The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. In addition, we have advanced zavegepant, our intra-nasal CGRP receptor antagonist, successfully through its first pivotal trial, also for the acute treatment of migraine. TOKYO and CAMBRIDGE, England , Dec.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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KIF1A

JULY 1, 2023

Read the Pre-print Rare Roundup A seemingly small semantic issue is a major roadblock to develop treatments for rare diseases We’ve spoken often about the goal of repurposing existing drugs to better treat KAND – this is a reality for many families who utilize off-label prescriptions. * What’s a pre-print?

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The Pharma Data

JANUARY 25, 2021

.–( BUSINESS WIRE )– Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. Boxer, PhD, Chief Operating Officer of Veralox Therapeutics. About VLX-1005.

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Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

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The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. Source: FDA.

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The Pharma Data

MAY 6, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

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PerkinElmer

NOVEMBER 9, 2022

Immunotherapy has revolutionized cancer treatment and proved to be pivotal in the field of oncological research. To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs).

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The Pharma Data

FEBRUARY 25, 2022

“Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”. Biosimilars play an important role in the treatment of autoimmune conditions.

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The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

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The Pharma Data

NOVEMBER 15, 2020

Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).

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New Drug Approvals

DECEMBER 16, 2023

2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. This approval was based on favorable results obtained from the phase III APPL-PNH and APPOINT-PNH studies, where 82.3% 1] It is a complement factor B inhibitor that was developed by Novartis. [1]

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The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.”

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.

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The Pharma Data

OCTOBER 15, 2020

Manufacturing cells is not like manufacturing small molecules,” Brian Culley, CEO of Lineage Cell Therapeutics , told BioSpace. On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option.

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The Pharma Data

JANUARY 31, 2021

Convergent is currently conducting advanced human trials relating to prostate cancer treatments involving peptide receptor radionuclide therapy (“PRRT”) that targets the prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells. as a single agent treatment for prostate cancer.

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The Pharma Data

DECEMBER 23, 2020

LYT-100 is an anti-fibrotic and anti-inflammatory oral small molecule that has been designed to overcome the tolerability challenges associated with pirfenidone, an anti-inflammatory, anti-fibrotic drug currently on the market. The trial is ongoing in the U.S. and Europe, and PureTech Head of Innovation, Dr. Michael C.

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

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Vial

DECEMBER 11, 2023

Despite advances in clinical research, there remain significant challenges as only 20% of HCV cases are diagnosed, and of these, only 15% receive treatment. The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Two highly effective pan-genotypic DAAs are used worldwide.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Specifically, after 2 to 4 weeks of treatment with this combination of two correctors and a potentiator, such patients experienced about a 10 percentage point improvement in forced expiratory volume in 1 second (FEV1), which is a key measure of lung capacity. About 30,000 Americans have CF.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved.

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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The Pharma Data

SEPTEMBER 8, 2020

Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September 2020. “We

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Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Even newer from the pharma benches are 12 small molecule drugs highlighted by Chris de Savi [4], whose structures were first disclosed at the ACS and AACR meetings in Q1 2023. Of these 12 drugs, 9 contain at least one fluorine! Christopher D.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”

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Codon

APRIL 2, 2023

When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Read The FDA is reviewing a “controversial cell therapy for ALS,” developed by BrainStorm Cell Therapeutics.

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The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition.

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Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). Recent Events. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. AbbVie announced that the U.S.

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The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. reflecting lower treatment compliance during the COVID-19 pandemic. In February, Libtayo ® was approved in two new indications in the U.S.

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The Pharma Data

NOVEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Source: Pfizer, inc. Posted: November 2020. Source link.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.

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Conversations in Drug Development Trends

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials. Initial approval in 2022: FDA, U.S.

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The Pharma Data

MAY 7, 2021

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., 4), iv192-iv237.

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Drug Target Review

FEBRUARY 15, 2024

Protection from a vaccine may not be durable or complete, and persons may still require treatment with medications for their infection. 11 Health agencies globally must collaborate with academic research centres and industry to address this important gap in drug treatments for pandemic-prone pathogens. Antiviral Research. Office USGA.

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The Pharma Data

AUGUST 3, 2021

“As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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