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Home » Newsletters » BioWorld

BioWorld

July 7, 2023

View Archived Issues
Leqembi

Biogen, Eisai FDA win with Leqembi ‘a big deal’ in AD space; CMS on board, too

The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space. Read More
Money-financing

Biopharmas raise $6.82B in June, reflecting industry resilience

In June 2023, biopharmas collectively raised $6.82 billion through 109 financing transactions. The amount raised is 32.95% more than last June’s $5.13 billion, and the number of transactions is up 26.74%, compared to 86 in June 2022. This echoes the 23.34% increase seen in financings in the first half of 2023 compared to last year. Read More
Dermatologic-atopic-dermatitis2

Aslan shares slide on mixed phase IIb data for eblasakimab, chasing Dupixent in atopic dermatitis

Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market. Read More
Mental illness illustration

Psych Symposium 2023: Psychedelics could bridge mental health treatment gap

After 50 years of censorship, there is now growing pressure on EU policymakers to stand up and play a role in promoting the development of psychedelics as medicines and in preparing the ground to ensure equitable access once there are approved products. Read More
Illustration of intestines with inflammation

Microba enters clinic with gut microbiome-derived therapy for inflammatory bowel disease

Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD). Read More
Document illustration

Stakeholders seek clarity on intended use, combo products in FDA’s change control draft

The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance. Read More

Appointments and advancements for July 7, 2023

New hires and promotions in the biopharma industry, including: Bpgbio, Chiesi, Nurexone. Read More

Financings for July 7, 2023

Biopharmas raising money in public or private financings, including: Abeona, Bausch Health, IGC, Truebinding. Read More

In the clinic for July 7, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allarity, Aslan, Biodexa, Celldex, Eli Lilly, Horizon, Novavax, OSE, Pfizer, Photocure, Revive, Simcha, Tolerogenixx, Ultragenyx, Vaxart, Verastem. Read More

Other news to note for July 7, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aimed Bio, Almirall, Genequantum. Read More

Regulatory actions for July 7, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan. 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 6, 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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