Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.
Two regulatory agencies have rejected the drug, but analysts indicate the pipeline acute heart failure treatment could have limited market success.
Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep
Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.
The $225-million deal will give Mylan one of two generics for the deep vein thrombosis drug.
Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.
Evolocumab holds the FDA's first filed biologics license application for the class.
Half-measures, like diabetes educational materials without a part B, fared poorly.
Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.
Generics made up almost 75% of prescriptions in the United Kingdom last year.
A study indicates they may do little to reduce the risk of stroke or heart attack.
The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.
Editorial says risk is small, researchers say it could be clinically relevant.
Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.
Gene mutations lead researchers to rethink ways to protect the heart.
Two studies found two different facets of statin therapy—one found patients moved less a year after starting their regimens, and another that the drugs upped the diabetes risk for some.
The company signed a deal with AstraZeneca in which high-risk heart disease patients can bypass step therapy and go straight to the branded cholesterol fighter.
The company is settling around 4,000 cases for around $162,500 apiece.
The drugmaker is set to start patient testing.
Novartis says the FDA wants more serelaxin efficacy data.
GlaxoSmithKline announced Tuesday its Phase-III drug from the Human Genome Sciences acquisition failed to hit its primary endpoint.
Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.
The company's 11-country poll found overall awareness about heart failure to be low. The geographic bloc is in the same bucket as the US in terms of mortality rates.
The drugmaker said successful results prompted an independent Data Monitoring Committee to recommend stopping the trial. The news follows an uneven week of pipeline drug news.
Analyses by Jefferies indicate that although doctors are interested in the experimental anti-cholesterol drugs, CV data will be a critical differentiator.
The state's attorney general says the drugmakers did not reveal that the drug could have a different impact—if any—on patients with East Asian or Pacific Islander heritage.
Researchers find that Canada has been a significant contributor to Zetia sales.
Researchers say saturated fat may not cause heart disease, but critics say the study is too narrow.
The FDA approved the blood drug to prevent deep vein thrombosis and pulmonary embolism among hip- and knee-replacement patients. The approval means BMS and Pfizer may encroach upon the territory of J&J's Xarelto.
The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.
*Group discounts available on request
Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.