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

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

JULY 14, 2022

In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

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

JUNE 20, 2022

Amvuttra’s FDA approval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. The condition has very limited treatment options.

FDA Approval 98

FDA Approval Protein Genetics RNA 98

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 Licensing Licensing 98

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

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

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. A second liver biopsy will be performed after 18 months.

Licensing 52

Licensing Licensing Protein Antibody 52

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

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 Production 92

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

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

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

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

XTalks

AUGUST 15, 2023

struck a worldwide collaboration (excluding Japan) and license agreement with niraparib developer Tesaro (acquired by GSK in 2019) for exclusive rights to the drug in prostate cancer. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

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

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. In its acquisitions, J&J also acquired antibody-drug conjugate (ADC) developer Ambryx and cardiac med tech Laminar along with more than 50 smaller, early-stage licensing deals and partnerships.

Pharma Companies 52

Pharma Companies Sales FDA Approval Vaccination 52

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 Trials 59

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

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

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

JANUARY 11, 2024

Related: March-In Rights Could be Exercised by Biden Administration to Help Lower Drug Prices “The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M.

Drugs 69

Drugs Cosmetics Medicine FDA Approval 69

XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd).

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

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

Delveinsight

JANUARY 19, 2021

A Sweet Year For Daiichi/ AZ As Enhertu Gets FDA Approval For Gastric Cancer. CABIM, the industry-academia research and development consortium, is a joint effort of Fujifilm, Harvard University, Massachusetts Institute of Technology, Cytiva (formerly part of GE Healthcare Life Sciences), and Alexandria Real Estate Equities, Inc.

Manufacturing 40

Manufacturing Gene Therapy Life Science FDA Approval 40

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

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

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 Hormones Drugs 94

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

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

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

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.

Production 98

Production Marketing Development Pharmacy 98