22:18 , May 20, 2019 |  BioCentury  |  Product Development

Making Orphan drug prices work for society

The Orphan Drug Act worked too well. It didn’t just stimulate development of therapies for rare diseases, it reoriented huge swaths of the industry to the pursuit, all attracted by the high prices and product...
19:14 , May 20, 2019 |  BC Extra  |  Clinical News

May 20 Clinical Quick Takes: Keytruda misses in TNBC; plus Medicines Co., Acadia, Takeda, Ocular

Keytruda fails in previously treated TNBC  Monotherapy with PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) missed the primary endpoint of improving overall survival vs. physician’s choice of single agent chemotherapy in the...
21:02 , May 14, 2019 |  BC Extra  |  Company News

May 14 Company Quick Takes: F-star rejiggers Merck KGaA deal; plus Roche/Spark, AbbVie/Boehringer, Ipsen

F-star to keep lead bispecific in new deal with Merck KGaA   F-star Biotechnology Ltd. (Cambridge, U.K.) reconfigured its 2017 bispecific antibody deal with Merck KGaA (Xetra:MRK) and will now retain rights to lead candidate...
18:21 , May 10, 2019 |  BC Extra  |  Politics & Policy

Final interchangeability guidance allows non-U.S.-licensed comparators

FDA has released its final guidance on the interchangeability of biosimilars with one notable change from the draft version: sponsors may now use data from non-U.S.-licensed comparator products to demonstrate interchangeability. The agency said sponsors...
00:02 , May 1, 2019 |  BC Extra  |  Company News

April 30 Company Quick Takes: Merck, G1, Pfizer, Amgen and more

Merck sales rise in China Merck & Co. Inc. (NYSE:MRK) said product sales in China were $725 million for 1Q19, up 67% on an ex-exchange basis from 1Q18 and driven by products in its vaccines...
00:17 , Apr 24, 2019 |  BC Extra  |  Company News

AbbVie successor to Humira in psoriasis gains FDA approval

With Humira set to face increasing biosimilar competition internationally this year, AbbVie notched its first U.S. approval for a successor to the blockbuster, Skyrizi risankizumab-rzaa, late Tuesday. FDA approved the IL-23 inhibitor to treat plaque...
23:55 , Mar 28, 2019 |  BC Extra  |  Clinical News

Filgotinib hits more RA endpoints

Gilead and Galapagos took a step closer to submitting regulatory applications for filgotinib to treat rheumatoid arthritis after the partners reported positive data from the two remaining Phase III trials of the oral Janus kinase-1...
15:47 , Mar 28, 2019 |  BioCentury  |  Product Development

Contracting practices limiting U.S. biosimilars uptake

The U.S. biosimilars market lags Europe’s and won’t catch up until physicians understand and become comfortable with the concept of similarity, Sheila Frame, who heads up Sandoz’s North American biosimilars business, told BioCentury. To create...
00:27 , Mar 16, 2019 |  BioCentury  |  Politics, Policy & Law

Spreading the costs and pain in Part D

The Trump administration’s proposed changes to Medicare Part D would shift costs from the federal government to patients, manufacturers and insurers, all of which are sure to lobby against it and derail it in Congress....
22:28 , Feb 26, 2019 |  BC Extra  |  Politics & Policy

Pharma CEOs present united front - except on biosimilars

Seven pharma leaders expressed strong support for eliminating rebates to PBMs and insurance companies, shifting from volume- to value-based reimbursement, and reducing out-of-pocket costs for drugs in testimony Tuesday to the Senate Finance Committee. The...