The Pharma Data

JANUARY 13, 2021

Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma. Knopp’s preclinical Kv7 platform is directed to small-molecule treatments for developmental and epileptic encephalopathies, other epilepsies, neuropathic pain, and tinnitus. Source link.

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Trials Small Molecule Clinical Trials Treatment 52

Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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Drugs Small Molecule Production Disease 75

The Pharma Data

APRIL 28, 2021

I am honored that Takeda receives two awards for the production and packaging of small molecule solid dosage form products,” said Thomas Wozniewski, global manufacturing & supply officer of Takeda. “In We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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Packaging Small Molecule Pharmaceutical Companies Pharmaceuticals 52

The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies.

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Small Molecule Engineering Clinical Development Pharmaceuticals 52

The Pharma Data

MARCH 1, 2022

“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. Source link: [link].

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The Pharma Data

JANUARY 6, 2021

IPF is a devastating condition with an estimated mean survival of 2-5 years from time of diagnosis, and currently there are no available therapies that stop the progression of fibrosis or treat the underlying causes of the disease,” said John Hood, Ph.D., Taladegib is a small-molecule inhibitor of the Hedgehog signaling pathway.

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The Pharma Data

DECEMBER 9, 2020

333-222268) previously filed with the Securities and Exchange Commission (the “SEC”) on December 22, 2017 and declared effective by the SEC on January 5, 2018. SAN DIEGO, Dec. 09, 2020 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc. per share, less underwriting discounts and commissions.

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The Pharma Data

JULY 15, 2021

JJIPO@Monash was originally launched in 2018 to provide crucial support to researchers and companies in the Victorian life-science sector as part of the Government’s commitment to the medical technologies and pharmaceuticals sector – one of eight priority growth sectors. .

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The Pharma Data

APRIL 23, 2021

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. Hormone replacement therapy for endocrinopathies should be instituted as warranted.

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Therapies Treatment Licensing Licensing 40

The Pharma Data

APRIL 7, 2023

BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Integrating biomarkers and targeted therapy into colorectal cancer management. American Lung Association.

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The Pharma Data

MARCH 23, 2022

In fact, antiviral therapies designed to treat viruses such as hepatitis C (Sofosbuvir/SOVALDI) work by blocking viral polymerase. Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase.

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Virus Small Molecule Protein Production Research 52

The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. 1 Lederman, S. International Immunol. (11):1583

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The Pharma Data

JANUARY 18, 2021

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. ZTlido ® was approved by the FDA on February 28, 2018. for the treatment of post-herpetic neuralgia. for the treatment of post-herpetic neuralgia. For more information visit www.sorrentotherapeutics.com.

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Clinical Trials Small Molecule Trials Therapies 40

New Drug Approvals

SEPTEMBER 13, 2024

19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 30 January 2018. nM vs. 24.0

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The Pharma Data

NOVEMBER 17, 2020

LYT-100 is a deuterated, oral small molecule designed to overcome the challenges associated with pirfenidone, an approved and marketed anti-inflammatory and anti-fibrotic drug. ERJ Open Research , 4(4), 00084-2018. doi:10.1183/23120541.00084-2018. Photo: Business Wire). 1 Cottin, V., Koschel, D., Günther, et al.

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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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The Pharma Data

DECEMBER 2, 2020

Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018.

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Licensing Licensing DNA Vaccine 52

The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

SEPTEMBER 2, 2020

From the success of our first-in-class B-cell MS therapy OCREVUS, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of ENSPRYNG.”. Roche’s Chief Medical Officer and Head of Global Product Development.

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Clinical Trials Disease Treatment Therapies 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

OCTOBER 26, 2020

We are grateful to those who participated in our clinical studies supporting these regulatory filings and proud that the FDA has granted abrocitinib both Breakthrough Therapy and Priority Review designations. Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. About Abrocitinib.

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Drug Target Review

MAY 31, 2024

Incredible advances in machine learning-driven tools allow us to predict the 3D structure of previously unsolved proteins, unlocking the power of structure-based drug design for drugging these targets, and most recently, the ability to predict protein assemblies, which contain both the protein and putative small molecule binders.

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Organic Chemistry Computational Chemistry Small Molecule Disease 45

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range.

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FDA Biosimilars Science Drugs 52

Agency IQ

APRIL 19, 2024

Patients frequently receive up to four therapies at once and go through multiple prolonged courses of treatment to keep recurrence and progression at bay. Commonly combined treatment options include antineoplastics (chemotherapies), radiation therapy, corticosteroids, immunomodulators, proteasome inhibitors, and monoclonal antibodies.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). AbbVie and Frontier Medicines, Corp.,

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Production Clinical Trials International Small Molecule 52

New Drug Approvals

APRIL 18, 2023

H]Cl.NCCCCN(CC1=NC2=CC=CC=C2N1)[C@@H]3C4=NC=CC=C4CCC3 AMD-070 is a small molecule drug candidate that belongs to a new investigational class of anti-HIV drugs known as entry (fusion) inhibitors. 2018 Jul;40(1):303-308. Molecular Weight 349.47 Appearance Solid Formula C 21 H 27 N 5 CAS No. 2309699-17-8 SMILES [H]Cl.[H]Cl.[H]Cl.NCCCCN(CC1=NC2=CC=CC=C2N1)[C@@H]3C4=NC=CC=C4CCC3

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Clinical Trials Virus Small Molecule Trials 52

The Pharma Data

APRIL 27, 2021

At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Neurology and Immunology. Net sales (€ million). Change at CER.

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Vaccine Production FDA Disease 52

Drug Target Review

NOVEMBER 7, 2024

In these conditions, the goal of therapy is typically to suppress or mitigate immune activity. Understanding the intricate role of PSGL-1 in immune-cell recruitment and activation is essential for developing targeted therapies aimed at modulating immune responses in various inflammatory and autoimmune disorders.

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Disease Immune Response Regulations Engineering 52

Drug Target Review

MARCH 26, 2025

Hormone replacement therapy (HRT) for low hormone levels is one of the oldest treatments utilised in Western medicine and can be traced back centuries. 6 Both testosterone and oestrogen are also used for gender-affirming therapy. Likarda initially developed CSS to overcome the lack of effective delivery systems for cell therapies.

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