biopharmaceuticals

  • sam patrick posted an article
    Nephron prepping to fill COVID vaccines in state see more

    Courtesy of WSPA-TV

    VIDEO: https://www.wspa.com/news/sc-pharmaceuticals-company-says-theyll-be-ready-to-fill-covid-19-vaccines-in-2021/

     

    LEXINGTON COUNTY, SC (WSPA) — With a potential COVID-19 vaccine looming, one South Carolina company said they’ll be able to fill vaccines next year.

    According to Nephron Pharmaceuticals CEO and Founder Lou Kennedy, the company is in the midst of a $215 million expansion. They are adding new office and new warehouse space. The investment will also create more than 380 jobs the company said.

    The expansion also includes vaccine production space. Kennedy said once completed, they’ll be able to fill COVID-19 vaccines at their facility.

    “We’re actively looking for the right partner that will produce and we’ll fill the vaccine. We’re speaking with people throughout the federal government and Department of Defense to find the right partner,” Kennedy said.

    Tuesday, the company held a beam raising ceremony to celebrate their expansion. Kennedy said she expects to have the vaccine production space completed by March 2021.

    As of Tuesday afternoon, the FDA has not approved a COVID-19 vaccine for distribution. However, preliminary reports on vaccines from Moderna Inc. and Pfizer Inc. show their vaccines have at least a 90% effectiveness rate.

    Kennedy said they are anticipating a medical grade glass shortage because of the high demand for the vaccine. She said they have the ability to work around that. “Our option will be to put the vaccine in plastic. We have the technology and the capability.”

    Under the South Carolina Department of Health and Environmental Control’s (SCDHEC) statewide vaccine plan, front line medical personnel and nursing home residents will be some of the first South Carolinians to get doses of an approved vaccine. They anticipate vaccine supply will be limited to start off, but Kennedy hopes they can help alleviate that.

    She said, “We’re right in tandem with the research work and the clinical trials that are going on. We’re trying to time that perfectly for the vaccine filling side of it.”

  • sam patrick posted an article
    Moderna vaccine results looking very good early see more

    The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.

    Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.

    Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.

    Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.

    Read the entire story here.

  • sam patrick posted an article
    Nephron CEO and SCBIO Board Chair Lou Kennedy speaks out see more

    The team at Nephron Pharmaceuticals Corp. in West Columbia has been honored to answer the call to serve during the unprecedented COVID-19 pandemic.

    We have shipped hundreds of millions of doses of life-saving respiratory medications to patients nationwide. We have provided tens of thousands of gallons of Nephron-made, FDA-approved hand sanitizer to students, businesses, families and those in need. And we recently announced a $216 million expansion that includes factory production space where we will fill COVID-19 vaccines.

    Every Nephron employee has a sense of pride. Of patriotism. But I would be remiss if I failed to mention that we also share a sense of concern.

    China is one of the world’s largest suppliers of the precursor chemicals used to make active pharmaceutical ingredients and personal protective equipment. What we have come to recognize firsthand are the perils of dependence on foreign counties, such as China, for medicine and medical supplies.

    As trade tensions between China and the United States grew last year, I was afraid China could intentionally disrupt the drug supply chain to the United States, exacerbating the drug shortage crisis, increasing the cost of drugs and potentially killing American patients.

    The recurring question I had was: What can America do to break this dangerous dependence?

    Now, as the world considers how to deal with China in the aftermath of this pandemic, the picture of a potential supply chain disruption is grimmer, serving as a vivid reminder that we are talking about matters of life and death.

    I have been vocal about this issue for quite some time. In fact, I discussed America’s dependence on China for drug ingredients last year with federal officials, including President Donald Trump, Vice President Mike Pence and Health and Human Services Secretary Alex Azar. When U.S. Sen. Lindsey Graham visited our plant a few weeks ago, we agreed: Something must be done to find American solutions to this American public health crisis.

    So, it should be no surprise that I am excited about the executive order President Trump signed last week to shore up the domestic supply chain for life-saving medicines, reduce dependence on foreign sources of drugs and medical supplies and expand domestic production of both.

    When the president signed this new executive order, he said: “As we’ve seen in this pandemic, the United States must produce essential equipment, supplies and pharmaceuticals for ourselves. We cannot rely on China and other nations across the globe that could one day deny us products in a time of need. We can’t do it. We can’t do it. We have to be smart.”

    I could not agree more.

    This is a no-brainer. The pandemic has taught us an important lesson. The best way to protect American patients, families and businesses is onshoring production of the things we need to keep them healthy and safe.

    Over the past five months, the American people have endured hardships no one could have foreseen. We grieve with those who have lost loved ones to this unrelenting silent enemy. We support business owners small and large who want to slow the spread of this virus so we can reopen the world’s greatest economy. And we share the frustrations many people feel with politicians who are focused on winning the next election, rather than preparing for the next public health crisis.

    We are grateful for these first steps President Trump is taking to make sure we never end up in this place again.

    At Nephron, we have the technology, resources and people it takes to successfully partner with the federal government to make the public health preparedness infrastructure of this nation stronger than ever. South Carolina can and will be a leader in the effort to find American solutions for American public health.

    This new executive order is the right way to do it.

  • sam patrick posted an article
    Five–year commitment by BMS builds on long-standing investment in health equity see more

    -Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation announced today a combined investment of $300 million as part of a series of commitments. For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.

    The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.

    “Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science.”

    This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.

    Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.

    The commitments include:

    • Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.

    “Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.”

    • Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.
    • Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.
    • Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.

    “As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve,” added Ann Powell, chief human resources officer, Bristol Myers Squibb. “We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce.”

    • Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.

    The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.

    About Bristol Myers Squibb

    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedInTwitterYouTubeFacebook, and Instagram.

    About the Bristol Myers Squibb Foundation

    The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about the Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.

  • sam patrick posted an article
    Partnership Reduces Barriers to Testing, Provides Top Quality to Customers see more

    Compliments of MidlandsBiz

    Partnership Reduces Barriers to Testing, Provides Top Quality to Customers

    Nephron Pharmaceuticals Corporation, one of the fastest-growing pharmaceuticals companies in the country, announced a new collaboration with Methapharm.

    As a part of this collaboration, Nephron will produce kits of methacholine chloride sterile inhalation solution in ready-to-administer concentrations for bronchoprovocation challenge testing, when diagnosing respiratory illnesses, such as asthma.

    “Methapharm will be a fantastic partner,” said Nephron CEO Lou Kennedy. “Patients deserve access to the very best respiratory tests available, that’s what this collaboration will offer, and that’s why we are looking forward to working with Methapharm.”

    Working together with Methapharm, Nephron will be able to supply stable room temperature solution kits, ensuring that testing facilities can continue to rely on the quality and reliability of Provocholine for their bronchoprovocation testing needs.

    “Through this partnership with Nephron, Methapharm continues its mission to help reduce barriers to testing, provide the level of quality our customers expect, and contribute to better healthcare outcomes for our patients,” said Craig Baxter CEO of Methapharm. “We’ve been impressed by Nephron’s capabilities and professionalism.”

    Provocholine® is the only FDA-approved methacholine chloride powder for use in humans. Methapharm, the manufacturer of Provocholine, has always tried to be responsive to needs of our testing partners. For example, in response to the revised ERS technical standard, Methapharm initiated a comprehensive nebulizer characterization study to support the recommendation of PD20 as a clinical endpoint. This was published in a technical bulletin earlier this year.

     

    Nephron

    A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.

  • sam patrick posted an article
    Softbox Systems is making its mark globally see more

    Compliments of Upstate Business Journal

    It might not be the first supply chain you think about, but while countries around the world are rushing to find a vaccine for COVID-19, the cold chain behind medical transport is more and more relevant. A company in Greenville, Softbox Systems, has become a global leader in temperature-controlled packaging, helping transport the products of top pharmaceutical companies to hospitals, doctors’ offices and homes around the world.

    Softbox Systems creates packaging — often for the pharmaceutical sector — for different temperature ranges. The packaging is used to transfer individual vials, finished products or active pharmaceutical ingredients from one location to another while keeping the necessary temperature steady for the item. These products can be flu vaccines, EpiPens, inhalers or one of the other countless medications that need to be kept at certain temperatures..

    “If the shipment gets too hot or cold, it can break down molecular properties of said item, and it becomes ineffective,” John Hammes, general manager for the Americas at Softbox Systems explained. “It might work differently with what the intention was, or it may not work at all.”

    Softbox Systems was founded in the U.K. in 1995, and the company maintains its global headquarters there. Hammes started with the company in 2009 to help spearhead U.S. operations since they had been relying on a third party for distribution. The company also has locations in Spain, India, Singapore, Belgium and elsewhere.

    “We had a good product. We knew the industry, so we just put our head down and got to work,” Hammes said. 

    In 2013, the company opened a 29,000-square-foot facility off of Pelham Road in Greenville for its Americas division. Eventually, the company grew too large for that facility and moved to Park Commerce Road in a 65,000-square-foot ISO-certified facility where almost 60 Softbox System employees work.

    While what they do is simple, how they do it isn’t, since medications require different temperatures, Hammes explained. They’ve even worked with Merck Pharmaceuticals on a drone shipper that could be used to transport medicine across disaster areas or war zones, he said. 

    Another product that’s caught people’s attention is  Tempcell ECO — an all paper-based packaging unit launched six months ago that won recognition for innovation by Fast Company. There’s a push, Hammes said, to be more sustainable. 

    Besides developing sustainable products, Softbox Systems also partnered with American Forests. For each Tempcell ECO sold, the company makes a monetary donation to plant a tree. So far, they’ve been able to donate enough to plant more than 20,000 trees. 

    “What we are looking at as a company is to be the global leader not only in temperature control packaging but sustainability,” Hammes said. “We have a corporate drive to do that.”

  • sam patrick posted an article
    Nephron steps up to support USC's planned reopening with donations of sanitizer see more

    Courtesy of Columbia Regional Business Report

    Nephron Pharmaceuticals Corp. is donating more than 100,000 bottles of company-manufactured hand sanitizer to the University of South Carolina as part of the West Columbia-based company's ongoing efforts to help fight COVID-19.

    The first 5,000 bottles arrived on campus today, hand-delivered by Nephron president and CEO Lou Kennedy and Nephron's new van bearing its clinical lab logo to a group of student leaders on the university’s Horseshoe.

    “No matter how tall the challenge is, Gamecocks step up,” Kennedy, a 1984 USC graduate, said in a news release. “Our company is proud to do our part to help the university make sure it is ready to welcome students, staff and faculty back to campus.”

    USC, which closed its campuses in March in response to the COVID-19 pandemic, is resuming in-person instruction in mid-August.

    “We’re grateful to Lou and Bill Kennedy and the entire team at Nephron Pharmaceuticals for this generous gift,” Bob Caslen, USC president, said. “This donation helps support the safe return of our students and employees to campus and exemplifies what the Gamecock spirit is all about: making our communities better through selfless service and caring for others.”

    The bottles bear a private label requested by the university, Kennedy said.

    Nephron develops and produces generic respiratory medication, including inhalation solutions and suspension products that can be used to treat severe respiratory symptoms associated with COVID-19.  

    In March, Nephron began making its own hand sanitizer, and previously donated 50 liters to the William Jennings Bryan Dorn Veteran Affairs Medical Center. The company added a production line in April be used in the manufacturing of bronchodilator albuterol as demand for its products soars during the pandemic.

    Last month, the company announced an expansion of its COVID-19 testing capabilities through a partnership with medical technology company One Medical. Kennedy told the Columbia Regional Business Report today that Nephron’s on-site clinical lab began testing company employees last week and plans to process samples collected during a drive-thru testing clinic June 19 and 20 at Benedict College’s football stadium.

    “We are trying to be a good partner with DHEC, a good partner with the local hospitals, and see how we can take some of the stress off of their labs for testing,” said Kennedy, who said Nephron has also developed, in partnership with Lexington Medical Center, a transport medium for nasal swabs used in the testing process.

    Nephron has hired its own nurse practitioner and installed a chief medical officer, Kennedy said. She said the department-by-department testing of employees will continue through this week.

    “The more we test, we’re going to find people that are asymptomatic, but it’s important for us to get this contact tracing thing figured out, get a baseline, get people home and get them well,” she said.

  • sam patrick posted an article
    Nephron announces new partnership see more

    Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country, announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees.

    “Re-opening businesses, and getting our economy moving again, is one of our highest priorities,” said Nephron CEO Lou Kennedy, who is a member of Governor Henry McMaster’s #accelerateSC, the coordinated COVID-19 advisory team tasked with recommending economic revitalization plans for South Carolina. “Part of the new normal for businesses is testing employees to make sure the workplace is safe. We couldn’t be prouder to offer COVID-19 testing services to our employees and neighbors.”

    Kennedy and John Singerling, Chief Network Officer of One Medical and a longstanding healthcare executive based in South Carolina, are working together to make this partnership a reality, hoping that it serves as an example for businesses around the country.

    The Nephron CLIA-Certified lab has procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing for its own employees, and for employees of neighboring businesses. The lab intends to integrate with One Medical’s technology platform, which is capable of supporting a comprehensive workplace reentry COVID-19 testing program. One Medical’s virtual care solutions facilitate scheduling for specimen collection and digitally documenting those test results. It also screens and evaluates clinical risk factors and symptoms and supports employer tracking and reporting needs.

    “I am very pleased to be working alongside the Nephron team to leverage One Medical’s digital health platform as a way to help get South Carolinians back to work safely,” said One Medical Chief Network Officer, John Singerling. “Currently working with over 7,000 employers nationwide has allowed One Medical to build a comprehensive workplace reentry program that is grounded in medicine and testing, and powered by our technology, which allows for seamless tracking, tracing and ongoing monitoring.”

    SARS-CoV-2 PCR tests diagnose whether a person is infected with the virus by using technology that analyzes viral genetic material. Antibody tests check blood for antibodies. If present, antibodies indicate a person has been previously or is currently infected by the virus.

     

    Nephron Pharmaceuticals Corporation has been on the frontlines of the nationwide COVID-19 response. The West Columbia-based company develops and produces safe, affordable generic inhalation solutions and suspension products that can be used to treat severe respiratory distress symptoms associated with COVID-19. In addition, the company operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. These products are used, many times, to sedate patients and keep them comfortable when health care professionals place them on ventilators in the fight against the virus.

  • sam patrick posted an article
    New leadership named at helm of BIO see more

    The Executive Committee of the Biotechnology Innovation Organization (BIO) and its Board of Directors have announced the appointment of Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020.  

    "With her background as a scientist and physician, her health policy and experience in federal government, her leadership within industry as a champion of scientific progress, her commitment as an advocate for patients, and her gifts as a communicator, Dr. McMurry-Heath is the right person at the right time to lead us into the future," the official announcement released today stated.

    Dr. McMurry-Heath is a coalition-builder and change agent who comes to BIO from Johnson & Johnson (J&J). She served in numerous senior leadership roles at J&J since 2014, most recently serving as Vice President of External Innovation, Global Leader for Regulatory Science and Executive Director of Scientific Partnerships for JLABS @ Washington, D.C. There, she led a large global team charting the evidence generation and regulatory strategy across J&J’s medical device companies. And she worked to knock down regulatory barriers that were hindering the ability of small innovators to partner and grow.

    Prior to her work at J&J, Dr. McMurry-Heath served in scientific leadership roles at the FDA from 2010 to 2014. Her driving purpose at the FDA was to devise strategies to incorporate the patient point of view into FDA decision-making and develop new ways for patients to collaborate with innovators.

    BIO’s incoming leader is a clinician-scientist with experience working at the bench in molecular immunology. She is the first African-American to graduate from Duke’s Medical Scientist Training Program, receiving an MD/PhD in immunology along the way. While Harvard-educated, she was raised in the San Francisco Bay Area – one of the great epicenters of biotechnology.

    Throughout her impressive career, Dr. McMurry-Heath has been focused on the social impact of medicine so that more people in our society can benefit from its transformative potential. She led health and science policy on Capitol Hill for Senator Joe Lieberman, where she drafted legislation to protect the country from biological attacks, and then went on to sharpen her policy skills at the Robert Wood Foundation.

    Dr. McMurry-Heath will become just the third leader of BIO since our organization’s founding in 1993. She will succeed a towering figure in our industry, the Honorable Jim Greenwood, who for 16 years has built the most consequential biotechnology advocacy organization in the world.  Mr. Greenwood was a champion of the cause even before he was BIO's leader, reforming the FDA and fighting for broad acceptance of stem-cell science during his 12 years of principled, pragmatic leadership in the United States Congress.

    As BIO’s leader, Mr. Greenwood has brought incomparable political and policy acumen to bear on the needs of our industry. During his tenure at BIO and as the United States built an innovation ecosystem that is the envy of the world, he played a pivotal role. After he hands over the reins on June 1st to Dr. McMurry-Heath, he has committed to work with her and will stay on in a strategic advisory role. The industry and BIO are grateful for his outstanding leadership, professionalism and continued contribution.

  • sam patrick posted an article
    Nephron gets nod from FDA see more

    West-Columbia headquartered-Nephron Pharmaceutical Corp.’s fight against the COVID-19 pandemic has received an additional weapon.

    The Food and Drug Administration approved the company’s request to add a production line used in the manufacturing of bronchodilator albuterol today, Nephron CEO Lou Kennedy told the Columbia Regional Business Report.

    “This news came in 20 minutes ago,” Kennedy said Monday morning. “People are cheering. It’s like The Price is Right or something.”

    Kennedy said she expects to hear whether a second production line has been approved later this week.

    Last month, Kennedy petitioned the FDA to add up to six production lines moved to Columbia from the company’s previous Florida headquarters in 2019. Kennedy said the additional lines could help the sterile respiratory medication manufacturer keep up with unprecedented demand.

    Kennedy said March saw a 141% increase in the doses of inhalation solutions Nephron typically produces a month.

    “We went from a regular month of about 80 million shipped to 193 million shipped in March. That’s just for the respiratory side,” she said. “For our sterile injectable medications that we make for all the hospitals in America that have drug shortage needs, that was up by like 22%. We’re seeing the same exact trend in April.”

    Kennedy praised the FDA for its quick response, saying the federal agency granted Nephron a CBE-30, “which means Change Being Effected. That’s giving you a goal date of 30 days or less to review your material and be able to say yes or no,” she said.

    “That’s really something. You’ve just got to know and feel good as a patient or a potential patient in America that the FDA has been working with me on the phone almost every day, or by email, trying to get this through expeditiously so that we can crank up a few more lines.

    “As much as we can make, we’re selling. I don’t want to get behind. So if we can get these other lines approved pretty quickly, then we’ll be able to pump out — if I get four lines, at least another 50 million a month.”

    Also helping meet demand, Kennedy said, are the efforts of the S.C. Ports Authority.

    Last Thursday, four gigantic containers of automated packaging equipment arrived at Nephron headquarters from Switzerland. Today, the company is expecting air delivery of critical supplies from Italy, one of the countries hardest-hit by the COVID-19 pandemic.

    “You know how difficult that was to pull off?” Kennedy said.

    Kennedy developed a working relationship with the port as she moved hundreds of millions of dollars in equipment from Florida to West Columbia when Nephron relocated to South Carolina in 2014. During her time as chair of the S.C. Chamber of Commerce from 2018-19, Kennedy came to know S.C. Ports CEO Jim Newsome and COO Barbara Melvin well.

    Expecting last week’s shipment of automated equipment to help Nephron workers quickly label, package and ship products, Kennedy called Melvin.

    “I reached out to see what the situation was going to be like in getting these pieces of equipment,” she said. “That equipment, which was four giant containers, arrived to the dot at 9 a.m. (Thursday) morning all because of two great South Carolina partners — UPS and its hub that’s located one exit from me, and the Ports Authority.

    “All of these drugs that are packaged will go to benefit speedier to-market products for patients with COVID-19. … This is front-line equipment that we need to get our products to market quicker.”

    Nephron is also gearing up to begin releasing 100-mL saline bags for administration of sodium chlorine. The minibags, made scarce after the 2017 hurricane season hit manufacturer Baxter Healthcare hard, are once again in short supply, Kennedy said.

    “We are very happy to say that we’ve been producing 100-mL saline for the last two weeks in anticipation for this going on shortage,” said Kennedy, who said the bags would be released this past Friday.

    While Nephron has ramped up production in response to previous respiratory illnesses such as SARS and H1N1, Kennedy said the COVID-19 crisis is unlike anything she’s ever seen. Nephron began making its own hand sanitizer last month, distributing 50 liters to the William Jennings Bryan Dorn Veteran Affairs Center.

    “I had absolutely no idea we’d reach these levels. I couldn’t even imagine, can’t even imagine, still am trying to process,” Kennedy said. “One particular day, two or three weeks ago, one hospital system in New York ordered 3,000 nebulizers from us. A typical thing might be 50, no more than 100. They ordered 3,000.”

    S.C. Ports and other transportation partners have helped Nephron fill the exploding demand, Kennedy said, while Nephron workers are proud to be playing a role in combating the virus.

    “I couldn’t even begin to compare ourselves with what they’re doing at hospitals, but there is a true sense of patriotism,” she said. “People are coming to work optimistic in the fact that they’re helping, in their own small way, American patients.”

  • sam patrick posted an article
    It's Monday... start your day right with two minutes of good news, right here see more

    SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from South Carolina Hospital Association's Thornton Kirby that expresses appreciation to the SC life sciences industry, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links.  Click here.

     

  • sam patrick posted an article
    BMS steps up to help newly uninsured patients see more

    PRINCETON, N.J. – April 7, 2020 – Bristol Myers Squibb (NYSE: BMY) today announced an expansion of its existing patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic.

    The expanded program offers access to any branded Bristol Myers Squibb medicine for free, including some of its most widely prescribed products, as well as those prescribed via telehealth services. The program features:

    • Immediate access for patients who have lost their employment and health insurance;
    • A simple, single point of entry;
    • Streamlined enrollment process; and
    • Vouchers to assist with continuity of care for several self-administered BMS medicines, for eligible patients

    All Bristol Myers Squibb patient support programs, as well as, additional eligibility requirements, can be reached by calling (800) 721-8909 or by visiting BMS.com.

    “The COVID-19 pandemic has created unprecedented financial challenges for patients and families, adding considerable new stress to the millions of Americans who have lost their jobs and health insurance,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “As more patients face difficult decisions in their daily lives, it is important to continue their treatments.”

    Bristol Myers Squibb’s Response to COVID-19
    Bristol Myers Squibb recognizes this is a challenging time for everyone. The company will continue to take all necessary actions to promote public health and carry out its mission of providing life-saving medicines to the patients who depend on us. Please visit BMS.com to learn more about our actions to date.

    About Bristol Myers Squibb
    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

  • sam patrick posted an article
    Nephron, Ritedose to the rescue with respiratory drugs see more

    Two South Carolina companies that make drugs used to treat respiratory illnesses and symptoms, like those experienced by people infected with the coronavirus, have upped their production amid increased demand.

    Nephron Pharmaceuticals in West Columbia and Ritedose Corp. make generic versions of almost all the respiratory drugs used in the United States, including albuterol sulfate and ipratropium bromide, according to the CEOs of the two companies.

    Business at Nephron spiked last week, CEO Lou Kennedy said, with orders up 48 percent. The CEO of Ritedose, Jody Chastain, said his company has received a slight increase in demand.  Click to read full story, courtesy of The Post and Courier...

  • sam patrick posted an article
    Test to Predict Pre-Treatment, Patient-Specific Responses see more

    GREENVILLE, S.C. – March 2, 2020 – KIYATEC, Inc. today announced that VA Portland Health Care System (VAPORHCS) has joined the growing roster of institutions participating in its 3D-PREDICT clinical study to validate the company’s test as a patient-specific predictor of response to cancer therapies for patients with glioblastoma, an aggressive form of brain cancer.

    “Glioblastoma, one of the most common and deadly forms of brain cancer, is notoriously difficult to treat. Patients and clinicians do not have the luxury of time to experiment with drug therapies they don’t know will work, so we developed our investigational glioblastoma drug response profile to help clinicians optimize therapeutic decision-making for their patients over the course of their disease,” said Matthew Gevaert, CEO of KIYATEC. “We are honored to welcome VAPORHCS to the 3D-PREDICT study and salute the important commitment to cancer clinical studies demonstrated by all VA hospitals.”

    3D-PREDICT is a prospective, open-label, non-interventional study to validate KIYATEC’s glioblastoma drug response profile, which leverages the company’s ex vivo 3D cell culture technology platform to assess pre-treatment, patient-specific response to a panel of 12 drugs most commonly used to treat patients with newly diagnosed or recurrent glioblastoma.  Details on the study can be found at https://clinicaltrials.gov/ct2/show/NCT03561207.

     

    About KIYATEC, Inc.

    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory.  The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

  • sam patrick posted an article
    South Carolina's Zylo Therapeutics partners with Hoth on lupus treatment see more

    NEW YORK, May 14, 2019 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH) a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced that the company has signed a term sheet with Zylö Therapeutics Inc (Zylö) to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE).  CLE is a chronic autoimmune disease that affects the skin.

    Zylö, dedicated to bringing innovative technologies to multiple facets of medicine, has an innovative sustained-release drug-delivery system that was developed by Joel Friedman MD PhD, Adam Friedman MD FAAD, and Andrew Draganski PhD. The delivery system uses patented xerogel-derived nanoparticles, called Z-pods™, to deliver—in a sustained and controlled manner—notoriously hard-to-deliver therapeutic agents through topical administration. For more information, please visit; http://www.zylotherapeutics.com/

    Scientists at Einstein College of Medicine recently demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus. This work reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases.

    The work at Einstein supports the thesis that AEA loaded into Z-pods™ improves drug skin penetration, reduces the expected inflammatory cytokine secretion by keratinocytes when exposed to ultraviolet radiation, prevents the development of CLE skin lesions, improves skin histopathology, prevents inflammation and structural damage on histology and reduces macrophages and C3 accumulation.

    According to estimates by the Lupus Foundation of America (LFA), 1.5 Million Americans currently suffer from lupus, with 16,000 new cases reported annually. Tragically, lupus strikes mostly women of child-bearing age. Worldwide, the LFA estimates that at least five million people may have some form of the disease. Of the people diagnosed, approximately two-thirds will develop CLE. The annual average cost to provide medical treatment for a person with lupus: $6,000 to $10,000, with some treatment costing several thousand dollars a month.

    "Management is extremely pleased to partner with Zylö Therapeutics, enhancing our portfolio of unique treatments for patients suffering from various dermatological related ailments," stated, Mr. Robb Knie, CEO of Hoth Therapeutics.  "Zylö's initial work shows significant promise in combating Cutaneous Lupus Erythematosus, and we look forward to working with them in order to bring this treatment to market."

    "We are thrilled to partner with Hoth, a company that is committed to innovative solutions and partnerships to develop treatments for diseases with a high unmet clinical need, such as lupus," said Scott Pancoast, CEO of Zylö. "As we work with the Hoth team to advance AEA-loaded Z-pods through the next stages of development, we expect to further demonstrate the important role that our patented Z-pod delivery system plays in improving treatment outcomes."

    The term sheet is non-binding and neither party thereto shall have any obligation to consummate a transaction of any kind until such time as the parties have entered into a mutually agreeable definitive agreement. There can be no assurance that any such definitive agreement will be entered into or that the transaction will be completed on the terms set forth in the term sheet, or at all.

    About Hoth Therapeutics, Inc.

    Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.

    Forward Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth's current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Hoth's Form 10K for the period ending December 31, 2018, and Hoth's other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.