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Home » Newsletters » BioWorld

BioWorld

April 5, 2023

View Archived Issues
Glass vials with radioactive label

Radiopharma pipeline gathers atomic speed

The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report. Read More
Regulatory icons

Keeping up with the technology a growing task for regulators

The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices. Read More
cancer-cell-light.png

Proxygen partners with Merck in $2.6B molecular glue deal

Merck & Co. Inc. has seen promise in Proxygen GmbH’s molecular glue degrader technology, agreeing to pay the drug discovery company up to $2.55 billion if specified research, development and commercial milestones are met. Read More

Inflarx’s COVID-19 treatment, once on the ropes, gets an EUA

Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality though there was a relative reduction in mortality in the active arm vs. placebo. Read More
Optogenetics illustration

PYC Therapeutics enters clinic with RNA therapy for retinitis pigmentosa

PYC Therapeutics Ltd.’s lead candidate, VP-001, is entering the clinic, and the RNA therapy could be the first potential treatment for retinitis pigmentosa type 11, which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age. Read More

US FDA: Timely, detailed info needed to mitigate drug shortages

As the number of drug shortages continues to grow in the U.S. and globally, the FDA is issuing a draft guidance spelling out drug and API manufacturers’ responsibility to give the agency a timely, informative heads-up about changes in their production that could lead to a shortage. Read More

US FDA completes guidance series on patient-focused drug development

The last draft guidance in the U.S. FDA’s four-part series on patient-focused drug development is making its debut. Read More

The BioWorld Insider Podcast – Radiopharmaceuticals: The next big disrupter?

It all goes to show how a good idea can’t be kept down. Madam Curie started radiopharmaceuticals in the late 1800s and now it’s a multibillion-dollar industry. BioWorld’s eight-part series on a new era of radiopharmaceuticals reveals their increasing importance as part of cancer treatments because they have fewer side effects and cause far less damage to tissue than previously. The big idea is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them. That’s what makes this evolving technology a disrupter. The series, led by BioWorld Staff Writer Tamra Sami, takes a close look at the different radiopharmaceutical moieties and the science behind them, the supply chain vulnerabilities, the regulatory landscape, the patient journey and therapies in the pipeline. Sami summarizes this special report in the latest edition of the BioWorld Insider Podcast. Read More

Appointments and advancements for April 5, 2023

New hires and promotions in the biopharma industry, including: Biorchestra, Clearside, Clexbio, Generation, Rocket, Sisaf, Sparingvision, Surrozen, Walden. Read More

Financings for April 5, 2023

Biopharmas raising money in public or private financings, including:  Addex, Celularity, Cellectis, Protagonist, Transcode. Read More

In the clinic for April 5, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzamend, Alterity, Arrowhead, Axial, Bioarctic, EIP, Eisai, Innocare, Iomx, Lundbeck, Lynk, Mythic, Otsuka, Precision, Skye, Sobi, Takeda. Read More

Other news to note for April 5, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Aeterna, Alora, Anagram, Biomed X, Biotheryx, Cyclerion, Dr. Reddy’s, Eagle, Ginkgo, Incyte, Liminal, Merck KGaA, Scilex, Sorrento, Stridebio. Read More

Regulatory actions for April 5, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Aim, Amarin, Astellas, Caribou, Gennova, Hutchmed, Pfizer, Phathom, Scisparc, Seagen, Shionogi. Read More

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