Drug prices come under fire as US pharma lobby nears spending records

europeanpharmaceuticalreview | April 23, 2019

Drug prices come under fire as US pharma lobby nears spending records
More ambitious changes may be needed to lower pharmaceutical prices as the Trump administration proposes new rules and approves a slew of new generic drugs. Large drug makers and the pharmaceutical industry’s primary trade group neared previous spending records on lobbying in the first three months of 2019 as President Donald Trump and US Congress increase pressure to reduce the cost of medicine.

Spotlight

The U.S. healthcare ecosystem has faced a myriad of changes in just the last decade, and pharmaceutical companies continue to face the effects of those changes. The players have become more diverse, and today’s target audience for pharmaceuticals has expanded to include healthcare organizations, payers, government agencies, pharmacy benefit managers and, most importantly, patients.


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PHARMACY MARKET

medical leverage, a communications company positions itself for 2022 growth

medical leverage | January 15, 2022

medical leverage, a communications company is pleased to announce the promotion of Justin Reed to VP of Finance, Alexandra Rivers to HR and Training Manager, and Janeanne Josephson to Associate Marketing Manager. These changes drive the company's mission to meet the challenges of today's unique market. With the additional hiring of several project managers to the team, ml is positioning itself well for growth in 2022. These promotions are all important shifts in responsibility that will ensure ml's service levels are enhanced during its expansion efforts. "Our 2022 expansion efforts started at the stroke of midnight on the new year, thus spring-boarding our talent acquisition initiatives. We continue to attract top-notch thinkers and doers by focusing on creating a culture where we offer improved operations, continued staff training, and product enhancements to best serve our current and future clients. As always, our expansion approach is guided by our core values and steered by our Executive Leadership Team." medical leverage's president, Dave Oury ABOUT medical leverage is a medical communications company that provides full-service solutions to pharmaceutical, biotech, biopharmaceutical, medical device, and medical diagnostic companies. We elevate healthcare communications through education by partnering strategically with life science companies and providers. For over twenty years, we have had the distinct honor of working with marketing, medical affairs, sales training, and market access teams within US and international companies. We know that behind every program there is a product and behind every healthcare professional there is a patient. We focus on our clients, so they can focus on healthcare professionals and, ultimately, their patients.

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BUSINESS INSIGHTS

Cullinan Oncology Forms Strategic Collaboration Agreement with Mount Sinai to Advance Oral HPK1 Protein Degrader for Cancer Treatment

Cullinan Oncology, Inc. | January 10, 2022

Cullinan Oncology, Inc. a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today announced the Company has entered into a collaboration agreement with the Icahn School of Medicine at Mount Sinai to develop novel small molecule immune modulators.​ This exclusive option and multi-year collaboration agreement will be focused on the optimization and development of oral protein degraders targeting hematopoietic progenitor kinase 1 (HPK1), a key regulator of immune cell activation and a high-priority target in immune-oncology. The collaboration aims to accelerate the development of novel, best-in-class HPK1 degraders that stimulate robust anti-tumor immunity. The research will be conducted by leading scientists at both Cullinan and Icahn Mount Sinai. Cullinan will fund the collaboration and has an exclusive option to license the intellectual property for further development and commercialization. The Icahn Mount Sinai team will be co-led by Steven J. Burakoff, M.D., Lillian and Henry M. Stratton Professor of Cancer Medicine, Dean for Cancer Innovation, and Chief, Pediatric Oncology at Icahn Mount Sinai, and Jian Jin, Ph.D., Mount Sinai Professor in Therapeutics Discovery and Director, Mount Sinai Center for Therapeutics Discovery, at Icahn Mount Sinai. “Our team is excited to work with the talented and experienced cancer drug developers at Cullinan. Our research has already demonstrated that a degrader approach to targeting HPK1 may control tumor growth more effectively compared to simply inhibiting HPK1 kinase activity. We believe this collaboration will help us identify novel, differentiated oral HPK1 degraders and can bring future benefit to cancer patients worldwide.” Dr. Jin “We are proud to partner with Icahn Mount Sinai, which is at the forefront of cancer research and patient care,” said Leigh Zawel, Chief Scientific Officer, Small Molecules, of Cullinan Oncology. “We are very excited to build on the synergy between the deep scientific expertise of the Icahn Mount Sinai team and the strong drug development capabilities at Cullinan to advance therapies that have the potential to significantly improve the lives of patients with cancer. We look forward to a fruitful collaboration in this novel area of science.” About Cullinan Oncology Cullinan Oncology is a biopharmaceutical company that is developing a diversified pipeline of targeted therapeutic candidates across multiple modalities in order to bring important medicines to cancer patients. The Company’s strategy is to source innovation through both internal discovery efforts and external collaborations, focusing on advanced stage assets with novel technology platforms and differentiated mechanisms.

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PHARMA TECH

Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor

Zynex | January 04, 2022

Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system. "I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable. This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events." said Thomas Sandgaard, CEO "We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance," said Donald Gregg, Vice President, Zynex Monitoring Solutions. "The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market." The Zynex Fluid Monitoring System is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume. About Zynex, Inc. Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems.

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BUSINESS INSIGHTS

Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into Clinical Trials

Dermaliq Therapeutics | January 18, 2022

Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. today announced the establishment of Dermaliq Therapeutics, Inc (Dermaliq), a newly formed Delaware-based pharmaceutical development company, and the signing of a USD 15 million Series A financing round. 3E Bioventures Capital, a leading international life science investor, led the round and was joined by Beijing Whale Technology Corporation Ltd. Dermaliq's existing shareholder Novaliq has transferred, and licensed Intellectual Property (IP) related to the field of dermatology to Dermaliq. Skin diseases are the fourth leading cause of non-fatal disease burden worldwide, underscoring the role of dermatology in the growing field of global health. Skin conditions have significant impact on patients' well-being, mental health, and social participation. Although topical and local delivery of active ingredients to diseased skin is the preferred treatment route for the majority of patients, current therapies often lack satisfactory skin penetration and patient compliance. Dermaliq is developing the next generation of skin care therapies to enhance targeted penetration into skin tissues and to reduce unwanted side effects for millions of patients. The unique and proprietary technology now owned by Dermaliq, called hyliQ™, is designed to allow cutaneous drug delivery with unmatched bioavailability. The technology enables the development of superior, highly effective liquid drug products with exceptional cosmetic properties. The proceeds will be used to conduct three Phase 1/2a clinical dermatology programs with the goal to demonstrate safety and efficacy and to advance this novel skin care drug category to market to improve the lives of millions of patients: DLQ01 is a liquid drug candidate for the topical treatment of female and male androgenetic alopecia, targeting the prostamide E2 (PGE2) receptor in hair bulbs through specific follicular drug delivery. DLQ02 is a novel and liquid topical calcineurin inhibitor drug therapy for plaque psoriasis, particularly in difficult to treat areas. DLQ03 is a broad-spectrum liquid antibiotic drug candidate that targets topical treatment of bacterial skin and soft tissue infections, including the reduction of antibiotic-resistant strains. The Company has demonstrated proof-of-principle for enhanced topical drug delivery using hyliQ™ in nonclinical models for all three applications. "We are excited that 3E Bioventures Capital and Beijing Whale Technology Corporation have committed to support Dermaliq as new investors in the Series A round. Our spin-off from Novaliq and successful raising of significant funds provides us with the opportunity to build a leading specialty pharmaceutical company and expand the application of Novaliq's transformative drug delivery technology into dermatology." Dr. Frank Löscher, Chief Executive Officer of Dermaliq "3E is committed to investing in global leading life sciences and biomedical companies and help them grow with access to globalized resources and capabilities," said Karen Liu, Managing Director 3E Bioventures Capital. "Dermaliq is using a unique, and scientifically sound technology to achieve high efficiency drug delivery across the skin. The technology is already proven in ophthalmology and holds great promise for dermatology. We will be excited to explore additional drug pipelines in China and synergize with Dermaliq on both pre-clinical and clinical development." "Whale Technology values the solid science foundation of Dermaliq's proprietary hyliQ™ technology platform," said Ming Gao, founder and Chief Executive Officer of Whale Technology Co. Ltd. "Dermaliq's founding team demonstrates a great combination of science, clinical experience and commercialization strength. We see great potential of Dermaliq's pipeline in the field of dermatology after Novaliq's proven clinical and commercial success in ophthalmology." "Dermatology is the logical next step into using Novaliq's proprietary technology platform outside eye care," said Dr. Christian Roesky, Chief Executive Officer Novaliq. "The spin-off into an independent company allows Dermaliq to greatly benefit from our experience in ophthalmology while being fully committed to the multiple product development activities in dermatology, and likely to further broaden its pipeline to other skin conditions." To reflect the new shareholder structure, Karen Liu of 3E Bioventures Capital will join Dermaliq's Board of Directors. Dr. Löscher has also transitioned from his role as Chief Technology Officer at Novaliq to lead Dermaliq as its CEO & President. About Dermaliq Dermaliq Therapeutics, Inc. is a private company founded in 2021 through a spin off from Novaliq to reimagine topical dermatology. The Company is incorporated in Wilmington (DE), USA under Delaware law. The company has signed a USD 15 million series A round to advance three transformative skin care drug therapies through clinical trials. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. About 3E Bioventures Capital 3E Bioventures Capital is a healthcare venture capital firm, dedicated to investing in cutting-edge life sciences and biomedical technologies, with a focus on breakthrough first-in-class therapies and disruptive cross-disciplinary innovations in medical devices and diagnostics. 3E Bioventures takes on a science-driven, entrepreneur-friendly investment philosophy by working closely with companies and research institutions to develop drugs or products that have strong unmet medical needs. With offices in Beijing, Shanghai, and the San Francisco Bay Area, 3E Bioventures leverages its experience, capabilities, and network to help companies tap into markets and resources across the Pacific and advance with greater speed and capital efficiency. The motto of 3E Bioventures Capital is captured in its name 3E: Expertise, Efficiency, Execution. About Beijing Whale Technology Corporation Ltd Beijing Whale Technology Corporation Ltd. is a China-based pharmaceutical group committed to the long-term sustainable development in the fields of chemistry, pharmaceuticals and aesthetics. With more than 20 years of history, Whale Tech. has developed two core business units. On one hand, Whale Pharmaceutical Co. Ltd., Whale Chemistry Co. Ltd. and Whale Pharmatech Co. Ltd. are grouped as pharmaceutical and chemistry business unit. On the other hand, Whale Biotech is a research stage biotech company with the focus of developing aesthetics products. About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eyedrop technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies.

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Spotlight

The U.S. healthcare ecosystem has faced a myriad of changes in just the last decade, and pharmaceutical companies continue to face the effects of those changes. The players have become more diverse, and today’s target audience for pharmaceuticals has expanded to include healthcare organizations, payers, government agencies, pharmacy benefit managers and, most importantly, patients.

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