Startup Clade Therapeutics Inc. has an ambitious goal: to create scalable, off-the-shelf stem cell-based medicines that can be as accessible to patients as antibody therapies are today. Backed by more than two decades of advances in the area of induced pluripotent stem cells, the Cambridge, Mass.-based firm drew $87 million in a series A financing led by Syncona Ltd., which co-founder and CEO Chad Cowan said should allow Clade to develop a first cellular therapy targeting cancer and move it into clinical testing.

CDC endorses Pfizer’s COVID-19 vaccine for children as White House preps nationwide rollout

A few hours following the CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc.-Biontech SE’s COVID-19 vaccine, the agency’s director, Rochelle Walensky, endorsed the recommendation. Paired with the FDA’s awarding of emergency use authorization of the vaccine for children, President Biden called it a “turning point in our battle against COVID-19” and added that his administration has secured enough vaccine supply for every child in America. The White House will hold a briefing later on Wednesday to further outline its plans as the vaccine becomes available to children.

Antios series B-1 adds $75M; would-be curative HBV backbone in phase IIb

Antios Therapeutics Inc. banked $75 million in a series B-1 financing to support the phase IIb effort underway to test the potential of lead candidate ATI-2173, described as an active site polymerase inhibitor nucleotide. The company hopes the compound will become the backbone of a once-daily, curative regimen for chronic hepatitis B virus infection. Epiq Capital Group co-led the investment with Gordonmd Global Investments. Antios’ series B round in April collected $96 million.

Lilly pulls EU filing for COVID antibody cocktail as authorities back rivals, US places $1.29B order

Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency. The EU in September had ordered 220,000 courses of the combination that was contingent on approval by the EMA.

Biopharma stocks boosted by pandemic, pressured by changing landscape

Although the Bioworld Biopharmaceutical Index (BBI) has recovered slightly within the last month, it is showing only a small gain since the start of the year. Up by 2.82%, it is somewhat in line with the Nasdaq Biotechnology Index gain of 4.8%, but significantly beneath the broader markets. The Dow Jones Industrial Average, for example, was up by 17% at the end of October. Management changes, portfolio pressures, clinical results and catalysts, as well as COVID-19 vaccine and therapeutic options, are all reasons biopharma stocks have fluctuated over the past month.

US drug pricing reforms back in the budget picture

It looks like direct Medicare drug price negotiations are back in the U.S. fiscal 2022 budget bill. Nearly a week after President Joe Biden dropped drug pricing reforms from his Build Back Better framework, congressional Democrats came together on a slightly scaled-back version of the controversial pricing provisions originally included in H.R. 3. Their proposal allows Medicare to negotiate the prices of up to 10 drugs in 2023, with those prices to take effect in 2025. The provisions also include annual spending caps for seniors and a penalty tax on price increases that exceed inflation.

Takeda exercises option to acquire UK’s Gammadelta to develop gamma delta T-cell therapy

Four years after an initial investment, Takeda Pharmaceutical Co. Ltd. exercised its option to acquire Gammadelta Therapeutics Ltd. to develop gamma delta T-cell therapies for solid tumors and hematologic malignancies. The option included a pre-negotiated up-front payment as well as potential development and regulatory milestones. The deal is expected to close in the first quarter of fiscal 2022. Takeda initially inked a $100 million equity, R&D funding and option-to-buy deal with Gammadelta in May 2017 after the startup was founded by venture capital group Abingworth in 2016.

Also in the news

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