“LSK BioPharma and Huntsman Cancer Institute Announce an Exclusive License Agreement for HCI-1401, a BTK inhibitor for treatment of B-cell malignancies and other diseases”
“Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic (blood forming) stem cell-based cellular and antibody therapies for blood disorders and cancer, announced that patient dosing has commenced in its multi-center, open-label, randomized controlled Phase 2 clinical t
“Coherus BioSciences, Inc. (CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it has finalized the Biologics License Application (BLA) enabling clinical program for CHS-1701, a pegfilgrastim biosimilar candidate, and initiated a pivotal
“the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the U.S. Food and Drug Administration (FDA) for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. The orig
“ Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade (Infliximab) biosimilar candidate, has been submitted to the European Medicines Agency (EMA). This is the second biosimilar candidate MAA that Samsung Bioepis has submitted to the
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LSK BioPharma and Huntsman Cancer Institute Announce an Exclusive License Agreement for HCI-1401, a BTK inhibitor for treatment of B-cell malignancies and other diseases - Pipelinereview
Emergent BioSolutions Expands Commercial Product Portfolio With FDA Approval of IXINITY, a Recombinant Factor IX Treatment for Hemophilia B - Pipelinereview
Cellerant Announces Dosing of First Patient in Randomized Phase 2 Clinical Trial of CLT-008 in Acute Myeloid Leukemia Patients - Pipelinereview
Coherus Finalizes CHS-1701 BLA Enabling Clinical Program and Initiates Pivotal Pharmacokinetic and Pharmacodynamic Study - Pipelinereview
Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Treatment of Hepatitis C Genotype 3 - Pipelinereview
Samsung Bioepis Submits Marketing Authorization Application For SB2, A Remicade (Infliximab) Biosimilar Candidate, To The European Medicines Agency - Pipelinereview
