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Home » Newsletters » BioWorld

BioWorld

July 15, 2022

View Archived Issues
FDA approved metal stamp

Organoids making their US clinical debut with CIDP drug

The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these advanced cell models. Read More

Simcere’s CDK4/6 inhibitor gains nod for myelosuppression in China

China’s NMPA gave the green light to Simcere Pharmaceutical Group Ltd. for Cosela (injectable trilaciclib hydrochloride) as a treatment to decrease the risk of chemotherapy-induced myelosuppression. It is intended for adult patients with extensive-stage small-cell lung cancer (ES-SCLC), before they undergo a platinum/etoposide-containing regimen. Read More
Connected during pandemic

As pandemic drags on and with war on its doorstep, Europe turns to research-based industries for answers

It’s a delicate time in Europe, where the recovery from the pandemic has been stifled by the war on its doorstep in Ukraine. Although the crisis caused by the Russian invasion is dominating the short-term political agenda, there are serious concerns about Europe’s long-term economic prospects and whether its research-led industries are falling by the wayside. Read More
Gene editing illustration

CRISPR co-inventor’s Epic Bio launches with $55M series A

Controlling the epigenetics of a patient, figuring out what genes are expressed and understanding their level of expression, is at the center of Epic Bio, a new company founded by Stanley Qi, co-inventor on the CRISPR patent held by the University of California. Read More
cybersecurity-data-lock.png

MDMA blasts FDA cybersecurity draft for mention of health care facility networks

The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network. Read More

Appointments and advancements for July 15, 2022

New hires and promotions in the biopharma industry, including: Astria, Aurinia, Covis, Enveda, Omass, Springworks. Read More

Financings for July 15, 2022

Biopharmas raising money in public or private financings, including: First Wave, Histogen. Read More

In the clinic for July 15, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cocrystal, Contrafect, LG, Novan, Regeneron, Revelation, Roche, Sanofi, Starton, Theratechnologies, Xequel. Read More

Other news to note for July 15, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biora, Creative, Cytomx, Genscript, Grunenthal, Halberd, Pasithea, Repertoire, SK, Ultragenyx. Read More

Regulatory actions for July 15, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Beigene, G1, Lantern, Novavax, Revolo, Sinovac, Summit. Read More

Money raised by biopharma: 2022 vs. 2021 vs. 2020 vs. 2019

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

Biopharma money raised: Jan. 1-July 14, 2022

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

Biggest gainers and losers for the week of July 11-15, 2022

The top 10 biopharma stock gainers and losers for the week. Read More

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