Coronavirus tracker: Gilead's remdesivir; White House's vaccine project; Pfizer, BioNTech's vaccine progress; AstraZeneca's pipeline

Fiercepharma | April 29, 2020

Coronavirus tracker: Gilead's remdesivir; White House's vaccine project; Pfizer, BioNTech's vaccine progress; AstraZeneca's pipeline
As headlines multiplied and analysts began sussing out Gilead Sciences' first controlled trial readout on remdesivir, NIAID director Anthony Fauci hailed the drug as real progress against the virus. Meanwhile, word emerged that the Trump administration is working up a Manhattan Project style vaccine initiative, bringing biotech, pharma and federal agencies together to speed up the work—and let the U.S. government take on the financial risks. Plus, Pfizer and BioNTech said they've dosed the first cohort in their COVID-19 vaccine trial, setting the shot well on its way to conducting full human trials in the coming months. And AstraZeneca is pooh-poohing the novel coronavirus' effect on clinical trials, saying its late-stage pipeline can weather any pandemic effects.  As of Wednesday, the number of global confirmed cases had passed 3.17 million, according to the Johns Hopkins University tracker, and more than 224,000 people had died.

Spotlight

Pharmaceutical drug naming and branding can seem like a complicated mystery to most consumers. Because of extensive research and regulations, medication names are getting less and less intuitive but marketed more than ever. It wasn’t too long ago that doctors were the only ones driving decisions about what to prescribe to their patients.

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Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Avacta | November 29, 2021

Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States. AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression. The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022. “We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000. Dr. Alastair Smith, Chief Executive of Avacta Group Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272. We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK.” Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.”

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PHARMACY MARKET

Spotlite360 Introduces Pharmaceutical Industry Initiative for Supply Chain Tracking, Tracing, and Sustainability

Spotlite360 | July 07, 2021

SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc. In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains: • Every year, about USD 200 billion in counterfeit medicines are sold worldwide. • Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average. • Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018. The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody. Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities. About Spotlite360 Technologies Inc. Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.

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PHARMACY MARKET

Rx Linc Partners with Scriptera to Enhance Pharmacies Bottomline

Rx Linc | October 08, 2021

Rx Linc, an emerging Business Intelligence pharmacy Switch network, and Scriptera, an organization whose mission is to create data opportunities for their health care partners, announced a strategic partnership that enables pharmacies to monetize their market-level data through a unique revenue sharing program. We are very excited and pleased to bring Scriptera's data platform and industry opportunities to Rx Linc's Switch Network. Rx Linc is focused on delivering data-driven solutions that provide value and opportunity to our pharmacy customers, By partnering with Scriptera, they fit directly into that mission where we now can monetize de-identified pharmacy claims data back to those that are producing the data daily. For too many years, pharmacy has been producing data that provides significant value to the healthcare ecosystem. It's exciting to be able to deliver value in monetizing this data utilization and at a NO cost program. - Josh Cline, Vice President of Rx Linc. Empower your data with a NO-cost program Scriptera is excited to partner with Rx Linc to bring our platform to their network at no cost, The core values of Scriptera and Rx Linc align perfectly as our core mission is to help see pharmacies succeed in such a challenging time. Scriptera unlocks the hidden value that independent pharmacies have been missing out on by empowering their data. - Kevin Laxer, founder of Scriptera. This partnership comes at a critical time in the pharmacy space as Rx Linc strives to deliver more viable revenue streams to pharmacies. Together, Scriptera and Rx Linc are committed to transforming how pharmacies can benefit from providing de-identified healthcare data. About Rx Linc Rx Linc is a Nationwide Switch network delivering data-driven solutions to their pharmacy customers. Since 1998, Rx Linc has been helping a wide range of pharmacies save time and money through data analysis and proactive outreach to minimize claim errors and maximize reimbursements. Rx Linc's data analytics combined with market intelligence improves pharmacy performance by identifying opportunities at every stage of the claims process. About Scriptera Scriptera creates data opportunities for all our partners in order to unlock more precise and faster insights than ever before. We specialize in solutions for pharmacies, wholesalers, manufacturers, and pharmacy companies. Scriptera's team has deep relationships with all these stakeholders to truly understand and identify their unmet needs.

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Spotlight

Pharmaceutical drug naming and branding can seem like a complicated mystery to most consumers. Because of extensive research and regulations, medication names are getting less and less intuitive but marketed more than ever. It wasn’t too long ago that doctors were the only ones driving decisions about what to prescribe to their patients.