XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

XTalks

DECEMBER 18, 2024

In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis. It also received the FDAs rare pediatric disease priority review voucher along with the approval, which will help expedite the agencys assessment of another application.

Genetics 116

Genetics Hormones Trials Drugs 116

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

XTalks

DECEMBER 7, 2022

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). The median time to complete remission was 1.9 billion deal.

FDA Approval 52

FDA Approval Drugs Licensing Licensing 52

XTalks

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). Last year, the FDA approved the first generic version of Restasis.

FDA Approval 98

FDA Approval Gene Therapy Gene Marketing 98

XTalks

MARCH 21, 2023

Daybue’s FDA approval was accompanied by a Rare Pediatric Disease Priority Review Voucher, which can be used to obtain priority review for a subsequent application. Daybue’s FDA approval was supported by results from the pivotal Phase III LAVENDER study that involved 187 female patients five to 20 years of age with Rett syndrome.

FDA Approval 94

FDA Approval Gene Therapy Gene Genetics 94

XTalks

JANUARY 16, 2025

It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDA approval in 2020. Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

Trials 59

Trials Clinical Trials Clinical Trials Insulin 59

XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. RELATED: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic Why is There a Semaglutide Shortage?

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

XTalks

JULY 10, 2023

“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.

Pharmacy 90

Pharmacy FDA Approval Licensing Licensing 90

XTalks

JULY 6, 2021

As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug. SER-109 “repopulates” the microbiome to induce compositional and functional changes that are critical to a sustained clinical response.

Marketing 105

Marketing Drugs Bacteria FDA Approval 105

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.

Pharmacy 104

Pharmacy Drugs Production Sales 104

XTalks

FEBRUARY 29, 2024

After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. The journey of Aduhelm from its accelerated approval and predicted blockbuster status to discontinuation has been fraught with controversy, debate and ultimately, disappointment.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

Drugs 98

Drugs FDA Approval Genetics Clinical Trials 98

XTalks

APRIL 17, 2023

These results are very promising for patients with atopic dermatitis,” said Jonathan Silverberg, MD, professor of dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies, in the company’s press release. Dupixent inhibits signaling of both IL-4 and IL-13.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

FEBRUARY 20, 2024

“The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. Pereira, MD, chief executive officer of Visterra Inc.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Antibody 59

XTalks

MAY 30, 2024

Potential New CIDP Treatment: argenx’s Efgartigimod Alfa The US Food and Drug Administration (FDA) has accepted argenx’s supplemental Biologics License Application (sBLA) for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for priority review to treat CIDP.

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

RNA 52

RNA Antibody Life Science Protein 52

XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one.

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Production Marketing Development Pharmacy 98

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

Life Science 40

Life Science Development Sales Drugs 40

XTalks

JANUARY 12, 2023

The approval is based on Phase II data that demonstrated a reduction in amyloid-beta plaques (the defining characteristic of Alzheimer’s disease) in patients with early Alzheimer’s disease treated with Leqembi. Alzheimer’s disease develops in the part of the brain controlling our thoughts, memories and language abilities.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. Nizoral is prescribed off-label, while the others are FDA approved. What Is a Surrogate Endpoint? Novartis’ Signifor (pasireotide) is also indicated in the treatment of the disease.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

MAY 28, 2024

In March 2024, the VRBPAC met once again and made their recommendations for the strains of A(H1N1) and A(H3N2) as well as the B virus to be included in the 2024/25 Northern Hemisphere trivalent formulation of influenza vaccines licensed for use in the US.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

XTalks

MAY 20, 2024

FDA-Approved Treatments for Schizophrenia Schizophrenia treatment typically involves a combination of medication, therapy and comprehensive social support. The US Food and Drug Administration (FDA) has approved many antipsychotic medications central to managing schizophrenia.

Clinical Trials 52

Clinical Trials Clinical Trials Trials FDA Approval 52

XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Production 98

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore was granted the approval for Kimmtrak several weeks ahead of the scheduled PDUFA date of February 23. Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore.

FDA Approval 98

FDA Approval Development Containment Licensing 98

XTalks

FEBRUARY 12, 2025

Nerandomilast is Boehringers next candidate for PPF and IPF following their FDA-approved treatment, Ofev (nintedanib) one of only two approved therapies for IPF, alongside pirfenidone.

Clinical Trials 66

Clinical Trials Clinical Trials Trials FDA Approval 66

XTalks

MARCH 7, 2025

Roche’s Gazyva/Gazyvaro for Lupus Nephritis Roche submitted a Biologics License Application (BLA) for Gazyva/Gazyvaro (obinutuzumab) in the treatment of lupus nephritis. Reata Pharmaceuticals (now part of Biogen) secured FDA approval for Skyclarys (omaveloxolone) in 2023, targeting mitochondrial dysfunction in kidney disease.

Clinical Trials 59

Clinical Trials Clinical Trials Marketing Research 59

XTalks

NOVEMBER 2, 2020

It received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of eosinophilic granulomatosis with polyangiitis in 2018, and hypereosinophilic syndrome and eosinophilic oesophagitis in 2019. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., PONENTE Trial.

Trials 94

Trials FDA Approval Drugs Hormones 94

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. The treatment requires three initial doses at 14-day intervals, followed by a maintenance dose every 28 days. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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Life Science Drugs FDA Approval Vaccine 97

XTalks

JANUARY 4, 2024

Pfizer licensed Beqvez from Spark Therapeutics nine years ago. Related: Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease While the Health Canada approval is a significant inaugural win, Pfizer is looking to discontinue development of viral vector-based gene therapies. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

XTalks

JUNE 9, 2021

While the FDA approval does not indicate that the drug is for a specific group of patients, aducanumab was studied in a specific subset of patients with early disease and who were positive for a component found in amyloid brain plaques. Since then, many in the Alzheimer’s world were awaiting the FDA’s decision on the drug.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Currently, the only other viable malaria vaccine, known as RTS,S/AS01 (Mosquirix), has a demonstrated efficacy of 55.8

Vaccine 105

Vaccine Vaccination Immune Response Trials 105