As tariffs affect the pharma industry, business strategies must evolve

STAT | September 25, 2019

The trade conflict with China seems to escalate, although it can change with a tweet. The first of two rounds of tariffs on billions of dollars’ worth of Chinese goods is now in effect, even as the final positioning or even talk of deals and delays are in flux. These tariffs have implications for pharmaceutical companies’ supply chain planning for active pharmaceutical ingredients (APIs), the components of drugs that produce their therapeutic effects. Tariffs on APIs imported from China pose risks for pharmaceutical companies, both for generic and name-brand products. According to IHS Markit, in 2017, the U.S. imported $3.9 billion worth of generic ingredients from China. Further, an estimated 80% of all APIs come from abroad, mainly China and India. Due to the fact that the Food and Drug Administration generally defines a drug’s country of origin as the final stop in the manufacturing process, companies can claim origins of a product in the U.S. even if they contain APIs from China, meaning that name brands are just as subject to the threat of tariffs. Compromising API importation will have financial impact on pharmaceutical companies and the patients they serve and could limit access to treatments because of potential slowdowns in production caused by limited API availability.

Spotlight

On www.xtalks.com - Just two months after Catalyst Pharmaceuticals received a rarely-issued Refuse to File letter from the US Food and Drug Administration (FDA), the biotech has faced more hurdles with the regulatory agency.

Spotlight

On www.xtalks.com - Just two months after Catalyst Pharmaceuticals received a rarely-issued Refuse to File letter from the US Food and Drug Administration (FDA), the biotech has faced more hurdles with the regulatory agency.

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BUSINESS INSIGHTS

ARS Pharmaceuticals Expands Executive Leadership Team with Addition of Pharmaceutical Commercialization Veterans

ARS Pharmaceuticals, Inc. | February 10, 2022

ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the expansion of its executive leadership team with the appointments of Harris Kaplan as executive vice president, commercial strategy and Daniel Relovsky as senior vice president, sales and marketing. Mr. Kaplan and Mr. Relovsky, accomplished industry veterans with proven track records of commercial strategy and launch execution, will be responsible for preparing for and leading the commercialization of neffy™, once approved. neffy, a proprietary composition of epinephrine, is a small, reliable, easy-to-use option that allows for needle-free intranasal delivery of epinephrine, the only drug approved for the emergency treatment of Type I allergic reactions, including anaphylaxis. "The appointments of both Harris and Dan to the ARS team represent another building block in our ongoing commercialization preparations for neffy. We believe neffy's 'no needle, no pain' delivery, small size for convenient portability, and ease of use can provide a patient-friendly solution for individuals and caregivers to more easily and reliably administer epinephrine sooner, achieving more rapid symptom relief and preventing the allergic reaction from becoming severe or life-threatening. I'm excited to welcome Harris and Dan, both of whom bring decades of product launch and commercial leadership experience to our leadership team, and look forward to benefiting from their expertise as we progress toward our mission of being an innovative pharmaceutical leader in the treatment of severe allergy." Richard Lowenthal, founder, chief executive officer and president of ARS Harris Kaplan, MBA, executive vice president, commercial strategy, will join the ARS commercial team as lead for commercial strategy and oversee launch preparations for neffy. He brings more than 40 years of global experience across the pharmaceutical, biotechnology and healthcare consulting industries and most recently served as managing partner of Red Team Associates. Throughout his career, Mr. Kaplan has worked on the development, launch and commercialization of over 125 new products across more than 40 therapeutic categories, including LIPITOR®, Nexium, VIAGRA®, HUMIRA®, ALLEGRA®, HERCEPTIN® and Trikafta, and Yescarta. He has extensive experience in establishing and building new product planning initiatives, leadership and development programs and managing global strategic operations. Mr. Kaplan earned an MBA in marketing and operations research from Temple University where he also taught in the MBA program for several years. Daniel Relovsky, senior vice president, sales & marketing, will be responsible for leading the U.S. sales and marketing organization for neffy. He brings more than 30 years of commercial and operational experience, including product launch leadership in highly competitive markets and in establishing new standard-of-care therapies. Mr. Relovsky specializes in commercial planning and efficient team building to address complex executions, and brings a diverse background and success record in specialty, orphan, and major therapeutic markets. Prior to joining ARS, Mr. Relovsky held various senior commercial and operational leadership positions at MAIA Biotechnology, Inc., Clarity Global Solutions, LLC., Puma Biotechnology, Inc., Somaxon Pharmaceuticals, Inc., Cephalon, Inc. (now Teva Pharmaceuticals, Inc.), Salmedix, Inc., Maxim Pharmaceuticals, Inc., Agouron Pharmaceuticals, Inc. (now Pfizer, Inc.), Women First Healthcare, Inc., and IQVIA. Mr. Relovsky earned his B.S. in business administration, finance from Drexel University. About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The company is developing neffy™, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient, and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

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CPD AND LEARNING

PostEra and NeuroLucent Partners on identifying small-molecule therapeutics for Alzheimer's disease

PostEra | November 27, 2020

PostEra, a biotechnology organization offering restorative science fueled by AI, today reported a joint effort with NeuroLucent, a Chicago-put together organization centered with respect to creating novel medicines for Alzheimer's sickness and different dementias. The disappointment of late-stage clinical preliminaries to reveal viable treatments for Alzheimer's illness has underscored the need to investigate novel helpful methodologies. NeuroLucent is creating novel little atom aggravates that standardize a key calcium direct that is dysregulated in Alzheimer's neurons and reestablish ordinary neuronal capacity in different preclinical Alzheimer's models. NeuroLucent has collaborated with PostEra to quicken its quest for a helpful up-and-comer. PostEra will utilize its AI innovation to upgrade NeuroLucent's lead mixes through a progression of 'plan make-test' cycles that has recently been appeared to quicken therapeutic science crusades. PostEra will likewise use its Manifold stage, which gives admittance to mixes through an overall organization of merchants and accomplice contract research associations. Business terms incorporate a forthright installment to PostEra, with extra installments upon the accomplishment of specific achievements. "We're excited about the potential of integrating PostEra's technology into the design of more potent compounds," said Bill Kohlbrenner, CEO of NeuroLucent. "We are intrigued by PostEra's machine learning algorithm since it doesn't require detailed structural information related to the drug target. We're looking forward to seeing what impact PostEra's AI solutions will have on our program." About NeuroLucent NeuroLucent holds an exclusive license to technology developed at the Rosalind Franklin University of Medicine and Science by Dr. Grace (Beth) Stutzmann, who uncovered a link between aberrant Ca2+ signalling, long known to occur in Alzheimer's neurons, and a Ca2+ channel that becomes 'leaky' in disease. NeuroLucent's preclinical stage compounds have been validated in multiple disease models and the current company focus is on identifying a clinical development candidate that addresses the cognitive loss associated with Alzheimer's disease.

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Telix Pharmaceuticals Enters Strategic Collaboration with Varian Medical Systems for Advanced Prostate Imaging

Telix Pharmaceuticals Limited | September 07, 2020

Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announced it has entered into a strategic collaboration agreement with Palo Alto-based Varian Medical Systems, to evaluate the use of advanced prostate cancer imaging within Varian’s radiation treatment planning platform. Under the terms of the agreement, the parties will leverage Telix’s extensive clinical data for imaging prostate-specific membrane antigen (PSMA) with positron emission tomography (PET) to potentially develop new image-guided treatment planning functions, automated analysis and artificial intelligence capabilities within Varian’s radiation treatment planning technology platforms. The goal of the collaboration is to ensure that the latest standard of care in prostate imaging is able to be an integral part of radiation treatment planning.

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