APhA: Transparency, Safety and Availability Must Be Core Principles for Strengthening America's Drug Supply Chain

APhA | August 11, 2020

The reliability, quality and safety of our nation's drug supply chain are essential to the nation's security and health and well-being of the American public. Therefore, we welcome comprehensive federal efforts to improve the state of our drug supply chain, particularly at a time when our health care system is under extraordinary stress. The President's Executive Order last week, "Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States," is an important step forward, recognizing that available and safe medications and medical devices are essential to the health and well-being of our nation.

Spotlight

The diversity of products that contain cannabis means that a “one-size-fits-all” regulatory framework would be ineffective.

Spotlight

The diversity of products that contain cannabis means that a “one-size-fits-all” regulatory framework would be ineffective.

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PHARMA TECH

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex | December 14, 2020

Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42. The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients. Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed,novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature. "We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."

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BUSINESS INSIGHTS

CordenPharma Completes Acquisition of Three Manufacturing Facilities from Vifor Pharma

CordenPharma | February 01, 2022

CordenPharma, a leading, full-service Contract Development & Manufacturing Organization supplying APIs, Excipients, Drug Products, and associated Packaging services, announced today the completion of the acquisition of three manufacturing facilities from Vifor Pharma, to be ultimately renamed Corden Pharma Fribourg S.A. in Switzerland, and Corden Pharma Lisbon S.A. in Portugal. "We welcome the three sites and their employees as new members to the CordenPharma Group and look forward to working with Vifor in the future to supply Vifor Pharma's finished drug products, including to their already existing customers. The acquired pharma sites have a well-trained workforce with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities." Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma The acquisition of the Vifor Pharma manufacturing sites will expand CordenPharma's capabilities and capacities in the manufacturing of non-sterile drug product dosage forms, including but not limited to, Oral Solid Dosage (OSD) forms such as tablets and capsules. With the addition of these three new facilities, CordenPharma's global network now consists of twelve locations (11 GMP sites and 1 R&D laboratory), supported by > 2,600 employees generating expected sales of over 800 Mio € in 2022. About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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PHARMACY MARKET

Sensyne Health and Phesi Form a Joint Commercial Development Partnership with a Leading Pharmaceutical Company

Sensyne Health, Phesi | May 24, 2021

Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc. Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client. This collaboration's financial terms have not been disclosed. About Sensyne – Phesi Strategic Alliance Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients. About Sensyne Health Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines. About Phesi Inc. Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.

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