PHARMA TECH

Saama Launches Active Safety Analytics for Pharma (ASAP), Co-built With Gilead to Transform Safety Surveillance

Saama Technologies, Inc. | October 27, 2020

Saama Launches Active Safety Analytics for Pharma (ASAP), Co-built With Gilead to Transform Safety Surveillance
Saama Technologies, Inc. (“Saama”), the AI clinical analytics platform company, announced today the launch of the new Active Safety Analytics for Pharma (ASAP) product. ASAP is the first validated pharmacovigilance solution to leverage the U.S. Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals. ASAP was co-built with Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Saama and Gilead partnered to develop ASAP, with scientific advice from the Reagan-Udall Foundation for the FDA, and accelerate the life sciences industry’s paradigm shift to adopt active safety analytics.

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Related News

US and UK 'lead push against global patent pool for Covid-19 drugs'

The guardian | May 18, 2020

Ministers and officials from every nation will meet via video link on Monday for the annual world health assembly, which is expected to be dominated by efforts to stop rich countries monopolising drugs and future vaccines against Covid-19. As some countries buy up drugs thought to be useful against the coronavirus, causing global shortages, and the Trump administration does deals with vaccine companies to supply America first, there is dismay among public health experts and campaigners who believe it is vital to pull together to end the pandemic. While the US and China face off, the EU has taken the lead. The leaders of Italy, France, Germany and Norway, together with the European commission and council, called earlier this month for any innovative tools, therapeutics or vaccines to be shared equally and fairly.

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BUSINESS INSIGHTS

Glaukos Announces Licensing Agreement with Attillaps Holdings, Inc.

Glaukos | September 20, 2021

Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that it has entered into a licensing agreement with Attillaps Holdings, Inc. under which Attillaps has granted Glaukos a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites, which are the root cause of Demodex blepharitis and often associated with meibomian gland dysfunction and related ophthalmic diseases. Demodex blepharitis and Demodex-driven meibomian gland dysfunction are caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. Demodex blepharitis is characterized by eyelid inflammation and irritation resulting in eyelid redness, discomfort and debris. Demodex-driven meibomian gland dysfunction is characterized by decreased lipid secretion into the tear film and is a leading cause of dry eye disease. Under the agreement, Glaukos has the exclusive global right to research, develop, manufacture and commercialize products using certain acetylcholinesterase (AChE) inhibitors for the treatment of ophthalmic diseases caused by Demodex mites. Attillaps’ lead compounds have demonstrated promising in-vitro results in preclinical settings. We are incredibly excited about the development and commercial prospects of our novel platform in various therapeutic applications, particularly in the ophthalmology sector. Glaukos is a world-class ophthalmic company, and we couldn’t envision a more compelling licensing partner to advance our platform as a potential solution for the many patients suffering from these challenging conditions that currently have no approved treatments. - Frank Spallitta, founder and chief executive officer of Attillaps About Attillaps Attillaps is a developmental-stage pharmaceutical company pioneering novel drug platforms for the treatment of ophthalmology and dermatology conditions such as rosacea and blepharitis, with other indications of interest that include meibomian gland dysfunction, atopic dermatitis, acne vulgaris, ocular rosacea and hidradenitis suppurativa. The proprietary unique applications of these AChE inhibitors limit systemic exposure, further increasing the known safety of these molecules while effectively targeting the cutaneous inflammation. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.

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Lannett Signs Agreement To Be Exclusive Distributor Of Generic Flovent® Diskus®

Prnewswire | August 17, 2020

Lannett Company, Inc. today announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals Co. Ltd. According to the Orange Book, all patents covering Flovent Diskus have expired. U.S. sales of Flovent Diskus, which have been increasing in recent years, were $94 million for the 12 months ending June, 2020 according to IQVIA, although actual generic market values are expected to be lower. The company also said its previously announced exclusive U.S. distribution agreement with Respirent for the therapeutically equivalent generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) has been extended from 10 years to 12 years. The term of the agreement commences upon distribution of the product.

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Key Potential Drug Launches in 2020 infographicSupport more effective drug pipeline and portfolio strategies