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Home » Newsletters » BioWorld

BioWorld

April 12, 2023

View Archived Issues
Scientists at Aspect Biosystems bioprinter

Aspect and Novo enter a deal worth up to $2.6B

In collaborating with Novo Nordisk A/S, privately held Aspect Biosystems Ltd. entered its biggest ever deal that could bring in more than $2.6 billion while advancing its 3D, bioprinted tissue therapeutics technology. The two companies will collaborate to develop up to four diabetes and/or obesity products, a Novo specialty, using implantable bioprinted tissues to replace, repair or supplement human biological functions. The initial target will be type 1 diabetes. Read More
Puzzle-pieces-globe.png

Biopharma deals slip in Q1, completed M&As remain low

Despite strong deal activity throughout each of the last two years, the volume and value of partnerships began sliding in the first quarter (Q1) of 2023, while M&As continue to trail several other years. Read More
EU flag, syringe, capsules

Improved dialogue with pharma on agenda as EMA seeks to enhance Prime scheme

Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval. Read More

Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation

Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder. Read More
Lung cancer illustration

Immutep’s LAG-3 efti plus pembrolizumab extends efficacy in NSCLC

Immutep Ltd.’s lead immunotherapy candidate, eftilagimod (IMP-321, efti), plus pembrolizumab reverted previous resistance to PD-1/PD-L1 therapy in part B of the TACTI-002 phase II trial in second-line metastatic non-small-cell lung cancer (NSCLC) in patients refractory to anti-PD-1/PD-L1 therapy. Read More

With clock ticking, FDA seeks longer hold on abortion drug order

As an April 15 deadline looms, the U.S. Court of Appeals for the Fifth Circuit is being asked to intervene immediately to keep mifepristone on the U.S. market as an abortion option while legal challenges continue to play out in court. Read More

Appointments and advancements for April 12, 2023

New hires and promotions in the biopharma industry, including: Aim, Arbor, Bausch + Lomb, Cellares, Century, Cue, Cybrexa, Dyve, Gennao, Invivyd, Kronos, Maplight, Mithra, Neuronascent, Northstar, Sonoma, Theravance, Totus, Viridian. Read More

Financings for April 12, 2023

Biopharmas raising money in public or private financings, including: Araris, Eterna, Geneos, Immunebridge, Inflarx, Intrabio, Oncosec. Read More

In the clinic for April 12, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Airway, Altimmune, Bavarian, Chinook, Genexine, Hibio, Hotspot, Humacyte, Maia, Moderna, Paradigm, Quadriga. Read More

Other news to note for April 12, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive, Amryt, Biogen, Blue Water, Chiesi Farmaceutici, FSD, Takeda, Treventis, Tenax. Read More

Regulatory actions for April 12, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acurx, Biosyngen, Boan, Bone, HRA, Nova Mentis, Regenxbio, Sarepta, Takeda, Telix, Vertex. Read More

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