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Home » Newsletters » BioWorld

BioWorld

Aug. 3, 2023

View Archived Issues
3d illustration of ovarian cancer

Aravive misses a phase III primary endpoint and faces tough decisions on two other studies

Aravive Inc.’s sole asset missed a phase III primary endpoint in ovarian cancer but the company still has studies planned for treating renal cell carcinoma and pancreatic cancer. Aravive’s stock (NASDAQ:ARAV) dwindled dramatically on Aug. 3, with shares closing 77.2% lower at 28 cents each. That’s a massive drop from heights seen in the past 12 months, as shares hit $2.46 each in March 2023 and $2.09 each in November 2022. The company plans to study the data and make a decision about whether to proceed with the other studies. Read More

Off script(s)? Blueprint laid out for ‘continued cadence’ with Ayvakit

More than two months after Blueprint Medicines Corp. gained a broadened label for Ayvakit (avapritinib), the company is “really pleased to see the diversity of revenue this early in the launch across specialties and across both the academic and community settings,” said Philina Lee, chief commercial officer. The situation “bodes very well for a continued cadence of prescribing [into] the foreseeable future,” she said. Read More
Arrows-up.png

Higher rates in store for most US FDA user fees

The old adage of “what goes up must come down” rarely applies to U.S. FDA user fees. Most of the fiscal 2024 fees, which go into effect Oct. 1, continue in an upward slope. Under the PDUFA agreement, the fees for NDAs/BLAs are surging 25%. All but one of the MDUFA fees are going up 9.5%; the lone exception is growing by 18%. The MDUFA hikes are building on top of this year’s hefty increases. In the generics realm, the drug master file fee is going up 21%, but other fees increases are in the single digit range. Biosimilars, however, are the exception to the rule, with all the BsUFA fees seeing big drops. Read More
Jeanne-Marrazzo, NIAID-director

Academic researcher named to fill Fauci’s shoes at NIAID

While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID). Read More
3D heart in chest

Amarin taps Lotus to expand Vazkepa in SE Asia, Korea

Amarin Corp. plc has chosen Taiwan-based Lotus Pharmaceutical Co. Ltd. to make headway in Southeast Asia and South Korea for omega-3 fatty acid-based Vazkepa, its icosapent ethyl drug that’s facing increasing generic and pricing pressure in the U.S. and Europe. Read More

Appointments and advancements for Aug. 3, 2023

New hires and promotions in the biopharma industry, including: Akari, Allakos, Cara, Complement, Fulcrum, Immunitybio, Karuna, Molecular Templates, Shasqi, SK, Ten63, Vaxil. Read More

Financings for Aug. 3, 2023

Biopharmas raising money in public or private financings, including: Amber, Bio-Path, Kyverna, Mira, Nymox, X4. Read More

In the clinic for Aug. 3, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cybin, Enlivex, Ideaya, Immunis, India Globalization, Inimmune, Oculis, Theriva. Read More

Other news to note for Aug. 3, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Agios, Alnylam, Amygdala, Bavarian Nordic, Bit.bio, Bluerock, Boehringer, CDR-Life, Eom, GSK, Hefei, Indivior, Kala, Mekanistic, Neubase, Oramed, Pfizer, Recce. Read More

Regulatory actions for Aug. 3, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hipra, M8, Molecular Targeting, Satellos. Read More

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