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Home » Newsletters » BioWorld

BioWorld

April 4, 2023

View Archived Issues
Woman receiving radiotherapy treatments for cancer

Disrupting the oncology space

After spending decades developing targeted chemotherapy and bringing a dozen or so compounds into the clinic, Fusion Pharmaceuticals Inc. Chief Scientific Officer Christopher Leamon switched careers to focus on radio-oncology because he saw the need for “a really strong bomb to target cancer to get it to respond.” That was radiotherapy, said Leamon, who was one of the scientific founders of Endocyte Inc., which Novartis AG acquired. Read More

Scientifically, radioligands may head from bedside back to bench

If its challenges can be overcome, radioligand therapy is poised to change the way many cancers are treated. It is also likely to become an example of how scientific advances, once they are translated successfully, can enable further insights in a bench-to-bedside-to-bench loop. David Piwnica-Worms, professor and chair of cancer systems imaging at The University of Texas MD Anderson Cancer Center, predicted that as radioligand therapy expands, many questions will be answered about both radiation biology and the interaction of radiation with the immune system more specifically. Read More
us-supreme-court.png

Advamed, BIO urge US Supreme Court to find for defendants in False Claims Act litigation

The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies. Read More

FDA approves anti-PD-1/ADC combo for urothelial cancer

As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy. Read More
Collaboration illustration

Scorpion strikes precision oncology deal worth up to $553M with Pierre Fabre

Scorpion Therapeutics Inc. has out-licensed two of its small-molecule EGFR inhibitors to Pierre Fabre SA in exchange for a $65 million up-front fee and could also earn up to $553 million in potential milestone payments, plus royalties on net sales. Read More

US CMS’ Part B inflation rebate list gets a shave

The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023. Read More

Deaths, partial hold bring end to Gossamer’s BTK inhibitor for CNS lymphoma

A few weeks after Gossamer Bio Inc. said it was pausing enrollment in a phase Ib/II study of CNS-penetrant BTK inhibitor GB-5121 in relapsed/refractory CNS lymphoma, citing the drug’s risk/benefit profile observed to date and a prioritization of resources, the company is dropping the drug’s development entirely. Read More
Antibody-drug conjugate illustration

Innate out-licenses antibodies for celiac disease to Takeda in deal worth $400M

Innate Pharma SA inked a licensing deal that grants Takeda Pharmaceutical Co Ltd exclusive worldwide rights to research and develop antibody-drug conjugates using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in celiac disease. Read More

Adcendo raises $34M in series A extension to advance lead ADC

Adcendo ApS has added a further €31 million (US$33.6 million) to its series A round, providing the means to take its lead antibody-drug conjugate (ADC) through to clinical proof of concept in the treatment of sarcoma. Read More

More oversight issues facing the US NIH

The U.S. NIH once again faces questions about its oversight of certain research. In the latest round, the U.S. Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards. Read More

Anvisa issues guidelines for synthetic drugs

To help drug manufacturers comply with the technical requirements of RCD 753/2022 and other related standards regarding proof of a drug’s safety and efficacy, Brazil’s Anvisa issued three new guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs. Read More

Appointments and advancements for April 4, 2023

New hires and promotions in the biopharma industry, including: Acasti, Aicuris, Arkuda, Biogen, Entrada, Flamingo, Legend, Mitsubishi Tanabe, Quantro. Read More

Financings for April 4, 2023

Biopharmas raising money in public or private financings, including: Cure Ventures, Diamond, Mosaic, OS Therapies, Psyence, Recce, Redhill, Viking. Read More

In the clinic for April 4, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abcuro, Akebia, Ascendis, Alzamed, Citius, Contrafect, Corvus, Ensysce, Fibrogen, Kodiak, Lipocine, Oncosec, Oryzon, Pardes, Scioto, Travere, Vico. Read More

Other news to note for April 4, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alaunos, Arbutus, Arrowhead, Beactica, Biontech, Briacell, Diamyd, Enzyvant, Forcefield, Freeline, Genevant, Gri, GSK, Histogram, Indivumed, Liquidia, Medigene, Metabolon, Myovant, Oncternal, Oscotec, Pfizer, Precigen, Sumitomo, Sumitovant, Tonix, Urovant, Vallon, VBI. Read More

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