1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven And Lilly

 
• By Mandy Jackson, Jessica Merrill, Emily Hayes, and Sue Sutter

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: Biogen may be looking for gene therapy partner, Lilly CEO says Loxo is just the start, GSK plays up its BCMA, Amgen vows to put money into deals, Biohaven readies oral CGRP inhibitor to compete, and Roche talks value-based payments. 

Classic view of historic traditional Cable Cars riding on famous California Street in morning light at sunrise with retro vintage style cross processing filter effect, San Francisco, California, USA - Image

Biogen Inc. has made a lot of early initiatives in gene therapy but nothing concrete has come out of the effort. The most notable setback has been a delay getting a gene therapy for spinal muscular atrophy (SMA) into the clinic, while rival Novartis AG has gotten its SMA gene therapy AVXS-101 all the way to the FDA. Novartis acquired its gene therapy with the $8.7bn acquisition of AveXis Inc. last April, a deal some Biogen investors wished at the time that the big biotech had done instead, since AVXS-101 will be a threat to Biogen's own Spinraza (nusinersin). (Also see "Biogen's SMA Ambitions Run Up Against A New Deep-Pocketed Rival" - Scrip, 9 April, 2018.)

Biogen had no update on the gene therapy program for investors at the J.P

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.