Humanigen's COVID-19 prospect flunks
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Today's Rundown

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Biogen gains prominent ally in bid for Supreme Court to review Tecfidera patent case

After the U.S. Court of Appeals for the Federal Circuit scuttled Biogen’s bid for a rehearing on its Tecfidera patent case in March, the big biotech was left with few options but to appeal to the Supreme Court. Now, as the high court considers whether to take up the case, Biogen has snared the support of a prominent science and legal advocacy group.

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Top Stories

Labcorp launches blood test for a wide range of neurodegenerative diseases and brain injuries

The clinical services giant is rolling out its first blood test to help identify and confirm the signs of multiple neurodegenerative diseases and brain injury, including ALS, dementia and Parkinson’s disease, as well as concussions.

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Humanigen's COVID-19 prospect flunks NIH trial, sinking stock and raising doubts about its future

Humanigen’s COVID-19 program has ended in defeat. After failing to win emergency authorization on the strength of its phase 3 trial, the New Jersey-based biotech has seen its prospect flunk an NIH study, sinking the stock and raising doubts about its future.

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Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management

The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics.

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Citing inequity, hospitals campaign to overturn LA's new $25 minimum wage for healthcare workers

A hospital industry-backed campaign argues that a new pay hike's exclusion of public facilities and other provider organizations will lead to an exodus of workers. Proponents of the measure say it will rejuvenate a battered workforce and that the industry is simply looking to protect pandemic profits.

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Novo Nordisk's new weight loss drug Wegovy needs a 'significant discount,' ICER says

ICER's review suggests GLP-1 meds like Novo Nordisk’s Wegovy and Saxenda represent “a step forward in the magnitude of weight loss achieved.” Still, caveats abound, and, compared to earlier weight loss offerings from Vivus and Currax Pharmaceuticals, the price tags on Novo’s drugs leave something to be desired, the group said.

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Eko secures heart murmur AI clearance for digital stethoscopes

Eko’s smart stethoscopes have been used by U.S. physicians to automatically detect signs of atrial fibrillation and heart murmurs since its first FDA clearance arrived in 2020. A new regulatory OK unveiled this week aims to make the devices even smarter.

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FDA chief says US has 'got to do better' at generating medical product data

FDA chief Robert Califf, M.D., says the U.S. has "got to do better" at generating medical product evidence to better inform regulators and clinicians.

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CMS threatens to ax UNC Health's Medicare funding after flagship hospital cited for serious noncompliance

UNC Medical Center fell short on four different conditions of participation relating to infection control, quality assessment, hospital governance and patient rights during a mid-June compliance survey, the regulator wrote.

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Alnylam ratchets up Pfizer, Moderna infringement fight on same day it scored new patent

Alnylam is adding more fuel to the fire in its infringement lawsuits against Pfizer and Moderna, claiming both companies violated a patent that was just granted to the company on Tuesday. The fight is over mRNA technology Pfizer and Moderna used in developing their respective COVID-19 vaccines. Alnylam originally filed lawsuits against each vaccine maker in March.

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Atara's stock plummets 55% following inconclusive phase 2 MS analysis

Atara Biotherapeutics’ stock plunged following an interim analysis that deemed phase 2 data for its progressive multiple sclerosis candidate to be inconclusive.

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Twist Bioscience intertwines with DNAnexus to bring analytics tools to sequencing data

A new partnership between Twist Bioscience and DNAnexus seeks to weave together two crucial pieces of the genomic sequencing puzzle.

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Amgen touts early combo data with Sanofi-backed KRAS partner in a bid to lift Lumakras' prospects

Amgen is touting early phase 1 combo data testing Lumakras with a Sanofi-backed KRAS partner as part of a bid to boost the commercial prospects of the lung cancer therapy. Data suggested the combo was more effective in patients that had yet to be treated with a KRAS inhibitor versus those that had.

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Blue Cross NC taps Headway to expand mental health access for underserved members and children

In its latest effort to address critical mental health needs in the state, Blue Cross and Blue Shield of North Carolina is tapping a fast-growing mental health startup to help expand its network of behavioral health providers.

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Resources

Case Study: Roche cuts feasibility process by 36%

Explore how Cognizant SIP helped Roche streamline its global feasibility process.

eBook: 12 Pitfalls in Europe

For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed.

eBook: Download the Cell Therapy Handbook

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: Jump Start for Biotech: New Lab Startup Guide

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

Article: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?