOBER 14, 2021

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said the data showing a 36% reduction in the risk of death “are compelling”.

Chemotherapy

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. In the recent FDA guidance on nanomedicine, the microbiological control aspects are featured.

Vaccines