BioSpace News Archive

Drug Development

Master AML Trial Gives Patients New Lease on Life

Also called an umbrella or basket trial, the master trial allows for a more targeted approach to cancer treatment, faster patient enrollment and the flexibility to pivot.

December 20, 2023
·
4 min read
·
Maddie Bender
Drug Development

Argenx Nixes Efgartigimod’s Development in Pemphigus After Phase III Flop

Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.

December 20, 2023
·
2 min read
·
Tristan Manalac
Policy

Biogen Secures Tecfidera Exclusivity in EU Until Early 2025

The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.

December 20, 2023
·
2 min read
·
Tristan Manalac
FDA

Chiesi’s $1.25B Amryt Buy Pays Off with FDA Approval of Filsuvez

Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.

December 20, 2023
·
2 min read
·
Tristan Manalac
Drug Development

UniQure Touts Phase I/II Results for Huntington’s Disease Candidate, Wall Street Balks

Gene therapy company uniQure announced Tuesday “ongoing evidence” of a clinical benefit for its Huntington’s disease treatment. However, investors were not impressed as the stock dropped nearly 20%.

December 20, 2023
·
2 min read
·
Tyler Patchen
Deals

2024 Predictions for Biotech M&As

Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year, experts tell BioSpace.

December 20, 2023
·
4 min read
·
Karen Fischer
Policy

German Court Nullifies CureVac’s Patent Case Against BioNTech

A court in Germany on Tuesday nullified one of CureVac’s intellectual property rights in a patent case against BioNTech. However, court proceedings involving seven other patent rights will continue.

December 20, 2023
·
2 min read
·
Tyler Patchen
Drug Development

Merck Secures FDA Decision Date for Pneumococcal Vaccine, Race Heats Up with Pfizer

The competition between Merck’s pneumococcal vaccine and Pfizer’s Prevnar series of vaccines is intensifying after the regulator granted priority review to the former’s BLA for V116.

December 20, 2023
·
2 min read
·
Tyler Patchen
Drug Development

A World War II-Era Company Reshapes Itself as a Biotech Powerhouse

Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.

December 20, 2023
·
6 min read
·
Tyler Patchen
Drug Development

Every move you make: Biopharma industry under heavy scrutiny

On this episode of the Weekly: Biden administration puts pressure on the biopharma industry; renewed interest in psychedelics after MindMed announces LSD-based candidate meets primary endpoint; bluebird changes its tune.

December 20, 2023
·
1 min read
·
Lori Ellis