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Home » Newsletters » BioWorld

BioWorld

Aug. 4, 2023

View Archived Issues
Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval. Read More

340B stakeholders find common ground in pointing a finger at PBMs

When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBM) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services. Read More
HKEX on phone, digital stock chart

Biologic cancer drug developer Sunho targets HK IPO

On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million). Read More
performance-hit-target.png

Nexo emerges with $60M series A, takes aim at ‘elusive’ targets

When looking for a name, the founders of startup Nexo Therapeutics Inc., which recently emerged from stealth mode with a $60 million series A financing and a research collaboration with the University of Texas MD Anderson Cancer Center, sought a moniker that truly captured its approach to drug development. Read More
Amber Bio co-founders Jacob Borrajo and Basem Al-Shayeb

With $26M in funding, RNA editing firm Amber Bio targets diverse mutations

New company Amber Bio emerged on Aug. 3 with $26 million in seed funding that will help advance an RNA-based gene editing platform that leverages Cas-based systems to create safer medicines. Through the company’s platform, a single drug can be used to treat diseases with high allelic diversity. The company plans to develop its own genetic medicines internally, while also licensing out the technology to expand its reach. Read More

Appointments and advancements for Aug. 4, 2023

New hires and promotions in the biopharma industry, including: Deciphera, Structure, Terns, Xilio. Read More

Financings for Aug. 4, 2023

Biopharmas raising money in public or private financings, including: Blue Water, Innocan. Read More

In the clinic for Aug. 4, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aravive, Arbele, Areteia, Asklepios, Bolt, Cage, Celsius, CNS, Perfuse, Regeneron, Ultimovacs, Vertex, Xylocor. Read More

Other news to note for Aug. 4, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Assertio, Catalent, Evox, Fuji, Galapagos, Ionis, Kiora, Mind, Mithra, Novartis, Zydus. Read More

Regulatory actions for Aug. 4, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Aardvark, ABM, Orchard, Taiho. Read More

Money raised by biopharma

Total raised in public, private and other financings of biopharma companies, comparing 2023 vs. 2022 vs. 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-July 28, 2023

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

Biopharma money raised by month in 2023 (US$M)

Biopharma money raised to-date and by month in 2023, including public, private and other financings. Read More

BioWorld and Nasdaq stock indices

These graphs compare the performance of the biotech stocks for all of 2023 using the BioWorld Stock Indicator and the Nasdaq Biotech Index. Read More

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