| The pace of IPOs may have slowed compared to 2018, but healthcare companies still made up the lion’s share with 43% of the total. And though no one was able to eclipse Moderna’s $604 million record, five biotech companies walked away with billion dollar-plus valuations—along with some of the best returns to boot. Our report on 2019’s top 10 follows below, along with our top stories from the week—plus our coronavirus update, tracking J&J’s "skunkworks" program, the WHO’s assessment of Gilead’s antiviral, and the latest Trump administration response. | |
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Featured Story | | | Monday, February 24, 2020 Novartis has touted early success for its new eye drug Beovu, but an alert tying the drug to potential vision loss might cause docs to balk when it comes to prescribing the medicine. The American Society of Retina Specialists issued a note Sunday night to members about 14 cases of retinal vasculitis for Beovu patients, 11 of which were occlusive retinal vasculitis that can lead to vision loss. |
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| | [Webinar] Managing the Risks of Implementing E6R2 Wednesday, March 25 | 1pm ET / 10am PT Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common misconceptions, and review lessons Rho has learned through implementation of RBQM. Click here to register! |
Top Stories Of The Week Tuesday, February 25, 2020 Moderna shares shot up a massive 18% after-hours last night on the fairly standard news that it was about to start a drug trial. The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Monday, February 24, 2020 Analysts and investors were less than amazed when Eli Lilly revealed cardiovascular outcomes data for its GLP-1 diabetes med Trulicity in late 2018. It wasn't that the study didn't hit its mark, they argued, but that the results weren't impressive enough to move the needle in a competitive field. Friday, February 21, 2020 BioMarin’s hemophilia A drug has been set an Aug. 21 PDUFA date as the California biotech looks to gain a speedy approval for the first gene therapy for the bleeding disease. Wednesday, February 12, 2020 President Donald Trump has selected Vice President Mike Pence to lead the U.S. coronavirus response. Meanwhile, U.S. authorities reported the first COVID-19 case from an unknown origin in California, suggesting the novel coronavirus is already spreading in America. South Korea reported more than 500 new cases in a day, and more. Tuesday, February 25, 2020 Co-Diagnostics received European approval for its in vitro diagnostic test for the novel coronavirus. The Salt Lake City-based developer said its Logix Smart test is now available to be exported from Utah to countries requiring the CE Mark. Monday, February 24, 2020 New CEO Paul Hudson has pledged to squeeze €2 billion out of Sanofi’s annual costs in a couple of years through a mix of methods that leans heavily on clamping down on its manufacturing budgets. It has now announced a plan that it says will not only do that but add to its top line. Tuesday, February 25, 2020 Roche’s Genentech is paying $30 million (€28 million) upfront to work with Bicycle Therapeutics on the development of immuno-oncology therapies. Bicycle will apply its discovery platform to multiple targets, putting itself in a position to pull in up to $1.7 billion in milestones as the assets progress. Wednesday, February 26, 2020 Amarin scored an FDA win with blockbuster potential last year when its fish oil-derivative Vascepa received a heart-helping nod on top of statins. Now, with Amarin's fleshed out sales force nearly in place and prescriptions soaring, the drugmaker is ready to take Vascepa to the next level. Monday, February 24, 2020 University of Toronto researchers used a live-cell-based screening system to identify drugs that can enter cells and target EGFR mutations in lung cancer. In so doing, they discovered that Astellas’ Xospata and Novartis’ Rydapt, both approved to treat leukemia, may be useful in treating lung cancer patients who have developed resistance to EGFR inhibitors. Resources Sponsored by: Reprints Desk/Research Solutions 3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: The Kinetix Group Read about the innovative ways payers are making smart moves in the healthcare game. Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Clinical Ink Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? 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. | 