The Premier Consulting Blog

NOVEMBER 20, 2024

For drugs with FDA Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), and EMA PRIority MEdicines designation (PRIME), all clinical, non-clinical, and CMC requirements are still required for regulatory approval, despite being on pathways for an expedited approval process.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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LifeSciVC

APRIL 24, 2024

and whether a molecule’s pharmacology can help to mitigate safety risk. Especially for oligo or small molecule discovery and development, it’s important to understand whether there are highly homologous sequences or proteins that may be impacted by a given therapeutic approach. in liver, in CNS)?

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The Pharma Data

APRIL 22, 2023

While no cure is available for MS, existing disease-modifying therapies in the form of small molecule and protein drugs either directly target the self-reactive immune cells or broadly dampen inflammation. “Current MS therapies do not specifically target myeloid cells.

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Drug Target Review

JULY 7, 2023

There is a clear need for new and approved, safe, effective and innovative targeted therapies to address the underlying causes of autoantibody diseases. The power of precision therapy Targeted — or precision — therapy, a technique that has been honed for many years in cancer treatment, is now being applied in a wider context.

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LifeSciVC

APRIL 2, 2024

And the experience of those around you, including Board members and internal investors. We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

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The Pharma Data

JANUARY 31, 2021

Convergent has exclusive rights to technology related to next generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. The key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-?, or its ability to internalize PSMA.

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PLOS: DNA Science

SEPTEMBER 5, 2024

Gleevec is a small molecule that interferes with entry of an enzyme – a tyrosine kinase – that enables growth signals to enter specific cells and trigger division. A name ending in “nib” means a small molecule that inhibits an enzyme called a kinase, and is short for “inhibit.”

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The Pharma Data

JANUARY 17, 2021

The study enrolled 5,050 patients who received either vericiguat or placebo in combination with available heart failure therapies. Myelosuppression happens when radiation damages internal organs, including bone marrow. HFrEF was formerly known as systolic heart failure. The NDA was built on data from the Phase III VICTORIA trial.

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The Pharma Data

MAY 15, 2023

Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. XinThera is backed by a group of international investors including Foresite Capital, OrbiMed Advisors, LLC and TTM Capital.

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The Pharma Data

APRIL 28, 2021

OSAKA, Japan, April 28, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories.

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The Pharma Data

JANUARY 19, 2021

TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. Its lead candidate is CLN-081, an oral small molecule designed to be a next-generation, irreversible EGFR inhibitor.

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The Pharma Data

OCTOBER 15, 2020

a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, today announced that the company’s internal program to develop selective degraders that target key proteins within the TRK family has been published by the Journal of Medicinal Chemistry.

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The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

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The Pharma Data

NOVEMBER 18, 2020

Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. .” Presentation number: 397P / Poster: ID 680. Presenter: Ching-Liang Ho MD, et.al. Session Title: E-poster Display session – Thoracic tumours, metastatic.

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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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The Pharma Data

OCTOBER 18, 2020

Dr. Berk most recently has served as a consultant to several companies developing oncology therapies. Dr. Berk completed his internship, residency, and fellowship in internal medicine, hematology, and medical oncology at the Weill Cornell Medical College and New York Presbyterian Hospital, where he also served as a faculty member.

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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., senior vice president, R&D, chief scientific officer, AbbVie. “I am delighted with the closing of this deal.

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NIH Director's Blog: Drug Development

MAY 21, 2020

Just one infusion of this combination antibody therapy lowered the amount of viral genetic material in the animals’ lungs by as much as 30 percent compared to the amount in untreated animals. Meanwhile, there’s been other impressive recent progress towards the development of monoclonal antibody therapies for COVID-19.

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The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. International Immunol. (11):1583 The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. WO 2021/001458 A1. Structure.

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The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment.

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KIF1A

MAY 31, 2024

Trail Blazing in Australia International KAND Speech Study Our new research network partners at the Translation Centre for Speech Disorders in Australia welcomed families to take part in a study on speech and nonverbal communication in KIF1A Associated Neurological Disorder (KAND). You can read about her journey and first dose in our blog.

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The Pharma Data

MAY 16, 2022

About Digestive Disease Week® Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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The Pharma Data

JANUARY 7, 2021

ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist in late-stage clinical development for recurrent gliomas that harbor the H3 K27M mutation. This acquisition builds upon the vision of my co-founder Wolfgang Oster, M.D., scientific founder Wafik El-Deiry, M.D.,

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The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, Small Molecules.

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Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

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New Drug Approvals

JANUARY 31, 2024

PATENT The free base and salts of the compound of formula (I) may be prepared for example, according to the procedures given in International Patent Application No. It works as a colony-stimulating factor 1 ( CSF1 ) receptor inhibitor. [1] PCT/US2007/066898 filed on Apr. 18, 2007 and published as WO2007/121484 on Oct.

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The Pharma Data

JANUARY 3, 2021

Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. Alternatively, the call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4787 (international) and referring to conference ID 5824089. SOUTH SAN FRANCISCO, Calif., Median PFS was 9.2 Exelixis, Inc.

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The Pharma Data

JULY 15, 2021

Vincent’s Institute of Medical Research (SVI)’s multi-year research collaboration with Janssen Pharmaceuticals, Inc. Vincent’s Institute of Medical Research (SVI)’s multi-year research collaboration with Janssen Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 18, 2020

Separate from the AML trial, Aptose is conducting a Phase 1 a/b dose escalation study with CG-806 in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies. About CG-806.

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The Pharma Data

DECEMBER 14, 2020

The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT). At the stage of GBM relapse and recurrence, no effective therapy strategies currently exist. Contact.

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Vial

FEBRUARY 19, 2024

Explore the groundbreaking VersAptx bioconjugation platform, designed to elevate cancer therapies and uncover the delicate balance between clinical excellence and commercial viability in the dynamic landscape of pharmaceuticals. Can you elaborate on how the platform allows your company to tailor therapy? Ahmed Hamdy: Absolutely.

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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 13, 2020

RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127.

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The Pharma Data

FEBRUARY 18, 2022

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

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KIF1A

JUNE 30, 2023

This program helped obtain wheelchairs for 2 KAND patients and a vibration therapy plate to help one patient with their circulation. With these models established, we are preparing to test our first batch of small molecules drugs later this year! It also happens to be International Superhero Day.

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The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. These data represent the longest period of durability observed to date by a gene therapy for hemophilia B patients.

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