| 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 ADCT says decision to pull HER2 drug doesn’t affect other candidates Daiichi DMD trial misses primary efficacy endpoint Novartis-bound AveXis posts early look at data from pivotal SMA gene therapy trial [Sponsored] Can the SEC step in to support small businesses if Congress stalls? Celldex to ax 20% of staff after midstage glembatumumab rout With $60M and a new CEO, Corvidia Therapeutics is all systems go Mackay’s Rallybio rare disease startup raises $37M in first funding round Novartis debuts FocalView app, a digital move into ophthalmic clinical trials Shire and Takeda come to terms with a $64B deal, the biggest pharma M&A in years What's your Aimovig rollout plan, Amgen? Growth-hungry investors want to know Featured Story | | | Wednesday, April 25, 2018 Swiss biotech ADC Therapeutics has abandoned a midpipeline candidate for HER2-positive cancers because of toxicity issues in a phase 1 trial in solid tumors. |
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| This week's sponsor is Deloitte. | | | |
Top Stories Wednesday, April 25, 2018 An early-phase trial of Daiichi Sankyo’s Duchenne muscular dystrophy (DMD) drug has failed to show clear evidence of efficacy. But, buoyed by safety data and evidence of exon-skipping activity, Daiichi is pushing ahead with further development of the antisense oligonucleotide. Wednesday, April 25, 2018 AveXis has posted an early look at data from a pivotal trial of its spinal muscular atrophy gene therapy. The neuromuscular scores of the first group of patients improved as expected over the early months of the study, raising hopes the Novartis-bound gene therapy will deliver positive data. Monday, April 23, 2018 Congress is debating whether to include small businesses in the Senate’s bank bill. But the SEC has an opportunity to take action on SOX 404(b) on its own. Tuesday, April 24, 2018 After terminating its lead program, Celldex Therapeutics is laying off 41 employees and choosing not to fill 18 open positions to cut costs and stay afloat. Wednesday, April 25, 2018 The new funding will advance Corvidia's lead clinical programs in chronic kidney disease and ramp up its preclinical work. Wednesday, April 25, 2018 Rallybio, a new, early-stage startup from Alexion Pharmaceuticals veterans Martin Mackay, Stephen Uden and Jeffrey Fryer, announced it raised $37 million in series A financing since it launched earlier this year. Wednesday, April 25, 2018 Pharma giant Novartis is taking a digital approach to clinical trials to track the progression of ophthalmic disease through its new FocalView app. Wednesday, April 25, 2018 We have a deal—at least a preliminary one. Late Tuesday, Shire said Takeda had finally landed on a buyout offer worth recommending to shareholders. Namely, £49 per share, about 44% of that in cash. Takeda shareholders weren't exactly thrilled, though. The Japanese drugmaker's shares dropped 7% Wednesday morning. Wednesday, April 25, 2018 Amgen’s migraine drug Aimovig isn’t even approved by the FDA yet, but questions about its insurance coverage overshadowed the company’s better-than-expected quarterly earnings. One reason why, perhaps? Pharmacy benefits manager Express Scripts is urging the company to rethink its expected $8,000 to $10,000 list price. | This week's sponsor is PharmaCord. | | | |
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 to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. 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: 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 Drug Development Immersion April 25-26, 2018 | New York City Biotech for the Non-Scientist May 2-3, 2018 | San Diego, CA Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, 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 Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 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! | 