Trump trade adviser, citing 'broken system,' calls for more drug manufacturing in Puerto Rico

Fiercepharma | June 01, 2020

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico. In an interview with the Washington Examiner, White House trade adviser Peter Navarro faulted a “broken system” that pushes manufacturing offshore. He called on Congress to use the next round of COVID-19 relief to incentivize manufacturing on the island territory.

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Doctors often use survival rates as a standard way of discussing a person's outlook (prognosis). These numbers can’t tell you how long you will live, but they might help you better understand your prognosis. Some people want to know the survival statistics for people in similar situations, while others might not find the numbers helpful, or might even not want to know them.

Spotlight

Doctors often use survival rates as a standard way of discussing a person's outlook (prognosis). These numbers can’t tell you how long you will live, but they might help you better understand your prognosis. Some people want to know the survival statistics for people in similar situations, while others might not find the numbers helpful, or might even not want to know them.

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WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware

WuXi AppTec | August 17, 2022

WuXi STA, a leading Contract Research, Development, and Manufacturing Organization is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. First announced in June 2021, this site will be WuXi STA's second facility in the United States, offering expanded capacity and greater flexibility to meet the needs of customers in the U.S. and around the world. The WuXi STA Middletown site is located in the Middletown Business Center at 1091 Industrial Drive, and the new state-of-the-art facility will create approximately 500 full-time jobs by 2026. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution services for clinical trial materials and commercial drug products. WuXi STA has 12 sites across the U.S., Europe and Asia that offer a range of services and meet or exceed all regulatory standards. Together with three other drug product manufacturing sites in Couvet Wuxi City (China) and Shanghai this new facility will further enhance the company's global drug production capacity and capabilities. "The biopharmaceutical industry is part of Delaware's DNA. Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware's fastest-growing communities, bringing with it good jobs and economic growth. This campus is only possible because of Delaware's world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible." Delaware Governor John Carney "The First State continues to be a first-rate destination for businesses looking to innovate and grow," said Senator Tom Carper. "This investment by WuXi STA helps position Delaware as a continued global leader in biopharmaceuticals, further cementing the manufacturing might of one of our fastest growing communities. Delaware's workforce is ready to help build the future of our life-saving pharmaceuticals. This state-of-the-art campus will create good jobs and help fortify our supply chains here at home." "This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region," said Senator Chris Coons. "I am excited about WuXi STA's decision to choose Middletown for one of their new manufacturing facilities. This isn't just the largest private-sector investment in Middletown's history – it's a defining moment that will bring many more good-paying jobs to Delaware and will further cement the First State as a world leader in biopharmaceutical research and manufacturing. Thanks are due to everyone from Middletown to Dover to Washington who helped us get to this point, whether by making continued investments in NIIMBL, improving our education system from kindergarten to our universities, or ensuring that Delaware workers have the skills manufacturers like WuXi AppTec are looking for." "As the First State, Delaware has always had a spirit of innovation – constantly seeking new opportunities and ventures that will strengthen our economy and our state as a whole," said Rep. Lisa Blunt Rochester. "Today's groundbreaking of the WuXi STA pharmaceutical manufacturing plant represents another step in that spirit of innovation – bringing good-paying jobs to Middletown and strengthening communities throughout Delaware. The state-of-the-art facility will bring 500 full-time jobs over the next several years, growing our state's workforce and allowing us to manufacture more goods domestically - enhancing our economic competitiveness on the global stage." "We are truly looking forward to our partnership with WuXi STA, as the groundbreaking today marks the kick-off to them making their new home in Middletown, Delaware. WuXi STA will be joining our bustling industrial area, just steps away from Clarios, Datwyler, Amazon and Breakthru Beverage, just some of the companies that have invested in Middletown. When asked by WuXi STA about our business-friendly attitude, these businesses expressed their wholehearted support for how we do business and we couldn't be more excited about WuXi STA wanting to join them, and the Town of Middletown, in our journey together," said Middletown Mayor Ken Branner. Branner added he was thankful for the support of Gov. John Carney and the Delaware Prosperity Partnership. "I would like to thank our federal, state and local partners in Delaware for their continued support in the establishment of this site," said Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA continues to increase our capabilities and capacities to better serve our customers through a more robust and reliable supply chain. With our integrated Contract Research, Development, and Manufacturing Organization platform and proven quality system, we look forward to working with our customers to swiftly deliver their innovative therapies to market in order to save lives and improve healthcare for patients." About WuXi STA WuXi STA a subsidiary of WuXi AppTec is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Research, Development, and Manufacturing Organization WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

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BUSINESS INSIGHTS

Cosán and Genomind Partner to Help Prevent Adverse Prescription Drug Events for Older Adults

Cosán and Genomind | July 20, 2022

Cosán, a provider of technology-driven preventative care services for older adults and the physicians that support them, and Genomind, a leading precision healthcare company, have partnered to fill an existing gap in aging adult care management by providing Cosán’s network of physicians with Genomind’s integrated precision medication management platform. The platform will provide insights that will help Cosán to achieve the best outcomes for their patient population, prevent adverse drug events and reduce avoidable costs of medication mismanagement. With over 40% of U.S. adults 65 years of age and older taking five or more prescription medicines, aging populations are at high-risk for adverse drug events. Through this partnership, Genomind’s analytic capabilities will provide Cosán with risk stratification insights, enabling Cosán clinicians to target individuals that are most likely to benefit from medication reviews and pharmacogenetictesting, also known as drug-gene testing. Genomind’s PGx test adds a layer of precision medicine that leverages genetics to help providers select appropriate medications and dosing. Equipped with advanced pharmacogenetic screening, clinical concierge services and access to expert pharmacists, Cosán’s care teams can then incorporate individualized insights into each patient’s chronic care management plan so medications are administered safely. “This partnership brings a new level of pharmacy and genetic expertise to the thousands of providers and the patients they support, marking yet another stride in the delivery of effective preventative care management services. These unique drug analytic and genetic testing capabilities provide Cosán’s network of physicians and care coordinators with another tool designed to help eliminate avoidable drug risks and improve overall care quality for vulnerable patients receiving care from their homes.” David Hunt, Founder & President at Cosán According to the CDC, adverse drug events cause approximately 1.3 million emergency department visits each year, and older adults are nearly seven times more likely to end up hospitalized after such events than younger persons. Many of these adverse events are caused by just a few drugs. This new platform will help physicians develop personalized therapeutic approaches for patients based on their individual genetic makeup and are designed to improve patient and physician satisfaction and reduce medical expenses. With the recent expansions by Medicare to cover PGx testing in certain circumstances, this population is particularly suited to dramatically benefit from this platform. “The prevalence and cost of medication mismanagement is unacceptable, costing thousands of lives and billions of dollars annually. We’re thrilled to join Cosán in helping to improve care management for older adults, who are at high risk for these adverse drug events,” said Cynthia Kilroy, Co-CEO, Genomind. About Cosán Group Cosán Group, established in 2015, is an industry-leading healthcare organization creating new pathways to modern aging with technology-driven preventative care services, offering concierge home care for older adults. Early market exposure in the delivery of technology and services to support the Chronic Care Management (CCM) program, and Behavioral Health Integration (BHI) programs with Remote Patient Monitoring (RPM) has propelled Cosán to deliver a practice and patient-centric approach to remote care coordination. About Genomind Genomind is a leading precision health company focused on optimizing the treatment experience for individuals and healthcare providers through actionable genetic insights and innovative health technology. Genomind’s platform integrates precision health technology and pharmacogenetic testing on an individual and population level beyond mental health. Built on the foundation of compassionate care and clinical expertise, Genomind is empowering a more targeted and personalized approach to medication management and supporting providers in a new standard of care.

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Catalent to Acquire Metrics Contract Services for $475 Million to Expand High-Potent Capabilities and Oral Development and Manufacturing Capacity

Catalent, Inc. | August 10, 2022

Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that it has reached an agreement to acquire Metrics Contract Services a full-service specialty Contract Development and Manufacturing Organization with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited. Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent's capacity to handle highly potent compounds. The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units. “This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas,” said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment. “Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers,” Scott Richards, Chief Executive Officer of Mayne Pharma The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms. The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity. ABOUT CATALENT Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce of approximately 19,000 includes more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. ABOUT METRICS CONTRACT SERVICES Metrics Contract Services, a division of Mayne Pharma Group Limited, is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for novel oral dosage forms. Metrics provides formulation development, analytical testing and commercial manufacturing from its single-campus facility in Greenville, North Carolina

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