| “The Trends Behind Successful Cancer Treatments” Powerful new cancer treatments such as CAR T-cell therapy, anti-cancer vaccines and immunotherapies are showing unprecedented response rates and bringing patients new hope. The uptick of successes are generating optimism among scientists and companies looking to get their drug to market. Is your approach setting you up for success? Unlock More Potential with TD2. | Today's Rundown Apellis climbs as its drug beats Alexion's Soliris in phase 3 As Rhythm Pharmaceuticals preps for first approval, CEO hits the exit AstraZeneca taps MiNA to treat metabolic diseases by activating genes Magenta CSO Michael Cooke jumps to IFM Therapeutics Galecto to merge with onetime Celgene partner PharmAkea Arcutis eyes $100M IPO to bankroll dermatology programs Deep Genomics nabs $40M round, doubles down on AI and Wilson disease work A new strategy for boosting PD-1 blockers in melanoma Merck's Keytruda misses key mark in small cell lung cancer trial, dashing big expansion hopes Featured Story | Tuesday, January 7, 2020 Apellis Pharmaceuticals’ pegcetacoplan has beaten Alexion’s blockbuster Soliris in a head-to-head phase 3 trial. The result suggests Apellis can challenge Alexion’s dominance in paroxysmal nocturnal hemoglobinuria, but the biotech needs to talk to the FDA before deciding on the next steps. |
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| Top Stories Tuesday, January 7, 2020 Fierce 15 winner Rhythm Pharmaceuticals is on the cusp of gaining its first approval in 2020, but it will be ushering in this potential milestone without its chief. Tuesday, January 7, 2020 AstraZeneca has teamed up with MiNA Therapeutics to test small activating RNA (saRNA) molecules in metabolic diseases. The agreement gives AstraZeneca the option to negotiate a license for saRNA molecules after getting a look at preclinical data on the candidates. Tuesday, January 7, 2020 IFM Therapeutics snagged a new chief scientific officer. Michael Cooke, Ph.D., joins from stem cell biotech Magenta Therapeutics, where he held the same position. He arrives a month after IFM promoted R&D chief Martin Seidel, Ph.D. to CEO and raised $55.5 million to bankroll an incubator and up to three new subsidiaries. Tuesday, January 7, 2020 Galecto is set to merge with PharmAkea. The deal will see Denmark’s Galecto incorporate in the U.S. and add a clinical-phase treatment for idiopathic pulmonary fibrosis (IPF) to its pipeline. Tuesday, January 7, 2020 Dermatology player Arcutis Biotherapeutics set up shop in 2016 but stayed under the radar until early last year. Now, with a trio of clinical-stage programs and more than $160 million in the bank, the company is looking to hit the street with a $100 million IPO. Tuesday, January 7, 2020 Canadian drug development company Deep Genomics has got off a $40 million series B round as it looks to double down on its rare genetic disease and artificial intelligence work. Tuesday, January 7, 2020 In melanoma, at least half of patients don’t respond to PD-1 blockers like Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda. Sanford Burnham researchers are proposing a new way to sensitize melanoma to PD-1 blockade by inhibiting a protein called Siah2. In mouse models, the strategy restricted T regulatory cells, allowing killer T cells to attack the cancer. Tuesday, January 7, 2020 Merck & Co.’s Keytruda may be the star in non-small cell lung cancer, but a combo of it and chemo just failed to significantly outdo chemo alone at prolonging patients’ lives in small cell lung cancer, a market that one analyst dubbed "one of the largest metastatic market opportunities remaining" for the PD-1 drug. | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. | 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: ICON Clinical Research Ltd The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more. Sponsored by: snapIoT, Inc. Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials. Sponsored by: EVERSANA How are your launch strategies can convert “innovation” into value for patients? 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: 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 Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud. 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: 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. 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 BIO International Convention June 8-11, 2020 | San Diego, CA Middle East Healthcare Compliance Certificate Program March 23-26, 2020 |