Pharmaceuticals policy

Boticário Group Digitally Transforms the Manufacturing of 300 Million Products a Year with Dassault Systèmes

Retrieved on: 
Tuesday, July 27, 2021
Electronic design automation, Cosmetics, Data management, Retail, Technology, Software, Barcodes, Forest certification, Pharmaceuticals policy, Radio-frequency identification, Systems engineering, Traceability, Articles, Technology, Systems science, Dassault Systèmes, Grupo Boticário, DASSAULT SYSTèMES, GRUPO BOTICáRIO

The first step in our growth strategy is to integrate manufacturing processes and improve operations with real-time monitoring and traceability.

Key Points: 
  • The first step in our growth strategy is to integrate manufacturing processes and improve operations with real-time monitoring and traceability.
  • Boticrio Group identified the need to better orchestrate its manufacturing know-how to create long-term value a key element of todays Industry Renaissance, said Philippe Loeb, Vice President, Consumer Packaged Goods & Retail Industry, Dassault Systmes.
  • Dassault Systmes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries.
  • The company also works on environmental, social, and cultural fronts through Fundao Grupo Boticrio and Instituto Grupo Boticrio.

Lumos Pharma Appoints Pediatric Endocrinologist Experienced in Clinical Research and Pharmaceutical Development, Mark Bach, M.D., Ph.D., to Clinical Scientific Advisory Board

Retrieved on: 
Monday, July 26, 2021
Bayer, Kenilworth, New Jersey, Merck & Co., Schering-Plough, Companies, Health care, Pharmaceutical companies, Pharmaceuticals policy

Dr. Bach is a pediatric endocrinologist with 30 years of clinical research and pharmaceutical development experience, including extensive global experience building and leading clinical teams that have successfully launched innovative pharmaceutical products into worldwide markets.

Key Points: 
  • Dr. Bach is a pediatric endocrinologist with 30 years of clinical research and pharmaceutical development experience, including extensive global experience building and leading clinical teams that have successfully launched innovative pharmaceutical products into worldwide markets.
  • Prior to Janssen, Dr. Bach held positions of increasing responsibility in Clinical Research at Merck & Co., Inc., ending his tenure there as Vice President of Clinical Research Operations Worldwide.
  • Early in his career, Dr. Bach conducted extensive clinical and preclinical research on growth hormone, IGF-1 and LUM-201 (MK-0677), with data from this work published in scientific and medical journals.
  • Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases.

Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

Retrieved on: 
Monday, July 26, 2021
Acura Pharmaceuticals, Euphoriants, Morphinans, Health care, Pharmaceuticals policy, Ketones, LTX, Acura, Hydromorphone, Pharmaceutical industry in China, Psychoactive drugs, Health

PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.

Key Points: 
  • PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.
  • Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested.
  • Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse.
  • LIMITx is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.

Cosmos Holdings CEO Greg Siokas Converts an Additional $1.25 Million of Debt into Common Stock at $6.00 Per Share

Retrieved on: 
Monday, July 26, 2021
Pharmaceutical industry in China, Pharmaceuticals policy, Pharmacy in China, Science and technology in the People's Republic of China, THESSALONIKI, Cosmos, 1st millennium BC, Geography of Greece

Over the past two months, Mr. Greg Siokas has converted $4.0 million of the Companys debt.

Key Points: 
  • Over the past two months, Mr. Greg Siokas has converted $4.0 million of the Companys debt.
  • Greg Siokas, Chief Executive Officer of Cosmos Holdings, stated, Reducing the Companys debt allows us to focus on scaling the business while enhancing our cash flow as we rapidly expand our distribution network across Europe, Asia and North America.
  • Cosmos Holdings Inc. is an international pharmaceutical company, with a proprietary line of branded and generic pharmaceuticals, nutraceuticals, OTC medications and medical devices and an extensive, established EU distribution network.
  • Cosmos Holdings has offices and distribution centers in Thessaloniki, Greece, Athens, Greece and Harlow, UK.

Universe Pharmaceuticals INC Hosts Reception for Member of Chinese Academy of Engineering and Expert Group from Tianjin University of Traditional Chinese Medicine

Retrieved on: 
Monday, July 26, 2021
Pharmaceutical industry in China, Pharmaceuticals policy, Pharmacy in China, Science and technology in the People's Republic of China, Dietary supplement

Gang Lai, Chairman and CEO of the Company, introduced the Companys core product, Guben Yanling Pill during the reception.

Key Points: 
  • Gang Lai, Chairman and CEO of the Company, introduced the Companys core product, Guben Yanling Pill during the reception.
  • Mr. Boli Zhang and the experts thought highly of the Company's achievements in bringing health benefits to people and society.
  • Universe Pharmaceuticals INC, headquartered in Jian, Jiangxi, China, is a pharmaceutical producer and distributor in China.
  • The Company also distributes and sells biomedical drugs, medical instruments, Traditional Chinese Medicine Pieces, and dietary supplements manufactured by third-party pharmaceutical companies.

Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Hypothalamic Obesity

Retrieved on: 
Monday, July 26, 2021
Health, Clinical medicine, Congenital disorders, Pharmaceuticals policy, Amphetamine, Bariatrics, Body shape, Obesity, Appetite, Prader–Willi syndrome, Orphan drug

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity (HO).

Key Points: 
  • Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity (HO).
  • Saniona is proud to be pioneering a regulatory path forward for people living with HO, and we are thrilled to have received the first-ever FDA orphan drug designation in HO.
  • Wood Foundation and parent of a child living with hypothalamic obesity, commented, The recognition of the first orphan drug designation in hypothalamic obesity is a critical milestone for the HO community.
  • Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control.

PulmoSIM Therapeutics Announces Strategic Partnership with Top Respiratory Hospitals to Initiate Clinical Development of PT001 to Treat Pulmonary Arterial Hypertension

Retrieved on: 
Monday, July 26, 2021
Research, Hospitals, Venture capital, Clinical trials, Professional services, Biotechnology, Health, Pharmaceutical, Science, Health sciences, Life sciences, Health, Pharmaceuticals policy, Drug discovery, Biotechnology law, Orphan drug, Breakthrough therapy, United Therapeutics, Arcturus Therapeutics

The Food and Drug Administration (FDA) recently granted orphan drug designation for PT001 for the treatment of PAH.

Key Points: 
  • The Food and Drug Administration (FDA) recently granted orphan drug designation for PT001 for the treatment of PAH.
  • We are leveraging VeriSIM Lifes Virtual Drug Development Engine, BIOiSIM , to prioritize the development of PT001, which, unlike currently available therapeutics, has the ability to stop and reverse the progression of PAH.
  • "We are excited to work with the PulmoSIM team and clinical investigator-partner from Brown University to develop PT001 further to show its clinical efficacy.
  • About PulmoSIM Therapeutics: PulmoSIM Therapeutics is developing breakthrough therapies for rare and progressive respiratory diseases to improve patient outcomes and quality of life.

International Patent Reviews Releases Study on Sun Pharmaceuticals' LEVULAN® KERASTICK® patent

Retrieved on: 
Monday, July 26, 2021
Patent law, Pharmaceuticals policy, Monopoly, Patent, Pharmaceutical industry in China, United States patent law, Chemical patent, Articles, Outline of patents

DALLAS, July 26, 2021 /PRNewswire/ -- Today, International Patent Reviews, LLC (IPR) released a study on Sun Pharmaceuticals' U.S. Patent No.

Key Points: 
  • DALLAS, July 26, 2021 /PRNewswire/ -- Today, International Patent Reviews, LLC (IPR) released a study on Sun Pharmaceuticals' U.S. Patent No.
  • However, many pharmaceutical filings are purposefully structured to artificially extend the reach of protection afforded by our patent system."
  • IPR has developed a comprehensive and multifaceted process for identifying pharmaceutical patent filings that have taken advantage of the patent system.
  • The first patent for LEVULAN KERASTICK was issued in January of 1992.

Biofrontera enters into license and supply agreement with Medac for the marketing of Ameluz® in Poland

Retrieved on: 
Friday, July 23, 2021
Health sciences, Skin care, Pharmaceutical sciences, Life sciences, Pharmaceutical industry, Pharmacology, Pharmacy, Cosmetics, Pharmaceuticals policy, Pharmaceutical industry in China, Draft:Flen Health

The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin.

Key Points: 
  • The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin.
  • Ameluz has been marketed in the EU since 2012 and in the United States since May 2016.
  • In the EU, the company also sells the dermocosmetics series Belixos, which offers specialized care for damaged or diseased skin.
  • Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house.

Inotiv, Inc. to Report Third Quarter Fiscal 2021 Financial Results and Host Conference Call on Wednesday, August 11, 2021

Retrieved on: 
Thursday, July 22, 2021
Health sciences, Life sciences, Pharmaceutical sciences, Pharmaceutical industry, Pharmacology, Pharmacy, Pharmaceuticals policy, Contract research organizations, Pharmaceutical industry in China, European Federation of Pharmaceutical Industries and Associations

Inotiv, Inc. is a pharmaceutical development company providing contract research services and monitoring instruments to emerging pharmaceutical companies and the world's leading drug development companies and medical research organizations.

Key Points: 
  • Inotiv, Inc. is a pharmaceutical development company providing contract research services and monitoring instruments to emerging pharmaceutical companies and the world's leading drug development companies and medical research organizations.
  • The Company focuses on developing innovative services supporting its clients discovery and development objectives for improved decision-making and accelerated goal attainment.
  • The Companys products focus on increasing efficiency, improving data, and reducing the cost of taking new drugs to market.
  • Visit inotivco.com for more information about the Company.