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FDA Accepts Eisai and Biogen Supplemental Biologics Licence Application
Monday, March 06, 2023Eisai and Biogen announced that the US Food and Drug Administration FDA has accepted Eisais supplemental Biologics Licence Application sBLA for LEQEMBI lecanemabirmb mgmL injection for intravenous use supporting the conversion of the accelerated app...
Ractigen Therapeutics Receives FDA Orphan Drug Designation for the Novel Oligonucleotide Conjugate RAG-17
Friday, March 03, 2023Ractigen Therapeutics announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to RAG a novel siRNA modality for the treatment of Amyotrophic Lateral Sclerosis ALS The approval of RAG to ALS patients can show signifi...
U.S. FDA Broadens Indication for Verzenio® (abemaciclib)
Friday, March 03, 2023Eli Lilly and Company announced that the US Food and Drug Administration FDA approved an expanded indication for Verzenio abemaciclib in combination with endocrine therapy ET for the adjuvant treatment of adult patients with hormone receptorpositive...
The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Programme
Thursday, March 02, 2023Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals Inc one of the Janssen Pharmaceutical Companies of Johnson and Johnson Janssen announced the launch of the Phase Librexia programme studying milvexian an investigational oral factor...
Ipsen Completes Acquisition of Albireo
Thursday, March 02, 2023Ipsen announced it has completed the acquisition of Albireo Pharma The acquisition enriches Ipsens Rare Disease portfolio with promising therapeutics for paediatric and adult rare cholestaticliver diseases innovative pipeline potential as well as sci...
Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application
Thursday, March 02, 2023Intellia Therapeutics announced that the US Food and Drug Administration FDA has cleared the companys Investigational New Drug IND application for NTLA for the treatment of hereditary angioedema HAE enabling the company to include the United States i...
Chugai and Biofourmis Enter into New Partnership
Thursday, March 02, 2023Chugai Pharmaceutical and Biofourmis announced that they have entered into a new partnership agreement for the continued development and realworld use of digital solutions to objectively measure pain in patients with endometriosis Endometriosis affec...
Bionxt Signs Agreement for Study of Transdermal Rotigotine Patch
Wednesday, March 01, 2023BioNxt Solutions announced agreement to carry out its comparative drug absorption study for the Companys transdermal TDS Rotigotine patch for the treatment of Parkinsons disease The comparative study is designed as a randomised crossover twoperiod si...
BioLife Solutions Launches Ultraguard™ -70°C Phase Change Material (PCM)
Wednesday, March 01, 2023BioLife Solutions announced the launch of Ultraguard the first ever nontoxic nonhazardous and nonflammable C phase change material PCM for ultralow temperature ULT protection The Ultraguard PCM form factor is an ergonomicfriendly plastic bottle or br...
Oragenics Enters into an Exclusive Global Licence Agreement with Inspirevax
Wednesday, March 01, 2023Oragenics announced that the Company has entered into an exclusive global licence agreement with Inspirevax for its novel intranasal mucosal adjuvant BDX for the development of NTCoV Oragenics lead intranasal COVID vaccine candidate Under the exclusi...
