Fourth carcinogen discovered in heart pills used by millions

Indiatimes | June 19, 2019

Fourth carcinogen discovered in heart pills used by millions
An online pharmacy told U.S. regulators it found another cancer-causing chemical in widely prescribed blood-pressure pills, raising new questions about a complex global web of companies that produces medicine for millions of people. A solvent called dimethylformamide was discovered in the drug valsartan made by several companies, including Swiss pharmaceutical giant Novartis AG, according to a filing last week to the Food and Drug Administration by New Haven, Connecticut-based Valisure. Dozens of forms of generic valsartan have been recalled since July 2018, when the carcinogenic chemical N-Nitrosodimethylamine, or NDMA, was detected in a version of the drug made by a Chinese company. Valsartan is a decades-old treatment for hypertension that is frequently combined with other medicines into a single pill. Valisure found DMF in valsartan that is still on the market in the U.S., including in medicines the FDA had highlighted as alternatives to recalled drugs.

Spotlight

The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasingly strategic role. There will be a need for greater agility and improved speed to market – while ensuring compliance with myriad regulatory requirements in countries – forming a challenging landscape for the global pharma industry.

Related News

KYAN Therapeutics Exclusively Licenses Small Molecule HDAC Inhibitors for AI-Powered Cancer Drug Development

KYAN Therapeutics, Inc. | September 24, 2020

KYAN Therapeutics, Inc. ("KYAN"), a frontier biotech company with a novel drug-dose combination optimizing platform, Optim.AI, has entered into an exclusive license agreement with Georgetown University for novel selective Class II HDAC inhibitors. KYAN has already commenced preclinical development of the lead candidate, which has been designated as KYAN-001, with early positive results. In vitro and in vivo studies of KYAN-001 have shown high efficacy for Multiple Myeloma and Prostate Cancer. The low toxicity and metabolic stability of KYAN-001 indicates a better safety and tolerability profile than FDA approved pan-HDAC inhibitors which suffer from toxicity issues and side effects. KYAN-001 also uniquely inhibits HDAC4 nucleoshuttling to further drive its anti-cancer effects.

Read More

PHARMA TECH

KSP Specialty Pharmacy now offers access to non-oncology drugs and launches new website featuring pharmacy patient portal

Karmanos Cancer Institute | October 05, 2021

The Barbara Ann Karmanos Cancer Institute and KSP Specialty Pharmacy (KSP) are pleased to announce the launch of new services and a new website: www.ksppharmacy.org. The new site features provider resources and information for payers and pharmaceutical companies. Most notably, the site includes an online portal where patients can refill their prescriptions. This tool also allows patients to see their list of medications, get reminders and interact with their pharmacist. A portal for patient education and tips is forthcoming. Additionally, KSP has begun offering non-oncology specialty drugs to serve providers and patients throughout the McLaren Health Care network. KSP is a specialty pharmacy within the McLaren Health Care Network, serving the needs of patients with complex disease states and high-cost therapeutic treatments. KSP began as an extension of the Barbara Ann Karmanos Cancer Institute in 2019 and has since grown to assist with specialty medication needs of patients throughout the McLaren system in Michigan, Ohio and Indiana. Additionally, the Karmanos ambulatory pharmacy, which provides non-specialty medication, has launched a portal with similar functionality. Those undergoing cancer treatment at Karmanos can now access their prescription information and request refills on the Karmanos pharmacy web page. We are continually striving to provide our patients with tools and convenience to help them understand their treatment. The new website and app will provide the outstanding service we offer over the phone and in person on a new, convenient platform, - Stephen Smith, RPh, MS, FASHP, Chief Pharmacy Officer. KSP provides patient care and customer service through a panel of expert clinical pharmacy specialists that can assist in drug education and management of not only a patient's specialty prescriptions, but their entire prescription portfolio. The pharmacy team has direct access to the patient's medical records and providers to ensure the time to delivery of the first dose is swift. In fact, the average rate to the first dose at KSP during fiscal year 2021 is 3.92 days, while the industry standard is more than ten days. A primary goal is to ensure that our in-house social worker and account resolution team find unique programs to allow patients access to high-cost medications without being financially burdened. This allows patients to stay adherent and compliant with their prescribed therapies and start a path to faster healing and recovery. Specialty medications are used to treat complex health conditions that include hepatitis C, multiple sclerosis, cancer, rheumatoid arthritis, organ transplant, migraines and others. KSP Specialty Pharmacy's expanded services include the ability to dispense medications for patients within the McLaren Health System who face these disease states. These medications may need to be administered by a health care professional, self-injected or taken by mouth, which may require clinical monitoring. Specialty medications often require special handling, delivery and storage requirements. KSP is accredited by the Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC). URAC designation was earned in 2020 and allows for the provision of agents in other specialized areas, such as HIV, gastroenterology, neurology and many others. About the Barbara Ann Karmanos Cancer Institute Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment and compassion. Our vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in the state of Michigan. For more than 75 years, our administrative and research headquarters, along with our premier specialty cancer hospital, have been located in downtown Detroit. Our 15 network sites throughout the state deliver market-leading cancer care and clinical trials conveniently to the communities where many of our patients live. Karmanos is recognized by the National Cancer Institute as one of the best cancer centers in the nation. Our academic partnership with the Wayne State University School of Medicine provides the framework for cancer research and education – defining new standards of care and improving survivorship.

Read More

PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

Read More

Spotlight

The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasingly strategic role. There will be a need for greater agility and improved speed to market – while ensuring compliance with myriad regulatory requirements in countries – forming a challenging landscape for the global pharma industry.