Merck antiviral misses pharmacist prescribing boost
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Today's Rundown

Featured Story

Biden to sign executive order formalizing reproductive care, privacy protections

Measures outlined in the Friday executive order generally fall in line with the administration's recent promises, which may not be enough for Democrats calling upon the White House to flex its emergency powers.

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Top Stories

Ex-Theranos President Balwani found guilty on all 12 fraud charges

Another chapter in the saga of disgraced blood testing company Theranos has drawn to a close after a California jury on Thursday delivered its verdict in the criminal fraud trial of Ramesh “Sunny” Balwani, the startup’s former president and chief operating officer.

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FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio

After authorizing Pfizer’s COVID-19 oral antiviral Paxlovid to be prescribed by pharmacists, the FDA said it will not extend the same privilege to Merck and Ridgeback’s antiviral pill Lagevrio. The regulator cited Lagevrio’s side effect profile as reason to leave the decision in the hands of physicians.

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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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Schrödinger eyes 'hundreds' of programs over a decade amid clinical-stage evolution

Led by former top Merck scientist Karen Akinsanya, Schrödinger is expanding its horizons, developing wholly-owned, clinical-stage assets for the first time. But even as phase 1 nears, the company is realistic about its commercial-stage ambitions.

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SEC charges ex-Mazor exec with insider trading over $1.6B Medtronic buyout

The SEC filed charges against a former Mazor Robotics executive and two associates, alleging that they made more than $500,000 in profits through an insider trading scheme related to Mazor's 2018 acquisition by Medtronic.

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More than 600 providers impacted by ransomware attack on payment vendor

A payment vendor was hit with a ransomware attack back in February that may have exposed patient data from more than 600 healthcare providers and organizations. Also this week, federal officials issued a warning that hackers sponsored by North Korea's government have been using the Maui ransomware to target healthcare and public health services providers since last May.

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AstraZeneca escapes one Seroquel pay-for-delay claim but loses bid to scrap another

Apparently, a $107 million deal value isn't large enough to be considered anticompetitive when viewed in the context of delaying generics to a blockbuster brand. A Delaware federal judge reached that conclusion in throwing out an antitrust claim targeting a pay-for-delay deal involving AstraZeneca's antipsychotic Seroquel XR.

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Provention snags $60M in private placement as future of diabetes therapy hangs in the balance

Provention Bio may be waiting a bit longer for the FDA's decision on its diabetes prevention drug teplizumab, but at least the biotech has $60 million cash in the meantime to work through launch preparations.

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Horizon's Krystexxa wins FDA combo nod to fight drug resistance

Krystexxa, approved in 2010, is getting a new partner medicine in the chemotherapy and immunosuppressive drug methotrexate. The combo won FDA approval based on a trial in which 71% of patients with uncontrolled gout met the threshold of serum uric acid reduction for the primary endpoint.

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AbbVie dumps Alector's Alzheimer's immunotherapy after phase 1 review

Alector’s new approach to amyloid beta has ended the way of many of the old ideas for how to tackle the troublesome peptide. After going over data including phase 1 results, AbbVie has severed its ties to the potential Alzheimer’s disease immunotherapy—and the asset has vanished from Alector’s pipeline.

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Medical billing startup Cedar cuts 24% of workforce as market constricts

As health tech companies try to navigate a market downturn, Cedar joins other digital health startups in cutting its workforce with an eye on its bottom line.

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Roche, EarlySign expand partnership to include AI-powered lung cancer diagnosis

Less than a year after entering into a collaboration focused on using artificial intelligence tools to improve the early detection of cancer, Roche and Medial EarlySign are taking their relationship to the next level.

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Resources

Executive Summary: Highly Potent API Drug Product Development and Manufacturing using Micronization Technology

Pharmaceutical drug developers continue to realize the strong therapeutic potential of highly potent active pharmaceutical ingredients (HPAPIs). This is particularly true for therapeutic areas such as oncology, where highly potent drugs are becoming more commonplace.

Case Study: Roche cuts feasibility process by 36%

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

Executive Summary: Effective Scale-Up and Technology Transfer Strategies for Spray Dried Pharmaceutical Products

Pharmaceutical development companies face several challenges when developing orally bioavailable formulations of active pharmaceutical ingredients. Up to 70% of new drug molecules are poorly soluble in gastrointestinal fluids and can exhibit poor absorption across the gut wall.

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?