Top U.S. health officials self-quarantine after COVID-19 cases in White House

Fiercepharma | May 11, 2020

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. As many businesses in America take steps toward carefully reopening, top U.S. officials guiding the pandemic response are dealing with a COVID-19 outbreak in the country's most high-profile workplace—the White House. After a White House staffer tested positive for COVID-19, FDA Commissioner Stephen Hahn, M.D.; National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D.; and Centers for Disease Control and Prevention Director Robert Redfield, M.D., are going into partial or full quarantines for two weeks, CNN reports.

Spotlight

Breast cancer can happen to nearly any woman or man, but certain factors can increase a person’s risk for the disease. On The Doctors, our Dr. Freda Lewis-Hall explains why not all risk factors are created equal.

Spotlight

Breast cancer can happen to nearly any woman or man, but certain factors can increase a person’s risk for the disease. On The Doctors, our Dr. Freda Lewis-Hall explains why not all risk factors are created equal.

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PHARMA TECH

Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation

Sebela Pharmaceuticals | January 06, 2021

Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States. SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. The tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients' willingness to undergo colonoscopy screening for colorectal cancer. 1 The American Cancer Society and the U.S. Preventive Services Task Force recommend adults undergo screening for colorectal cancer beginning at age 45.2 Colonoscopy is the gold standard detection method for colorectal cancer, a leading cause of cancer-related deaths that can be more effectively treated if caught early through screening.3 Within the last decade, the rate of colonoscopy procedures has increased significantly with approximately 18 million people now screened annually for colorectal cancer. "Alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "With the introduction of SUTAB tablets, we hope to take yet another important step toward removing some of the burden often associated with the preparation process – allowing more patients to feel confident in their choice to undergo a colonoscopy." The FDA approved SUTAB on November 10, 2020. The approval was based on positive Phase 3 clinical trials, which evaluated the safety and efficacy of SUTAB compared to FDA-approved preparations in 941 patients, including a traditional polyethylene glycol and ascorbate preparation (PEG-EA) for bowel cleansing prior to a colonoscopy.4

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PHARMACY MARKET

Edenbridge Pharmaceuticals Announces the Launch of DARTISLA ODT

Edenbridge Pharmaceuticals | March 01, 2022

Edenbridge Pharmaceuticals, LLC announced that DARTISLA ODT is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies. “DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.” “Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,” Deepak Thomas, Founder and CEO of Phil The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water. Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. About Edenbridge Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. About Phil Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access.

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BUSINESS INSIGHTS

Orsini Specialty Pharmacy Selected By Sanofi As A Limited Distribution Partner For Nexviazyme®

Orsini Specialty Pharmacy | September 28, 2021

Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that Sanofi has selected it as a limited distribution partner for Nexviazyme® (avalglucosidase alfa-ngpt). Nexviazyme, an enzyme replacement therapy (ERT), is used for treating patients one year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). This progressive and debilitating muscle disorder impairs a person's ability to move and breathe. For more information about Nexviazyme, please see the Full Prescribing Information. Pompe disease affects an estimated 3,500 people in the United States. It can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age. However, due to the broad spectrum of clinical presentations and progressive nature of the disease, it can take seven to nine years before patients receive an accurate diagnosis. As the disease progresses, people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility. Orsini's dedicated Pompe Disease Care Team's number one priority is providing exceptional care and compassionate support to patients and their families, We are proud to expand our partnership with Sanofi and add Nexviazyme to the growing number of enzyme replacement therapies we dispense to patients with rare diseases. - Mike Fieri, Orsini's Founder and Chief Executive Officer. About Orsini Specialty Pharmacy Providing patients with comprehensive and compassionate care since 1987, Orsini is the leading independent specialty pharmacy focused on rare diseases, gene therapies, and complex conditions. Orsini's high-touch care model centers around experienced, therapy-specific care teams that provide personalized care to patients based on their specific conditions and treatments. The company's comprehensive solutions include medication adherence programs, data analytics, customized manufacturer programs, and nationwide nursing coverage for convenient in-home infusion services. Headquartered in Elk Grove Village, IL, Orsini Specialty Pharmacy holds accreditations with URAC, the Accreditation Commission for Health Care (ACHC), ACHC's Distinction in Rare Diseases and Orphan Drugs, The Joint Commission, and the National Association of Boards of Pharmacy (NABP).

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