Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients

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  Deep Dive

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

  Pfizer looks likely to report initial results from its late-stage study early next month, a bit later than CEO Albert Bourla's predictions of late October.

  UPDATED: Oct. 29, 2020 at 11:26 a.m.

  Pharma

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  Regulatory-driven material control with SAP

  Learn about material segmentation, a unique approach for characteristics-based planning and execution.

  Pharma

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  Bristol Myers taps machine-learning biotech for help finding ALS drugs

  The companies hope Insitro's technology can lead to a deeper understanding of how ALS progresses and, in turn, help them discover better treatments.

  Deals

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  US to pay Lilly $375M for supply of COVID-19 drug

  Lilly has asked the FDA for emergency approval of the antibody-based treatment, but scaling up production will take time. 

  Pharma

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  Trump administration to require insurers cover coronavirus vaccines

  Late-stage vaccine results are expected soon from Pfizer and Moderna, putting pressure on the Trump administration to put in motion plans for what's likely to be a complex and challenging distribution process.

  Marketing

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  EQRx builds cancer drug pipeline as plans to challenge big pharma take shape

  The startup, which aims to develop lower-cost alternatives to branded medicines, has licensed two drugs from CStone Pharmaceuticals in a deal that could signal a coming price war in cancer immunotherapy.

  Marketing

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  Novartis, Molecular Partners partner to develop a scalable COVID-19 drug

  The two Swiss firms will develop protein drugs that are meant to have similar effects as coronavirus antibodies, but would be easier to mass produce.

  Manufacturing

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  Bayer to buy AskBio for $2B in bid to become a gene therapy player

  Founded by gene therapy pioneer Jude Samulski, AskBio boasts a pipeline of experimental gene therapies as well as its own manufacturing capabilities.

  UPDATED: Oct. 26, 2020 at 11:55 a.m.

  Deals

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  Exact Sciences, challenging Illumina, to buy cancer screening company Thrive

  The deal for Thrive comes weeks after Illumina agreed to pay $8 billion for liquid biopsy developer Grail, and reflects expectations of a larger role for cancer tests.

  UPDATED: Oct. 27, 2020 at 12:12 p.m.

  Deals

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  Sanofi, GSK pledge 200M doses to an international coronavirus vaccine alliance

  The two drugmakers are aiding an international effort to ensure low- and middle-income countries can get access to successful coronavirus shots. 

  Pharma

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  Lilly antibody drug doesn't help hospitalized COVID-19 patients in NIH study

  The results could raise doubts about the ability of synthetic antibody drugs to help patients already very sick with COVID-19.

  UPDATED: Oct. 27, 2020 at 11:45 a.m.

  Pharma

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  Mirati cancer drug results spark hopes of outperforming Amgen's

  The biotech's KRAS-blocking pill trails Amgen's sotorasib in development, but early data suggest it might match the bar set by Amgen.

  Biotech

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  5 takeaways from the FDA's closely watched coronavirus vaccine meeting

  Experts convened by the regulators debated how much data would warrant an approval, while pressing government officials on their distribution plans.

  FDA

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  At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials

  An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.

  FDA

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  AstraZeneca, J&J cleared to restart major coronavirus vaccine studies

  The U.S. trial of AstraZeneca's shot has been paused over safety concerns since early September, while J&J's was halted in mid-October. 

  UPDATED: Oct. 24, 2020 at 2:59 p.m.

  FDA

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  Ultragenyx expands into Duchenne gene therapy with Solid Bio deal

  The rare disease drug developer is betting it can create a better DMD treatment by combining Solid's research with its manufacturing and gene delivery technology.

  Gene Therapy

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  Facing vaccine doubts, US grapples with building confidence in coronavirus shots

  The CDC, for example, doesn't support vaccine mandates for healthcare workers or essential employees, an agency official told experts convened by the FDA last week.

  Marketing

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  Gilead's Veklury becomes first FDA-approved drug for COVID-19

  The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.

  UPDATED: Oct. 23, 2020 at 10:05 a.m.

  FDA

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  Roche joins the COVID-19 antiviral drug race, betting $350M on a startup

  A deal with Atea Pharmaceuticals gives Roche rights to an oral antiviral for coronavirus disease that would compete with emerging therapies from Pfizer and Merck.

  Manufacturing

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  Moderna enrolls final volunteers into key coronavirus vaccine study

  Recruiting 30,000 participants for the late-stage trial took Moderna just three months, even after the company slowed enrollment to boost participation of people of color. 

  Clinical Trials

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  Sarepta, continuing its gene therapy push, helps launch a startup

  The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million. 

  Biotech

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  Lilly hires consultant to help fix issues at COVID-19 drug manufacturing plant

  The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.  

  Manufacturing

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  Biogen is running out of safety nets

  Third quarter earnings underscore just how vital it is that Biogen secure approval of its experimental Alzheimer's drug, given the challenges elsewhere in its business.

  Biotech

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  Ex-Medivation team nets $500M to take their new cancer drugmaker to Wall Street

  Nuvation Bio, a large oncology startup run by former Medivation executives, is capitalizing on a boom in mergers with so-called special purpose acquisition company, or SPACs.

  Biotech

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  An Indiana startup aims to join the US drug manufacturing push

  Incog BioPharma Services has become the latest entity to sprout up as part of a concerted U.S. effort to onshore production of pharmaceuticals.

  Manufacturing

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  Purdue, reaching $8B settlement with US, pleads guilty to charges over opioid sales

  Under a deal reached with the Department of Justice, Purdue faces fines and a forfeiture worth more than $5 billion — the largest penalties ever for a drug company.

  Marketing

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