Warren blasts Gottlieb's jump to Pfizer, but ex-FDA chief says he's proud

FiercePharma | July 02, 2019

Scott Gottlieb and Pfizer surely knew critics would challenge the former FDA commissioner’s decision to join the pharma giant's board-less than three months after his departure from the agency, no less. And at least one high-profile lawmaker is doing just that, as Sen. Elizabeth Warren called on Gottlieb to reconsider. The move smacks of corruption, Warren wrote in a letter following the announcement. Gottlieb will join a company that has billions of dollars at stake in the decisions made by the agency you used to head and the employees you used to lead, Warren wrote. Such a fast move from government to industry makes the American people rightfully cynical and distrustful about whether high-level Trump Administration officials are working for them, or for their future corporate employers, she added. The move could prove to be lucrative for Gottlieb as Pfizer compensates its board members well, Warren pointed out. Last year, the company paid directors $335,000 in cash and stock.

Spotlight

Data analytics in pharma has altered the way pharmaceuticals were a few years back. In the current era of industry 4.0, big data analytics compelled enterprises to make decisions discriminatively because Artificial Intelligence and Machine Learning prove themselves.

Spotlight

Data analytics in pharma has altered the way pharmaceuticals were a few years back. In the current era of industry 4.0, big data analytics compelled enterprises to make decisions discriminatively because Artificial Intelligence and Machine Learning prove themselves.

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PHARMACY MARKET, PHARMA TECH

Prescryptive Health Partners with Lilly on First-to-Market Value-Based Program to Stabilize Insulin Pricing

Prescryptive Health | December 16, 2022

Prescryptive Health, a healthcare technology company on a mission to rewrite the script for the U.S. pharmaceutical market, today announced a partnership with Eli Lilly and Company on a new and first-to-market subscription model to help lower costs for people who pay for their Lilly insulin through their employer-sponsored benefits. Through a flat, per-member, per-month subscription fee, employers can offer insulin to their employees with predictable, affordable, and transparent costs. This unique value-based program is designed to create price stability related to insulin utilization, with Lilly refunding a portion of the subscription fee if an employer's total medical spend increases over time for their employees who live with diabetes. "We are proud to partner with Lilly on this unique and first-to-market value-based program. This solution challenges the traditional drug pricing model and reduces the burden on employers who sponsor pharmacy benefits. The result is that it insulates employers against increased drug prices and aligns interests to focus on patient access and health outcomes." Chris Blackley, Prescryptive Health CEO This new program can help address controversial rebates in the pharmacy benefit manager pricing model and will be available through Prescryptive free of any margin or price mark-up, further reducing the cost to employers, health plans, and ultimately healthcare consumers. Additionally, the program offers opportunities for employers to supply insulin at lower costs, or at no cost, to their employees. Added benefits for employers participating in the program include the Prescryptive mobile experience that supports patient engagement and adherence for diabetes care. "In the U.S., more than 34 million people have diabetes, and some people who have employer-based insurance still need affordability solutions to ensure they don't pay too much out-of-pocket for their insulin," said Mike Mason, President, Lilly Diabetes. "At Lilly, we strive to provide new solutions to help lower costs at the pharmacy, including partnering with Prescryptive Health to ensure people with diabetes have access to affordable options to help them reach their treatment goals." According to the American Diabetes Association people with diagnosed diabetes spend about 2.3 times more on medical costs than those without diabetes, which impacts not only every individual patient and plan member, but also employers who sponsor their benefits coverage. Additionally, costs related to the condition include $3.3 billion in increased absenteeism. About Prescryptive Health Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.

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RESEARCH, PHARMA TECH

Alliance Pharma Opens State-of-the-Art Bioanalytical Laboratory in Brisbane

Alliance Pharma | December 08, 2022

Alliance Pharma a global leader providing bioanalytical, DMPK, and CMC testing services in the pharmaceutical and biopharmaceutical industry, has opened its new 20,000-square-foot bioanalytical laboratory, Alliance Pharma Pty, Ltd., in Brisbane, Australia. The new Australia facility, which the company announced plans for earlier this summer, includes an expansive lab to provide much-needed small and large molecule bioanalytical services for a region with limited choices for bioanalytical support. “Alliance Pharma’s expanded presence in Australia affirms our commitment to combining scientific talent and technology to deliver global drug development solutions. In this new purpose-built laboratory, our talented teams will use their diverse experience and expertise to provide high-quality bioanalytical services.” Alliance CEO, Patrick Bennett “Our new state-of-the-art science facility in Brisbane will further strengthen our global bioanalytical capabilities. It will allow biotech companies to work with us in Australia in the early phase and then transfer the knowledge on these assays to other regions to support the later development phases. Our objective is to accelerate the growth of our best-in-class portfolio and deliver industry-leading drug development service for our worldwide clients,” said Alliance Pharma Site President, Australia, Jason Wang, Ph.D. About Alliance Pharma Founded in 2008, Alliance is a contract research organization with bioanalytical, DMPK, and CMC testing labs in Malvern, PA, Brisbane, AU, Cambridge, U.K., and Sandwich, U.K. The labs specialize in advanced research services for all drug molecules, cell and gene therapies, and drug metabolism studies to support pharmaceutical and biotechnology companies’ drug discovery and development programs. Alliance’s mission is to build a trusted partnership with our clients to support their successful drug development programs. Our business philosophy is based on a foundation of trust, professional ethics, scientific excellence, and regulatory compliance.

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BUSINESS INSIGHTS, PHARMACY MARKET

RespireRx Pharmaceuticals Inc. Enters a Collaboration With National Institute for Neurological Disorders and Stroke to Advance its Lead GABAkine

RespireRX Pharmaceuticals Inc. | December 06, 2022

RespireRx Pharmaceuticals Inc. a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that RespireRx has been accepted into the NIH HEAL Initiative® NINDS Preclinical Screening Platform for Pain program. The Company’s lead GABAkine, KRM-II-81, has been shown to be effective in relieving acute, chronic, and neuropathic pain in a number of models without tolerance development or sedation. The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide. The RespireRx team is led by Dr. Arnold Lippa, RespireRx Executive Chairman and Chief Scientific Officer and Drs. James M. Cook, Jeffrey M. Witkin and Rok Cerne, all of whom are RespireRx Research Fellows in addition to their academic affiliations at University of Wisconsin-Milwaukee, Ascension St. Vincent and Indiana University/Purdue University, respectively. The team has extensive expertise in drug discovery and development including the development of novel analgesic drugs and an extensive publication record with a combined total of over 1,000 scientific publications. The team has already profiled KRM-II-81 activity in a broad range of preclinical studies where it has displayed a high degree of analgesic activity and is excited at the prospect of advancing the Companay’s lead GABAkine toward clinical development. In cellular studies, KRM-II-81 preferentially bound to specific subtypes of GABAA receptors and boosted the ability of GABA to inhibit pain sensory neurons in the spinal dorsal root ganglia. In intact animal models of acute and chronic pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression, or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic. Unrelated to the NINDS project, KRM-II-81 has also shown promising results in multiple animal models of treatment resistant epilepsy and in human translational studies by reducing epileptiform electrical signaling in brain tissue removed from treatment resistant epileptic patients undergoing surgery. Dr. Cerne commented “We believe that the expansion of our understanding of GABAA receptor structure and function has created a new surge in the discovery and development of GABAkines that target such receptors in a unique manner. This opens the promise of improved medicines for pain, epilepsy and other disorders caused by disruption of neuronal signaling.” “We are very excited about developing KRM-II-81 and expanding the IND enabling studies so as to begin human studies. Pending clinical validation, we believe that KRM-II-81 has the potential to represent a breakthrough treatment for pain, epilepsy, and other neuropsychiatric disorders.” Dr. Lippa About RespireRx Pharmaceuticals Inc. RespireRx Pharmaceuticals Inc. is a leader in the discovery and development of medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including attention deficit hyperactivity disorder epilepsy, pain, recovery from spinal cord injury ertain neurological orphan diseases and obstructive sleep apnea. RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate AMPA-type glutamate receptors and GABAA receptors, respectively. The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs. EndeavourRx: Neuromodulators GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. The Company currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.

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