Breakthrough therapy

Immunomedics Announces Positive Results from Phase 3 ASCENT Study of TRODELVY™ in Previously-Treated Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Monday, July 6, 2020 - 12:55pm

The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC.

Key Points: 
  • The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC.
  • The median PFS for patients treated with Trodelvy was 5.6 months (95% CI, 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p
  • Trodelvy also met key secondary endpoints of the study, including overall survival and objective response rate.
  • The international, open-label confirmatory Phase 3 study enrolled more than 500 patients with metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease.

EspeRare Receives FDA Breakthrough Therapy Designation for Investigational Prenatal Treatment ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Monday, July 6, 2020 - 12:00pm

These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .

Key Points: 
  • These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .
  • The FDA Breakthrough Therapy Designation intends to expedite the development and review of drugs for serious or life-threatening conditions.
  • Having the FDA Breakthrough Therapy Designation means scientists can aspire starting a clinical trial to confirm the findings for ER-004 and ultimately, if successful, make this treatment an option for families.
  • In Europe, the program receives support from the EMA's PRIME (Priority Medicines) and also the Orphan Drug Designation.

EspeRare Receives FDA Breakthrough Therapy Designation for Investigational Prenatal Treatment ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Monday, July 6, 2020 - 12:00pm

These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .

Key Points: 
  • These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .
  • The FDA Breakthrough Therapy Designation intends to expedite the development and review of drugs for serious or life-threatening conditions.
  • Having the FDA Breakthrough Therapy Designation means scientists can aspire starting a clinical trial to confirm the findings for ER-004 and ultimately, if successful, make this treatment an option for families.
  • In Europe, the program receives support from the EMA's PRIME (Priority Medicines) and also the Orphan Drug Designation.

Major Shareholder Announcement

Friday, July 3, 2020 - 8:18pm

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.

Key Points: 
  • Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
  • Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis.
  • A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis.
  • This Company Announcement contains forward looking statements.

2020 Insights into Head and Neck Cancer Disease Industry - Coverage Forecast and Market Analysis to 2024 - ResearchAndMarkets.com

Friday, July 3, 2020 - 11:23am

The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.

Key Points: 
  • The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.
  • Though a heterogenous group of diseases, the overwhelming majority (90%) of HNCs are comprised of squamous cell carcinomas of the head and neck (HNSCCs).
  • As such, there has been much interest in the development of immunotherapies to allow for a more targeted treatment program.
  • The first immunotherapies approved for recurrent/metastatic HNSCCs are the checkpoint inhibitors Keytruda (for first and second line) and Opdivo (second line only).

Major Shareholder Announcement

Friday, July 3, 2020 - 8:51am

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.

Key Points: 
  • Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
  • Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis.
  • A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis.
  • This Company Announcement contains forward looking statements.

2020 Study into the Global Macular Edema Industry - Market Size and Drug Sales - ResearchAndMarkets.com

Thursday, July 2, 2020 - 3:50pm

This report provides comprehensive insights into the Macular Edema pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.

Key Points: 
  • This report provides comprehensive insights into the Macular Edema pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.
  • This research analyzes and forecasts the Macular Edema market size and drug sales.
  • This research covers the following: Macular Edema treatment options, Macular Edema late stage clinical trials pipeline, Macular Edema prevalence by countries, Macular Edema market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.
  • Macular Edema pipeline: Find out drugs in clinical trials for the treatment of Macular Edema by development phase 3, phase 2, and phase 1, by pharmacological class and company
    Macular Edema drugs: Identify key drugs marketed and prescribed for Macular Edema in the US, including trade name, molecule name, and company
    Macular Edema market valuations: Find out the market size for Macular Edema drugs in 2019 by countries.

CytoDyn Releases Mechanism of Action Animation for Leronlimab in Immuno-Oncology

Thursday, July 2, 2020 - 11:00am

CytoDyn is currently exploring the efficacy of leronlimab for several immuno-oncology indications, including metastatic triple-negative breast cancer, a mechanism of action basket trial for 22 solid tumors, and a Phase 2 combination therapy for metastatic colorectal cancer.

Key Points: 
  • CytoDyn is currently exploring the efficacy of leronlimab for several immuno-oncology indications, including metastatic triple-negative breast cancer, a mechanism of action basket trial for 22 solid tumors, and a Phase 2 combination therapy for metastatic colorectal cancer.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Tuesday, June 30, 2020 - 11:45pm

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Key Points: 
  • For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.
  • BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIOplus best supportive care (BSC) as first-line maintenance treatment.

Sun BioPharma, Inc. Receives FDA Fast Track Designation for SBP-101

Tuesday, June 30, 2020 - 9:15pm

One of FDAs Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs.

Key Points: 
  • One of FDAs Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs.
  • Programs with Fast Track Designation may benefit from more frequent meetings with and written communications from FDA, in addition to being eligible for accelerated approval and priority review if certain criteria are met.
  • Fast Track Designation also provides eligibility for a rolling review of a New Drug Application (NDA), which allows for completed sections of an NDA to be submitted for FDA review.Usually NDA review does not begin until the company has submitted the entire application to the FDA.
  • Fast Track Designation is important for Sun BioPharma because it enhances our ability to develop SBP-101 as efficiently as possible, said Suzanne Gagnon, M.D., Chief Medical Officer of Sun BioPharma.