| This week's sponsor is TD2. | | | 6 Signs You Need a New CRO for Your Preclinical Research
Are your preclinical studies where they deserve to be? If progress has stalled, maybe it's your CRO that's the problem...not you. Learn these six telltale signs it's time to switch. Fast-Track Your Research with TD2. |
Today's Rundown Hanmi calls time on troubled Tagrisso rival olmutinib Rigel falsely claims FDA approval in ‘website error’ Pfizer puts Bamboo’s muscular dystrophy gene therapy to the test Inventiva raises €36M to prep for phase 3 NASH trial Personalized vaccine could boost survival in late-stage ovarian cancer Holmes asks Theranos’ investors for cash as crunch looms EuroBiotech Report—Alexion’s $855M deal, Novartis sells drug, Novo’s sickle cell play, Enterprise and Promethera FiercePharmaAsia—Novartis’ kickback allegation, Samsung’s Humira biosim, Takeda’s Shire plan Chutes & Ladders—Ex-Ariad, Roche executives lead Roivant and Arbutus’ RNA joint venture Featured Story | | | Friday, April 13, 2018 Hanmi Pharmaceutical’s long and turbulent development of lung cancer drug olmutinib finally came to an end this week after the company abandoned the program. |
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| This week's sponsor is Deloitte. | | | |
Top Stories Friday, April 13, 2018 Rigel Pharmaceuticals has falsely claimed its chronic immune thrombocytopenia drug Tavalisse is FDA approved. The erroneous claim was up on Rigel’s website for more than 24 hours before a spike in the company’s stock raised awareness of the mistake. Friday, April 13, 2018 Pfizer has dosed the first patient in a trial of a Duchenne muscular dystrophy gene therapy acquired as part of its $700 million takeover of Bamboo Therapeutics in 2016. Friday, April 13, 2018 Inventiva has raised €36 million ($44 million) to gear up for a phase 3 trial of pan-PPAR activator lanifibranor in NASH. The financing will see Inventiva through a period in which it will drop data from a phase 2b NASH trial and a two-year carcinogenicity study. Friday, April 13, 2018 An international team found that a personalized ovarian cancer vaccine was most effective when administered alongside a pair of approved cancer meds. Friday, April 13, 2018 Theranos CEO Elizabeth Holmes has warned investors that the company risks defaulting on a loan following delays to its Zika virus assay, BuzzFeed News reports. The embattled executive wants investors to save Theranos from the prospect of running dangerously low on cash by the end of July. Thursday, April 12, 2018 In this week's EuroBiotech Report, Alexion pens $855 million Wilson buyout, Novartis sells failed cancer drug, Novo inks sickle cell deal and more. Friday, April 13, 2018 Novartis is facing allegations in China that it laundered doctor kickbacks through fake academic events, Samsung Bioepis has pushed back the U.S. launch of its Humira biosimilar by years, Takeda is seeking billions of dollars in loans to finance its Shire bid, and more. Friday, April 13, 2018 Fomer Ariad CEO Paris Panayiotopoulos leads Roivant and Arbutus' new RNA joint venture, Purdue Pharma names a new R&D head, Immunomedics poaches AstraZeneca immuno-oncology expert as R&D chief, plus more hirings, firings and retirings throughout the industry. | This week's sponsor is Sensors Expo. | | | |
Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: WCG Small biopharma companies are conducting almost 50% of the clinical trials in the US today, yet they face unique challenges that large pharma do not. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on small biopharma teams and timelines. Sponsored by: Halo Pharma Why does confidence matter when outsourcing Fixed-Dose Combination products? Download Halo Pharma’s white paper on the importance of product design, technology, and analyticals tools for FDC. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon, part of Thermo Fisher Scientific Patheon's Stephen Lam reviews the formidable challenges and decisions facing biopharma manufacturing executives. Watch as he shares unique insights and perspectives and demonstrates how there is really no one-size-fits-all solution in biomanufacturing, regardless of company size. Presented by: Charles River How do you get your oncology therapy to the clinic? The path isn’t always clear. In vitro, ex vivo, xenograft, syngeneic, PDX, humanized models, immunology considerations, safety regulations – which do you need to plan for and when? Sponsored by: DocuSign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Presented by: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Presented by: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented by: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented by: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented by: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored by: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA Field Service USA 2018 April 17-April 20, 2018 | JW Marriott Palm Desert Resort & Spa, CA
Drug Development Immersion April 25-26, 2018 | New York City Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | West Windsor, NJ BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 