Skip to main content

Helixgate

Skip to main content

Helixgate

Uncategorized

FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking

Published

on

Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Uncategorized

BioNTech picks Sobi CEO Oelkers to lead as founders plot new mRNA biotech

Published

on

BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take over as CEO in early 2027.

Continue Reading

Uncategorized

STAT+: Sandoz to pay $478.5 million to settle price-fixing allegations in long-running battle with states

Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.

Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.

The agreement marks the latest settlement in a long-running battle between numerous states and many of the largest players in the generic drug industry, which were accused of fixing prices for their medicines. Previously, Glenmark Pharmaceuticals, Lannett, Bausch, Apotex, and Heritage Pharmaceuticals collectively settled lawsuits for nearly $98 million.

Continue to STAT+ to read the full story…

Read More

Published

on

Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.

Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.

The agreement marks the latest settlement in a long-running battle between numerous states and many of the largest players in the generic drug industry, which were accused of fixing prices for their medicines. Previously, Glenmark Pharmaceuticals, Lannett, Bausch, Apotex, and Heritage Pharmaceuticals collectively settled lawsuits for nearly $98 million.

Continue to STAT+ to read the full story…

Read More

Continue Reading

Uncategorized

Novo’s late-stage IL-6 stumble shakes inflammation space

Published

on

Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.

Continue Reading
Advertisement

Trending