BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

CHMP backs Ebola vaccine, targeted cancer therapies  EMA’s CHMP recommended approval of a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Friday. The agency also backed two targeted cancer therapies:...
BC Extra | Oct 23, 2019
Company News

Oct. 22 Company Quick Takes: Zealand acquires Encycle; plus Novartis, Vitalis, Roche-Spark

Zealand expands peptide platform with Encycle acquisition  Zealand Pharma A/S (CSE:ZEAL; NASDAQ:ZEAL) said it will expand its peptide therapeutics platform through the acquisition of Encycle Therapeutics Inc. In return for all its outstanding shares, access...
BC Extra | May 15, 2019
Company News

Takeda veterans, Frazier launch Phathom with $90M to develop GI drug vonoprazan

Marking the partners' second company launch with a Takeda-discovered asset, Frazier Healthcare Partners and the Japanese pharma launched Phathom with rights to gastrointestinal drug vonoprazan. The start-up, which will focus on developing treatments for acid-related...
BC Innovations | Mar 29, 2019
Targets & Mechanisms

AACR moves in a myeloid direction

Myeloid cells are showing up everywhere at this year’s AACR conference, suggesting the research community is rapidly expanding the ways it can harness the cell types to improve cancer immunotherapy responses. One of those ways...
BC Week In Review | Mar 1, 2019
Clinical News

Brilinta reduces CV events in patients without prior heart attack, stroke

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Brilinta ticagrelor met the primary endpoint of reducing major adverse cardiovascular events (MACE) in the Phase III THEMIS trial in patients with coronary artery disease and Type II diabetes with...
BC Extra | Feb 25, 2019
Clinical News

Brilinta reduces CV events in patients without prior heart attack, stroke

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Brilinta ticagrelor met the primary endpoint of reducing major adverse cardiovascular events (MACE) in the Phase III THEMIS trial in patients with coronary artery disease and Type II diabetes with...
BioCentury | Nov 15, 2018
Politics, Policy & Law

Requiring Drug Prices in TV Ads Violates First Amendment

Drug companies, which have learned to live with advertisements calling out a litany of possible side effects for their drugs, may want to take a couple of aspirin. The recent announcement by CMS that it...
BC Innovations | Oct 4, 2018
Tools & Techniques

Lilly: academic about manufacturing

As Eli Lilly and Co. moves toward continuous manufacturing, the pharma is deepening ties with two academic centers to meet an array of engineering challenges. Through partnerships with Carnegie Mellon University, and the U.K.’s Imperial...
BioCentury | Oct 20, 2017
Regulation

Realities of real-world evidence

After countless conferences, white papers and speeches, stakeholders across the healthcare ecosystem are finally coming together to figure out how to extend the use of real-world evidence beyond pharmacovigilance and into drug development. The payoffs...
BC Week In Review | Sep 1, 2017
Clinical News

Xarelto lowers CV risk, ups major bleeds in Phase III for artery disease

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) reported full data from the Phase III COMPASS trial showing that twice-daily 2.5 mg oral Xarelto rivaroxaban (BAY 59-7939) plus once-daily 100 mg...
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