BioSpace News Archive

First Round of Humira Biosimilar Launches in US

AbbVie’s Humira will now face competition from new biosimilars, including Boehringer Ingelheim’s Cyltezo, Celltrion’s Yuflyma, Organon and Samsung’s Hadlima, and Sandoz’s Hyrimoz.

July 3, 2023
·
2 min read
·
Tristan Manalac
Policy

Gilead and Teva Prevail in Potentially $3.6B ‘Pay-to-Delay’ Lawsuit

The verdict, rendered by a California jury on Friday, found that the companies did not engage in an anticompetitive conspiracy to delay generic versions of HIV PreEP medicines.

July 3, 2023
·
2 min read
·
Heather McKenzie
Drug Development

J&J to Take Protagonist-Licensed Oral Psoriasis Drug to Phase III

After initial Phase II data for the oral IL-23 receptor antagonist licensed from Protagonist Therapeutics spooked investors, Janssen provided a fuller readout and advanced the candidate.

July 3, 2023
·
4 min read
·
Alejandra Manjarrez and Heather McKenzie
Drug Development

AstraZeneca’s Phase III Lung Cancer Data Underwhelms Investors

Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.

July 3, 2023
·
2 min read
·
Kate Goodwin
Policy

Biopharma Lawsuit Tracker 2023: Pfizer Settles Trade Secrets Case

Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.

July 3, 2023
·
12 min read
·
Lisa Munger
Business

Mostafa Kamal to succeed Ken Paulus as Prime Therapeutics’ President and Chief Executive Officer

Prime Therapeutics LLC announced that Mostafa Kamal will succeed Ken Paulus as President and CEO of Prime Therapeutics.

July 3, 2023
·
3 min read
FDA

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the launch of its authorized generic for Xyrem®1 (Sodium Oxybate) oral solution CIII in the United States.

July 3, 2023
·
8 min read
Biotech Beach

Acutus Medical Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - July 03, 2023

Acutus Medical, Inc. granted equity awards on July 1, 2023 that were approved by the Compensation Committee of its Board of Directors under Company’s 2022 Inducement Equity Incentive Plan, as a material inducement to employment to 3 individuals hired by Acutus in June 2023.

July 3, 2023
·
2 min read
Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress

Nicox SA announced that additional data on NCX 470 have been presented at the 10th World Glaucoma Congress (WGC) being held from June 28 to July 1, 2023 in Rome, Italy.

July 3, 2023
·
6 min read
Drug Development

Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients with Advanced Non Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial

Topline results from the TROPION-Lung01 phase 3 trial showed datopotamab deruxtecan demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior therapy.

July 3, 2023
·
8 min read