Organ systems

Fragile X Syndrome (FXS) Epidemiology Forecast, 2030 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 13, 2020

The "Fragile X Syndrome (FXS) - Epidemiology Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Fragile X Syndrome (FXS) - Epidemiology Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • This report delivers an in-depth understanding of the disease, historical and forecasted Fragile X Syndrome (FXS) epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
  • The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalence of Fragile X Syndrome in 7MM, Gender-specific Diagnosed Prevalence of Fragile X Syndrome in 7MM, Age-specific Diagnosed Prevalence of Fragile X Syndrome in 7MM, the scenario of Fragile X Syndrome (FXS) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
  • The prevalent population of Fragile X Syndrome in 7MM is expected to increase at a CAGR of 0.62% for the study period, i.e.

Ovid Therapeutics and Angelini Pharma Enter into Exclusive License Agreement to Develop, Manufacture and Commercialize OV101 for the Treatment of Angelman Syndrome in Europe

Retrieved on: 
Monday, July 13, 2020

"We are excited to enter into a strategic collaboration with Angelini Pharma with the goal of bringing OV101, if approved, to the Angelman community in Europe as quickly as possible.

Key Points: 
  • "We are excited to enter into a strategic collaboration with Angelini Pharma with the goal of bringing OV101, if approved, to the Angelman community in Europe as quickly as possible.
  • In addition, the European Commission (EC) has granted orphan drug designation to OV101 for the treatment of Angelman syndrome.
  • The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101.
  • The Company's most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome.

Ovid Therapeutics and Angelini Pharma Enter into Exclusive License Agreement to Develop, Manufacture and Commercialize OV101 for the Treatment of Angelman Syndrome in Europe

Retrieved on: 
Monday, July 13, 2020

Angelini Pharma will execute the agreement through its new affiliate Angelini Pharma Rare Diseases AG.

Key Points: 
  • Angelini Pharma will execute the agreement through its new affiliate Angelini Pharma Rare Diseases AG.
  • In addition, the European Commission (EC) has granted orphan drug designation to OV101 for the treatment of Angelman syndrome.
  • The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101.
  • The Company's most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome.

CBD OF DENVER, INC. (CBDD) Announces the Largest Transaction in Company History

Retrieved on: 
Monday, July 13, 2020

On June 30, Rockflowr GmbH entered into an agreement for 24 months with a Swiss company for the sale of bulk CBD flower.

Key Points: 
  • On June 30, Rockflowr GmbH entered into an agreement for 24 months with a Swiss company for the sale of bulk CBD flower.
  • The first purchase by the customer was signed on July 7, for 500 kgs (more than half a ton) of Hybrid Indoor CBD Flower.
  • "This is the largest sale in company history and we are very excited to be able to share this information with our current and future investors," said CBDD CEO Marcel Gamma.
  • Black Pearl CBD has 0% THC, but is not an Isolate where the THC is stripped from the product rendering it ineffective.

Adverum Biotechnologies Announces First Patient Randomized in Phase 2 INFINITY Trial of ADVM-022 Single Injection Gene Therapy for Diabetic Macular Edema (DME)

Retrieved on: 
Monday, July 13, 2020

We are excited to have randomized the first patient in INFINITY, said Aaron Osborne, MBBS, chief medical officer of Adverum Biotechnologies.

Key Points: 
  • We are excited to have randomized the first patient in INFINITY, said Aaron Osborne, MBBS, chief medical officer of Adverum Biotechnologies.
  • INFINITY is a Phase 2, multi-center, randomized, double-masked, active comparator-controlled trial designed to assess a single intravitreal (IVT) injection of ADVM-022 in patients with diabetic macular edema (DME), the most common cause of vision loss in patients with diabetic retinopathy (DR).
  • Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME.
  • Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases.

Innovative New Level2™ Digital Health Therapy Resulted in Better Health for People with Type 2 Diabetes

Retrieved on: 
Monday, July 13, 2020

In the future, UnitedHealth Group may offer the Level2 model to support people with other chronic conditions beyond type 2 diabetes.

Key Points: 
  • In the future, UnitedHealth Group may offer the Level2 model to support people with other chronic conditions beyond type 2 diabetes.
  • Maintaining appropriate blood sugar levels, as measured by hemoglobin A1C, is a key focus for people with diabetes.
  • To date, Level2 has helped participants improve their health to the degree they eliminated the need for more than 450 prescriptions.
  • The combination of insights and resources in Level2 provides a high-touch, therapeutic benefit to help participants take charge of their type 2 diabetes and achieve better health, said Amy Meister, D.O., CEO of Level2.

Cytokinetics Announces Participation in the Launch of Kainomyx, Inc. Focused to the Treatment of Parasitic Diseases

Retrieved on: 
Monday, July 13, 2020

In addition, Kainomyx will incubate at Cytokinetics facilities in South San Francisco, CA, subject to a separate sublease agreement.

Key Points: 
  • In addition, Kainomyx will incubate at Cytokinetics facilities in South San Francisco, CA, subject to a separate sublease agreement.
  • Parasitic diseases remain amongst the most intractable global health problems, said Jim Spudich, Chief Executive Officer of Kainomyx.
  • Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Ovid Therapeutics and Angelini Pharma Enter into Exclusive License Agreement to Develop, Manufacture and Commercialize OV101 for the Treatment of Angelman Syndrome in Europe

Retrieved on: 
Monday, July 13, 2020

Angelini Pharma will execute the agreement through its new affiliate Angelini Pharma Rare Diseases AG.

Key Points: 
  • Angelini Pharma will execute the agreement through its new affiliate Angelini Pharma Rare Diseases AG.
  • We are excited to enter into a strategic collaboration with Angelini Pharma with the goal of bringing OV101, if approved, to the Angelman community in Europe as quickly as possible.
  • The U.S. Patent and Trademark Office has granted Ovid patents directed to methods of treating Angelman syndrome and Fragile X syndrome using OV101.
  • The Companys most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome.

electroCore Announces FDA Emergency Use Authorization for use of gammaCore Sapphire™ CV for the Acute Treatment of Asthma Exacerbations in Known or Suspected COVID-19 Patients

Retrieved on: 
Monday, July 13, 2020

FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives.

Key Points: 
  • FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives.
  • An FDA approved or cleared device should be used instead of the gammaCore Sapphire CV under EUA, when applicable and available.
  • The companys initial targets are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
  • Investors: Hans Vitzthum LifeSci Advisors 617-430-7578 [email protected] or Media Contact: Jackie Dorsky electroCore 973-290-0097 [email protected]

Axonics® Reports Preliminary Second Quarter 2020 Revenue

Retrieved on: 
Monday, July 13, 2020

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today reported preliminary unaudited second quarter 2020 revenue and provided an operational update.

Key Points: 
  • Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today reported preliminary unaudited second quarter 2020 revenue and provided an operational update.
  • Preliminary unaudited net revenue is expected to be $15.2 million for the second quarter 2020, as compared to net revenue of $1.5 million in the prior year period.
  • European hospital customers in England, the Netherlands, Germany, and Switzerland did not, for the most part, conduct elective procedures in the second quarter of 2020 due to COVID-19 and accordingly, the contribution to revenue from these markets was modest.
  • Axonics will report complete second quarter 2020 financial results and provide a further operational update after the market closes on August 6, 2020.