Erythema

Your skin is a mirror of your health – here’s what yours might be saying

Retrieved on: 
tisdag, januari 30, 2024

It is the largest and most visible organ in the human body.

Key Points: 
  • It is the largest and most visible organ in the human body.
  • Being the most visible of our organs, the skin also offers us a view into the body tissues that it protects.
  • So don’t think of your skin merely aesthetically – think of it as a reflection of your health.

Bullseye

  • But while the vast majority of tick bites won’t make you ill, there is one rash that should prompt a visit to your doctor if you spot it.
  • Erythema migrans, a rash named for its ability to rapidly expand across the skin, is a hallmark of Lyme disease, a potentially severe bacterial illness.
  • This rash forms a classic target pattern, like a bullseye on a dartboard.

Purpura

  • Some rashes are given a colourful namesake – purpura is one such example.
  • Purpura refers to a rash of small purple or red dots.
  • Purpura signals an issue with either the walls of the tiny blood vessels that feed the skin or the blood within them.

Skin spiders


Skin rashes can also take on recognisable shapes. Spider naevi represent an issue within skin arterioles (small arteries which supply the skin with blood). Arterioles open and close to control the loss of heat from the body’s surface. But sometimes they can get stuck open – and a spider-like pattern will appear.

  • Crush the body under a fingertip and the whole thing disappears, as your touch temporarily stops the blood flow.
  • Treat the underlying cause, and the spiders often vanish with time – though they may persist or reappear later.

Black velvet

  • This “black velvet” skin appearance is more commonly seen in darker skins.
  • Usually, the condition is associated with disorders of the metabolism – namely type 2 diabetes and polycystic ovary syndrome.

Butterfly rashes

  • Cardiac valves have the important role of correctly directing the journey of blood through the heart and preventing backflow.
  • The body’s natural response is to preserve core blood volume, shutting off flow towards the skin.
  • The net effect can produce a purple-red rash, high across the cheeks and the bridge of the nose, like the outstretched wings of a butterfly.


Dan Baumgardt does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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måndag, januari 29, 2024

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae.
  • The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema.
  • HYQVIA first received approval from the EC for the treatment of primary immunodeficiency (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8

U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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tisdag, januari 16, 2024

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
  • Because it is delivered subcutaneously, HYQVIA can be administered by a healthcare professional in a medical office, infusion center or at a patient’s home.
  • “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”
    HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the U.S.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.6

STRATA Skin Sciences to Present Poster Showcasing Safety and Efficacy of TheraClear®X for Acne at Maui Derm 2024 Conference   

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måndag, januari 8, 2024

The poster highlights the safety and efficacy of one treatment session using STRATA’s TheraClear®X technology for cystic and papular acne reduction.

Key Points: 
  • The poster highlights the safety and efficacy of one treatment session using STRATA’s TheraClear®X technology for cystic and papular acne reduction.
  • Majority of lesions demonstrated ≥50% clearing by 1-2 weeks, exceeding the criteria of ≥30% reduction in lesion size at two follow-up visits.
  • At 1-2 weeks, the most frequently reported event was mild hyperpigmentation; erythema, edema, and flaking were observed in ≤10% of lesions.
  • “The TheraClear®X Photopneumatic acne system used with the additional needle insert is a very effective and safe treatment for both cystic and pustular acne lesions.

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

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måndag, januari 8, 2024

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

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fredag, januari 5, 2024

SCOTTSDALE, Ariz., Jan. 05, 2024 (GLOBE NEWSWIRE) --  Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the Company has submitted a New Drug Application (“NDA”) to the FDA seeking approval for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.

Key Points: 
  • DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.
    “This NDA submission is a significant milestone for Journey Medical and we look forward to collaborating with the FDA during its review to bring DFD-29, a potentially differentiated, best-in-class oral rosacea treatment, one step closer to patients.
  • The NDA submission is supported by positive data from Journey Medical’s two DFD-29 Phase 3 clinical trials for the treatment of rosacea.
  • The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues.
  • DFD-29 has the potential to become the only oral, systemic therapy to address both inflammatory lesions and erythema (redness) from rosacea, as demonstrated in the clinical trials.

scPharmaceuticals Announces Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue

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torsdag, januari 4, 2024

BURLINGTON, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced preliminary unaudited fourth quarter 2023 net FUROSCIX revenue in a range of $5.9 million to $6.1 million, representing sequential growth of 55% to 61% over $3.8 million net FUROSCIX revenue reported for the third quarter of 2023.

Key Points: 
  • For the full year 2023, the Company anticipates net revenue to be in a range of $13.4 million to $13.6 million.
  • The gross-to-net discount decreased to approximately 18% from launch through the end of Q4 versus 21% from launch through the end of Q3.
  • Inventory levels at the end of Q4 2023 were consistent with levels at the end of Q3 2023.
  • scPharmaceuticals will report its final and complete fourth quarter and full-year 2023 financial results in March.

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised