Industry News
Pharmaceutical Industry News
The FDA has converted its…
The FDA has converted its accelerated approval for Novartis' Fabhalta into a full blessing to treat patients with immunoglobulin A nephropathy (IgAN). The drug is endorsed to slow kidney function decline in adults at risk
The FDA has converted its…
The FDA has converted its accelerated approval for Novartis' Fabhalta into a full blessing to treat patients with immunoglobulin A nephropathy (IgAN). The drug is endorsed to slow kidney function decline in adults at risk
From Indiana to Iceland, the FDA…
From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with troubled regulatory histories.
From Indiana to Iceland, the FDA…
From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with troubled regulatory histories.
ADCs from Kelun-Biotech and Hansoh…
ADCs from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck and GSK, delivered positive phase 3 readouts. AstraZeneca reached out to its spinout Dizal for an EGFR lung cancer med. Biotechs are growing protective of
ADCs from Kelun-Biotech and Hansoh…
ADCs from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck and GSK, delivered positive phase 3 readouts. AstraZeneca reached out to its spinout Dizal for an EGFR lung cancer med. Biotechs are growing protective of
Foundation Medicine has started…
Foundation Medicine has started the “Quality First” initiative to create awareness of how “not all cancer biomarker tests are created equal.”
In the past six years, the…
In the past six years, the pharmaceutical industry has sought to show itself to the world more than ever before. The COVID-19 pandemic brought these companies into the spotlight and, rather than shy away, many
What to Know About the New Cholesterol Pill and How it Compares to Statins
How does it compare to statins? Should you take it? And how much does it cost?
CG Life and its rare disease…
CG Life and its rare disease awareness platform 24/364 will host a first-of-its-kind rare disease film festival in San Diego next March featuring documentaries exploring the lived experience of patients with rare diseases.
Zhejiang Huahai Pharmaceutical has…
Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility.
Clinical teams have long used real…
Clinical teams have long used real world evidence to understand how a drug works. Now commercial teams can mine evidence from unstructured data to drive action.
A bipartisan bill reintroduced by…
A bipartisan bill reintroduced by three senators aims to increase transparency around foreign influence on the United States’ drug supplies, marking a potential first step to imposing restrictions.
Vanda Pharmaceuticals is…
Vanda Pharmaceuticals is sponsoring an IndyCar to fuel awareness of its motion sickness pill, Nereus. The biotech backed the No. 47 car to represent its end of the multi-decade wait for a prescription therapy.
Gilead Sciences Canada and The…
Gilead Sciences Canada and The Local Collective worked up a bronze-winning campaign for HIV med Descovy featuring AI-generated animals.
The FDA has approved Merck’s…
The FDA has approved Merck's internally developed cholesterol-lowering treatment Lipfendra for adults with hypercholesterolemia, or high levels of "bad" cholesterol. The drug, which is the first oral PCSK9 inhibitor to reach the market, has been
As Pfizer and Moderna have tied…
As Pfizer and Moderna have tied off certain threads in their separate webs of mRNA patent litigation, Sanofi has opened a new front to challenge the companies’ blockbuster COVID-19 vaccines.
The European Commission has…
The European Commission has granted marketing authorization for Novo Nordisk’s Wegovy pill for people with obesity or who are overweight. The approval comes as Novo’s weight-loss rival, Eli Lilly, awaits European clearance for its oral
As AI, data and rising HCP…
As AI, data and rising HCP expectations redefine medical affairs, leaders need a more connected model for turning insight into action.
Merck & Co.’s almighty…
Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer.