GSK strikes $3.3B Affinivax buyout to MAP out challenge to Pfizer's blockbuster pneumococcal vaccine RhoVac's prostate cancer vaccine phase 2 failure forces biotech to cut costs After oncology wind-down, TG's pivot to MS faces setback as FDA pushes approval decision After Axsome’s migraine med rejection, phase 3 data keeps hope alive for depression drug Bouncing back from late-phase fail, Minoryx pockets €51M to guide rare disease drug to market The top 20 drugs by worldwide sales in 2021 Novel cancer vaccines by Dana-Farber and Stanford look beyond T cells to better fight tumors Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma Fat could hold key to stem cell treatments for Parkinson's disease MIT, Brigham push oral, oil-based delivery gel toward clinic to expand pediatric toolkit Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod Moderna CEO pledges to donate most of his $4B fortune: Bloomberg 'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines Featured Story | By Nick Paul Taylor GSK is betting big to reenergize its fight for a share of the pneumococcal vaccine market, agreeing to pay $2.1 billion upfront to acquire Affinivax for a challenger to Pfizer’s blockbuster Prevnar franchise. read more |
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Top Stories By James Waldron RhoVac’s attempt to develop the first antigen vaccine for prostate cancer has ended in a phase 2 trial failure and forced the Swedish biotech to initiate cost-cutting measures. RV001, also known as onilcamotide, failed to significantly prevent or delay the progression of prostrate cancer. read more By James Waldron After disappointing trial results prompted TG Therapeutics to put its oncology work on the back burner, its pivot to multiple sclerosis has hit a setback. Its lead candidate, ublituximab, now faces a three-month delay for an FDA decision. read more By Gabrielle Masson Positive phase 3 trial results have maintained momentum for Axsome Therapeutics' convoluted depression drug application, less than a month after the FDA rejected the company's migraine treatment. read more By Nick Paul Taylor Minoryx has persuaded investors to overlook the failure of its phase 2/3 clinical trial, enabling it to reel in 51 million euros ($55 million) to support attempts to bring the rare disease drug to market in Europe and the U.S. read more By Kevin Dunleavy While the global sales rankings of Big Pharma's superstar drugs naturally feature the biggest names in the business, several new meds popped up on the list this year because of the coronavirus. Pfizer's COVID-19 vaccine displaced AbbVie's Humira at the top slot, which the immunology drug had held for nearly a decade. read more By Angus Liu Most cancer immunotherapies primarily rely on T cells to neutralize tumors. But in two new studies, scientists at Dana-Farber Cancer Institute and Stanford University have described novel immuno-oncology approaches, showing that mobilizing B cells and NK cells may achieve better antitumor effects. read more By Angus Liu Novartis isn’t giving up on its CAR-T therapy Kymriah despite a recent high-profile trial flop. The drug has just scored an FDA nod that allows it to compete with Gilead Sciences’ rival, Yescarta, in the most common indolent lymphoma. read more By Max Bayer,James Waldron Could fat hold the key to finally treating Parkinson's? Researchers at Harvard and Massachusetts General Hospital has suggested fatty tissue could produce a source of homegrown stem cells needed to create long-sought-after regenerative treatments for a range of central nervous system disorders. read more By Nick Paul Taylor A potential new delivery format for children and other people with swallowing difficulties is closing in on the clinic. Researchers at Brigham and Women’s Hospital and the Massachusetts Institute of Technology have developed the tech to address the need for cheap, temperature-stable formats for the delivery of both water-soluble and insoluble molecules. read more By Andrea Park A new artificial intelligence algorithm may be the key to slashing the drawn-out period between when pulmonary hypertension symptoms first arise and a definitive diagnosis is reached. read more By Eric Sagonowsky Moderna's efforts to develop, manufacture and market its massively successful COVID-19 vaccine have made CEO Stéphane Bancel a billionaire. Eventually, the helmsman plans to give away most of his fortune, he told Bloomberg. read more By Teresa Carey This week on "The Top Line," we discuss the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. We also talk about Dexcom's potential megamerger with Insulet, the upcoming ASCO meeting and the week's other big headlines. Plus, we have a special announcement about the prestigious Fierce 15 competition. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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