The Latest

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    Deep Dive

    After a record run, fewer biotechs are going public. Here’s how they’re performing.

    A pair of stock offerings from Neumora and RayzeBio, which raised $250 million and $311 million respectively, could crack open the IPO window for the biotech sector this fall.

    Updated Sept. 11, 2023
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    Latest trial win further supports expanded use of Bristol Myers’ Opdivo in lung cancer

    The drug, which is already cleared as a neoadjuvant lung cancer treatment, could further compete with Merck’s Keytruda if it gains approval in the adjuvant setting for patients with the non-small cell form of the disease.

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    AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

    Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

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    selvanegra via Getty Images
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    Cell therapy developer closes funding round to support diabetes program

    More than $50 million in venture funding has now gone into Seraxis, which is among a series of biotechs trying to fundamentally alter diabetes treatment.

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    Novo Nordisk parent backs cell therapy manufacturing facility

    The Novo Nordisk Foundation’s planned manufacturing facility will help both private companies and academic researchers develop new cell therapies.

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    Adeline Kon/BioPharma Dive
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    Deep Dive

    Biotech M&A is picking back up. Here are the latest deals.

    The acquisition of antibiotics developer Paratek Pharmaceuticals, which closed Thursday, was part of a surge of springtime buyouts.

    Updated Sept. 21, 2023
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    Roche’s Genentech bets on radiopharmaceuticals in partnership with PeptiDream

    The new deal expands on a yearslong partnership between the two drug developers to advance targeted radioisotopes for certain cancers.

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    Taysha drops lead gene therapy following FDA feedback

    Additional studies proposed by the FDA would be too challenging, according to Taysha, which simultaneously announced that its partner Astellas has declined to pick up an option for the therapy, called TSHA-120.

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    Alvotech gets new FDA review for Humira biosimilar

    The regulator has twice rejected Alvotech’s copycat drug due to manufacturing issues with a plant in Europe.

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    PBMs, PhRMA trade blame over drug costs in House hearing

    Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

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    Histogen plans to wind down operations after failing to find a partner

    All but two employees will be gone by Sept. 30 as the company seeks shareholder approval for a dissolution plan.

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    Kinnate lays off 70% of staff, reorganizes pipeline

    The company is restructuring its workforce and discontinuing programs, including its monotherapy combination of its drug exarafenib with Pfizer’s Mektovi. 

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    FDA panel backs Alnylam drug despite doubts over benefit

    “There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

    Updated Sept. 14, 2023
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    UK biotech AlveoGene launches with plans for inhaled gene therapy

    The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.

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    CDC endorses new COVID boosters as focus turns to rollout

    This fall will now feature vaccination campaigns for COVID-19, influenza and respiratory syncytial virus.

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    Akili cuts 40% of workforce, plans shift to non-prescription model

    The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

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    2Seventy CEO Leschly to step down as company cuts staff, spending

    Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back spending.

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    Emerging biotech

    After IPO success, Acelyrin hits trial setback with inflammation drug

    Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

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    Actio, a precision medicine startup, launches with $55M and a mouse lab partnership

    The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

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    Emerging biotech

    With latest fundraise, Rome Therapeutics works to drug the ‘dark genome’

    Johnson & Johnson and Bristol Myers Squibb have joined a group of new investors backing Rosana Kapeller’s startup, which launched in 2020 after incubating with GV.

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    Bausch + Lomb seeks funding for eye drug acquisition from Novartis

    Fitch Ratings called the deal to buy the Xiidra treatment “strategically sound” even as the company’s plan for funding the deal would increase its leverage.

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    Ex-Sanofi executive Sibold joins Madrigal as new CEO

    Bill Sibold will replace Paul Friedman as head of the NASH drug developer as it attempts to win approval of what could be the first medicine for the liver disease. 

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    Emerging biotech

    New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs

    Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

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    Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

    The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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    Sarah Silbiger via Getty Images
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    FDA approves updated COVID boosters from Pfizer, Moderna

    Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect their reformulated shots will soon be available in the U.S.