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Pharmacists Reimagine Myeloma Care With Insights from ASCO

Pharmacy Times

This is progressing through a phase 3 trial and includes comparator arms with standard-of-care treatments like daratumumab, bortezomib (Velcade; Millennium/Takeda and Janssen Pharmaceutical Companies), and lenalidomide. 2 We’re still trying to figure out where these new treatments best fit.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.

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Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmTech

Pharmaceutical companies have responded with growing investment in the research and development of novel eye treatments and drug delivery systems designed to address key challenges in ocular therapy. 2023 39 (2), 102-116. link] Gautam, M.; Intracameral Drug Delivery: A Review of Agents, Indications, and Outcomes.

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EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

PharmTech

SHOW MORE EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies. In October 2023, EMA published a concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs testing approaches (4). EC.europa.eu. EC.europa.eu.

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Sanofi to Begin Globally Shipping Beyfortus Ahead of RSV Season

Pharmaceutical Commerce

and outperformed maternal vaccines in public health programs. Vaccines to treat RSV normally start in early fall, and having these additional shipments in advance is expected to give healthcare providers (HCPs) an additional assurance and confidence. Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages.

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FDA Approves Label Update for Novartis’ Leqvio to Enable Twice-Yearly Monotherapy for LDL-C Management in Adults with Hypercholesterolemia

PharmExec

The company also noted that the label update meets an unmet need, with up to 80% of patients with atherosclerotic cardiovascular disease (ASCVD) facing challenges in achieving the LDL-C guideline-recommended target of less than 70 mg/dL. He also explains dark social, how to combat misinformation, closing the trust gap, and more.

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Harnessing industry advancements to accelerate upstream process development

European Pharmaceutical Review

In recent years, leading pharmaceutical companies, such as Sanofi, successfully launched smart factory programmes. Li Yang, PhD Vice President of CMC Development, Altruist Biologics Dr Li Yang brings over 10 years of industry expertise in biological drug and vaccine development, manufacturing and registration.