Pharmaceutical Technology

FEBRUARY 13, 2023

The continued high level of interest in small molecules presents multiple opportunities to select a candidate that is ‘developable’, with subsequent rapid progression toward first-in-human (FIH) clinical testing. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

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pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. The post Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3 appeared first on.

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XTalks

JUNE 14, 2023

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. Attendees will understand best practices for novel drug delivery design and development.

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Gene Silencing Drug Delivery FDA Approval RNA 97

pharmaphorum

JANUARY 29, 2021

US drugmaker Eli Lilly – still waiting for an FDA decision on one non-opioid pain drug – has just added another to its pipeline via a licensing agreement with Japan’s Asahi Kasei worth up to $410 million. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.

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Licensing Licensing Bioavailability Antibody 52

XTalks

OCTOBER 2, 2024

Recognized with Fast Track designation from the US Food and Drug Administration (FDA), fasedienol could become a much-needed treatment option for the 30 million Americans affected by SAD. If successful, this trial could pave the way for a New Drug Application (NDA) submission.

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The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. While SLV213 can be dosed orally or intravenously, Selva is first advancing it as an oral drug candidate for COVID-19.

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Protein Bioavailability Development Drugs 52

The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. In addition to the ongoing clinical studies, Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir. About Molnupiravir.

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pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed.

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The Pharma Data

JULY 12, 2021

“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If About Molnupiravir.

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Delveinsight

JULY 30, 2020

Key pharma players such as Bluebird Bio , Minoryx Therapeutics , MedDay Pharmaceuticals , Magenta Therapeutics , and others are proactively focusing on developing therapies to address the unmet needs prevailing in the ALD market. The pharma players are evaluating their pipeline candidates in different stages of clinical development.

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The Pharma Data

NOVEMBER 19, 2020

20, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces a progress update for its R&D program focused on the design and development of novel drugs targeting the SARS-CoV-2 coronavirus and to treat COVID-19. . TOKYO and CAMBRIDGE, England , Nov.

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Delveinsight

AUGUST 25, 2020

The drug, Spartalizumab, is an experimental monoclonal antibody designed as immunotherapy to target the human programmed death-1 (PD-1) receptor. The drug uses an optimized salt form of niclosamide, which is a safe oral drug and is in use for decades as an anthelmintic drug.

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XTalks

MAY 23, 2024

Drugs such as pembrolizumab (Merck’s Keytruda) and nivolumab (Bristol Myers Squibb’s Opdivo) have revolutionized the treatment options for skin cancer. is a biotech and life sciences company dedicated to advancing the clinical development of innovative and groundbreaking therapeutic assets.

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XTalks

SEPTEMBER 19, 2024

It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies. Zanubrutinib has five US Food and Drug Administration (FDA)-approved indications and the broadest label in its class.

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FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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