FDA approves first medical device ADHD treatment

pharmaphorum | April 23, 2019

US regulators have given the green-light for the first medical device to treat attention deficit hyperactivity disorder (ADHD). NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the Food and Drug Administration (FDA) and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. It’s a mobile phone sized device that generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient’s forehead and delivers a low-level electrical stimulation that should feel like a tingling sensation on the skin. Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation, a first of its kind.

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BUSINESS INSIGHTS

AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. The FDA clearance marks the company's transition into a clinical stage company. In addition to AM3101, the company's pipeline also includes AM1101, which is being developed for osteoarthritis, and AM2101, with an indication to treat degenerative disc disease. "We are very proud to announce the clearance for AM3101. Despite their commonality, service men and women have limited treatment options for acute meniscal tears. While suturing is often the most frequent approach, the failure rate for surgery is quite high due to the limited reparative capacity of much of the tissue. Our research has found that our Active Pharmaceutical Ingredient (API) provides pain relief and promotes regeneration of the meniscus, as well as several other structurally related joint tissues. In this way, the transition of Amplicore into a clinical stage company represents a critical development for all patients suffering from musculoskeletal conditions." Chief Executive Officer/Founder Dr. James Lin Amplicore also announced the addition of Steve Schrader to its advisory board. A high-impact financial leader with three decades of experience in corporate finance, Schrader has held Chief Financial Officer positions in a variety of industries, including an international auto glass company, a private healthcare company, a Fortune 500 public utility, and a NASDAQ-listed startup. Throughout his career, Steve has increased revenue and raised over $1.3 Billion in capital for companies. He has also taken two firms from start-up to manufacturing. Schrader will advise on financial planning and fundraising efforts. "Amplicore is a leader in developing injectable therapeutics for musculoskeletal disorders. I am excited to join the board during this pivotal time as they work to close their Series A investment round, and I look forward to being a part of their future success." ABOUT AMPLICORE, INC. Amplicore, Inc. is an early-stage biotech start-up company based on technology developed in the laboratory of CEO/Founder Dr. Chia-Ying Lin at the University of Cincinnati. Headquartered in Mason, OH, the company is dedicated to developing novel injectable therapeutics to serve unmet medical needs for degenerative musculoskeletal disorders. Unlike current therapies that focus solely on palliative treatment, Amplicore is also taking a regenerative approach to treating these disorders. The company's lead products, AM3101, AM1101, and AM2101, address significant deficiencies in the current standard of care for the treatment of acute meniscal tear, osteoarthritis, and degenerative disc disease, respectively. Amplicore's overall mission is to translate scientific innovation into effective but minimally invasive products that can be easily delivered to patients.

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PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

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BUSINESS INSIGHTS

Septerna Strengthens Leadership Team to Advance Novel Small Molecule GPCR Medicines

Septerna | July 29, 2022

Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases. We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.” “Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.” Ms. Bhatt Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University. Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst. About GPCRs G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged. About Septerna Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.

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