J&J, beginning final test, shares first data on coronavirus vaccine

The Latest

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  Deep Dive

  The coronavirus vaccine frontrunners are advancing quickly. Here's where they stand.

  With J&J's Phase 3 start, the drugmaker joins Moderna, Pfizer, AstraZeneca and several Chinese groups already in late-stage testing.

  UPDATED: Sept. 23, 2020 at 9:58 a.m.

  Pharma

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  Novavax starts large-scale coronavirus vaccine trial in UK, as cases surge

  The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.

  Biotech

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  FDA sets back Novartis plans to expand use of SMA gene therapy

  The agency has asked the company to run a new study of the Zolgensma formulation that it aims to bring to older patients with spinal muscular atrophy.

  Pharma

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  Drugmakers push forward on large-scale production of coronavirus vaccines

  HHS Secretary Alex Azar said six vaccine developers involved with Operation Warp Speed had begun commercial manufacturing of their experimental shots. 

  Manufacturing

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  J&J begins largest Phase 3 study of a coronavirus vaccine

  The trial, which launched Wednesday in the U.S., South Africa and several South American countries, will enroll as many as 60,000 participants.

  Pharma

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  Blueprint's bet on itself pays off with rare disease drug data

  Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

  Clinical Trials

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  Regeneron forges ahead in lung cancer, but will need more to unseat Merck

  The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

  Clinical Trials

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  FDA decision on Bristol Myers cell therapy could come down to the wire

  An FDA decision on Bristol Myers' myeloma treatment ide-cel could come four days before a key deadline related to the pharma's buyout of Celgene. 

  Pharma

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  Merck matches Roche in search for next cancer immunotherapy

  The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

  Clinical Trials

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  Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

  Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

  Biotech

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  With Eli Lilly data, another drug emerges to stop breast cancers from returning

  The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

  Pharma

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  Roche buys Inflazome as pharma interest in targeting inflammation grows

  The wide-ranging role of an inflammatory protein known as NLRP3 has made it a hot drug target — particularly for Roche, which has now bought two startups developing drugs to block it.

  Deals

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  Illumina buys spinout Grail, betting $8B on the future of cancer screening

  The acquisition, announced shortly before a planned IPO by Grail, establishes sequencing giant Illumina as a major player in the chase to use blood tests to catch cancers early. Wall Street, however, isn't sold on the deal.

  Deals

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  What to watch as the first late-stage coronavirus vaccine trials near potential readouts

  Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.

  UPDATED: Sept. 17, 2020 at 5:35 p.m.

  Clinical Trials

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  Seattle Genetics stays step ahead of rivals with bladder cancer data

  Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

  FDA

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  Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials

  Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.

  UPDATED: Sept. 19, 2020 at 3:33 p.m.

  Biotech

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  In unexpected finding, Roche claims arthritis drug may have role in treating COVID-19

  Previous study findings from Roche and others had indicated the Swiss drugmaker's Actemra, and other drugs like it, weren't helping patients hospitalized with coronavirus disease. 

  Clinical Trials

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  Moderna and Pfizer, having shown speed with coronavirus vaccines, see opportunity in seasonal flu

  Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.

  Biotech

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  BioNTech to buy Novartis manufacturing plant to bolster vaccine supply

  The site, set to be one of the largest mRNA manufacturing plants in Europe, will help BioNTech and partner Pfizer make 750 million more doses of their coronavirus shot per year.

  Manufacturing

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  Arrowhead shares soar on liver disease data from four patients

  Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

  Pharma

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  Lilly offers first evidence that its antibody drug may help treat COVID-19

  The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear. 

  Pharma

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  Takeda adds to cell therapy push with new manufacturing site

  The Japanese drugmaker has made cell therapy a focus, advancing three experimental cancer treatments into clinical testing with plans for two more.

  Manufacturing

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  Pfizer says coronavirus vaccine study still on track for October readout

  Unusually, the drugmaker also shared blinded safety results from its ongoing Phase 3 trial, showing participants' side effects were generally mild to moderate.

  Clinical Trials

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  Trump releases long-awaited drug price order, but effects are likely far off

  The White House disclosed details of an order to cut Medicare prices to international rates. But the proposed plan will be difficult to carry out and could take months to enact.

  Drug Pricing

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  Lilly says its arthritis drug helps speed COVID-19 recovery

  The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.

  Clinical Trials

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