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Home » Newsletters » BioWorld

BioWorld

June 24, 2024

View Archived Issues
Vyvgart Hytrulo

FDA approves Argenx's Vyvgart for rare autoimmune disease CIDP

Argenx SE gained U.S. FDA approval of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The company’s stock (NASDAQ:ARGX) was up 11.7% to $440.59 at the close of trading June 24. About 24,000 people in the U.S. are being treated for CIDP, and patients are generally diagnosed between 40 and 60 years of age. Read More

‘Big win’ as Alnylam’s vutrisiran succeeds in rare heart disease

Any skepticism that might have been lingering in the wake of Alnylam Pharmaceuticals Inc.’s February decision to tweak the analysis plan for the Helios-B trial testing vutrisiran in transthyretin amyloidosis with cardiomyopathy appeared to dissipate as the company reported top-line data showing the study met the primary and all secondary endpoints. Read More
Breast cancer illustration

G1’s phase III misses in triple-negative breast cancer

Top-line phase III data from G1 Therapeutics Inc.’s pivotal Preserve 2 study of Cosela (trilaciclib) in treating metastatic triple-negative breast cancer missed its primary endpoint of overall survival, submerging the stock on June 24. Read More

Genentech’s Piasky cleared for paroxysmal nocturnal hemoglobinuria

Roche Holding AG’s Genentech Inc. unit received U.S. FDA approval on June 20 of Piasky (crovalimab) to treat adults and children 13 and older with paroxysmal nocturnal hemoglobinuria and a body weight of at least 40 kg (88 pounds). Read More
sepsis-bacteria-blood.png

Broader sepsis insights gleaned from SARS-CoV-2-driven research

New research has pinpointed gene signatures that determine what immune responses will be activated in the development of sepsis, pointing to novel targets and opening the way for the stratification of clinical trials and for patients to be treated on the basis of their immune response, rather than their symptoms. Read More

Takeda moves mezagitamab to phase III in thrombocytopenia

Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial. Read More

Théa ends deal with Olix, returns rights of ocular drugs

France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A. Read More

ICYMI: Week in review, June 17-21, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for June 17-21, 2024

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

Appointments and advancements for June 24, 2024

New hires and promotions in the biopharma industry, including: Nurexone, Omega, Oncolytics. Read More

Financings for June 24, 2024

Biopharmas raising money in public or private financings, including: Ascentage, Avrobio, Palatin, Rakovina, Takeda, Tectonic. Read More

In the clinic for June 24, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Hightide, Ocugen, Sarton, Zealand. Read More

Other news to note for June 24, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivexis, Johnson & Johnson, Melodia, Proteologix. Read More

Regulatory actions for June 24, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Emergex, Janssen, Lexicon, Sarepta. Read More

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