U.S. Senate Republican leaders postponed a vote on a healthcare overhaul after resistance from members of their own party, and President Donald Trump summoned Republican senators to the White House to urge them to break the impasse.
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 Announces Acquisition of Sentio to Enable Innovation in Minimally Invasive Spine Surgery
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.
As part of a strategic review, Cambridge, Mass.-based Dimension Therapeutics plans to cut 25 percent of its staff by the end of 2017.
Roche said a new Esbriet tablet formulation was approved in Europe for mild to moderate idiopathic pulmonary fibrosis (IPF), a fatal condition that causes irreversible, progressive scarring of the lungs.
Novartis’ generics unit Sandoz said the European Commission approved Erelzi – the company’s biosimilar to Amgen’s Enbrel – to treat inflammatory diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis.
Mobile Technology in Heart Failure Clinical Trials: Connecting with Patients Where They Live and Work
Management of heart failure can be overwhelming for patients and their caregivers. To help address this, a new study has been launched assessing patient-facing mobile health technologies to improve adherence to medication and to self-care routines such as physical activity and following fluid and sodium restrictions. Known as the Care Optimization through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT HF), this quality improvement study is enrolling high-risk, hospitalized patients with acute heart failure and reduced ejection fraction.
U.S. Senate Republicans are expected to issue a revised version of their healthcare bill, according to a Republican Senate aide, as the chamber’s leaders scurried to win support and get the bill passed by a July 4 holiday recess.
The first ever EU antitrust probe into excessive drug pricing is taking the European pharmaceuticals industry into uncharted territory, unnerving some companies and lawyers worried about the reach of market intervention.
Medtronic Plc said it signed an agreement with health insurer Aetna Inc. under which payment for its insulin pump systems will be tied to how well diabetes patients fare after switching from multiple daily insulin injections.
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Portola Pharmaceuticals announced that the U.S. Food and Drug Administration approved the potential blockbuster drug Bevyxxa (betrixaban).