The Lancet

Vaxcyte Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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화요일, 2월 27, 2024

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress

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목요일, 3월 7, 2024

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.
  • In November 2023, Arcturus received Orphan Drug Designation from the U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis.
  • We have achieved a total of approximately $396.0 million in upfront payments and milestones from CSL as of December 31, 2023.

Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress

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목요일, 2월 29, 2024

Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.

Key Points: 
  • Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.
  • Share repurchase: During the fourth quarter 2023, Innoviva repurchased 1,121,835 shares of its outstanding common stock for $15.4 million.
  • Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $561.0 million as of December 31, 2023.
  • In fourth quarter 2023, Innoviva invested an additional $5.0 million in one of our assets, Gate Neurosciences, to support its strategy of developing next generation targeted CNS therapies.

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

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목요일, 2월 15, 2024

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Preterm Births Linked to 'Hormone Disruptor' Chemicals May Cost United States Billions

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화요일, 2월 6, 2024

Then, the team looked for associations between these metabolite levels and preterm births.

Key Points: 
  • Then, the team looked for associations between these metabolite levels and preterm births.
  • "Otherwise, investigators are likely going to find the same study results in another few years about the next group of chemicals used as replacements."
  • California, among a few states, has banned some use of phthalates in consumer products, as have European Union member states.
  • Trasande cautions that further research is needed to better understand the specific mechanisms behind the link between phthalate exposure and preterm birth.

Atara Biotherapeutics and Pierre Fabre Laboratories Announce Publication of Phase 3 ALLELE Tab-cel® Data in The Lancet Oncology

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수요일, 1월 31, 2024

22 of 43 EBV+ PTLD patients achieved an objective response (51.2% objective response rate, or ORR).

Key Points: 
  • 22 of 43 EBV+ PTLD patients achieved an objective response (51.2% objective response rate, or ORR).
  • The median duration of response was 23.0 months and the median overall survival was 18.4 months.
  • These interim data were previously presented at the 2022 American Society of Hematology (ASH) Annual Meeting.
  • All this resonates perfectly with our purpose ‘every time we care for a single person, we make the whole world better,’” said Núria Perez-Cullell, Director of Medical Affairs, Patients & Consumers at Pierre Fabre Laboratories.

InflaRx Announces Initiation of its Commitment Program for GOHIBIC®(vilobelimab) to Help Broaden Access for Eligible Patients

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목요일, 1월 25, 2024

InflaRx is determined to support broader access to GOHIBIC for eligible patients.

Key Points: 
  • InflaRx is determined to support broader access to GOHIBIC for eligible patients.
  • ANN ARBOR, Mich., Jan. 25, 2024 (GLOBE NEWSWIRE) -- InflaRx Pharmaceuticals Inc., a subsidiary of InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that the Company has launched The InflaRx Commitment Program (Commitment Program).
  • With today´s announcement, we are demonstrating our strong commitment to help make GOHIBIC available for the most affected COVID-19 patients as a potential life-saving therapy.
  • For detailed information about the Commitment Program and to file a claim, please visit this link: The InflaRx Commitment Program .

Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy Utilizing the Company's Proprietary Platform, for the Treatment of Relapsed/Refractory Multiple Myeloma.

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월요일, 1월 29, 2024

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.

Key Points: 
  • OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D.
  • The therapy leverages Oricell's proprietary platforms including Ori®Ab antibodies, Ori®CAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells.
  • The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately.
  • "The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting and will significantly benefit multiple myeloma patients on a global scale.

The Biocodex Group Strengthens Its Position in Microbiota, With the Signature of a Licensing Agreement With My Health, a Belgian Biotech Company Specializing in Microbiota Solutions

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수요일, 1월 17, 2024

Biocodex, a French pharmaceutical group with expertise in microbiota, women's health, orphan diseases, and My Health, a Belgian biotech company specializing in microbiota solutions, announce that they have signed a licensing agreement covering several countries in which the Biocodex Group operates, to market the DUOSPORE® dietary supplement.

Key Points: 
  • Biocodex, a French pharmaceutical group with expertise in microbiota, women's health, orphan diseases, and My Health, a Belgian biotech company specializing in microbiota solutions, announce that they have signed a licensing agreement covering several countries in which the Biocodex Group operates, to market the DUOSPORE® dietary supplement.
  • My Health was founded in 2017 by Raf Dybajlo.
  • In 2021, the company published a clinical study in The Lancet Gastroenterology & Hepatology on the efficacy of My Health’s proprietary strains, MY01 & MY02, in the treatment of functional dyspepsia (unexplained stomach complaints).
  • Raf Dybajlo, CEO of My Health, expresses enthusiasm for the strategic partnership with Biocodex: “I’m honored that My Health’s innovative research and commercial success have been recognized by Biocodex.

Patient, Research and Industry Leaders Propose Biological Definition and First Biological Staging for Parkinson's Disease

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화요일, 1월 23, 2024

The new research framework stands to accelerate and increase the success of scientific discovery and therapeutic development at all stages of Parkinson's.

Key Points: 
  • The new research framework stands to accelerate and increase the success of scientific discovery and therapeutic development at all stages of Parkinson's.
  • And ultimately, a treatment that targets the biology of the disease — rather than just its symptoms — is the way to reach a cure.
  • (A similar biological framework in Alzheimer's disease resulted in successful trials and new drug approvals, with the first drugs to slow Alzheimer's-related cognitive decline appearing in 2022 and 2023.)
  • This landmark step forward was made possible by the breakthrough discovery of a test — validated in April 2023 by The Michael J.