FDA accepted for Priority Review an sNDA for Xarelto for a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy.
In light of a rejection from the U.S. FDA, Coherus Biosciences disclosed to the U.S. SEC that it plans to pink-slip 30 percent of its staff.
The U.S. Securities and Exchange Commission filed insider trading charges against two former executives and the husband of a former staffer of Ariad Pharmaceuticals.
We’re living in volatile times. If I were to put a positive spin on that, I’d say that we’re living in times where a lot of accepted ways of doing things are being questioned. And those questions can be healthy. Take the FDA, for example. Pretty much every new president pays at least some lip service to the idea of speeding up drug approvals, cutting red tape, and helping the life sciences become more innovative. But President Trump apparently seriously considered appointing Jim O’Neill or Balaji Srinivasan as FDA Commissioner. Both O’Neill and Srinivasan are associates of Silicon Valley libertarian/iconoclast Peter Thiel, and have argued that drugs should be approved on the basis of safety alone, with the “market” deciding on whether they’re effective. (Healthcare is hardly a market in the normal sense of the term, hence the quotes.) O’Neill in particular would have done away with most clinical trials altogether.
Investors in drugmaker AstraZeneca have taken defensive positions in the options market ahead of eagerly awaited results of a major trial of a lung cancer treatment.
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DePuy Synthes Products Inc., part of the Johnson & Johnson Medical Devices Companies, announced today that it has acquired Innovative Surgical Solutions LLC, doing business as Sentio LLC.
Alder BioPharmaceuticals’ late-stage study data on its experimental treatment to prevent episodic migraine fell short of investors’ expectation.
The U.S. FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.
Merck & Co. Inc. said its experimental cholesterol drug met the main goal of reducing coronary heart diseases in a late-stage study, sending the company’s shares up 2.4 percent in premarket trading.