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BioOrbit aims to kick off pre-clinical trials to study protein crystals for monoclonal antibodies (mAbs) produced in a pharmaceutical factory in space in 2026. Then, we will need to run pre-clinical trials of these crystals, which will be in 2026 or 2027. Image credit: Rini. com/ Shutterstock.
BiomX has already initiated a phase 2b trial of BX004, with topline results expected in the first quarter of 2026. aeruginosa cystic fibrosis infections.”
Even well-intentioned policies can create access disparities if communication and operational support are lacking. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set.
Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance. The updated ICH E6 (R3) guidelines introduce a range of critical changes aimed at modernizing clinical trials.
Anticipated next steps involve generating preclinical candidate data packages, which will include non-human primate studies expected in early 2026. Their efforts include exploring other oligomer-specific antibodies from Acumen’s library to identify potential lifecycle opportunities beyond sabirnetug alone.
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It is expected to enhance gross margin and contribute positively to operating income and earnings per share after 2026. July 21, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The acquisition of Blueprint provides Sanofi with a well-established foothold among allergists, dermatologists and immunologists.
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KalVista will receive an upfront payment of $11m, with an additional $11m contingent upon achieving a regulatory milestone anticipated by early 2026. In April 2025, KalVista Pharmaceuticals granted Kaken Pharmaceutical the commercialisation rights for sebetralstat in Japan. Sign up for our daily news round-up!
By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026. The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations.
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Experts gathered at the ongoing BIO International Convention in Boston, US, this week were reasonably confident the programme will be reauthorised in a legislative package before its expiry in September 2026. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
Takeda anticipates commencing commercialisation efforts for Gammagard liquid ERC in the US by 2026, with plans to follow suit in the European Union (EU) by 2027. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard.
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Communication between the manufacturing plant and retail stores. Construction on the new warehouse began in early 2025, and the company expects the facility to be operational in the first quarter of 2026. An expansion of the Latina site’s fill/finish line for biologics is also planned for the future.
As well as advancing DT-101, the new capital injection will also support the progression of two gamma-aminobutyric acid type A (GABA A ) receptor modulators towards clinical trials in 2026. These compounds have the potential for addressing a spectrum of neuropsychiatric disorders that currently lack adequate treatment options.
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A target action date of 28 April 2026 has been set under the Prescription Drug User Fee Act (PDUFA). The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for review to treat adults with virologically suppressed human immunodeficiency virus (HIV)-1.
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June 11, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The company intends to introduce its inaugural product candidate into clinical trials by 2026. The company is progressing several programmes, intending to introduce its inaugural product candidate into clinical trials by 2026.
The financial impact of this agreement on JCR’s consolidated results for the fiscal year ending 31 March 2026 has already been included in the current earnings forecast. We may still continue to send you service-related and other non-promotional communications. Sign up for our daily news round-up!
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A decision by the FDA is expected in H1 2026. Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications.
CMS’ proposed transitional relief for FY 2026—a one-time payment adjustment for hospitals facing wage index reductions greater than 9.75 percent—is narrow in scope and does not offer long-term protection for affected communities.
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Member states of the organisation agreed earlier this year to pay 20% more in membership fees to stopgap the US funding shortfall, though WHO’s overall budget for 2026-2027 will be lower than that for 2024-2025. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.
The candidate plans to enter Phase I human trials in early 2026. Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications.
While the CRL will delay the potential approval of UX111 to 2026, we are working with urgency to respond and resubmit.” We may still continue to send you service-related and other non-promotional communications. We believe the CMC observations are readily addressable, and many have already been addressed.
However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal. Give your business an edge with our leading industry insights. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
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HHS pauses CDC, FDA, and NIH communications with the public. Food companies agree to phase out eight synthetic dyes by the end of 2026 over concerns about behavioral problems in children. President signs more than two dozen executive orders, including eliminating DEI programs and freezing USAID contracts and other foreign aid.
Senior Manager of External Communications at Providence Alaska (Anchorage): Providence Alaska Medical Center’s Daily Device Review Initiative, launched in January 2025, targets the prevention of two prevalent hospital-acquired infections: catheter-associated urinary tract infections and central line-associated bloodstream infections.
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