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Concurrent Validation for Breakthrough and Orphan Drugs: Meeting the Needs for Accelerated Manufacturing

The Premier Consulting Blog

In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.

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Lead Pharma Teams with Roche on Oral Small Molecules for Immune-Mediated Diseases

The Pharma Data

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . This includes therapies against the nuclear receptor ROR?t,

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Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. ” Shinichi Tamura , Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.

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Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate

The Pharma Data

Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433.

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Biogen and Alectos Therapeutics Announce License and Collaboration Agreement for AL01811, a Novel GBA2 Inhibitor for the Potential Treatment of Parkinson’s Disease

The Pharma Data

(Nasdaq: BIIB) — Biogen and Alectos Therapeutics have entered into a license and collaboration agreement to develop and commercialize a novel preclinical selective GBA2 inhibitor, AL01811, which has first-in-class potential as an oral disease modifying treatment for patients with Parkinson’s disease (PD).

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Bayer to acquire exclusive license from Cedilla Therapeutics on selective inhibitors in pre-clinical precision oncology

The Pharma Data

Cedilla’s small molecules conditionally modulate the protein complex in its functional state resulting in highly selective inhibition. With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.”

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New drug triggers rapid cell death in cancer models

Broad Institute

This small molecule reactivates the apoptosis cascade in tumor cells while sparing healthy cells in animal models. Tags: Center for the Development of Therapeutics Licensing data, tools, and technologies Cancer Drug discovery Apoptosis, or programmed cell death, is a natural end process for all cells. Nature Cancer.

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