Pharma News, 2023

Scientists from Japan reveal the crystal structure of a cell cycle motor protein, which could be a potential anticancer drug candidate

The FDA is teaming up with the Lupus Research Alliance to launch the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to address challenges affecting clinical trial success. ...

Esperion is suing Daiichi Sankyo over a failure to pay a $300 million milestone payment for the cardiovascular drug Nexletol (bempedoic acid), a treatment for heterozygous familial hypercholesterolemi...

The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulato...

In an effort to bolster drug access in dozens of countries around the globe, three generics makers have obtained sublicenses to make low-cost versions of GSK’s long-acting HIV PrEP drug Apretude....

The European Commission has approved Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa) as a long-term enzyme replacement therapy for adult patients with late-onset Pompe disease, a rare neuro...

AstraZeneca's chief exec publicly criticized the U.K.'s tax policies last month, but that didn't stop officials there from backing the comp any's key asthma launch....

The FDA has granted Orphan Drug designation to Cyclerion Therapeutics’ investigational drug zagociguat for treatment of mitochondrial diseases.

The FDA has approved Glenmark Pharmaceuticals’ generic version of Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate), for topical treatment of plaque psoriasis. ...

The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data....

The UK’s National Institute for Health and Care Excellence (NICE) has recommended PTC Therapeutics’ Upstaza (eladocagene exuparvovec) for National Health Service (NHS) use in treating patients ...

The FDA has approved Pharming’s Joenja (leniolisib) twice-daily tablets as the first treatment for adult and pediatric patients 12 years and older with activated phosphoinositide 3-kinase delta s...