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

The Premier Consulting Blog

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. 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 enters into a Research Collaboration and License Agreement with Roche to Develop Oral Small Molecules for Immune Mediated Diseases

The Pharma Data

R&D collaboration building on Lead Pharma’s expertise in the discovery, design and optimization of small molecule treatments. Lead Pharma is a pharmaceutical company focusing on the discovery and development of innovative medicines for the treatment of immune diseases and cancer. About Lead Pharma.

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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. Teva Pharmaceutical Industries Ltd. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path.

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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. Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG. Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG.

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Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

The Pharma Data

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Pfizer Inc. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Source link: [link].

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Ribometrix and Genentech Partner in Potential $1 Billion+ RNA Deal

The Pharma Data

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. The first identifies the 3D RNA motifs.

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