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Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

World Pharma News - Mon, 07/01/2024 - 10:00
AstraZeneca's Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.

Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

Breakthrough research makes cancer-fighting viral agent more effective

World Pharma News - Fri, 06/28/2024 - 10:00
When a cancer cell doesn't respond to traditional therapies, doctors may turn to a sort of viral biological warfare, by deploying 'troops' in the form of viral agents that are specifically engineered to target and eliminate cancer cells. The mode of attack is to transform the tumor into an immunologically "hot" environment, making it more visible and recognisable to our immune system.

FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

Biospace news - Fri, 06/28/2024 - 02:00
FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info 6/28/2024

Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate

Biospace news - Fri, 06/28/2024 - 02:00
Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate 6/28/2024

ICER Doubles Down on Critique of Lykos’ MDMA Therapy, Cites Data Concerns

Biospace news - Fri, 06/28/2024 - 02:00
ICER Doubles Down on Critique of Lykos’ MDMA Therapy, Cites Data Concerns 6/28/2024

FDA Needs to Step Up As Use of Third-Party Manufacturers Leads to Rejections

Biospace news - Fri, 06/28/2024 - 02:00
FDA Needs to Step Up As Use of Third-Party Manufacturers Leads to Rejections 6/28/2024

With Latest Expansion in Ohio, Resilience Can Best Serve Partners and Patients

Biospace news - Fri, 06/28/2024 - 02:00
With Latest Expansion in Ohio, Resilience Can Best Serve Partners and Patients 6/28/2024

Illumina Reports $1.47B ‘Goodwill’ Impairment Charge After Grail Spinoff

Biospace news - Fri, 06/28/2024 - 02:00
Illumina Reports $1.47B ‘Goodwill’ Impairment Charge After Grail Spinoff 6/28/2024

AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff

Biospace news - Fri, 06/28/2024 - 02:00
AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff 6/28/2024

Fill the gap with the sine-patterned trap

World Pharma News - Thu, 06/27/2024 - 10:00
Antibiotic-resistant bacterial infections are becoming a major societal challenge. To solve this problem, researchers are working on new drugs that kill bacteria without developing resistance, and on new materials that prevent the formation of bacterial biofilms. The latter are the source of resistant variants but are notoriously difficult to remove. Recently, researchers from the Institute of Physical Chemistry, Polish Academy of Sciences have discovered that making the surface undulated can help limit the spread of resistant bacteria.

Merck’s ADC Pact With Daiichi Hits Regulatory Setback in FDA Rejection

Biospace news - Thu, 06/27/2024 - 02:00
Merck’s ADC Pact With Daiichi Hits Regulatory Setback in FDA Rejection 6/27/2024

Verona Wins FDA Approval for COPD Drug, Eyes Q3 Launch With $1B Financing for Rollout

Biospace news - Thu, 06/27/2024 - 02:00
Verona Wins FDA Approval for COPD Drug, Eyes Q3 Launch With $1B Financing for Rollout 6/27/2024

Novo Ends Phase III Kidney Disease Trial, Incurs More Than $800M Q2 Impairment Loss

Biospace news - Thu, 06/27/2024 - 02:00
Novo Ends Phase III Kidney Disease Trial, Incurs More Than $800M Q2 Impairment Loss 6/27/2024

AbbVie, Genmab Secure FDA Label Expansion for Epkinly in Follicular Lymphoma

Biospace news - Thu, 06/27/2024 - 02:00
AbbVie, Genmab Secure FDA Label Expansion for Epkinly in Follicular Lymphoma 6/27/2024

CDC Narrows RSV Vaccine Recommendations for Seniors

Biospace news - Thu, 06/27/2024 - 02:00
CDC Narrows RSV Vaccine Recommendations for Seniors 6/27/2024

New Team, Same Company: How to Transition to Your New Role

Biospace news - Thu, 06/27/2024 - 02:00
New Team, Same Company: How to Transition to Your New Role 6/27/2024

Leadership Lab: 3 Strategies for an Executive’s Discreet Job Search

Biospace news - Thu, 06/27/2024 - 02:00
Leadership Lab: 3 Strategies for an Executive’s Discreet Job Search 6/27/2024

5 Top Companies Hiring in the Washington, D.C., Area

Biospace news - Thu, 06/27/2024 - 02:00
5 Top Companies Hiring in the Washington, D.C., Area 6/27/2024

AI-based Alphafold: Its potential impact on predictive medicine

World Pharma News - Wed, 06/26/2024 - 10:00
AlphaFold is an outstanding example of artificial intelligence's computational capabilities in accurately predicting intricate protein structures. A new Review article explores AlphaFold's recent advancements and its potential impact on predictive medicine. The article is published in the peer-reviewed journal AI in Precision Oncology.

Vivek Subbiah, MD, from the Sarah Cannon Research Institute, and coauthors, describe a shift toward predictive medicine,

Lyell Reports Patient Death in Early-Stage CAR T Trial, Shows Otherwise Strong Response Rate

Biospace news - Wed, 06/26/2024 - 02:00
Lyell Reports Patient Death in Early-Stage CAR T Trial, Shows Otherwise Strong Response Rate 6/26/2024