The Pharma Data

DECEMBER 1, 2020

Presentations will be available for registered attendees via the Piper Sandler conference site through December 3. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. This indication is approved under accelerated approval based on overall response rate and duration of response.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Title: Targeted Therapy and Ovarian Cancer Trials. Pipeline Highlights.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “I BASEL, Switzerland, Dec.

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The Pharma Data

JANUARY 7, 2021

Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company’s head office is in Victoria, British Columbia and its U.S.

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DrugBank

MAY 6, 2024

Unlike conventional chemical-based medicines, biologics offer targeted therapies derived from living cells, which can result in more effective and personalized treatments. A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals.

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Fierce BioTech

SEPTEMBER 11, 2023

Aligning cross-functional teams across the organization to ensure medical, marketing, and market access are all in lock-step is even more crucial when launching a therapy into a rare disease market.

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The Pharma Data

SEPTEMBER 28, 2021

The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to 6 weeks aged and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne dystrophy (DMD).

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The Pharma Data

NOVEMBER 18, 2021

There are presently further than trials studying KEYTRUDA across a wide variety of cancers and treatment settings. KEYTRUDA is a humanized monoclonal antibody that blocks the commerce between PD-1 and its ligands, PD-L1 and PD-L2, thereby cranking T lymphocytes which may affect both excrescence cells and healthy cells.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

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Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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The Pharma Data

FEBRUARY 1, 2021

Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”. You should not place undue reliance on these statements or the scientific data presented. 3 Zhao Y, et al.

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The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. The benefit was independent of ejection fraction or diabetes status.

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Drug Target Review

MAY 14, 2024

How do hydrophobicity, electrostatic charge, and secondary confirmation of helical polypeptides influence the stimulation of innate immune pathways in antigen-presenting cells (APCs)? What potential therapeutic advantages do the engineered cationic polypeptides offer in the context of generating antitumour immune responses?

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The Pharma Data

JULY 12, 2021

The approval of finerenone offers a new path to protect patients from further kidney damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies.”. Chronic kidney disease (CKD) is a common and potentially deadly condition that is generally underrecognized.

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The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. These findings were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek. Kimberly Smith, M.D.,

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. You should not place undue reliance on these statements or the scientific data presented. About Biogen.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

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The Pharma Data

FEBRUARY 18, 2022

These data (Presentation #DOP44) will be presented at the 17 th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022. Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here. It is estimated that approximately 12.6

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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Drug Target Review

MAY 27, 2024

What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans? At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs.

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The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease.

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The Pharma Data

FEBRUARY 25, 2022

The company anticipates submitting study results for presentation at an upcoming medical congress. Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. These results were also recently published online in Rheumatology and Therapy in April 2021. The approved dose for RINVOQ is 15 mg. NORTH CHICAGO, Ill. 2 In August 2019 , RINVOQ received U.S.

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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. The agency requested that data be further standardized and presented by primary functional endpoint. Reference: [1] Hansen, et al.

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6]. 4] , [5] , [6].

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The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020. BOSTON–( BUSINESS WIRE )– Gamida Cell Ltd.

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

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The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Presentation Details.

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The Pharma Data

AUGUST 19, 2021

These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections ( virtual CROI 2021). 26-week data from the CAPELLA study were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. The most common adverse events observed were injection site reactions.

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The Pharma Data

SEPTEMBER 1, 2020

These data (Presentation #P0217) will be presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. At the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, Bristol Myers Squibb and collaborators will present 15 clinical and non-clinical abstracts that reinforce the breadth and depth of the company’s research in MS.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. NORTH CHICAGO, Ill.

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The Pharma Data

DECEMBER 9, 2020

The targeted indication is for treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).

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Conversations in Drug Development Trends

MAY 30, 2024

A condition of approval is the completion of a Phase 3 study designed to evaluate pheno-conversion in SOD1 mutation carriers (ATLAS study) to confirm clinical benefit. Moreover, exploring the repurposing of existing drugs offers additional pathways to potentially effective treatments through adopting a horizontal thinking-based approach.

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