Anti-parasitic drug said to 'kill' COVID-19 cells

Alcoholics Anonymous | April 09, 2020

Scientists in Australia have found that an anti-parasitic drug available on the market “can kill” the growing cell culture of the deadly coronavirus within 48 hours. However, researchers say the drug cannot be used in humans for COVID-19 until further testing and clinical trials prove its safety and effectiveness. “Scientists showed that a single dose of the drug, Ivermectin, could stop the SARS-CoV-2 [COVID-19] virus growing in cell culture,” said a statement by Melbourne-based Monash University, where the research is based. “Scientists showed that a single dose of the drug, Ivermectin, could stop the SARS-CoV-2 virus growing in cell culture,” the statement said. “The potential use of Ivermectin to combat COVID-19 remains unproven, and depends on funding to progress the work into the next stages,” the statement added.

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Though tablet compression does not generate large volumes of fugitive dust, safe and efficient collection of whatever dust is created by this process is critical.


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VIEWS AND ANALYSIS, PHARMA TECH

Novavax Announces Pricing of $150 Million Offering of Convertible Senior Notes

Novavax, Inc. | December 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the pricing of an offering of $150 million aggregate principal amount of its 5.00% convertible senior notes due 2027. The notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the offering of the notes, Novavax has granted to the initial purchasers a 30-day option to purchase up to an additional $25.25 million aggregate principal amount of the notes. The offering of the notes is expected to close on December 20, 2022, subject to customary closing conditions. The notes will represent senior unsecured obligations of Novavax and will accrue interest payable semi-annually in arrears and will mature on December 15, 2027, unless earlier converted, redeemed or repurchased. Novavax will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.01 per share or a combination of cash and shares of its common stock, at Novavax' election. The notes will be redeemable, in whole or in part for cash at Novavax' option at any time, and from time to time, on or after December 22, 2025, if the last reported sale price of common stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on and including the trading day immediately preceding the date on which Novavax provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. The notes will be convertible at an initial conversion rate of 80.0000 shares of common stock per $1,000 principal amount of notes. J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers and representatives of the initial purchasers for the offering of the notes. J. Wood Capital Advisors served as financial advisor to the Company in relation to the offering of the notes. Concurrently with the offering of the notes, Novavax also announced today the pricing of its previously announced underwritten public offering to sell up to 6,500,000 shares of its common stock at a public offering price of $10.00 per share, or $65 million worth of shares of its common stock. In connection with the common stock offering, Novavax granted the underwriters a 30-day option to purchase up to an additional 975,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering of the notes is not contingent upon the consummation of the concurrent common stock offering, and the concurrent common stock offering is not contingent upon the consummation of the offering of the notes. The concurrent common stock offering is expected to close on December 20, 2022, subject to customary closing conditions. Novavax may use the net proceeds from the offering of the notes and, if consummated, the concurrent common stock offering, for general corporate purposes, including but not limited to the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes. Novavax estimates that the net proceeds from the offering of the notes will be approximately $142.2 million after deducting the initial purchasers' discounts and estimated offering expenses payable by Novavax. The offer and sale of the notes are not being registered under the Securities Act of 1933, as amended any state securities laws. The notes may not be offered or sold in the U.S. except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws. The notes are being offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the World Health Organization.

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BUSINESS INSIGHTS

BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A

BioMarin Pharmaceutical Inc. | November 24, 2022

BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an advisory committee meeting but did not specify a date. The Company also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin's gene therapy manufacturing facility located in Novato, CA. "The review of a BLA is a dynamic process, and we appreciate FDA's ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A. We look forward to further dialogue with the Agency as it reviews our application." Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin About valoctocogene roxaparvovec The FDA granted Regenerative Medicine Advanced Therapy designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017. In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening, or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN™ on August 24, 2022. Robust Clinical Program BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A. Also ongoing is a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors. About Hemophilia A People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate or mild disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month. Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life. Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases.

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BUSINESS INSIGHTS, PHARMACY MARKET

Novo Nordisk & ATLATL announce winners in their joint program EntreStar

Novo Nordisk & ATLATL | December 06, 2022

Novo Nordisk Research Centre China and ATLATL jointly announce the winners of EntreStar program. Hangzhou DNano MetaBio and Modit Medicine stood out among all participants and won the awards. The two winners will be given priority access to one of ATLATL’s nation-wide facilities in China, and a prize of CNY 500K RMB each to pay for the ATLATL facilities and services. They are also entitled to mentoring by relevant experts of Novo Nordisk. There will be no strings attached for the two companies. Founded in 2022, Hangzhou DNano MetaBio Technology has been focusing on the design of nucleic acid nanocarriers with customized functions and great potential in clinical translation. The team has rich experience in nucleic acid structure design, which enables them to accurately regulate the organ-targeting ability and the on-demand drug release performance of the nanocarriers. “It’s our great honour to participate in EntreStar. We look forward to exploring collaboration opportunities with the community. Meanwhile, it is very much appreciated that we can receive guidance and help from Novo Nordisk’s experts in relevant fields, so that our company can develop in a healthy way.” Dr. Baoquan DING, President & Chief Scientist of DNano expressed his hopes in the award ceremony, Modit Medicine Inc., founded in 2022, is a biotech company focusing on RNA editing and therapeutics. The company owns cutting-edge and propriety RNA modification and editing methodologies and is devoted to the development of novel platform technologies. Instead of manipulating DNA sequences, technologies of Modit Medicine Inc. correct genetic errors at the RNA level, thereby providing opportunities for safe, efficacious and innovative therapeutics to treat human rare diseases, cancers, etc. Dr. Chengqi YI, Founder of Modit Medicine and Boya Professor of Peking University, commented on his participation, “By participating in the EntreStar program, Modit Medicine Inc. hopes to learn from global pharma about their insights on technology platform and marketing strategies in gene therapy, as well as to seek and form potential collaborations with Novo Nordisk. We also appreciate advice and suggestions from ATLATL about useful tips for start-up companies to connect with government and industry.” Dr. Dan HAN, President of NNRCC, shared her remarks: “We see great potential in the novel concepts proposed by DNano and Modit. By leveraging knowledge and experiences in our global organisation, we hope that Novo Nordisk can help pushing their research projects forward more effectively. As a Novo Nordisk affiliate in China, we partner with brilliant minds via INNOVO® program to facilitate translational research, with EntreStar initiative as its latest addition.” Dr. Pengcheng ZHU, Founder of ATLATL Innovation Center, commented on the role ATLATL plays: “It is my greatest pleasure to help make the EntreStar winners thrive at ATLATL’s platform, with access to global resources, such as our partners like Novo Nordisk. The ATLATL Innovation Center is a world-class scientific hub for the life sciences. We streamline the elements of R&D to improve resource utilization, and revolutionize the traditional asset-heavy investment model into an asset-light operation model. I am looking forward to collaborating with even more leading biopharmaceuticals and bringing success to these talented people.” About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk Research Centre China founded in 1997, takes pride in being the first research centre established by a multinational pharmaceutical company in China. With a focus on protein and peptide therapeutics, NNRCC has full capabilities and rich experiences in drug discovery research. About ATLATL The ATLATL Innovation Center is a world-class scientific hub for global life sciences. ATLATL streamlines the elements of R&D to improve resource utilization and revolutionizes the traditional asset-heavy investment model into an asset-light operation model. This much more time and cost-efficient model originated in Boston and continues to be optimized from 2017 onwards in China. ATLATL provides not only state-of-the-art facilities and professional operational management but also many R&D platforms staffed with scientists and project managers specializing in various fields. By collaborating with leading biopharma ATLATL integrates global resources to stimulate innovative developments. ATLATL currently has R&D platforms in Beijing, Shanghai, Suzhou, etc., leveraging the uniqueness of each site to help innovators quickly reach the next milestone.

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BUSINESS INSIGHTS, PHARMA TECH

Thermo Fisher Scientific’s Advanced Analytical Instruments Receive R&D 100 Awards

Thermo Fisher Scientific | December 19, 2022

Thermo Fisher Scientific Inc., the world leader in serving science, received R&D 100 Awards from R&D World Magazine for two of its most recently launched analytical instruments. The R&D 100 Awards competition honors the latest innovations in science and technology, identifying the top 100 revolutionary technologies of the past year. The Thermo Scientific Gallery Enzyme Master Enzyme Analyzer was recognized as an R&D 100 Award winner in the Analytical/Test category. It is the first automated discrete analyzer designed specifically for enzyme assay applications, streamlining workflows for industrial enzyme manufacturers and enzyme users in the food, beverage, biopharmaceutical, fuel ethanol and chemical, and solid waste management industries. The analysis the technology enables ultimately helps society in numerous ways, including making food taste better and helping industrial processes to become less energy intensive and more sustainable while using less hazardous chemicals. The Thermo Scientific Orbitrap Exploris MX Mass Detector was also a recipient of an R&D 100 Award in the Analytical/Test category. The mass spectrometer was recognized for its ability to offer high resolution accurate mass data for intact analysis of monoclonal antibodies, oligonucleotide mass determination and peptide mapping in drug discovery applications. The Orbitrap Exploris MX Mass Detector is a part of a multi-attribute method workflow that is designed for efficient, scalable production, to enable drug safety and to accelerate drug approval so that new drugs become available to patients faster. “We are honored to receive this distinguished award for two of our latest innovations, recognizing the hard work and dedication of our colleagues. We’re committed to prioritizing innovation to develop new technologies that enhance research and drive science forward, enabling our customers to make the world healthier, cleaner and safer.” John Lesica, president, chromatography and mass spectrometry, Thermo Fisher Scientific The renowned R&D 100 Awards have identified revolutionary technologies introduced to the market since 1963, and, in 2022, the program received entries from more than a dozen countries and regions. This year’s esteemed panel of judges included nearly 50 well-respected industry professionals from around the world. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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