Health care

EBS 6-DAY DEADLINE ALERT: Hagens Berman Encourages Emergent BioSolutions (EBS) Investors to Contact the Firm Before June 18th Deadline in Securities Fraud Action

Saturday, June 12, 2021 - 5:06pm

SAN FRANCISCO, June 12, 2021 (GLOBE NEWSWIRE) -- Hagens Berman urges Emergent BioSolutions Inc. (NYSE: EBS) investors with $100k or more losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, June 12, 2021 (GLOBE NEWSWIRE) -- Hagens Berman urges Emergent BioSolutions Inc. (NYSE: EBS) investors with $100k or more losses to submit your losses now .
  • 31, 2021, media reports revealed the company mixed up ingredients for J&Js and AstraZenecas vaccines, contaminating up to 15 million J&J vaccine doses.
  • Were focused on investors losses and proving Emergent lied about its vaccine production capabilities, said Reed Kathrein, the Hagens Berman partner leading the investigation.
  • Hagens Berman is a national law firm with eight offices in eight cities around the country and over eighty attorneys.

ACAD 6-DAY DEADLINE ALERT: Hagens Berman Encourages Acadia Pharmaceuticals (ACAD) Investors with Losses to Contact the Firm, Deadline Approaching in Securities Class Action

Saturday, June 12, 2021 - 4:16pm

SAN FRANCISCO, June 12, 2021 (GLOBE NEWSWIRE) -- Hagens Berman urges Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) investors with significant losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, June 12, 2021 (GLOBE NEWSWIRE) -- Hagens Berman urges Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) investors with significant losses to submit your losses now .
  • Thereafter, the company repeatedly stated the FDA had not identified any potential review issues and reiterated the drugs efficacy.
  • Were focused on investors losses and proving Acadia misled investors by concealing FDA-related review risks for the sNDA, said Reed Kathrein, the Hagens Berman partner leading the investigation.
  • Hagens Berman is a national law firm with nine offices in eight cities around the country and eighty attorneys.

Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress

Saturday, June 12, 2021 - 4:45pm

CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab.

Key Points: 
  • CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab.
  • Over three quarters of patients initiated on CT-P10 achieved complete or partial response by 30 months.
  • We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab.
  • Real World Clinical Effectiveness and Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma: Results from a European Non-Interventional Post Authorization Safety Study.

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

Saturday, June 12, 2021 - 12:00pm

"These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."

Key Points: 
  • "These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."
  • Janssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease.
  • Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

 Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX®▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

Saturday, June 12, 2021 - 8:01am

These results strongly support the use of daratumumab, lenalidomide and dexamethasone as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma.

Key Points: 
  • These results strongly support the use of daratumumab, lenalidomide and dexamethasone as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma.
  • Janssen Research & Development, LLC, Janssen-Cilag Ltd., Janssen Pharmaceutica NV and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

European Hematology Association: Overall Survival Benefit Established With Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) in Elderly Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): Long-Term Interim Analysis of the MAI

Saturday, June 12, 2021 - 8:00am

At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.

Key Points: 
  • At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.
  • These results are despite 46% of patients who received subsequent therapy in the Rd arm receiving daratumumab.
  • The high overall response rate (93% vs 82%) further demonstrated the added clinical benefit of D-Rd versus Rd alone.
  • The Congress is aimed at health professionals working in or interested in the field of hematology.

European Hematology Association: Overall Survival Benefit Established With Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) in Elderly Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): Long-Term Interim Analysis of the MAI

Saturday, June 12, 2021 - 8:00am

At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.

Key Points: 
  • At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.
  • These results are despite 46% of patients who received subsequent therapy in the Rd arm receiving daratumumab.
  • The high overall response rate (93% vs 82%) further demonstrated the added clinical benefit of D-Rd versus Rd alone.
  • The Congress is aimed at health professionals working in or interested in the field of hematology.

DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Acadia Pharmaceuticals, Inc. and Encourages Investors to Contact the Firm

Saturday, June 12, 2021 - 4:00am

Investors have until June 18, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until June 18, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Acadia is a biopharmaceutical company that focuses on the development and commercialization of small molecule drugs that address unmet medical needs in central nervous system disorders.
  • Acadia advised that [t]he notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

CMS Grants Transitional Pass-Through (TPT) Payment for Shockwave’s Coronary IVL

Friday, June 11, 2021 - 9:03pm

In the July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), CMS issued a new device transitional pass-through code (C1761) for use by hospitals to bill for Shockwave C2 Coronary IVL catheters.

Key Points: 
  • In the July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), CMS issued a new device transitional pass-through code (C1761) for use by hospitals to bill for Shockwave C2 Coronary IVL catheters.
  • In addition, as part of the payment calculation, CMS announced that a customary deduction known as a device offset will not be applied to coronary stenting procedures involving coronary IVL.
  • The Shockwave C2 Coronary IVL device will be eligible for TPT payments for three years.
  • This announcement comes less than two months after CMS recommended Coronary IVL be eligible for incremental payment via a New Technology Add-on Payment (NTAP) as part of the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule.

Cliexa and American College of Cardiology Announce Collaborative Launch: Cliexa-Pulse, and Innovation in Digital Health Technology

Friday, June 11, 2021 - 9:00pm

PHILADELPHIA , June 11, 2021 --/PRNewswire-PRWeb/ -- Cliexa , a startup focused on home health monitoring, in collaboration with the American College of Cardiology (ACC) has launched a platform designed to remotely manage and monitor cardiovascular conditions.

Key Points: 
  • PHILADELPHIA , June 11, 2021 --/PRNewswire-PRWeb/ -- Cliexa , a startup focused on home health monitoring, in collaboration with the American College of Cardiology (ACC) has launched a platform designed to remotely manage and monitor cardiovascular conditions.
  • Created to seamlessly integrate with the delivery of care, including existing clinical workflows, cliexa-Pulse integrates with all major EMR/EHR systems in real time and can be leveraged to enhance delivery of care.
  • Teaming up though the ACC Innovation Program, which hosted a shark-tank style pitch competition focusing on transforming cardiovascular care and general heart health, cliexa was a finalist in the digital enabled device category.
  • In this partnership, cliexa's focus is enhancing the user experience from both the patient and clinician perspective.