| Flexible Biomanufacturing Solutions Your molecule has the power to change lives and shape the future. Take advantage of our science-driven, risk-based approach to every step of the biologic development and manufacturing process. Unleash the potential of your discovery. Download the Brochure. | Today's Rundown Minerva Neurosciences shares crushed under depression flop, development halted Biogen bets $45M on Ionis' phase 1 Alzheimer's med Epizyme's sarcoma drug sails through FDA panel with unanimous vote Forma Therapeutics nets $100M to push sickle cell treatment Rheos pens Roche collab for next-gen immunometabolism research Turnstone teams up with Takeda in $900M deal to work on biotech's oncolytic drug How Alexion's FcRn inhibitor attacks autoimmune diseases from 2 sides FTC puts the brakes on Illumina's $1.2B offer for DNA sequencing rival PacBio Seattle Genetics, Astellas snag quick FDA approval for bladder cancer fighter Padcev Featured Story | Thursday, December 19, 2019 First, Sage Therapeutics was hit this month with a big failure in depression. Now, Minerva Neurosciences (the namesake, incidentally, of the Roman goddess Minerva) is following suit. |
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| Top Stories Thursday, December 19, 2019 Looks like Biogen is going all in on Alzheimer’s disease—the Big Biotech is picking up a tau-targeting treatment from Ionis for $45 million upfront. Currently in phase 1, the antisense treatment, IONIS-MAPTRx, is designed to cut down on the production of tau proteins in the central nervous system. Wednesday, December 18, 2019 Despite questions raised by FDA staff about its safety and efficacy—not to mention the small trial size—Epizyme's epithelioid sarcoma drug walked away from the meeting with an “unusually uniform” 11-0 vote. Thursday, December 19, 2019 Genentech veteran Frank Lee landed at Forma Therapeutics as it aimed to transition from an early discovery and development company to one that was knocking on the door of approvals and commercialization. Now, Forma is reeling in $100 million to bankroll that growth. Thursday, December 19, 2019 Rheos Medicines has sealed a near $800 million biobucks deal with Swiss major Roche to seek out and develop new meds for autoimmune and inflammatory diseases. Thursday, December 19, 2019 Fierce 15 winner Turnstone Biologics has penned a near $1 billion biobucks deal with biotech’s best friend, Takeda. Wednesday, December 18, 2019 Working with investigators at Brigham and Women’s Hospital, scientists from Syntimmune, now part of Alexion, have shown that its FcRn inhibitor takes a two-pronged approach to tackling autoimmune diseases, by lowering both IgG levels and IgG circulating immune complexes. Wednesday, December 18, 2019 The Federal Trade Commission has moved to block Illumina’s $1.2 billion takeover of its emerging rival, Pacific Biosciences, saying the DNA sequencing giant would substantially be harming competition. Wednesday, December 18, 2019 Historically, metastatic bladder cancer has been “a very bad prognosis,” in the words of Seattle Genetics CEO Clay Siegall. But his company and partner Astellas now have a shot at trying to change that. Wednesday, the FDA approved Padcev, a first-of-its kind antibody-drug conjugate. Resources Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 |