Novartis

New England Journal of Medicine publishes Phase III data showing Xolair® (omalizumab) significantly reduced allergic reactions across multiple foods in people with food allergies

Retrieved on: 
Sunday, February 25, 2024

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.

Key Points: 
  • Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.
  • The US Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
  • "While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
  • The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure."

Omalizumab Increases the Reaction Threshold for Peanut and Other Common Food Allergies

Retrieved on: 
Sunday, February 25, 2024

WASHINGTON, Feb. 25, 2024 /PRNewswire-PRWeb/ -- Sixteen weeks of omalizumab results in a higher tolerated threshold for multiple food allergies according to new research presented today at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and published in the New England Journal of Medicine.

Key Points: 
  • "Food allergies affect millions of individuals in the U.S., and those impacted face a daily threat of life-threatening reactions.
  • To remain safe, constant vigilance is required and even then, accidental exposures are very common," said Dr. Robert A.
  • "The OUtMATCH study demonstrated that omalizumab (Xolair) significantly increased the threshold for reaction in most patients for peanut and the six other foods studied, enough to provide real protection against small, accidental exposures.
  • As food allergies are common, this study highlights a valuable option for safe and effective food allergy treatment.

FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies

Retrieved on: 
Friday, February 16, 2024

People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance").

Key Points: 
  • People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance").
  • Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens3.
  • Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
  • "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."

Smart Immune appoints key new members to its Board of Directors

Retrieved on: 
Friday, February 16, 2024

Markus Goebel, Grégoire Cayatte, Federico Mingozzi and Pablo Silveri will join existing directors, Dominique Costantini and Fouzia Laghrissi-Thode, to accelerate and support the growth of Smart Immune.

Key Points: 
  • Markus Goebel, Grégoire Cayatte, Federico Mingozzi and Pablo Silveri will join existing directors, Dominique Costantini and Fouzia Laghrissi-Thode, to accelerate and support the growth of Smart Immune.
  • Karine Rossignol, CEO and Co-founder of Smart Immune, said: “We are delighted and proud to welcome such distinguished experts to the Board, led by Markus Goebel as our new Chairman.
  • We are grateful to our outgoing Chairman for his 5-year commitment and support to Smart Immune.”
    Markus Goebel, CEO and Founder of M&G Advisors and Chairman of Smart Immune’s Board of Directors, said: “I am thrilled to join and lead the Board of Smart Immune.
  • He is on the Boards of Halozyme, ADC Therapeutics and Aprea Therapeutics and now an Observer on the Board of Directors at Smart Immune.

Royalty Pharma Reports Q4 and Full Year 2023 Results

Retrieved on: 
Thursday, February 15, 2024

In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.

Key Points: 
  • In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.
  • Royalty Pharma began repurchasing its Class A ordinary shares in April 2023 under a $1.0 billion multi-year share repurchase program.
  • During the fourth quarter of 2023, Royalty Pharma announced new transactions of up to $1.6 billion.
  • Royalty Pharma will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2023 results today at 8:00 a.m., Eastern Time.

Firefly Bio Debuts With $94 Million Series A Financing

Retrieved on: 
Thursday, February 15, 2024

Firefly Bio emerged from stealth mode with a $94 million Series A financing co-led by founding investor Versant Ventures and by MPM BioImpact alongside Decheng Capital and with participation from Eli Lilly & Company.

Key Points: 
  • Firefly Bio emerged from stealth mode with a $94 million Series A financing co-led by founding investor Versant Ventures and by MPM BioImpact alongside Decheng Capital and with participation from Eli Lilly & Company.
  • Firefly has developed a novel platform to treat cancer using degrader antibody conjugates (DACs).
  • Firefly was incubated in close collaboration with scientists at Versant’s Ridgeline Discovery Engine in the Basel Technology Park.
  • “At Firefly, we’ve assembled a unique talent base and platform to significantly advance this promising field,” said Jerel Davis, Ph.D., Managing Director at Versant and a Firefly board member.

Genmab Publishes 2023 Annual Report

Retrieved on: 
Wednesday, February 14, 2024

COPENHAGEN, Denmark; February 14, 2024 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2023.

Key Points: 
  • COPENHAGEN, Denmark; February 14, 2024 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2023.
  • Below is a summary of business progress in 2023, financial performance for the year and the financial outlook for 2024.
  • Genmab will hold a conference call in English to discuss the full year results for 2023 today, February 14, 2024 at 6:00 pm CET, 5:00 pm GMT, 12:00 pm EST.
  • Net sales of DARZALEX by Janssen were USD 9,744 million in 2023 compared to USD 7,977 million in 2022.

Scinai Welcomes Liat Halpert as Head of Business Development and Sales

Retrieved on: 
Tuesday, February 13, 2024

JERUSALEM, Feb. 13, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, today announced the appointment of Liat Halpert as Head of Business Development and Sales.

Key Points: 
  • JERUSALEM, Feb. 13, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, today announced the appointment of Liat Halpert as Head of Business Development and Sales.
  • Scinai's broad pharmaceutical development experience, along with its end-to-end biologics drug development and GMP manufacturing facility, drove the Q3 2023 launch of Scinai Bioservices, a boutique end-to-end CDMO business unit, to assist biotech companies efficiently bring their products to market.
  • In addition to expanding the CDMO's business development and sales activities, Halpert will support partnering and out-licensing activities with mid and large cap pharma companies with which Scinai plans on bringing the NanoAbs through clinical trials and towards commercialization.
  • Halpert commented, "I am thrilled to join Scinai where I'll be leading business development and sales of our state-of-the-art end-to-end CDMO services in the global biotech arena.

Biologic Therapeutic Drugs: Technologies and Global Market Report 2024, with Company Profiles of Amgen, Abbive, Eli Lilly, Novartis and Glaxosmithkline - ResearchAndMarkets.com

Retrieved on: 
Monday, February 12, 2024

The "Biologic Therapeutic Drugs: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biologic Therapeutic Drugs: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.
  • The report also covers market projections through 2028, as well as key market players.
  • Estimate of the actual market size and revenue forecast, and a corresponding market share analysis by product type, therapeutic area and region.
  • Company profiles of major players within the industry, including Amgen, Abbive, Eli Lilly, Novartis and Glaxosmithkline

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

Retrieved on: 
Friday, February 9, 2024

BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.

Key Points: 
  • BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.
  • Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia.
  • Trastuzumab is a biosimilar of Herceptin® and Bevacizumab is a biosimilar of Avastin®3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers.
  • OGIVRI® and ABEVMY® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company.