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199

Lynparza expanding possibilities

AstraZeneca’s drug Lynparza received a new, broader approval for ovarian cancer, thus aligning the race with Tesaro’s Zejula. The FDA decided it Thursday not only for a new oral formulation of Lynparza, but for a new indication as a maintenance treatment—essentially, second-line therapy designed to keep cancer at bay as long as possible. What is…

200

FDA approved Besponsa

Yesterday Pfizer won FDA approval for a new drug for the treatment of relapsed / refractory acute lymphoblastic leukemia (ALL). The approval came at the important time because the treatment options for the next generation are already on the horizon. Besponsa was approved in an accelerated mode, helped by the FDA’s breakthrough therapy and orphan…

201

Parallel lines do cross

“Enabling patients’ access to medicines is no longer a job for regulators alone. Today, we need to work with all decision-makers in healthcare to make sure that medicines that can make a real difference to people’s lives can actually reach them,” said EMA Executive Director Guido Rasi. So, EMA and European Network for Health Technology…

202

Positive changes in Entresto sales

When Novartis launched Entresto two years ago at a price of 4,600 dollars a year, heart failure drug ran into certain problems at that time. The market was dominated by generic drugs, so the pricey new entry didn’t sit well with pharmacy benefits managers and insurers—despite ringing endorsements from the American College of Cardiology, the…

203

Development of vaccine for addiction

Vaccines are usually perceived to fight infectious diseases. But what about the vaccine for addiction? HHS Secretary Tom Price says one is being developed but experts say such a shot is not likely soon. Price, who has been looking for ways for the FDA to fight the opioid crisis, offered some hope for such treatment…

204

Amgen concede in dispute with Pfizer

Last week US Federal Court of Appeals decided against Amgen. The American company could not protect Epogen, the drug against anemia, from the Pfizer‘s biosimilar. However, failure at the Court of Appeal does not mean that Amgen will immediately face competition from a cheaper drug. The appeals expert group concluded that its jurisdiction does not…