Pharma News - Chemdiv

China NMPA accepts BeiGene’s sNDA for Brukinsa to treat CLL and grants breakthrough therapy designation

BeiGene, a global, science-driven biotechnology company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental...

EU Approves Pfizer’s Lorviqua for Treating ALK-Positive Advanced Lung Cancer

The European Commission has granted Pfizer’s Lorviqua (lorlatinib) — branded in the U.S. as Lorbrena — marketing authorization as a first-line treatment for adults with anaplastic lymphoma ki...

Glenmark Pharma arm gets final USFDA approval for blood pressure drug

Glenmark Pharmaceuticals Ltd on Thursday said its US subsidiary has received final approval from the country’s health regulator (FDA) for its generic Bisoprolol Fumarate and Hydrochlorothiazide t...

Senhwa's Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that the US Food and...

Samsung shells out $2.3 billion for Biogen stake in biosimilar joint venture

Samsung Biologics announced Thursday that it has agreed to buyout Biogen's stake in their nearly decade-long biosimilars joint venture Samsung Bioepis for $2.3 billion. ...

IAVI and Moderna Launch Trial of HIV Vaccine Antigens Delivered Through mRNA Technology

IAVI, the nonprofit scientific research organization, and biotechnology company Moderna announced today that first doses have been administered in a clinical trial of experimental HIV vaccine antig...

U.S. FDA declines to approve Merck's cough treatment

Merck & Co said the U.S. Food and Drug Administration declined to approve its experimental drug for the treatment of chronic cough and sought additional information on the treatment's effective...

Omicron relief: Pfizer and BioNTech initiate study into targeted vaccine

COVID-19 vaccine luminaries Pfizer and BioNTech study will examine data from the current booster and consider need for specific Omicron jab.

Moderna starts clinical trial of booster shot targeting omicron Covid variant

Moderna started a clinical trial to study the safety and effectiveness of a booster shot that specifically targets the omicron Covid variant, the company announced Wednesday. ...

Big Insulin Makers Spent Big Money on Lobbying in 2021

Two of the top producers of insulin increased their lobbying efforts last year amid public cries for pricing reform for all drugs, but insulin in particular.

FDA Revokes EUAs for Two Monoclonal Antibodies Shown to be Ineffective Against Omicron

The FDA has revoked the Emergency Use Authorization (EUA) for Regeneron’s REGEN-COV (casirivimab plus imdevimab) and Eli Lilly’s (bamlanivimab and etesevimab), both monoclonal antibodies that b...

J&J Forecasts Sales of $3.5 Billion for Its COVID-19 Jab in 2022

Though it’s the least-administered COVID-19 vaccine of the three approved in the U.S., Johnson & Johnson (J&J) said it believes global sales of its COVID-19 vaccine will reach $3.5 billio...