GOP senators distance themselves from Grassley, Trumps efforts to cut drug prices

Fiercepharma | July 26, 2019

The fight between policymakers intent on lowering prescription drug prices and the drugmakers who keep raising them intensified Thursday as a slew of Republican senators threatened to side with manufacturers against legislation supported by their own committee chairman and president. After months of closed-door meetings and high-profile hearings, the Senate Finance Committee voted 19-9 to advance legislation introduced by Sens. Chuck Grassley, R-Iowa, and Ron Wyden, D-Oregon, to rein in drug costs in the Medicare and Medicaid programs. But even some Republicans who supported it warned they may not back the sweeping package of proposals in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation. Other obstacles have piled up. Wyden announced that Democrats, who provided most of the bill’s support in committee, would not allow a Senate vote without the Republicans agreeing to hold votes on cementing insurance protections for people with preexisting conditions. Democrats have complained for months that GOP efforts to kill the Affordable Care Act (ACA) will leave people with these medical problems without any recourse to get affordable healthcare. Democrats also want to empower federal health officials to negotiate drug prices.

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Spotlight

Skin cancer is the most common cancer in the United States. Generally defined as the abnormal or uncontrolled growth of mutated cells in the skin, it may initially appear as a bump, nodule or irregular patch on the surface of the skin. Early diagnosis and intervention mean better chances of overcoming the disease.

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PHARMA TECH

Cambrex Completes First Phase of $30 Million Capacity Expansion Project in High Point, North Carolina

Cambrex | September 05, 2022

Cambrex today announced the completion of the first phase of its $30 million investment in its small molecule active pharmaceutical ingredient manufacturing facility in High Point, North Carolina. The newly constructed space adds analytical and chemical development laboratories totaling 30,000 square feet and provides future workspace for 85 analytical and chemical development scientists. These laboratories will support the development of APIs to be manufactured in the facility's current clinical manufacturing area, as well as the future expanded clinical manufacturing and commercial manufacturing suites. "With the growing number of therapies in clinical development and trend toward more targeted therapeutics, including orphan drugs, this expansion is preparing Cambrex to support the growing demand for small-scale API manufacturing. Our expansion goes beyond providing capacity – it provides state-of-the-art technology and laboratory equipment, an energy efficient infrastructure, and an ideal space for our scientific experts to work side-by-side with our clients." Tom Loewald, CEO, Cambrex Phase 2 of the project is ongoing and will approximately double the facility's manufacturing capacity with the addition of clinical and commercial manufacturing suites with reactors up to 2,000 liters. The new commercial area will provide an ideal scale for the manufacturing of orphan drugs and niche therapies, while larger volume products developed at the facility can be manufactured commercially at one of Cambrex's larger scale facilities in Iowa and Sweden. This expansion follows Cambrex's 2021 investment in the Cambrex High Point continuous flow R&D center of excellence, including expanded capabilities for continuous flow process development, manufacturing, and scale up. Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, stability storage, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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BUSINESS INSIGHTS

Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants." Stanley C. Erck, President and Chief Executive Officer, Novavax Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. 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, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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PHARMA TECH

Zerion Pharma and Hovione extend partnership to cover use of the Dispersome® technology platform in nutraceuticals

Zerion Pharma and Hovione | August 24, 2022

Hovione and Zerion Pharma announced an extension of their collaboration on Zerion's Dispersome® technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the solubility enhancing Dispersome® technology for the development and commercialization of certain nutraceutical products. The first product candidate selected for joint development is an antioxidant with multiple health benefits and known for its extremely low solubility and bioavailability. By applying the Dispersome® technology, Zerion has been able to demonstrate significant solubility improvements of this antioxidant. Under their collaboration, Hovione and Zerion will now upscale and develop commercial formulations of the antioxidant using the Dispersome® platform and make these products available for distribution by partners globally. Under the terms of the collaboration agreement, the two companies will share income from the commercialization of these products according to their respective contributions. In addition to the joint development projects, Zerion has granted Hovione an exclusive license to exploit the Dispersome® technology for other nutraceuticals/dietary supplements. In return, Hovione will pay Zerion license fees and royalties on sales of the licensed products. "The low oral bioavailability of some of the health-promoting nutraceutical compounds is a well-known challenge. The problem is compounded by the fact that some of the solutions used in pharma cannot be used in foods. Hovione is thrilled to be Zerion´s exclusive partner for the application of Dispersome® to the fields of nutraceuticals and dietary supplements. The Dispersome® platform and its enabling ingredient – beta-lactoglobulin or BLG – afford formulators new options which address unmet needs of the industry." Jean-Luc Herbeaux, CEO of Hovione "I am extremely pleased with this extension of our collaboration", says Ole Wiborg, CEO of Zerion and continues: "The Dispersome® technology is actually very well suited for use in dietary supplements because it employs BLG as its solubility enabling component. BLG is a sustainable natural material and in itself a beneficial nutritional product that we source in high quality from Arla Food Ingredients. Since we as a company only have limited resources to exploit these promising applications of the Dispersome® technology in the nutraceutical field, the collaboration with Hovione is a win/win situation." In February 2022, Zerion and Hovione announced a strategic partnership aimed at commercializing the Dispersome® technology within the drug development field. Under this partnership, Hovione and Zerion are offering pharma and biotech companies worldwide access to an innovative drug delivery platform combined with an unparalleled experience in formulation development, scale up and GMP manufacturing. This unique combination provides customers in the pharma industry with a line of sight over the entire drug development life cycle from the preclinical phase to commercial drug product. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma A/S Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems. By applying the Dispersome® technology, the solubility of poorly soluble, oral drugs is greatly enhanced, which improves their bioavailability and therapeutic outcomes for the patients. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research.

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