TG's pivot hits a snag with FDA delay
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GSK strikes $3.3B Affinivax buyout to MAP out challenge to Pfizer's blockbuster pneumococcal vaccine

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.

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Top Stories

RhoVac's prostate cancer vaccine phase 2 failure forces biotech to cut costs

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.

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After oncology wind-down, TG's pivot to MS faces setback as FDA pushes approval decision

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.

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After Axsome’s migraine med rejection, phase 3 data keeps hope alive for depression drug

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.

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Bouncing back from late-phase fail, Minoryx pockets €51M to guide rare disease drug to market

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.

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The top 20 drugs by worldwide sales in 2021

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.

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Novel cancer vaccines by Dana-Farber and Stanford look beyond T cells to better fight tumors

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.

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Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma

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.

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Fat could hold key to stem cell treatments for Parkinson's disease

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.

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MIT, Brigham push oral, oil-based delivery gel toward clinic to expand pediatric toolkit

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.

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Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod

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.

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Moderna CEO pledges to donate most of his $4B fortune: Bloomberg

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.

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'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines

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.

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Resources

Executive Summary: PBPK Modelling for Optimizing Controlled Release Dosage Form Development

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.

Whitepaper: Gain Operational Speed and Velocity by Sharing Quality Incident Data

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.

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

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.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

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?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

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