Pharma News - Chemdiv

UK study shows mixing Pfizer and AstraZeneca COVID-19 vaccines with Moderna elicits better immune response

Results show support in favour of heterologous dosing which may help to advance vaccination programmes in poorer countries.

FDA Approval Sought for Poziotinib in HER2 Exon 20–Mutated NSCLC

A new drug application (NDA) seeking the approval of poziotinib as a potential therapeutic option for patients with previously treated locally advanced or metastatic non–small cell lung cancer (...

Biohaven to seek FDA approval for second migraine drug after study success

Biohaven Pharmaceutical will soon ask the Food and Drug Administration for approval of its second migraine drug after a large, late-stage study showed treatment eased pain and the most bothersome h...

Keytruda gains eighth FDA approval this year

Merck’s megablockbuster Keytruda has returned to its roots with a new indication in melanoma, the therapy area where it was first approved seven years ago.

FDA under renewed fire over dubious approval of Alzheimer’s drug

Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on...

AbbVie's Rinvoq, Pfizer's Xeljanz and Lilly's Olumiant slapped with new FDA warnings amid JAK safety crackdown

The second regulatory shoe has finally dropped for AbbVie, Pfizer and Eli Lilly amid the safety review of JAK inhibitors for inflammatory diseases.

NICE Endorses AstraZeneca’s Tagrisso for NSCLC Patients With Specific Mutation

The UK’s National Institute for Health and Care Excellence (NICE) has said the Cancer Drugs Fund, part of the National Health Service, should offer AstraZeneca’s Tagrisso (osimertinib) for pati...

Court Rejects Moderna’s Challenge to Arbutus Biopharma Patents

The decision by the U.S. Court of Appeals for the Federal Circuit paves the way for a possible patent infringement complaint to be filed by Arbutus over its lipid nanoparticle technology allegedly ...

Phase III trial with Nubeqa™ (darolutamide) in combination with docetaxel and androgen deprivation therapy meets primary endpoint

The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary...

GSK says antibody drug sotrovimab works against Omicron mutations

GlaxoSmithKline and Vir Biotechnology announced an update to bioRxiv a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity ag...

Premas Biotech and Oravax to test their vaccine candidate against Omicron

Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution, as there is no need for freezer storage. ...

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal.