Hypotension

mHealth Solutions Market worth $395.0 billion | MarketsandMarkets

Retrieved on: 
Monday, March 27, 2023

The Health Apps segment accounted for the largest share in the mHealth solutions market, by mHealth Apps.

Key Points: 
  • The Health Apps segment accounted for the largest share in the mHealth solutions market, by mHealth Apps.
  • The mHealth solutions market, by mHealth Apps, is segmented into Healthcare Apps and Medical Apps.
  • By services, the remote monitoring services segment accounted for the largest share in the mhealth solutions market by service.
  • mHealth Solutions Market - Report Highlights:
    Emerging industry trends have been elaborated on in the industry insights chapter.

mHealth Solutions Market worth $395.0 billion | MarketsandMarkets

Retrieved on: 
Monday, March 27, 2023

The Health Apps segment accounted for the largest share in the mHealth solutions market, by mHealth Apps.

Key Points: 
  • The Health Apps segment accounted for the largest share in the mHealth solutions market, by mHealth Apps.
  • The mHealth solutions market, by mHealth Apps, is segmented into Healthcare Apps and Medical Apps.
  • By services, the remote monitoring services segment accounted for the largest share in the mhealth solutions market by service.
  • mHealth Solutions Market - Report Highlights:
    Emerging industry trends have been elaborated on in the industry insights chapter.

Chemotherapy Induced Diarrhea Epidemiology Forecast 2023 - 2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 24, 2023

The "Chemotherapy Induced Diarrhea - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chemotherapy Induced Diarrhea - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This "Chemotherapy-induced Diarrhea (CID) - Epidemiology Forecast - 2032" report delivers an in-depth understanding of the CID, historical and forecasted epidemiology as well as the CID market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
  • Chemotherapy-induced diarrhea (CID), also called chemotherapy-related diarrhea, can be associated with various chemotherapy agents but is most commonly described with fluoropyrimidines (particularly fluorouracil [FU] and capecitabine) and irinotecan.
  • The epidemiology segment also provides Chemotherapy-induced Diarrhea (CID) epidemiology data and findings across the United States, EU4 and the UK, and Japan.

EQS-News: PAION IS HOSTING A SPONSORED ANGIOTENSIN II SYMPOSIUM AT ISICEM IN BRUSSELS

Retrieved on: 
Thursday, March 16, 2023

One abstract about angiotensin II has been accepted for a presentation.

Key Points: 
  • One abstract about angiotensin II has been accepted for a presentation.
  • In addition, PAION has organised a Sponsored Symposium.
  • Poster number P219
    This post hoc analysis helps to understand which group of patients might be further studied to determine benefits from treatment with angiotensin II.
  • Angiotensin II mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure.

RVL Pharmaceuticals plc to Discuss Fourth Quarter and Full Year 2022 Financial Results and Provide Commercial Update

Retrieved on: 
Wednesday, March 15, 2023

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

Xilio Therapeutics Announces Pipeline and Business Updates for the Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 2, 2023

WALTHAM, Mass., March 02, 2023 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • “In 2022, we made significant progress against our goals, advancing the clinical development of all three of our novel tumor-activated immuno-oncology programs.
  • Report preliminary anti-tumor activity, safety, PK and PD data from the Phase 1/2 clinical trial in the third quarter of 2023.
  • Net Loss: Net loss was $22.5 million for the quarter ended December 31, 2022, compared to $19.7 million for the quarter ended December 31, 2021.
  • Net loss was $88.2 million for the year ended December 31, 2022, compared to $75.8 million for the year ended December 31, 2021.

Galera Announces FDA Acceptance and Priority Review of Avasopasem NDA for Radiotherapy-Induced Severe Oral Mucositis

Retrieved on: 
Wednesday, February 15, 2023

MALVERN, Pa., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients. With the 6-month priority review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for this NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.

Key Points: 
  • With the 6-month priority review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for this NDA is August 9, 2023.
  • The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.
  • The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of SOM induced by RT.
  • In the ROMAN trial, results on a pre-defined exploratory endpoint showed that avasopasem reduced cisplatin-induced chronic kidney disease by half at one year.

Chiesi Global Rare Diseases Announces FDA Approval of Lamzede®(velmanase alfa-tycv) for Alpha-Mannosidosis

Retrieved on: 
Thursday, February 16, 2023

BOSTON, Feb. 16, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food and Drug Administration (FDA) has approved Lamzede® (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase.

Key Points: 
  • "Today's approval of Lamzede represents a major milestone for people living with alpha-mannosidosis.
  • Lamzede is the first and only enzyme replacement therapy approved for alpha-mannosidosis in the United States, an achievement based on years of clinical development, as well as the dedication of our employees, clinicians, patients and their families," said Giacomo Chiesi, head of Chiesi Global Rare Diseases.
  • The prevalence of AM is approximately one in every 500,000 to one in every 1,000,000 babies born worldwide.
  • For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with Lamzede.

FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Wednesday, January 18, 2023

* Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.

Key Points: 
  • * Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.
  • In addition, FDA previously granted Competitive Generic Therapy designation for the prefilled syringe and the nalmefene hydrochloride injection vial.
  • There is no guarantee that nalmefene prefilled syringe will successfully complete development or gain FDA approval.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

RVL Pharmaceuticals plc Announces Preliminary Fourth Quarter Sequential Growth of 21% and Full Year 2022 UPNEEQ® Net Product Sales

Retrieved on: 
Monday, January 9, 2023

BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the “Company”), a specialty pharmaceutical company, today announced preliminary fourth quarter and full year 2022 net product sales of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the first and only U.S. Food and Drug Administration (“FDA”)-approved ophthalmic solution for blepharoptosis, or droopy eyelids, of approximately $12.1 million and $36.5 million, respectively. The preliminary fourth quarter 2022 net product sales of UPNEEQ represent a sequential increase of 21% from the third quarter 2022. The Company also announced that from February through year-end 2022 it had received orders from approximately 4,300 cumulative unique medical aesthetics practices.

Key Points: 
  • The preliminary fourth quarter 2022 net product sales of UPNEEQ represent a sequential increase of 21% from the third quarter 2022.
  • “We are proud of our progress in the fourth quarter, notably the continued upward trajectory of net product sales for UPNEEQ.
  • On a full-year basis, we expect our UPNEEQ revenues to exceed $36 million, representing nearly 400% growth over 2021.
  • The financial and operating data for the fourth quarter of 2022 and for the full year 2022 is preliminary and may change.