UPDATED: Sanofi and Regeneron pick up a blockbuster cardio approval–with a catch

Damian Garde Sanofi and Regeneron won an expected FDA approval for the first of a new class of cholesterol drugs expected to alter the landscape in cardiology, but regulators stopped ...

AbbVie falls short on Q2 sales–but don’t blame biosimilars, CEO says

Carly Helfand Huge sales leaps for AbbVie's Humira have been powering revenue forecast beats for the company in recent quarters. But this time, international sales of ...

Novartis wins an early approval for a new skin cancer drug

Damian Garde Novartis won accelerated approval for a promising oncology drug, gearing up to launch a new treatment for an advanced form of the most common type of skin cancer. FierceBiotech ...

Cancer docs try to rally public behind plan to fight drug prices

Eric Palmer Cancer doctors at the famed Mayo Clinic have been up in arms about escalating prices of cancer drugs. Now they have recruited a bunch of colleagues and are trying to rile ...

UnitedHealth uses newfound scale to negotiate pay-for-performance deals

Carly Helfand Newly bulked-up UnitedHealth now boasts the U.S.' third largest pharmacy benefits business–and it's using its scale to push for refunds when meds don't ...

Neos pulls off a $72M IPO to push its ADHD drugs forward

Damian Garde Texas biotech Neos Therapeutics cleared $ 72 million in an IPO, raising cash to develop some reformulated takes on existing drugs for ADHD. FierceBiotech News

New obesity meds ‘pretty safe,’ but some side effects bear watching: AdverseEvents

Emily Wasserman An analysis by AdverseEvents shows the new generation of obesity meds are holding their own, safety-wise. Still, postmarketing data flag some serious cardiovascular ...

Cara Therapeutics scores another positive PhII for lead opioid

John Carroll FierceBiotech News

‘Cures’ bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

Damian Garde The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers ...

Amgen’s Neupogen won’t face Novartis biosim till September: court

Carly Helfand Novartis' Sandoz may have the first FDA-approved biosimilar in Zarxio, but it doesn't have permission to launch–and it won't be getting ...

Bristol-Myers makes a ‘breakthrough’ on next-gen HIV therapy

John Carroll Bristol-Myers Squibb has nabbed a breakthrough therapeutic designation for a next-gen HIV therapy aimed at offering an option for patients who become resistant to the therapies ...

Bristol-Myers’ next-gen HIV med gets FDA ‘breakthrough’ designation

Tracy Staton Bristol-Myers Squibb nabbed a "breakthrough" tag from the FDA for its next-gen HIV therapy aimed at patients who become resistant to the drugs now in use. FiercePharma ...
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