Gilead Launches Two Phase III Trials of Remdesivir for COVID-19

BioSpace: | February 27, 2020

Gilead Sciences, based in Foster City, California, announced it will launch two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19, the disease caused by the novel coronavirus. The outbreak began in China in December and has since spread through much of the rest of the world, with most cases concentrated in Asia. The current number of confirmed cases worldwide is greater than 81,400 with a total death count of 2,770. The first cases of community spread of the virus—meaning not by someone who visited Asia recently—in the U.S. was reported yesterday.

Spotlight

For several decades, key actors managing pharmacy distribution, coverage, and access have largely played the same game to mitigate drug costs: carving out the pharmacy benefit from medical, using formulary and utilization management controls, maximizing rebates and discounts, and shifting the burden of pharmacy costs to consumers.

Spotlight

For several decades, key actors managing pharmacy distribution, coverage, and access have largely played the same game to mitigate drug costs: carving out the pharmacy benefit from medical, using formulary and utilization management controls, maximizing rebates and discounts, and shifting the burden of pharmacy costs to consumers.

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PHARMA TECH

Bayer and Mammoth Biosciences to Collaborate on Novel Gene Editing Technology

Bayer and Mammoth Biosciences | January 10, 2022

Bayer AG and Mammoth Biosciences, Inc., which is harnessing the diversity of nature to power the next-generation CRISPR products, announced a strategic collaboration and option agreement for the use of Mammoth’s CRISPR systems to develop in vivo gene-editing therapies. Mammoth Biosciences’ groundbreaking gene-editing technology is a key enabling technology, as well as a stand-alone therapeutic modality. It will significantly enhance Bayer’s efforts to develop transformative therapies for patients faster and strengthen the company’s recently established new cell and gene therapy platform. Under the terms of the agreement the two companies will start their collaboration with a focus on liver-targeted diseases. “Bringing together Mammoth’s novel CRISPR systems with our existing gene augmentation and our induced pluripotent stem cell (iPSC) platforms will allow us to unleash the full potential of our cell and gene therapy strategy. Partnering with Mammoth’s cutting edge scientific team is a fundamental pillar for our company to improve the lives of patients suffering from conditions that are currently still difficult to treat.” Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division “We’re excited to be working together with Bayer, building on the technology leap of our novel CRISPR systems, along with Bayer’s expertise in successful drug development,” said Dr. Peter Nell, Chief Business Officer and Head of Therapeutic Strategy at Mammoth. “This joint effort has the potential to benefit patients by developing CRISPR-based approaches for the clinic with the appropriate urgency, while ensuring scientific excellence and safety.” Cell and gene therapies are the next step in the evolution of drug development. By addressing the root cause of diseases, they are potentially capable of permanently reversing diseases with a one-time treatment. Gene editing serves as a key enabler for cell therapies when used outside the living body and allows therapeutic targeting of a wide range of genetic diseases with a high unmet medical need when used inside the living body. Mammoth Biosciences’ proprietary toolkit of ultra-small Cas enzymes, including Cas14 and Casɸ, allows for expanded high-fidelity gene editing to be combined with targeted systemic delivery. Under the agreement, Bayer gains access to this novel gene-editing technology, which offers the potential of an advanced in vivo applicability due to the ultra-compact size of these novel CRISPR systems. Under the terms of the agreement, Mammoth Biosciences will receive an upfront payment of USD 40 million and is eligible to receive target option exercise fees as well as potential future payments in the magnitude of more than one billion USD upon successful achievement of certain research, development, and commercial milestones across five preselected in vivo indications with a first focus on liver-targeted diseases. In addition, Bayer will pay research funding and tiered royalties up to low double-digit percentage of net sales. The companies are also exploring work on ex vivo projects on a nonexclusive basis. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. About Mammoth Biosciences Mammoth Biosciences is harnessing the diversity of life to power the next generation of CRISPR products. Through the discovery and engineering of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to develop permanent genetic cures through best-in-class in vivo and ex vivo therapies and to democratize disease detection with on-demand diagnostics. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13, Cas14, and Casɸ, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Redmile Group, Foresite Capital, Senator Investment Group, Sixth Street, Decheng, Mayfield, NFX, and 8VC.

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PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

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PHARMACY MARKET

Transaction Data Systems Achieves KloudScript, A Cloud-Based Specialty Pharmacy Solution

Transaction Data Systems | November 25, 2020

Exchange Data Systems (TDS), the pioneer in drug store programming answers for the network drug store market, today reported the obtaining of KloudScript, a strength drug store care arrangement. Right now 39% of network drug stores apportion a type of strength prescriptions, agreeing the National Community Pharmacy Association. Interest for strength meds has been consistently ascending to treat explicit sickness states and the constantly sick. With the maturing populace and the expansion in ongoing consideration, forte drug store is required to develop to $500 billion as strength meds arrive at half of outpatient drug spend by end of 2020. “Combining KloudScript’s capabilities with our market-leading solutions will empower our pharmacists to expand into specialty medication offerings,” said Jude Dieterman, CEO of TDS. “This acquisition further cements TDS’s leadership position in the independent pharmacy market and demonstrates our commitment to delivering the most clinically focused solution suite for community pharmacy.” The increase in specialty medications has caused a shift in distribution and dosage form from traditional injectable and infusible formulations to oral dosage. At the end of 2019, 60% of the new drugs awaiting FDA approval were specialty medications with a noteworthy number in oral dosage form. The growth of specialty drugs and the shift to oral medications has opened a path for patient-focused pharmacists to further distinguish themselves through coordinated care of chronic disease states. “We are excited to bring Kloudscript into the TDS suite of solutions and services,” stated Rinku Patel, Pharm D, KloudScript CEO and Founder. “Together we look forward to bringing innovative service solutions to our pharmacy, pharma, payor and prescriber partners that solve the accessibility, affordability and adherence challenges of patient care.”

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