Amgen, partnering with Seattle's Adaptive, begins coronavirus drug search

The Latest

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  Tracking biopharma's response to the new coronavirus

  The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.

  UPDATED: March 26, 2020 at noon

  Pharma

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  Novartis gives up on planned $1B generic drug sale to Aurobindo

  The companies called off the deal, which was supposed to close last quarter, after failing to secure regulatory sign-off from the FTC.

  Pharma

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  Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug

  Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen. 

  Pharma

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  Ultragenyx's gene therapy technology finds another interested party

  Daiichi Sankyo has agreed to pay $225 million to access a manufacturing platform that Ultragenyx acquired through its buy of Dimension Therapeutics.​

  Deals

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  A small NASH drugmaker finds positive data, but coronavirus makes for a 'tricky' path forward

  Results from a mid-stage study showed Akero Therapeutics' experimental drug could reduce liver fat in NASH patients, sending shares higher. 

  Biotech

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  Amarin shares slump as surprising court defeat puts Vascepa at risk

  In what one analyst called a "serious blow," a federal court ruled patents held by Amarin on its heart drug Vascepa were obvious and therefore invalid. 

  Marketing

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  With latest FDA submission, Bristol Myers keeps pace with Celgene milestones

  Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year. 

  Pharma

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  FDA clears emergency use of malaria pills to treat COVID-19

  The unusual authorization, granted by the agency over the weekend, allows the federal government to distribute millions of doses of the drug to states.

  FDA

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  J&J picks top coronavirus vaccine candidate; human tests to start in September

  Together with BARDA, the pharma has agreed to spend $1 billion co-funding vaccine research, development and testing.

  Manufacturing

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  For CAR-T, coronavirus brings uneven impact to studies, treatment

  Cancer cell therapy, approved only for the very sick, depends on a complex and precisely timed series of steps, all of which could be disrupted by COVID-19.

  Biotech

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  Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA

  Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.

  Marketing

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  Merck's search for growth outside Keytruda may not end in heart disease

  A study of vericiguat, which Merck is developing with Bayer, found the drug kept patients with declining heart function out of the hospital, but couldn't delay death.

  Pharma

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  Sanofi adds mRNA to coronavirus vaccine push

  A deal with Translate Bio to develop an mRNA-based vaccine adds the newer technology to the French pharma’s pandemic response.

  Pharma

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  Despite another delay, Intercept says its NASH drug remains on track

  The coronavirus outbreak, though, adds more uncertainty to what will be a closely watched regulatory review of Intercept's therapy.

  Biotech

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  Bluebird says gene therapy application delayed again, citing disagreement with FDA

  Discussions between Bluebird and the FDA are hung up on a release assay, data from which would be included in the company's application. 

  Biotech

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  Q&A

  Galapagos CEO talks next steps as coronavirus stalls the biotech's top drug

  The Belgian drugmaker announced this week that a series of Phase 2 and Phase 3 studies for filgotinib, an immune system regulator, had paused enrollment because of safety concerns related to COVID-19.

  Biotech

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  In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug

  After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.

  Pharma

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  AstraZeneca turns again to UK's Silence in renewed RNAi push

  AstraZeneca and Silence Therapeutics, which first partnered in 2007, will team up to develop RNA interference drug candidates for diseases of the liver, heart, kidney and lung.

  UPDATED: March 25, 2020 at 2:35 p.m.

  Pharma

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  China halts import of Bristol Myers cancer drug after inspection at US plant

  Chinese drugmaker Beigene, which sells Bristol Myers' Abraxane in China, said it's bracing for a disruption in supply of the chemotherapy. 

  Manufacturing

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  Coronavirus forces ASCO, cancer research's top meeting, to move online

  State governments, including ASCO's host state of Illinois, are calling for residents to stay home, making the prospect of holding a meeting that draws thousands untenable.

  Marketing

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  Novavax's positive flu data bring a stock bump and a spotlight on coronavirus vaccine

  A large study found Nanoflu to be non-inferior to Sanofi's Fluzone. Safety results, meanwhile, will add to a database that Novavax said it will use to support its COVID-19 program.

  Clinical Trials

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  Gilead, flooded with requests, suspends access to experimental coronavirus drug

  The biotech plans to transition to an expanded access program for remdesivir, which is being tested as a treatment for COVID-19 in five late-stage studies.

  Biotech

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  Lilly, Galapagos halt trials as coronavirus deepens impact on drug research

  The moves likely herald similar announcements by other large drugmakers as medical centers focus resources on treating patients with COVID-19.

  UPDATED: March 23, 2020 at 4:45 p.m.

  Pharma

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  Leukemia drug from Roche, AbbVie extends survival, study finds

  Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.

  Pharma

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  Drugmakers boost production of malaria pill touted by Trump as coronavirus treatment

  Chloroquine, a decades-old generic therapy, has drawn attention as a potential therapy for COVID-19, although the evidence supporting its promise is thin. 

  UPDATED: March 20, 2020 at 1:02 p.m.

  Manufacturing

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