Biotech News

The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time.

The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.  

One of the country's oldest and largest drug manufacturing plants will shut down Saturday, a casualty of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come.

Takeda allies with Frazier to spin out late-phase norovirus vaccinei ntaylor Fri, 07/30/2021 - 06:50

Ardelyx's FDA rejection points to long path back for CKD drug ntaylor Fri, 07/30/2021 - 06:47

Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbo charge work badams Fri, 07/30/2021 - 05:11

UK rapid diagnostics company Mologic will convert into a social enterprise after being acquired by a group of philanthropic funds and investors, in what experts predict may become an increasingly popular trend. The British biotech Mologic will entirely reinvest any profits into widening global access to affordable medical technology after being acquired in a deal worth at least €35M (£30M). Following the takeover, Mologic will become part of Global Access Health (GAH)—an altruistic initiative led by George Soros’ Economic Development Fund (SEDF) and supported by the Bill and Melinda Gates Foundation. The move to become a social enterprise — a company focused on social goals over profit — is unusual in the biotech industry. However, the concept is becoming more prominent amid growing recognition of global health inequalities during the Covid-19 pandemic and the role biotech can play in addressing them. In addition, investors are increasingly drawn to sustainable and responsible investment practices that recognize the importance of environmental, social, and corporate governance. “Mologic’s transition into a social enterprise is a deliberate, The post British Diagnostics Biotech Becomes Social Enterprise After Acquisition appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

Employers may have the dilemma of hiring employees or acquiring the services of an independent contractor (IC). These include freelancers, consultants, seasonal workers, and other temporary professionals.

The panels discussed key issues such as expanded access programs (EAPs), clinical trial diversity, conditional approval pathways, and patient experience data.

The FDA has already given its go-ahead to use lumasiran to treat PH1 and lower the urinary oxalate levels in pediatric and adult patients under the brand name OXLUMO.

Collaborating with Frazier Healthcare Partners, the team spun out a new company dubbed HilleVax to take Takeda’s norovirus vaccine into Phase 3 trials.

As Gilead gets ready to open its doors to its new operations site in North Carolina, the company reported its product sales for the second quarter increased 21% year-over-year primarily driven by Veklury.

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Annovis Bio’s therapy for Alzheimer’s disease is fast-acting and has the potential for Alzheimer’s patients to significantly improve cognition and motor function, according to data presented at the Alzheimer’s Association International Conference® 2021 (AAIC®), held July 26th through 30th.

The U.S. Centers for Disease Control and Prevention issued a warning that the Delta variant is as infectious as chickenpox and can cause a much more severe COVID-19 infection.

The United States and other wealthy nations now stand at an important place in their COVID-19 vaccine campaigns. The question largely turns to vaccinating the remainder of the population – namely, those under 12 years.

Research seems to concur that a person who has recovered from severe COVID-19 symptoms might experience cognitive function and memory loss later on.

Learn how to unlock product potential in this step-by-step guide to making the most of your commercialization investments.

Eli Lilly and Company presented data analysis from the Phase II TRAILBLAZER-ALZ study at the Alzheimer’s Association International Conference (AAIC) that supports the argument that decreases in beta-amyloid in Alzheimer’s disease slows cognitive decline.

The company is eager to diversify, putting Phase II clinical trials in sickle-cell disease, beta-thalassemia, kidney diseases, and pain management.

The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.

Biopharma and life science companies strengthen their leadership teams and boards with these Movers & Shakers.

Topline results from a late-stage trial announced Thursday show Regeneron Pharmaceuticals and Sanofi's Dupixent (dupilumab) significantly reduced itch and hives better than antihistamines alone in biologic-naiïve patients with moderate-to-severe chronic spontaneous urticaria.

Rakuten Medical rakes in $166M series D following drug-device combo's approval in Japan klahucik Thu, 07/29/2021 - 10:55

The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.