AbbVies rising immunology star Skyrizi scores nod from Englands cost watchdog.

fiercepharma | July 15, 2019

AbbVies rising immunology star Skyrizi scores nod from Englands cost watchdog.
With long time immunology blockbuster Humira on the decline, AbbVie is looking to next-gen competitor Skyrizi to chip in. A nod from England's cost watchdog could help. The National Institute for Health and Care Excellence (NICE) recommended (PDF) Skyrizi as a second-line treatment for severe plaque psoriasis in adults who've failed on conventional treatments such as ciclosporin, methoxotrate and phototherapy. In its final appraisal, NICE said second-line Skyrizi was more effective for plaque psoriasis than Humira and Johnson & Johnson’s Il-12/23 med Stelara and similar in health benefits to J&J’s Tremfya, a head-to-head IL-23 competitor. AbbVie has touted Skyrizi as a cost-effective alternative to its closest immunology rivals. That growing field includes the aging anti-TNF class, IL-23 and IL-12/23 inhibitors, and next-gen IL-17 inhibitors like Novartis’ Cosentyx, Eli Lilly’s Taltz and Bausch Health’s Siliq. That cost edge is one reason Skyrizi rolled out a pricing plan in April to include an $88,500 first-year price on the new med—inclusive of two starter doses—and $59,000 maintenance doses.

Spotlight

Researchers led by Carnegie Mellon University’s Marcel Just and the University of Pittsburgh’s David Brent have developed an innovative and promising approach to identify suicidal individuals by analyzing the alterations in how their brains represent certain concepts, such as death, cruelty and trouble.


Other News
PHARMA TECH

Milestone Scientific Names Andau Medical as an Additional Distributor for the STA Single Tooth Anesthesia System® in North America

Milestone Scientific, Inc. | December 24, 2021

Milestone Scientific Inc. a leading developer of computerized drug delivery instruments, that provide painless and precise injections, announced it has entered into an agreement with Andau Medical to distribute the STA Single Tooth Anesthesia System® in the United States and Canada. Arjan Haverhals, CEO of Milestone Scientific, stated, “We are pleased to announce the addition of Andau Medical to our growing roster of distributors for the STA Single Tooth Anesthesia System in the United States and Canada. We initially began our collaboration with Andau around our CompuFlo® Epidural Instrument in Canada. In addition to medical devices, they have a strong track record introducing dental instruments to the market, which we believe will help further fuel the strong momentum we’re experiencing within our dental division.” “We are excited to expand our existing partnership with Milestone Scientific by introducing the STA Single Tooth Anesthesia System through our broad network of dentists and hygienists across North America. The STA offers significant benefits to both patients and clinicians through painless injections, shorter wait times for anesthesia, fewer complications, and reduced patient cancellations. This enables dentists to grow their businesses while improving the patient experience.” Sandi Wright, Founder and CEO of Andau Medical About Andau Medical Andau Medical is a Medical Device and Dental Device company focused on providing U.S. and Canadian markets with quality technologies that improve patient outcomes and enhance the clinical experience in delivering exceptional patient care. Andau has expertise in sales, marketing, regulatory and distribution, thereby enabling quick market uptake of both existing and new technologies. About Milestone Scientific Inc. Milestone Scientific Inc. a technology focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical, dental and cosmetic applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic.

Read More

PHARMACY MARKET

Virpax Pharmaceuticals Recaps Milestones and Highlights Product Portfolio

Virpax® Pharmaceuticals, Inc. | December 29, 2021

Virpax® Pharmaceuticals, Inc. "Company" achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below. “I believe that Virpax has made significant progress this past year toward our stated goalsThese accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022. Anthony P. Mack, Chairman and CEO of Virpax “Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope Technology delivery platform licensed from Nanomerics, Ltd. has enabled the development of product candidates for central nervous system and anti-viral indications. In the second half of 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter anti-viral product candidate formulated to prevent the spread of respiratory infections like influenza, SARS-CoV-2 and rhinovirus. We added VRP324 which is an intranasally delivered cannabidiol formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences as a part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver which we believe reduces drug-to-drug interaction concerns for treatments using this technology. “On the corporate front, we strengthened our Board by appointing two new members adding expertise in commercialization and financial strategy. Additionally, in 2021 we raised approximately $58 million in aggregate gross proceeds from our initial public offering and an underwritten follow-on public offering. These funds are being used for research and development activities of our product candidates. We are on track to add accomplishments in 2022 and I remain confident that we have the significant financial strength to continue advancing our pipeline,” concluded Mr. Mack. Epoladerm™ Epoladerm is a diclofenac topical spray film product candidate that is being developed for pain associated with osteoarthritis of the knee. Virpax recently reported successful results of a Charles River Laboratories single dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation observed. The maximum plasma concentration was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24-hour post-dose for all animals. Upon completion of all the required IND enabling studies and subsequent review by the FDA, Virpax intends to conduct a Phase 1 study to evaluate the relative bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Altasciences Company, Inc., to conduct this study in Canada. Virpax anticipates enrollment of the first patient by early second quarter of 2022. Probudur™ Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional pre-clinical trials are being conducted with Lipocure, the product developer, to improve the formulation to potentially enhance manufacturing efficiencies, prolong duration and extend patent protection. Once completed, we plan to perform seven preclinical animal studies as part of required FDA IND enabling trials. Envelta™ Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. This product leverages Nanomeric’s MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal delivery enabling the enkephalin to permeate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS. Virpax recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the research, development and manufacturing of Envelta. These contracts are to support Good Manufacturing Practices production of drug substance and drug product, as well as to support Good Laboratory Practices toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and has procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin, the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to promptly suppress pain. AnQlar™ AnQlar is a high-density intranasal molecular masking spray in development as an anti-viral OTC product for protection against respiratory infections, such as SARS-CoV-2 and influenza, that Virpax anticipates will be used as an adjuvant to barrier-based personal protective equipment. Virpax recently announced a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar. Additionally, Virpax engaged Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in early 2022. VRP324 Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children and adults. Under this agreement, Virpax has the global rights to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare CNS diseases considered serious epileptic encephalopathies that cause epileptic seizures, as well as cognitive and behavioral changes, and are generally resistant to treatment. Preclinical studies of VRP324 have been initiated by Nanomerics which it anticipates will be completed in the first quarter of 2022. Upon completion, Virpax will collaborate with RRD International, a clinical drug development company which Virpax has engaged, to prepare the pre-IND briefing documents for the FDA. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.

Read More

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.

Read More

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.

Read More

Spotlight

Researchers led by Carnegie Mellon University’s Marcel Just and the University of Pittsburgh’s David Brent have developed an innovative and promising approach to identify suicidal individuals by analyzing the alterations in how their brains represent certain concepts, such as death, cruelty and trouble.

Resources