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Almirall Receives European Commission Approval of EBGLYSS® (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, November 17, 2023

“The arrival of novel biologic treatments is marking a new paradigm in the management of atopic dermatitis.

Key Points: 
  • “The arrival of novel biologic treatments is marking a new paradigm in the management of atopic dermatitis.
  • The approval of lebrikizumab represents a leap forward in our ability to provide patients with an effective therapeutic option with demonstrated safety profile.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland.

Mirum Pharmaceuticals Presents New Data at The Liver Meeting®

Retrieved on: 
Monday, November 13, 2023

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.
  • “PFIC is a chronic, debilitating cholestatic liver disease characterized by elevated bile acids and pruritus so severe that patients can be listed for liver transplant even in the absence of disease progression.
  • These data suggest overall improved liver health with maralixibat treatment in patients with PFIC that can be maintained long-term.
  • No clinically meaningful changes in liver enzyme levels or hematology parameters were observed after volixibat treatment.

Pusan National University Researchers Dive Deep Into the Safety of JAK Inhibitors for Atopic Dermatitis

Retrieved on: 
Friday, December 15, 2023

In this context, Janus kinase (or JAK) inhibitors are small molecules that have emerged as a promising treatment option for managing AD.

Key Points: 
  • In this context, Janus kinase (or JAK) inhibitors are small molecules that have emerged as a promising treatment option for managing AD.
  • However, the FDA has also issued a boxed warning for JAK inhibitors to include the risk of major adverse events.
  • Since then, many meta-analyses focusing on the safety of JAK inhibitors have been published, but these analyses are fraught with several limitations.
  • Title of original paper: The safety of systemic Janus kinase inhibitors in atopic dermatitis:

Sytheon Granted 2 New US Patents on Isosorbide Diesters for Treating Atopic Dermatitis, Seeking Exclusive Partner to Bring to Market

Retrieved on: 
Wednesday, December 13, 2023

PARSIPPANY, N.J., Dec. 13, 2023 /PRNewswire/ -- Sytheon is thrilled to announce that its new turnkey product for treating Atopic Dermatitis (eczema) has further patent protection – and is actively seeking an exclusive partner to bring it to the OTC dermatological market.

Key Points: 
  • PARSIPPANY, N.J., Dec. 13, 2023 /PRNewswire/ -- Sytheon is thrilled to announce that its new turnkey product for treating Atopic Dermatitis (eczema) has further patent protection – and is actively seeking an exclusive partner to bring it to the OTC dermatological market.
  • Sytheon is thrilled to announce that its new turnkey product for treating eczema has further patent protection.
  • There is currently an unmet need for a sustainable, safe, and cost-effective product for those with mild to moderate Atopic Dermatitis (AD).
  • Sytheon is actively looking for an exclusive partnership with the right organization to bring this turnkey product to the OTC dermatological market.

Triveni Bio Welcomes Jeff Albers and Allison Luo to its Board of Directors

Retrieved on: 
Wednesday, December 13, 2023

WALTHAM, Mass., Dec. 13, 2023 /PRNewswire/ -- Triveni Bio Inc., a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of I&I disorders, today announced the appointment of Jeff Albers as Chair of the Board and Allison Luo, M.D., to the Board of Directors.

Key Points: 
  • WALTHAM, Mass., Dec. 13, 2023 /PRNewswire/ -- Triveni Bio Inc., a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of I&I disorders, today announced the appointment of Jeff Albers as Chair of the Board and Allison Luo, M.D., to the Board of Directors.
  • Jeff Albers is an accomplished leader with over 25 years in the biopharmaceutical industry.
  • Jeff currently is board chair of Blueprint Medicines, and on the board of directors at Kymera Therapeutics and Spyre Therapeutics.
  • "I am honored to assume the role of Board Chair at Triveni and to work alongside this committed team," said Albers.

New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Retrieved on: 
Monday, December 11, 2023

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.

Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023

Retrieved on: 
Friday, December 1, 2023

As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:

Key Points: 
  • As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:
    IBI351 demonstrated encouraging antitumor activity.
  • IBI351 as a selective covalent irreversible KRAS G12C inhibitor, its monotherapy has demonstrated outstanding efficacy and manageable safety in advanced colorectal cancer with KRAS G12C mutation.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ESMO Asia Congress.
  • We will continue to explore the clinical development of IBI351 monotherapy and combination therapy in the fields of lung cancer, colorectal cancer and other solid tumors to benefit more cancer patients ."

The Skin of Color Society Kicks Off a Season of Giving with its My Best Winter Skin Campaign

Retrieved on: 
Tuesday, November 14, 2023

CHICAGO, Nov. 14, 2023 /PRNewswire/ -- The Skin of Color Society (SOCS), the world's leading professional skin of color dermatology organization, has established a national health awareness day known as My Best Winter Skin Day, kicking off an annual seasonal campaign built around public education, volunteerism and giving. While raising awareness about a common skin condition that affects people of all ages, skin types and tones in the colder months of the year, funds raised through this public educational campaign will go to the SOCS Foundation to help support innovative research and mentorship in skin of color dermatology.

Key Points: 
  • Winter skin is a seasonal condition that can be bothersome, uncomfortable or even unsightly for many people.
  • Wear gloves, mittens and scarves to protect your skin from the cold and the harsh effects of wind on the skin.
  • Protect skin.
  • To learn more about how to engage with SOCS and support mentorship and research, as well as the My Best Winter Skin Campaign, visit here.

Ipsen and Medison Pharma Announce Health Canada Approval of Bylvay™ (odevixibat) for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis (PFIC)

Retrieved on: 
Monday, November 13, 2023

ZUG, Switzerland and PARIS, Nov. 13, 2023 /PRNewswire/ -- Today, Ipsen (Euronext: IPN) (ADR: IPSEY), a global biopharmaceutical company focused on transformative medicines in oncology, rare disease and neuroscience, and Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, are pleased to announce the Health Canada approval for Bylvay™ (odevixibat) for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease.  Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.

Key Points: 
  • Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.
  • "At Medison, accelerating patients' access to innovative treatments is leading all that we do, so we are pleased and proud to bring Bylvay to patients in Canada," said Gil Gurfinkel, CEO at Medison Pharma.
  • "Until today, surgery was the only treatment option available for PFIC patients," said Mr. Walter Perez, President, Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network and father of a child living with PFIC.
  • We are extremely pleased that a less invasive treatment option is now available."

Ipsen and Medison Pharma Announce Health Canada Approval of Bylvay™ (odevixibat) for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis (PFIC)

Retrieved on: 
Monday, November 13, 2023

ZUG, Switzerland and PARIS, Nov. 13, 2023 /PRNewswire/ -- Today, Ipsen (Euronext: IPN) (ADR: IPSEY), a global biopharmaceutical company focused on transformative medicines in oncology, rare disease and neuroscience, and Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, are pleased to announce the Health Canada approval for Bylvay™ (odevixibat) for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease.  Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.

Key Points: 
  • Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.
  • "At Medison, accelerating patients' access to innovative treatments is leading all that we do, so we are pleased and proud to bring Bylvay to patients in Canada," said Gil Gurfinkel, CEO at Medison Pharma.
  • "Until today, surgery was the only treatment option available for PFIC patients," said Mr. Walter Perez, President, Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network and father of a child living with PFIC.
  • We are extremely pleased that a less invasive treatment option is now available."