ForwardVue Pharma Secures Funding to Advance Pre-Clinical Development Programs

prnewswire | August 26, 2020

ForwardVue Pharma has secured initial seed round funding in order to advance pre-clinical development of potent long acting anti-angiogenic molecules directed against diabetic eye disease and neovascular age related macular degeneration. As the Founder of ForwardVue Pharma, Alan has performed 40,000+ intravitreal injections as a practicing retina specialist with over 20 years of experience. He has served as principle investigator in a number of diabetic retinopathy and AMD trials, presents his work internationally and published multiple manuscripts on candidate molecules to treat these diseases.

Spotlight

arpenter, author of Reputation and Power:Organizational Image and Pharmaceutical Regulation at the FDA will join us to discuss the FDA and the pharmaceutical industry. The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Carpenter traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the prim

Spotlight

arpenter, author of Reputation and Power:Organizational Image and Pharmaceutical Regulation at the FDA will join us to discuss the FDA and the pharmaceutical industry. The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Carpenter traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the prim

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BUSINESS INSIGHTS

Indivior To Acquire Opiant Pharmaceuticals

Indivior | November 21, 2022

Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company. "Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders." Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment "We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose." Roger Crystal, M.D., Opiant's President and Chief Executive Officer Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO"). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

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PHARMA TECH

Emerald Health Pharmaceuticals Reports Data Showing Novel Drug Candidate is First-in-class B55α/PP2A Activator

Emerald Health Pharmaceuticals | October 14, 2022

Emerald Health Pharmaceuticals Inc. a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, today announced the publication of a scientific article in the peer-reviewed Journal of Neuroinflammation highlighting additional data supporting the unique mechanism of action of EHP-101, the company’s first-in-class drug candidate for the treatment of systemic sclerosis and multiple sclerosis. Titled “A cannabidiol aminoquinone derivative activates the PP2A/B55α/HIF pathway and shows protective effects in a mouse model of traumatic brain injury”, the paper was co-authored by Eduardo Muñoz, MD, PhD, EHP’s Chief Scientific Officer. The publication demonstrates that VCE-004.8, the active pharmaceutical ingredient of EHP-101, is a highly specific activator of the B55a subunit of the protein phosphatase, thus activating the hypoxia-inducible factor (HIF) pathway. This first-in-class activator of the HIF pathway via modulation of B55a provides a new mechanism to treat diseases where vascular integrity is compromised. Therefore, these findings support the use of EHP-101 for the treatment of SSc and MS, and illustrate the potential of VCE-004.8 for acute disorders including traumatic brain injury and stroke. “The results of Dr. Muñoz’s work, as published in this prestigious journal, validate EHP-101’s unique ability to address key disease factors associated with the complex pathophysiology of fibrotic and demyelinating diseases such as SSc and MS through complementary specific mechanisms of action,” Alain Rolland, Pharm.D., Ph.D., COO of EHP EHP is currently conducting a Phase 2a clinical study to evaluate the safety, tolerability, and preliminary efficacy of EHP-101 in SSc patients. The Company has also met the regulatory requirements to start a Phase 2 clinical trial of EHP-101 for MS. About Emerald Health Pharmaceuticals Inc. Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases. The Company has two families of patented new chemical entities that have been created through rational drug design to affect validated receptors and pathways in the body which are pertinent to targeted diseases. Its first drug product candidate, EHP-101, is in a Phase 2a study for the treatment of systemic sclerosis, a severe form of scleroderma, and has met regulatory requirements to start a Phase 2 study for multiple sclerosis. EHP-101 has received Orphan Drug Designation in the US and EU, as well as Fast Track status by the US FDA for systemic sclerosis. The Company’s second product candidate, EHP-102, is in non-clinical development with IND-enabling studies and is focused on treating Parkinson’s disease and Huntington’s disease. EHP-102 has received Orphan Drug Designation in the US and EU for Huntington’s disease.

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz. “From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.” “September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.” Natasha Giordano, President & CEO of PLx Pharma PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide. About VAZALORE VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. About PLx Pharma Inc. PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.

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