| This week's sponsor is Premier Research. | | | Opportunity Knocks: Seizing the Promise of Orphan Drugs
Orphan drug developers enjoy more favorable regulatory conditions today than ever. Read our white paper for tips on maximizing this opportunity. Premier Research. It's what we do. Best. |
Today's Rundown FDA refuses to review Alkermes’ depression drug, demands additional clinical trials AstraZeneca, Compugen sign immuno-oncology deal Relief for MediciNova as NASH drug clears phase 2 trial [Sponsored] Personalized Medicine Requires Personalized Measurement Longtime Novartis executive takes the helm at Macrolide Pharma Abeona taps ex-Alexion CCO as new chief, eyeing commercial operations France puts healthcare at heart of $1.8B AI strategy Johnson & Johnson, Bayer drop Fox show advertising after host belittles Parkland student This is it: Brineura, Imfinzi square off in #FierceMadness final Featured Story | | | Monday, April 2, 2018 The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed. |
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| This week's sponsor is STEMCELL Technologies. | | | |
Top Stories Monday, April 2, 2018 AstraZeneca has struck an immuno-oncology deal with Compugen. The agreement gives the Big Pharma a source of bispecific and multispecific antibodies in return for $10 million upfront and up to $200 million in milestones. Monday, April 2, 2018 Shares in the company rocket after biotech says tipelukast cut triglyceride levels significantly in patients with nonalcoholic fatty liver disease. Monday, April 2, 2018 How we measure outcomes will evolve from applying one solution to finding an empirical basis for a highly customized application of all of them. Personalized medicine needs a more personalized approach to measurement. Read more. Monday, April 2, 2018 After serving a stint at Intarcia Pharma, Mahesh Karande has signed on as president and CEO at Macrolide Pharmaceuticals. Before making the move to biotech, Karande wore a number of hats at Novartis, including vice president and head of Novartis' breast and renal oncology unit in the U.S. Monday, April 2, 2018 Abeona is tapping industry veteran Carsten Thiel, Ph.D., for its new leader in the cell and gene therapy space, with an eye to the commercial future. Monday, April 2, 2018 French President Emmanuel Macron has committed to investing $1.8 billion in artificial intelligence over the next four years. The spending plan will target the healthcare sector and is accompanied by a commitment to open up French data. Monday, April 2, 2018 Johnson & Johnson and Bayer joined more than a dozen consumer brand advertisers last week in dropping out of Fox news show “The Ingraham Angle.” The brands—including Nestle, Trip Advisor, Office Depot and Wayfair—canceled media buys on the weekday show after host Laura Ingraham made fun of Marjorie Stoneman Douglas High School student David Hogg over several college rejections. Monday, April 2, 2018 The final showdown in the FierceMadness drug name tournament is set: BioMarin’s Brineura will face off against AstraZeneca’s Imfinzi in the best drug name championship for 2018. | 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: USDM Life Sciences What are the biggest trends in life sciences this year? 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: 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. 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 IRT Europe – Interactive Response Technologies in Clinical Trials April 10th-11th, 2018 | Brussels, Belgium 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
BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13 - 14, 2018 | West Windsor, NJ Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 