Medsafe

Protalix BioTherapeutics Reports Second Quarter 2023 Financial and Business Results

Retrieved on: 
Monday, August 7, 2023

CARMIEL, Israel, Aug. 7, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2023 and provided a business update on recent regulatory, clinical and corporate developments.

Key Points: 
  • "2023 has been a transformational year for Protalix thus far," said Dror Bashan, Protalix's President and Chief Executive Officer.
  • On May 5, 2023, the European Commission (EC) granted marketing authorization to Elfabrio (pegunigalsidase alfa) in the European Union.
  • On June 26, 2023, the Company was included in the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution.
  • Financial expenses, net were $0.8 million for the three months ended June 30, 2023, compared to financial income, net of $0.2 million for the three months ended June 30, 2022.

Arbutus Reports Second Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Thursday, August 3, 2023

We plan to provide a further update on this clinical trial when we have additional meaningful patient data.

Key Points: 
  • We plan to provide a further update on this clinical trial when we have additional meaningful patient data.
  • Preliminary data from patients in the clinical trial are expected in the second half of 2023.
  • The Phase 1 clinical trial with AB-161 is on-going with single-ascending dose data expected in the second half of 2023.
  • We expect to nominate an nsp12 inhibitor clinical candidate and initiate IND-enabling studies in the second half of 2023.

AVM Biotechnology Announces Twenty-Eight (28) Solid Tumor and Blood Cancer Patients have been Treated with Immunomodulatory AVM0703 through Expanded Access/Compassionate Use Programs

Retrieved on: 
Tuesday, August 1, 2023

Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting [email protected] .

Key Points: 
  • Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting [email protected] .
  • “AVM Biotechnology is committed to providing AVM0703 to patients who cannot participate in our enrolling clinical trial.
  • Our team at AVM Biotechnology is dedicated to providing hope to patients and their loved ones.” Theresa Deisher, AVM Biotechnology , Founder and CEO.
  • AVM Biotechnology is a clinical stage company headquartered in Seattle, WA developing immunomodulatory therapies for hematological cancer, infectious and autoimmune diseases.

The Global Antipsychotic Drugs Market to Register Growth at a CAGR of ~7% by 2027 | DelveInsight

Retrieved on: 
Thursday, February 2, 2023

LAS VEGAS, Feb. 2, 2023 /PRNewswire/ -- DelveInsight's Antipsychotic Drugs Market Insights report provides the current and forecast market analysis, individual leading antipsychotic drugs companies' market shares, challenges, antipsychotic drugs market drivers, barriers, and trends, and key antipsychotic drugs companies in the market.

Key Points: 
  • LAS VEGAS, Feb. 2, 2023 /PRNewswire/ -- DelveInsight's Antipsychotic Drugs Market Insights report provides the current and forecast market analysis, individual leading antipsychotic drugs companies' market shares, challenges, antipsychotic drugs market drivers, barriers, and trends, and key antipsychotic drugs companies in the market.
  • As per DelveInsight estimates, North America is anticipated to dominate the global antipsychotic drugs market during the forecast period.
  • Furthermore, increased awareness resulted in increased adoption of these drugs in key countries, significantly increasing antipsychotic drugs market growth in key countries.
  • However, the high cost of drug development and launch, addiction caused by antipsychotic drugs, and the stringent regulatory approval process may stall the antipsychotic drugs market growth.

Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved By Medsafe In New Zealand

Retrieved on: 
Friday, January 27, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides.

Key Points: 
  • DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides.
  • Cardiovascular disease is a significant health issue for people living in New Zealand.
  • Currently, an estimated 175,000 adult New Zealanders are living with cardiovascular disease, and one in three deaths in New Zealand are caused by cardiovascular disease.i
    “The regulatory approval of VAZKEPA in New Zealand adds to the ongoing progress by Amarin to bring an important treatment to patients to help address their residual cardiovascular disease risk,” said Steven Ketchum, EVP & President, Research & Development, Amarin.
  • Amarin is now actively engaging with potential commercialization partners in New Zealand to support the introduction of VAZKEPA across the New Zealand market.

atai Life Sciences Announces Initiation of Phase 1 Trial for its MDMA Derivative, EMP-01

Retrieved on: 
Tuesday, September 27, 2022

NEW YORK and BERLIN, Sept. 27, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), which is developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment of post-traumatic stress disorder (PTSD) and other indications, announced today its Phase 1 study has received regulatory and ethics approvals required from Medsafe and HDEC, respectively, to initiate participant enrollment.

Key Points: 
  • Evidence shows that two-thirds of patients either do not respond or have only a partial response to these medications.
  • These modifications are designed to separate the entactogenic effects of MDMA from some of the known side effects, specifically its stimulant-associated effects.
  • Data on MDMA-assisted psychotherapy strongly suggests its potential for the treatment of PTSD, said Glenn Short, Senior Vice President, Early Development of atai Life Sciences.
  • atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.

Sharps Compliance To Be Acquired By an Affiliate of Aurora Capital Partners

Retrieved on: 
Tuesday, July 12, 2022

Pat Mulloy, President and Chief Executive Officer of Sharps, stated, Sharps is a leading provider of comprehensive solutions for the small to medium generators of medical, hazardous and pharmaceutical waste.

Key Points: 
  • Pat Mulloy, President and Chief Executive Officer of Sharps, stated, Sharps is a leading provider of comprehensive solutions for the small to medium generators of medical, hazardous and pharmaceutical waste.
  • Raymond James & Associates, Inc. acted as financial advisor and Norton Rose Fulbright US LLP acted as legal advisor to Sharps.
  • Headquartered in Houston, Texas, Sharps Compliance (NASDAQ: SMED) is a leading business-to-business services provider to the healthcare, long-term care and retail pharmacy markets.
  • Sharps Compliance offers comprehensive solutions for the management of regulated medical waste, hazardous waste and unused medications.

Sharps Compliance Partners with PharMerica Corporation to Bring MedSafe to Long-Term Care Facilities

Retrieved on: 
Monday, January 24, 2022

In addition to unused medication management, the MedSafe is designed to reduce cost to LTC facilities through effective and efficient collection, transportation and treatment.

Key Points: 
  • In addition to unused medication management, the MedSafe is designed to reduce cost to LTC facilities through effective and efficient collection, transportation and treatment.
  • Sharps Compliance and PharMerica are now partnering to expand the use of MedSafe in LTC communities.
  • Additionally, by utilizing the MedSafe, LTC facilities can reduce operating costs when compared to traditional methods of medication disposal.
  • It combines industry-leading secure receptacles with the reverse distribution, destruction, and reporting capabilities of Sharps Compliance via a patented inner liner system.

Sharps Compliance Reports Fiscal 2022 First Quarter Results

Retrieved on: 
Wednesday, October 27, 2021

Revenue in the first quarter of fiscal 2022 grew 6% to $13.9 million, compared to $13.2 million in the same prior year quarter.

Key Points: 
  • Revenue in the first quarter of fiscal 2022 grew 6% to $13.9 million, compared to $13.2 million in the same prior year quarter.
  • SG&A increased by approximately $0.4 million or 11% to $4.2 million in the first quarter of fiscal 2022, compared to the same prior year quarter.
  • Sharps recorded an EBITDA loss of $0.4 million in the first quarter of fiscal 2022 compared to EBITDA of $0.1 million in the first quarter of fiscal 2021.
  • Sequentially, billings for Unused Medications, which includes MedSafe, grew 31% in the first quarter of fiscal 2022 as compared to $2.0 million in the fourth quarter of fiscal 2021.