Small Molecules Lead in Recent New Drug Approvals

DCAT Value Chain Insights | February 05, 2020

Small molecules still lead over biologics in recent drug approvals, accounting for nearly three-fourths of drug approvals over the past several years, but will small molecules' dominance continue? DCAT Value Chain Insights takes an inside look. One measure to evaluate the role of small molecules versus biologics is to look how they have fared in recent approvals of new molecular entities (NMEs) by the US Food and Drug Administration’s Center for Drug Evaluation and Research. Between 2015 and 2019, small molecules have accounted for nearly three-fourths of NME approvals by the FDA’s

Spotlight

Major Depressive Disorder is one of the most common psychiatric disorders in the US, with over 15 million people impacted and costing $100 billion annually, of which less than half achieve symptom remission with the first medication tried. The cost associated with a prolonged duration of depressive symptoms is substantial, including lower employment levels and higher risk for a range of other general medical conditions.

Spotlight

Major Depressive Disorder is one of the most common psychiatric disorders in the US, with over 15 million people impacted and costing $100 billion annually, of which less than half achieve symptom remission with the first medication tried. The cost associated with a prolonged duration of depressive symptoms is substantial, including lower employment levels and higher risk for a range of other general medical conditions.

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BUSINESS INSIGHTS

Resilience Establishes Multi-Product Development and Manufacturing Collaboration with Takeda’s Plasma-Derived Therapies Business Unit

Resilience | February 16, 2022

National Resilience, Inc. a technology-focused manufacturing company dedicated to broadening access to complex medicines, announced a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit. As part of the agreement, Resilience will focus on supporting the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario. “I’m proud to establish this relationship with Takeda, a company that has been pioneering plasma-derived therapies for more than 75 years. By bringing new technologies and innovation to biomanufacturing, we aim to help companies like Takeda reach more patients in need.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience Resilience’s 136,000 sq ft (12,800 m2) biomanufacturing facility in Mississauga provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines. “We are delighted to form this strategic collaboration with Resilience, leveraging their expertise in both plasma therapy development and manufacturing to complement our current infrastructure and capabilities,” said Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for the Plasma-Derived Therapies Business Unit at Takeda. “Our partnership will allow us to optimally use our combined assets to continue to bolster our portfolio, drive innovation and help more patients around the world realize the benefits of plasma medicines.” About Resilience Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

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Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing

Thermo Fisher | October 15, 2020

Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing. As of mid-2020, 675 clinical trials were underway globally for cell therapy and cell-based immune-oncology, according to the Alliance for Regenerative Medicine. Yet few cell therapies in development become commercially available due to several factors: safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability of these therapies, high cost of facilities, labor and equipment, and complexity of the processes involved.

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BUSINESS INSIGHTS

FGC Health Expands Solutions Offerings With Acquisition of Pharmacy Access Solutions Inc (PASI)

FGC Health | March 04, 2022

FGC Health, a national leader in consumer health services, industry-specific business tools and provider of an industry-leading proprietary open-source platform, announced today it has acquired Pharmacy Access Solutions Inc. (PASI), an industry leader in the development of real-time, smart technology solutions in support of automated patient-centric programs and professional service modules, as well as financial and performance reporting for independent owners and banner groups. PASI will continue to operate as a standalone organization. FGC Health has acquired the entirety of PASI and its business for $4 million USD, and will begin integrating PASI’s solutions into its own industry-leading proprietary open-source platform, to further strengthen its own solutions’ capabilities, offering an end-to-end suite of business tools for the healthcare industry. “Our goal has always been to provide a complete suite of industry-specific business tools for businesses of all kinds within the Canadian healthcare system, and with today’s announcement, we are very excited to be able to bring the power of PASI’s solutions onto our platform, with the purpose of empowering independent pharmacies to thrive in a very competitive market. As a business who has served the Canadian healthcare industry for 20 years, PASI also brings with them a team with a deep well of industry knowledge and a shining track record of bringing excellence and innovation to the retail pharmacy industry, and we look forward to everything our businesses will be able to achieve together for Canadian healthcare providers in the future.” Dalbir Bains, CEO of FCG Health PASI’s software solutions include real-time automation capabilities, as well as a unique, cost-effective, and scalable “middleware” conduit, and centralized cloud-based data solution, allowing proprietary integration capability across multiple software and data platforms, including but not limited to Pharmacy Management Systems, Point of Sale Systems, Electronic Medical Records, and Financial Accounting Software, designed with the objective of improving operational efficiencies for independent retail pharmacy. About FGC Health FGC connects your health care business to FGC’s proprietary open-source platform. This connected platform enables health care professionals to practice at the top of their license along with providing a more connected and engaging experience for its patients. FGC owns, operates, and services independent pharmacies, medical clinics, home health care and ambulatory care services. Please visit www.fgchealth.com to learn more about the company and its software offerings. About Pharmacy Access Solutions Inc. Pharmacy Access Solutions Inc. (PASI) is an industry leader in the development of real-time, smart technology solutions that efficiently and effectively support the implementation of patient-centric programs and professional services within the pharmacist’s expanded scope of practice. .

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