| This week's sponsor is Ajinomoto Bio-Pharma Services. | | | |
Today's Rundown Sarepta dips on controversial Duchenne hospitalization report Autolus delays multiple CAR-T clinical programs U.K. plans post-Brexit easing of rules on migrant scientists Melinta CEO Johnson exits amid ‘changing circumstances’ Faulty manufacturing trips up Nektar's Bristol-partnered cancer drug in crucial trial Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting EuroBiotech Report—Bayer deal, GSK, Takeda-Heptares, Transgene fail and U.K. AI plan FiercePharmaAsia—Daewoong, Evolus’ Botox rival; Surprise FDA visits?; Daiichi’s cancer nod Chutes & Ladders—Amneal’s Bisaro, handpicked CEO out as generics business falters Featured Story | | | Thursday, August 8, 2019 Sarepta’s stock plunged 12% Thursday afternoon on the news that a patient in a study testing its gene therapy for Duchenne muscular dystrophy had been hospitalized for a serious illness—in February. |
|
|
Top Stories Friday, August 9, 2019 A manufacturing delay is stymying progress of a clutch of Autolus’ CAR-T programs. Autolus revealed the setbacks alongside news that it is dumping the first-generation version of AUTO2 in the face of tough competition in the BCMA space. Friday, August 9, 2019 The U.K. is set to open its doors to top scientists in a bid to retain and strengthen its leading position in the field after Brexit. Through a series of reforms, U.K. Prime Minister Boris Johnson aims to create a fast-track immigration route that facilitates the flow of talent from around the world. Friday, August 9, 2019 John Johnson, Melinta’s fourth CEO in as many years, is stepping down, along with Kevin Ferro, the chairman of the board. Johnson "voluntarily" resigned “due to changes in the Company’s circumstances and in order to pursue other opportunities," Melinta said. Friday, August 9, 2019 A manufacturing mix-up can hit just as hard as a straight-up efficacy failure, and Nektar has learned that the hard way. CEO Howard Robin admitted Thursday that a couple of bad lots eroded NKTR-214's efficacy numbers in a key trial, and investors dealt some serious punishment. Thursday, August 8, 2019 Everything has gone according to plan for Amarin’s fish-oil pill Vascepa, with scripts booming and a fast-track review underway for a label update. Only one thing could put a damper on the drug’s rosy outlook: the FDA taking a closer look at its cardiovascular benefits. Thursday, August 8, 2019 In this week's EuroBiotech Report, Bayer pens cell therapy buyout, GSK offloads Ebola vaccines and Takeda forms Heptares pact. Friday, August 9, 2019 Allergan was ordered to turn over Botox manufacturing information to rivals Daewoong and Evolus. A U.S. senator urged the FDA to conduct surprise inspections of drug production sites abroad. Daiichi Sankyo racked it up its first cancer nod since 2011. And more. Friday, August 9, 2019 Amneal's Paul Bisaro and its handpicked CEO Rob Stewart are out as its generics business falters, Teva CFO Michael McClellan is stepping down for "personal reasons" and Loxo CEO Josh Bilenker is taking over Lilly oncology on an interim basis. Resources Sponsored by: Patheon, by Thermo Fisher Scientific Patheon, part of Thermo Fisher Scientific, offers advanced API manufacturing technologies such as continuous processing and continuous analytics to deliver high-quality products with well-defined features to meet your timelines and volume requirements. Sponsored by: ICON Understanding the challenges for formulary decision makers and manufacturers. Sponsored by: Veeva This white paper details how leveraging new reporting capabilities, live UAT feedback sessions, and an agile design approach to study builds will save them time and money. Sponsored by: BBK Worldwide The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process. Sponsored by: Cambrex The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry. Sponsored by: Reprints Desk, Inc. Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery. Sponsored by: XiltriX North America Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Latin America Healthcare Compliance Certificate Program September 23-26, 2019 4th FierceBiotech Drug Development Forum October 28-29, 2019 | Boston, MA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register NOW and start Pre-Boot Camp Preparation! |
