Drug Safety

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces the Filing of a Securities Class Action on Behalf of Orphazyme A/S (ORPH) Investors

Retrieved on: 
Friday, July 16, 2021

Orphazyme investors have until September 7, 2021 to file a lead plaintiff motion.

Key Points: 
  • Orphazyme investors have until September 7, 2021 to file a lead plaintiff motion.
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • In September 2020, Orphazyme completed its IPO, selling approximately 4 million ADSs at $11.00 per share.
  • The same month, the Companys New Drug Application (NDA) for arimoclomol for NPC was accepted by the U.S. Food and Drug Administration (FDA).

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Orphazyme A/S (ORPH) Investors

Retrieved on: 
Friday, July 16, 2021

Orphazyme investors have until September 7, 2021 to file a lead plaintiff motion.

Key Points: 
  • Orphazyme investors have until September 7, 2021 to file a lead plaintiff motion.
  • Investors suffering losses on their Orphazyme investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .
  • In September 2020, Orphazyme completed its IPO, selling approximately 4 million ADSs at $11.00 per share.
  • The same month, the Companys New Drug Application (NDA) for arimoclomol for NPC was accepted by the U.S. Food and Drug Administration (FDA).

HUTCHMED’s Marketing Authorization Application for Surufatinib Submitted and Validated by the European Medicines Agency

Retrieved on: 
Friday, July 16, 2021

The EMAs validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.

Key Points: 
  • The EMAs validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.
  • The submission follows the acceptance of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), as announced on July 1, 2021.
  • They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant.
  • According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020.

Genexa, the World’s First and Only Clean Medicine Company, Announces Record-breaking Series A Round

Retrieved on: 
Wednesday, July 14, 2021

Genexa , the worlds first clean, over-the-counter pharmaceutical company, has just completed its unprecedented $60 million Series A of funding to advance its market leadership in this emerging space.

Key Points: 
  • Genexa , the worlds first clean, over-the-counter pharmaceutical company, has just completed its unprecedented $60 million Series A of funding to advance its market leadership in this emerging space.
  • Jared Stein, Co-Founder and Managing Partner of Monogram Capital led the round and was joined by some of the worlds most well-regarded investors, including Unilever Ventures, Verlinvest, Northcastle Partners, and Point King Capital.
  • Genexa is heralding in a sea change moment in medicine, giving consumers access to the first clean, better-for-you, efficacious option ever in the OTC market.
  • All of our products are made to the highest standards of medicine with no artificial dyes, common allergens, or unnecessary inactive ingredients.

Canadian researchers to study best approaches to possible adverse events following COVID-19 vaccination

Retrieved on: 
Tuesday, July 13, 2021

This study is an extension of an existing vaccine safety program that provides important public health information about adverse events following immunization (AEFI) for all vaccines authorized for use in adults and children.

Key Points: 
  • This study is an extension of an existing vaccine safety program that provides important public health information about adverse events following immunization (AEFI) for all vaccines authorized for use in adults and children.
  • The network also has international links to align with international standards, and to incorporate global evidence into the Canadian context.
  • To be included in the study, patients who experience an adverse event following COVID-19 vaccination can be referred to the SIC Network by a healthcare provider for further assessment.
  • We must systematically document and follow up with patients who experience a medically significant or unexpected adverse event.

Statement from the Chief Public Health Officer of Canada on June 30, 2021

Retrieved on: 
Wednesday, June 30, 2021

As well, COVID-19 activity varies, so it is important to continue following local public health advice, including adhering to gathering size limits and other public health measures, such as mask wearing and physical distancing in public spaces.

Key Points: 
  • As well, COVID-19 activity varies, so it is important to continue following local public health advice, including adhering to gathering size limits and other public health measures, such as mask wearing and physical distancing in public spaces.
  • Wherever you spend your day, I wish you a happy and safe Canada Day.
  • The Public Health Agency of Canada is also providing regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.
  • Nevertheless, we know that vaccination, in combination with public health and individual measures, are working to reduce spread of COVID-19.

 Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

Retrieved on: 
Wednesday, June 30, 2021

(TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter Solasia) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW).

Key Points: 
  • (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter Solasia) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW).
  • Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year.
  • If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.
  • Solasia plans to present the results of the study at an international academic conference to be held in the near future.

Direct Biologics Granted FDA Approval of Third IND Application for the Use of ExoFlo in Mild-to-Moderate COVID-19 Infusion Therapy

Retrieved on: 
Tuesday, June 29, 2021

This is Direct Biologics' third FDA-approved IND clinical trial, and it represents the very first IND approved by the FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.

Key Points: 
  • This is Direct Biologics' third FDA-approved IND clinical trial, and it represents the very first IND approved by the FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.
  • According to Mark Adams, Co-Founder and Chief Executive Officer, "The FDA's approval to initiate our third IND trial of ExoFlo for treatment of COVID-19 represents a significant milestone for Direct Biologics.
  • ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
  • Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process.For more information, visit www.directbiologics.com .

EQRx and Exscientia Enter Strategic Drug Creation, Development and Commercialization Collaboration to Accelerate the Advancement of New World-Class Medicines

Retrieved on: 
Thursday, June 24, 2021

Under the terms of the agreement, the strengths of both companies will be leveraged throughout the drug development process.

Key Points: 
  • Under the terms of the agreement, the strengths of both companies will be leveraged throughout the drug development process.
  • Exscientia will lead the discovery phase through to Investigational New Drug application (IND) filing, while EQRx will be responsible for clinical development, regulatory and commercialization efforts.
  • EQRx and Exscientia will equally share in the discovery, development and commercialization costs.
  • Exscientia is a leader in AI-driven drug discovery, and of particular note, have now brought multiple AI-engineered drug candidates to clinical trials.

EQRx and Exscientia Enter Strategic Drug Creation, Development, and Commercialization Collaboration to Accelerate the Advancement of New World-Class Medicines

Retrieved on: 
Thursday, June 24, 2021

Under the terms of the agreement, the strengths of both companies will be leveraged throughout the drug development process.

Key Points: 
  • Under the terms of the agreement, the strengths of both companies will be leveraged throughout the drug development process.
  • Exscientia will lead the discovery phase through to Investigational New Drug application (IND) filing, while EQRx will be responsible for clinical development, regulatory and commercialization efforts.
  • EQRx and Exscientia will equally share in the discovery, development and commercialization costs.
  • Exscientia is a leader in AI-driven drug discovery, and of particular note, has now brought multiple AI-engineered drug candidates to clinical trials.