This week's sponsor is CMIC Group. | | Partner with Japan’s Largest CRO for your global drug development CMIC is the largest CRO in Japan, with extended services in drug development and GMP manufacturing, site management, regulatory consulting and contract sales. We have the full end to end solution to help you enter Japan market and fulfill your drug development and manufacturing needs in US, Japan and Asia. To learn more, click here. | Today's Rundown For 2 biotech employees, coming out as trans means asking others to transition with you Latest CRISPR therapy concern weighs on share prices Celgene, Takeda invest in intratumoral microdosing firm Presage Ascentage third round garners $150M for apoptosis cancer drugs In a first, FDA approves SIGA’s smallpox treatment Spero nets $54M biodefense R&D contract for its lead antibiotic Here comes another 'vant'—this one focused on China Nimbus veterans launch allosteric drugmaker HotSpot Therapeutics with $45M series A Clinigen buys Novartis’ cancer drug Proleukin, eyes new combos Moderna opens $110M manufacturing site for its mRNA program Featured Story | Tuesday, July 17, 2018 Jennifer Petter, Arrakis chief scientific officer, and Clark Musto, a clinical research manager at Johnson & Johnson's Janssen unit, both transitioned this year and shared what it means to be trans in the biotech industry. |
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| Top Stories Tuesday, July 17, 2018 Yet another study warning of potential toxicity with the CRISPR/Cas9 gene-editing technique has hit the headlines, giving investors in CRISPR companies the jitters. Tuesday, July 17, 2018 Celgene and Takeda have invested in Presage Biosciences. The series D sets up Presage to expand use of an intratumoral microdosing platform designed to quickly evaluate how experimental solid tumor therapies perform in humans. Tuesday, July 17, 2018 Chinese biotech Ascentage has raised another $150 million for its pipeline of drugs designed to induce programmed cell death in cancer. Tuesday, July 17, 2018 The FDA has approved the first treatment for smallpox. SIGA Technologies tested the drug in 359 healthy volunteers to demonstrate safety and relied on animal data to show efficacy. Monday, July 16, 2018 Antibiotic developer and former Fierce 15 winner Spero Therapeutics has received $15.7 million in federal research funding for its oral carbapenem-class candidate, SPR994, which will be the subject of an interagency collaboration to evaluate the drug’s effectiveness against biological threats, including anthrax, plague and melioidosis. Tuesday, July 17, 2018 Roivant is debuting another "vant," dubbed Sinovant, whose mission is to "bring innovative medicines" to—you guessed it—China. Tuesday, July 17, 2018 HotSpot Therapeutics, a new drug discovery venture exploring protein regulation, has kicked off with $45 million in series A financing. Tuesday, July 17, 2018 U.K.-based CRO Clinigen has bought the rights to Novartis’ Proleukin (aldesleukin) outside the U.S. as it looks to boost sales with new dosing and tie-ups with other drugs. Tuesday, July 17, 2018 Moderna, which is pushing a pipeline of mRNA candidates into phase 2 trials, now has a manufacturing plant ready to advance its program. This week's sponsor is ExL Events. | | | Resources Sponsored by: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Sponsored by: Patheon, part of Thermo Fisher Scientific Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy. Drug Approval, Manufacturing Quality & Regulation 2018 | Online The Life Science Women's Conference August 8-9, 2018 | Austin, Texas Join 200+ Service and Support Leaders at Field Service Amelia Island this August August 27-29, 2018 | Amelia Island, FL RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program Sao Paulo, Brazil | Sep 24-27, 2018 Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA 10th International Leaders in Biobanking Congress October 14-16, 2018 | Cleveland, OH BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation |