This week's sponsor is Patheon, part of Thermo Fisher Scientific. | | Quickly proving efficacy in First-in-Human clinical trials is a make-or-break milestone for small biopharms whose hopes hinge upon one or two molecules. Read how CDMOs are helping these cash-strapped companies get to clinic faster. | Today's Rundown ASCO: Mixed reaction to BMS, Nektar’s high-stakes ‘confusing’ I-O trial ASCO: Roche punts taselisib after weak data, severe side effects Translate files for $115M IPO to trial ex-Shire mRNA cystic fibrosis treatment [Sponsored] It Might Be a Bumpy Ride: Why Life Sciences Companies Should Consider Embracing the New Wave of Change After Aravive’s CEO exits, Fierce 15 winner reveals near-death Versartis merger deal ASCO: Adaptimmune builds case for GlaxoSmithKline-partnered T-cell therapy ASCO: Loxo sees boosted response rates with LOXO-292 ASCO: Bluebird and Celgene’s CAR-T nears 1 year of PFS in multiple myeloma ASCO: X4 Pharma's I-O combo posts 23% ORR in kidney cancer ASCO: Zymeworks posts early responses to bispecific antibody in HER2+ cancers Enyo Pharma raises $47M to bring hepatitis B, NASH drug to phase 2 Featured Story | Sunday, June 3, 2018 Nektar Therapeutics’ much-anticipated data from a study pairing its immuno-oncology prospect NKTR-214 with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo seem to have resulted in a lot of head-scratching. |
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| This week's sponsor is SNBL. | | Does Your CNS Program Need a Boost? The Shortest Distance is a Straight Line. Nose-to-Brain Brain delivery can be a hurdle for CNS drugs targeting unmet medical needs. Our technology can deliver your drug directly to the brain. Find out how! | Top Stories Monday, June 4, 2018 Roche’s experimental PI3K hopeful taselisib is to be ditched after coming up short at this year’s ASCO cancer conference. Monday, June 4, 2018 Translate Bio has filed to raise $115 million from public investors. The IPO will tee Translate up to trial an mRNA candidate designed to enable all cystic fibrosis patients to produce fully functional CTFR proteins. Monday, June 4, 2018 Changes in technology and geopolitics, coupled with U.S. tax reform and new financial accounting standards, are creating disruption in accounting and financial reporting for life sciences companies. Monday, June 4, 2018 Just under a month ago, we reported that former Astellas executive Stephen Eck, M.D., Ph.D., jumped ship from his Aravive CEO role to Immatics US as its new CMO; now we have more color on why that unexpected move may have happened. Monday, June 4, 2018 Adaptimmune has presented updated clinical data on its T-cell therapies. The latest readouts link the GlaxoSmithKline-partnered NY-ESO SPEAR T-cells to a 50% partial response rate in heavily pretreated cancer patients and position Adaptimmune to dial up the dosing of two wholly owned assets. Saturday, June 2, 2018 Loxo made a big splash with its larotrectinib data at last year’s ASCO Annual Meeting, and in 2018 it’s hoping to make waves with its earlier-stage RET inhibitor LOXO-292. Friday, June 1, 2018 Bluebird Bio and Celgene have built upon their already impressive early-stage clinical responses in advanced multiple myeloma, now confirming that their bb2121 CAR-T therapy extended progression-free survival to just shy of one year in a new set of phase 1 data. Friday, June 1, 2018 X4 Pharma said the 23% objective response rate was "encouraging" as it was observed in third-line patients, a group whose response rate to single agents hovers around 10%. Friday, June 1, 2018 Zymeworks unveiled new phase 1 clinical data from its lead bispecific antibody, ZW25, demonstrating an overall response rate of just 36%, the result of 12 partial responses, as a single-agent treatment in a variety of heavily pretreated, HER2-expressing cancers. Monday, June 4, 2018 Enyo Pharma raised €40 million ($46.9 million) to fund the launch of its first two phase 2 clinical trials of its lead candidate, EYP001, in chronic hepatitis B and nonalcoholic steatohepatitis, by the end of the year. This week's sponsor is LabConnect. | | SciOps Provides Solutions for Lost Samples, Missed Timelines and Scientific Personnel Needs Managing outsourced studies can be challenging. Read how our team’s functional and strategic resourcing services allow you to focus on other core competencies. | Enrollment Showcase | Sponsored by: Bioinformatics at UTHealth SBMI UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics. |
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| Resources Presented By: Covance A solid RBM plan will not only help you comply with the ICH guidelines, but will help you mitigate risks which could ultimately delay your trials and increase costs. Download today! Presented by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. 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: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Innovation, Collaboration and Entrepreneurship in Drug Discovery June 28, 2018 | Cambridge, UK 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 CBI’s 14th Annual Medical Device Compliance Congress (MDCC) June 14-15, 2018 | Chicago, IL Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |