02:33 , Jul 21, 2018 |  BioCentury  |  Politics, Policy & Law

Getting serious

HHS Secretary Alex Azar isn’t waiting for the ink to dry on the department’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, or for his staff to digest tens of thousands of pages of...
23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
22:26 , Jul 20, 2018 |  BC Extra  |  Company News

Roche, other pharmas follow suit to halt price increases

Roche (SIX:ROG; OTCQX:RHHBY) is following the trend of suspending price increases in the U.S. for this year after President Donald Trump and HHS Secretary Alex Azar publicly demanded changes in drug pricing. Roche said in a...
22:22 , Jul 20, 2018 |  BC Extra  |  Company News

FDA approves Pfizer's Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The approval comes two days after FDA Commissioner...
17:44 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

FDA approves Xtandi for non-metastatic CRPC

FDA approved an sNDA for Xtandi enzalutamide from Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) to treat non-metastatic castration-resistant prostate cancer (CRPC). The oral androgen receptor antagonist is already approved to treat metastatic CRPC. Pfizer...
16:49 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

Pfizer begins Phase III lead-in study of hemophilia B candidate

Pfizer Inc. (NYSE:PFE) began an open-label Phase III lead-in study evaluating fidanacogene elaparvovec (formerly SPK-FIX, SPK-9001) as prophylaxis for hemophilia B in adults. Data from the study, which is slated to enroll about 110 patients, will...
16:42 , Jul 20, 2018 |  BC Week In Review  |  Company News

Novartis halts price increases, reports 2Q earnings

Novartis AG (NYSE:NVS; SIX:NOVN) announced on July 18 that it will suspend for the rest of the year price increases in the U.S. The pharma made the announcement in conjunction with the release of its 2Q18...
16:19 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

Pfizer's tanezumab meets in Phase III for OA pain

Pfizer Inc. (NYSE:PFE) and partner Eli Lilly and Co. (NYSE:LLY) said tanezumab met the three co-primary endpoints compared with placebo in the Phase III A4091056 trial to treat osteoarthritis pain. Pfizer said the data support...
22:04 , Jul 19, 2018 |  BC Innovations  |  Tools & Techniques

Immunotherapy Matchmaking

MD Anderson Cancer Center is using its access to patient samples to inject more rationality into decisions about which therapies should be paired with checkpoint inhibitors, and how to optimize the combos. The goal is...
22:01 , Jul 19, 2018 |  BC Extra  |  Company News

Merck to tie price increases to inflation

Merck & Co. Inc. (NYSE:MRK) followed Pfizer Inc. (NYSE:PFE) and Novartis AG (NYSE:NVS; SIX:NOVN) in publicly responding to President Donald Trump's demands for voluntary price reductions. Merck said it will not increase the average net...