FDA declares 40 generics free of carcinogens as 'sartan' recalls continue

FDA | April 05, 2019

As recalls on blood pressure drugs continue to plague drugmakers, the FDA declared a slate of 40 generic pills safe to use. On Thursday, the agency released a list of 40 generic angiotensin II receptor blockers (ARBs) that are free of three potentially carcinogenic compounds linked to various “sartan” drugs, including valsartan and losartan. The FDA launched a global recall in 2018 after a U.S. drug manufacturer found high levels of N-nitrosodimethylamine (NDMA) in the valsartan active ingredient it had bought from a Chinese supplier. Since then, the FDA discovered that NDMA, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA—all considered unsafe at certain levels—can be created during sartan drug manufacturing under certain conditions. The first global recall included all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco.

Spotlight

As new weight management medications are being developed, might the obesity market parallel the likes of hypertension or high blood pressure to become the next blockbuster Pharma category?

Spotlight

As new weight management medications are being developed, might the obesity market parallel the likes of hypertension or high blood pressure to become the next blockbuster Pharma category?

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BUSINESS INSIGHTS, PHARMACY MARKET

AEON Biopharma to Become Publicly Listed via Merger with Priveterra Acquisition Corp.; Accelerating Clinical Development of ABP-450

AEON Biopharma | December 14, 2022

AEON Biopharma, Inc. a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 injection for therapeutic indications, and Priveterra Acquisition Corp. a special purpose acquisition company announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol AEON Uniquely Positioned to Capitalize on Global Therapeutic Neurotoxin Opportunity Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX® Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products. The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX®, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA. Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450’s commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved. AEON’s therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success. About Priveterra Acquisition Corp. Priveterra Acquisition Corp. is a blank-check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in life sciences. Priveterra is sponsored by Robert Palmisano and Priveterra Capital, LLC.

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BUSINESS INSIGHTS, PHARMACY MARKET

Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma

Visiox Pharma LLC | December 09, 2022

Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced that it has received notification from the U.S. Food and Drug Administration that the agency has completed its filing review and accepted for filing the New Drug Application for PDP-716 for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act target action date of August 4, 2023. "The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716. If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals." Ryan Bleeks, Chief Executive Officer About Visiox Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals. Visiox plans to soon submit a second New Drug Application for SDN-037 to the U.S. FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJMTM proprietary formulation. The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 20501. PDP-716, SDN-037, and TearActTM delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.

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BUSINESS INSIGHTS, PHARMA TECH

Avita Acquires Q Care Plus, Renames It Avita Care Solutions

Avita Care Solutions | January 10, 2023

PMQ Investors, LLC, the parent company of Avita, has acquired Q Care Plus, Inc. This community-focused care management solution offers stigma-free access to care via telehealth, focusing on telePrEP services. Meanwhile, the terms and conditions of the deal are yet to be revealed. "Bringing Avita and Q Care Plus together comes at a time when reducing health inequities among underserved populations is more critical than ever," said Avita Chief Executive Officer Michael Yount. He further added, "A multiyear pandemic, partisanship-based politics that limit health care rights, and long-standing stigma, fear, and discrimination against marginalized populations like the LGBTQ+ community have exacerbated existing obstacles to health care and created a host of new ones." (Source: PR Newswire) Avita can now broaden its commitment to a community care management strategy that eliminates obstacles for patients and covered entities throughout the care continuum due to its acquisition of Q Care Plus. The company promotes patients' and covered entity partners' capacity to acquire culturally competent LGBTQ+, HIV, PrEP, and sexual wellness care by providing comprehensive access to pharmacy services, 340B program administration, clinical care delivery, and digital health choices. Avita is transitioning to Avita Care Solutions in light of its recent growth. This brand will encompass Avita Pharmaceutical, the company's pharmacy services section, and AvitaCare Atlanta, its new Atlanta medical and primary care center and pharmacy previously owned by AbsoluteCare. There are no plans to rebrand Q Care Plus' digital health platforms. In 2023, Avita will start selling Q Care Plus under the Avita family of brands. About Avita Care Solutions Avita Care Solutions is committed to improving health equity by giving underserved communities comprehensive, caring, and all-inclusive health care and pharmacy services. Its strategy for managing care in the community makes it possible for patients and covered entities to eliminate barriers across the care continuum. Over 145,000 patients and 320+ covered organizations at 65+ locations benefit from Avita's community care management strategy, which includes pharmacy services, program administration, digital health, and clinical care delivery.

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