| Today's Big NewsApr 18, 2023 |
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An ideal home for reshoring. U.S. manufacturers gain greater control of and visibility into their supply chains, as well as access to a robust STEM talent pool, by setting up operations in Puerto Rico. 
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| By Kevin Dunleavy 2022 was all about a return to normalcy from the COVID-19 pandemic. While a few companies continued to reap huge profits from COVID products, others benefited from a return to business as usual operations. It was a tough year for the global economy, but biopharma showed its resilience with all but a few recording revenue gains. |
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By Nick Paul Taylor Merck & Co. has a new challenger for the chronic cough market: GSK. The British Big Pharma is set to pay $2 billion to buy Bellus Health, securing a late-phase rival to Merck’s stuttering gefapixant program and completing a remarkable, 16-year turnaround for the biotech. |
By Annalee Armstrong After circling around the crop of biotechs ripe for a takeover, Big Pharma companies have finally decided to strike. Merck & Co. made the first jab for Prometheus Biosciences on Sunday, then GSK struck Tuesday. |
By Conor Hale With about 100,000 employees worldwide, the process of notifying people whether or not they still have a job could take months, the company said in a statement to Fierce Medtech. |
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Tuesday, May 23, 2023 | 2pm ET / 11am PT Clinical trials are complex, time-consuming, and costly. But what if you could use simulation to guide your decisions and optimize your trial design? In this webinar, we'll discuss the power of simulation-guided trial design (SGTD) and explain its benefits to clinical development strategies. Register now to join us. 
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By Kevin Dunleavy Three weeks after reducing its staff by 17% and shelving three pipeline candidates, cash-strapped Gamida Cell has received its long-awaited lifeline. Monday, the company scored FDA approval for Omisirge, an allogenic cell therapy to reduce the risk of infection in blood cancer patients. |
By Gabrielle Masson As difficult market conditions continue, two European-based biotechs are slashing costs and seeking ways to stay afloat as the end of the road nears. |
By Fraiser Kansteiner A $6.9 billion charge tied to J&J’s talc defense spurred a net earnings loss of $68 million in 2023’s first quarter, the company reported Tuesday. J&J is currently defending itself against tens of thousands of lawsuits claiming its talc-based products cause cancer. |
By Annalee Armstrong The overhaul of Johnson & Johnson’s infectious disease work, which includes the end of its adult RSV vaccine program, has resulted in expenses of $130 million for the first quarter. |
By Conor Hale Canadian newcomer Adela has shown that its test for detecting the faint traces of cancer in the bloodstream could spot 12 different types of the disease, including many in their early stages when they have the best chances of being treated. |
By Nick Paul Taylor Apellis Pharmaceuticals is eyeing happy days for its new geographic atrophy (GA) therapy Syfovre. With the market to itself, for now, the biotech is working to raise awareness about the disease and its warning signs—and has brought Henry Winkler on board to help get the message out. |
By Andrea Park If Tandem Diabetes Care's Control-IQ artificial pancreas system predicts an especially high spike in a user’s blood sugar, the algorithm can send out a correction dose of insulin up to once an hour to prevent hyperglycemia. |
By James Waldron Almost exactly a year after Nektar Therapeutics jettisoned 70% of its staff, the biotech is now contracting again. This time, 60% of its San Francisco-based workforce are being laid off as part of a reorganization that will also see the C-suite rejigged and the company focus on immunology. |
By Andrea Park Though it be but little, it is fierce: An implant that’s the width of just a few strands of hair is designed to take on the outsized symptoms of chronic pain—and is now cleared by the FDA to do just that. |
By Helen Floersh A nearly-decade-long study sponsored by actor Michael J. Fox's foundation has resulted in an assay that could pave the way for early intervention in Parkinson's disease—and maybe even new drugs that can prevent the disease. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about biotech’s top money raisers in 2022. We also cover J&J's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines. |
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Wednesday, April 26, 2023 | 12pm ET / 9am PT Our speakers will explore how science-based organizations are producing more data than ever before, and why digital transformation strategies to leverage this data, like AI and machine learning, require the right infrastructure of connected, searchable, and harmonized data. Register now. |
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Research Read the results of a two-phase scale-up strategy used to help decrease risk and ensure consistency in complex dry powder media formulations produced within customers’ specifications and timelines. Sponsored by: Thermo Fisher Scientific |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
Whitepaper We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing? Sponsored By: CCC |
Whitepaper How advanced medicines commercial readiness differs and the resources needed to maximize potential. Sponsored by: Herspiegel Consulting |
Whitepaper This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
Whitepaper For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| May 1-3, 2023 | Jersey City, NJ |
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