Pfizer continues recalls of menopause drug Duavee on faulty packaging concerns

Fiercepharma | June 09, 2020

Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence. Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said Monday. Pfizer launched the recall after manufacturers identified a flaw in the drug's foil laminate pouch that introduced oxygen and lowered the dissolution rate of active pharmaceutical ingredient bazedoxifene acetate, the MHRA said.

Spotlight

This guideline is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of quality products to ensure their intended purpose and to protect the public health. The requirement in this guideline is established based on the mandate given to the Authority as stipulated in the Proclamation Number 661/2009 for the establishment of Food, Medicines and Healthcare Products in Ethiopia. GMP ensures that quality is built into the organization and processes involved in the manufacture of the products and all those operations should be carried out strictly according to cGMP.

Spotlight

This guideline is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of quality products to ensure their intended purpose and to protect the public health. The requirement in this guideline is established based on the mandate given to the Authority as stipulated in the Proclamation Number 661/2009 for the establishment of Food, Medicines and Healthcare Products in Ethiopia. GMP ensures that quality is built into the organization and processes involved in the manufacture of the products and all those operations should be carried out strictly according to cGMP.

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PHARMA TECH

COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis

COUR Pharmaceuticals | January 11, 2022

COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles to treat immune disorders, today announced the U.S. Food and Drug Administration granted Fast Track Designation to the Company's investigational therapy CNP-104 for the treatment of Primary Biliary Cholangitis. CNP-104 aims to reprogram the immune system to address autoimmune causes of PBC. "We are pleased to have received Fast Track Designation for CNP-104, which demonstrates the FDA recognizes the importance of this potential treatment for PBC and the need for improved of clinical outcomes for patients with this degenerative autoimmune disease, which currently has no treatment to stop progression of disease. Based on data from another COUR autoimmune trial with a CNP platform product, our Phase 2 PBC trial is designed to show that we can stop progression of PBC disease with improved liver function. If successful in Phase 2, COUR would seek breakthrough therapy designation in PBC given that current therapies treat only symptoms." COUR CEO John Puisis Fast Track Designation is an FDA process designed to facilitate the development and review of potential therapies that seek to fill an unmet medical need. The FDA created this designation to help get new therapies to patients earlier. A therapy that receives this designation is eligible for more frequent communication with the FDA and may be eligible for Accelerated Approval and Priority review, if relevant criteria are met. The FDA accepted COUR's investigational new drug application for CNP-201 in October 2021 and COUR is currently opening the first human dosing in a proof-of-concept study for CNP-104 in early 2022 to evaluate the safety, tolerability, pharmacodynamics and efficacy of the therapy in PBC patients. CNP-104 uses COUR's proprietary nanoparticle platform, a novel system which combines disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying liver cells from the body. In November 2021, Ironwood Pharmaceuticals, Inc., a GI-focused healthcare company entered into a collaboration and license option agreement with COUR for the development and commercialization of CNP-104. This agreement gives Ironwood an option to acquire an exclusive license to develop and commercialize, in the U.S., COUR's investigational therapy CNP-104 for PBC. About COUR Pharmaceuticals COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR's platform of immune-modifying nanoparticles is designed to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression. Data from clinical and preclinical settings demonstrate the opportunity for the COUR nanoparticle platform to address a wide range of immune and inflammatory conditions. The underlying technology was acquired from Northwestern University and draws from more than 30 years of research by the laboratory of Stephen D. Miller, Ph.D., the Judy E. Guggenheim Research Professor of Microbiology-Immunology.

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PHARMA TECH

Specifica Announces Antibody Discovery Platform Transfer Agreement with Sanofi

Specifica | June 03, 2022

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody libraries and discovery tools, announced an agreement with the global healthcare company Sanofi under which Specifica’s patented Generation 3 Antibody Discovery Platform will be transferred to Sanofi. The comprehensive technology transfer package will enable the integration of Specifica’s Gen 3 platform into Sanofi’s antibody discovery programs. “We are absolutely delighted to partner with Sanofi and their cutting-edge antibody discovery teams by providing our complete antibody discovery platform through a combination of Gen 3 libraries, antibody optimization solutions, and integrated discovery tools. We look forward to the realization of our collaboration with Sanofi as they continue to pursue the development of life-changing treatments.” Ken Sharples, CEO and co-founder of Specifica Specifica’s Gen 3 libraries combine clinically validated antibody frameworks with compatible binding loop sequences (CDRs) from natural human antibodies that have been purged of sequence-based developability liabilities. The Gen 3 discovery platform consistently yields a broad diversity of specific and developable antibodies with very high affinities, thereby avoiding downstream hit-to-lead optimization bottlenecks such as affinity maturation and developability optimization. About Specifica Specifica is a rapidly growing antibody engineering company specializing in the creation of exceptional antibody libraries, using next-generation sequencing for quality control at all steps of construction and validation. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies directly from selections, minimizing the need for downstream affinity and biophysical engineering. Specifica provides its partners with exclusive libraries, each created from a unique donor diversity set not used for any other library, ensuring that each Gen 3 library is one of a kind. Specifica offers antibody library platforms in Fab, scFv and VHH formats. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery and optimization campaigns, or by full transfer of the platform technology. Additionally, Specifica recently introduced AbXtractTM, a powerful suite of antibody informatics tools, through its software partner OpenEye. Specifica is headquartered in Santa Fe, New Mexico

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PHARMACY MARKET

Treosulfan, a First-In-Class Conditioning Agent, is Licensed in Canada by Medexus Pharmaceuticals and Medac GmbH

Medexus Pharmaceuticals | July 13, 2021

Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada. Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it. Medexus has been distributing treosulfan in Canada through the Special Access Program, and Health Canada recently approved Trecondyv for the treatment of adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes who are at increased risk for standard conditioning therapies, as well as pediatric patients older than one year with AML or MDS. About medac GmbH medac GmbH is a privately owned global pharmaceutical firm that is expanding its pharmaceutical and diagnostics businesses. Since its inception in Germany in 1970, medac has specialized in treating diseases related to oncology, hematology, urology, and auto-immune disorders. medac is dedicated to improving current therapeutic products and creating new ones to enhance patients' quality of life. In addition, medac has earned a reputation for developing novel medicines in less common indications. This dedication has resulted in a diverse range of pharmaceutical goods that positively impact the lives of patients. medac is constantly investing in product development and manufacturing and logistical capacities to fulfill the requirements of both patients and healthcare professionals. About Medexus Medexus is a market leader in novel rare disease treatment solutions, with a solid commercial platform in North America. We are building a highly distinctive business with a portfolio of innovative and high-value orphan and rare disease medicines that will support our growth for the next decade, based on a foundation of proven best-in-class medications. Through our key principles of Quality, Innovation, Customer Service, and Teamwork, the Company's goal is to offer the finest healthcare products to healthcare professionals and patients. Medexus Pharmaceuticals specializes in the treatment of auto-immune illness, hematological, and allergies. Rasuvo and Metoject, a unique methotrexate formulation (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor

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