FDA

  • 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
    Nephron seeks to stem coronavirus concerns with expanded offerings see more

    In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.

    Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.

    Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.

    “We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.

    West Columbia-based Nephron has asked for FDA approval to add up to six filling lines for its respiratory medication manufacturing. CEO Lou Kennedy also announced the company will begin making hand sanitizer this week. (Photo/File)

    The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.

     

    “As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”

    To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.

    “We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”

    During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.

    “We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”

    The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.  

    Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.

    Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.

    Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.

    Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.

    “We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.

    Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.

    “We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”

  • Sam Patrick posted an article
    Nephron initiates EDI through Global Healthcare Exchange see more

    Nephron Pharmaceuticals Corporation initiated Electronic Data Interchange (EDI) ordering through the Global Healthcare Exchange, LLC (GHX) platform, accessible immediately.

    Joining GHX allows Nephron customers to purchase products on the FDA drug shortage list in one simple step. This platform enables purchasers to select products from multiple vendors in one place, rather than logging in to the Nephron online ordering system.  Utilizing the GHX cloud-based platform helps to reduce manual work and provides real-time data to view and validate order information. Nephron and its customers are working in real time, using all available data to streamline each process.

    “Nephron is constantly trying to improve the customer experience,” said Hank Jibaja, Chief Information Officer at Nephron. “We believe utilizing the GHX platform will decrease the time required from the hospital or ordering staff.”

    Nephron products including Sodium Bicarbonate, Phenylephrine, Labetalol and more are available for purchase through the GHX platform.

    Hospitals and surgery centers may contact Nephron toll free at 1-800-443-4313, or via email at customerservice@nephronpharm.com.

     

    About Nephron

    Nephron 503B Outsourcing is a division of Nephron Pharmaceuticals Corporation. This division produces pre-filled sterile syringes and IV bags for hospitals and surgery centers across America, in an effort to alleviate their drug shortage needs. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration as a sterile manufacturer of generic respiratory medications along with an Outsourcing Facility providing equal sterility and quality. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.

    About GHX

    Global Healthcare Exchange, LLC (GHX) is a healthcare business and data automation company, empowering healthcare organizations to enable better patient care and maximize industry savings using its world-class cloud-based supply chain technology platform. GHX brings together healthcare providers, manufacturers and distributors in North America, and Europe, who rely on proven healthcare-focused technology and comprehensive data to automate business processes and make more informed, timely and fact-based decisions. Solutions span procurement and accounts payable automation, contract and inventory management, vendor credentialing and management, business intelligence, payment management and other supply chain-related tools and services. For more information, visit www.ghx.com and The Healthcare Hub.

  • Sam Patrick posted an article
    FDA head Scott Gottlieb has resigned in an unexpected move see more

    WASHINGTON, March 5 (Reuters) - U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a sudden resignation that calls into question how the agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs.

    Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars.

    Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S. consumers and had the agency actively looking into possible solutions.

    Click here to read the full story.

  • Sam Patrick posted an article
    Learn about South Carolina Life Sciences Feb. 20! see more

    Industry subject matter experts to cover what businesses need to know

    about life sciences, South Carolina’s fastest-growing industry segment

     

    GREENVILLE, SC – February 4, 2019 – SCBIO will host a full day program February 20, 2019 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.

    To be held at the University of South Carolina’s Alumni Center in Columbia, the program will run from 8:30 a.m. until 4:30 p.m. and will feature a light breakfast followed by presentations from over half a dozen noted life sciences industry leaders.  Confirmed presenters and their topics are:

    • Tushar Chikhliker, Partner, Nexsen Pruet, “Pharma Industry Challenges Opportunities & Legal Insights”
    • Kathy Phlegar, Principal, Phlegar & Associates, “Product Development and Commercialization: The Changing  Landscape of Bringing MedTech Products to Market”
    • Maureen Thomas, National Institute on Aging/National Institutes on Health, “Early Stage Funding:  Accessing SBIR-STTR Capital”
    • Erica Jackson, Partner, K&L Gates, “Navigating the FDA: An Overview of Medical Product Approvals and Enforcement Trends”
    • Dave McGlashan, Life Sciences Team Architect, DPR Construction, “Optimizing Capability & Efficiency in Your Life Sciences Facility”
    • Darralyn Alexander, President, Reimbursement Strategies – “How To Gain Reimbursement For My New Technology”
    • Sam Konduros, President & CEO, SCBIO – “South Carolina Life Sciences 2019:  A Look Forward”

    SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations pay only $50 for the entire day.  Individual Members of SCBIO pay only $50 for the entire program, while the general public and Non-Members can attend for just $125.  To register or for more details, visit the Events page at www.SCBIO.org/.

    An additional highlight of the day’s program on “Early Stage Funding:  Accessing SBIR-STTR Capital” will be when presenter Maureen Thomas is joined for discussion and open Q&A by Tyler Tatum and Ron Gorman of 3PhaseSC – South Carolina’s only free resource for SBIR/STTR grant consulting.  Attendees may also schedule 1-on-1 time for afternoon discussion with Ms. Thomas between 1:15 PM and 3:30 PM for more detailed conversation and guidance.

    SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.

    SCBIO is also the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations.  SCBIO’s diverse membership is leading research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.

    For additional information on SCBIO, visit www.SCBIO.org.