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BioWorld - Monday, June 16, 2025
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MHRA advises industry that new requirements are now in place

June 16, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.
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Astrazeneca makes $5.3B drug R&D pact with CSPC

June 16, 2025
By Marian (YoonJee) Chu
No Comments
CSPC Pharmaceutical Group Ltd. announced June 13 that it struck a potential $5.33 billion deal with Astrazeneca plc to develop novel preclinical small-molecule candidates using CSPC’s AI-driven drug development platform.
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‘Be Part of Research,’ UK government urges with NHS app

June 16, 2025
By Nuala Moran
No Comments
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
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Aortyx catheter

Aortyx secures €13.8M for aortic dissection solution

June 13, 2025
By Shani Alexander
Aortyx SL secured €13.8 million (US$15.9 million) in a series A funding round for its solution which treats aortic dissection. The company developed a system to repair the aortic tear, which includes a biomimetic, bioresorbable adhesive patch inserted in the aorta using an endovascular catheter and a deployer.
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Enterome raises $19M to advance non-Hodgkin lymphoma therapy

June 13, 2025
By Nuala Moran
No Comments
As it prepares to present the latest data from the phase I/II clinical trial of EO-2463, Enterome SA has secured $19 million to expand and complete the study, and to scope phase III development of the microbiome-derived off-the-shelf immunotherapy in the treatment of non-Hodgkin lymphoma.
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Neurology/psychiatric

Startup Elkedonia raises €11M to advance neuroplastogen in depression

June 13, 2025
By Nuala Moran
No Comments
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
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Atalante X Wandercraft

Wandercraft secures $75M in series D funds for robotics portfolio

June 12, 2025
By Shani Alexander
Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.
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Two silhouettes with tangle, gear, spiral
Newco news

Startup Elkedonia raises €11M to advance neuroplastogen in depression

June 12, 2025
By Nuala Moran
No Comments
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
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Stock merger illustration

Biontech’s $1.25B Curevac buyout removes mRNA lawsuit uncertainty

June 12, 2025
By Karen Carey
No Comments
Three years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. The amount is lower than the $3 billion in backpay Curevac could win through the lawsuit if a low mid-single-digit royalty were awarded, Evercore ISI analysts Jon Miller and Umer Raffat said. But the legal uncertainty has weighed heavily on the company, which shed 30% of its workforce last July and sold off rights to two of its infectious disease vaccines.
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Fineheart Flowmaker

Fineheart pursues FIH study of Flowmaker fully implanted heart pump

June 11, 2025
By Shani Alexander
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
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