Europe

Who made a splash in the biotech world this week? Here are some notable people.
A new computer tool has been developed to predict how some cancers may respond to an investigational treatment before it has even been administered to a patient.
FDA
Shire plc snagged approval from the U.S. Food and Drug Administration for Takhzyro (lanadelumab-flyo), a prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
As Brexit creeps closer and closer, the British government, as well as pharmaceutical companies and the European Medicines Agency, are preparing contingency plans for dealing with the possibility that healthcare-related companies will not have contracts in place in time.
AstraZeneca has seen another setback in a late-stage trial for chronic obstructive pulmonary disease (COPD) treatments. The latest stumbling block includes a failure for AstraZeneca’s investigational treatment to distinguish itself from a drug already marketed by rival GlaxoSmithKline.
Novartis announced that its BYL719 (alpelisib) met the primary endpoint of progression-free survival (PFS) in its Phase III SOLAR-1 trial. The drug is an alpha-specific PI3K inhibitor, a category of cancer drugs that has a troubling history of adverse events.
Months after partnering with Sanofi on infectious diseases, Germany-based Evotec has formed another significant partnership with Novo Nordisk. The two companies will combine their forces to develop treatments for diabetes, nonalcoholic steatohepatitis (NASH) and other diseases.
Chicago-based AbbVie has exercised its exclusive license option to develop and commercialize Belgium-based Argenx’s ARGX-115. The compound is an antibody that targets novel immuno-oncology target glycoprotein A repetitions predominant (GARP).
The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for (ulipristal acetate).
An article published earlier this summer in the Journal of Dental Research suggests that “bioengineered tooth buds” are a “superior alternative tooth replacement therapy.” In the article “Bioengineered Tooth Buds Exhibit Features of Natural Tooth Buds,” the authors report that artificial implants do not exhibit the same properties as natural teeth and are therefore subject to certain complications.
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