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STAT+: Pharmalittle: We’re reading about an FDA review of Moderna’s flu shot, J&J’s focus on cancer, and more
And so, another working week will soon draw to a close — at least on this side of the pond where we have a holiday tomorrow. This means we are staring down a longer-than-usual agenda to fill. So far, we plan to manicure the Pharmalot campus and promenade extensively with the official mascots, and we hope to hold still another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The great outdoors, as always, is beckoning, which could mean a jaunt to the beach or perhaps a hike in the woods. Or maybe a stroll along city streets with an iced drink in hand. If the weather fails to cooperate, the great indoors also provides comfort — you can cook a favorite meal, curl up with an e-book, or binge-watch the telly. Well, whatever you do, have a grand time. But be safe, enjoy, and see you soon. And if dad is still around, remember to say hello. …
Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Bloomberg News writes. This sets J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight loss drugs from Eli Lilly and Novo Nordisk. J&J chief executive officer Joaquin Duato said the company aims to become the world’s leading cancer company, with oncology as one of its core growth pillars. Last year, J&J paid $3.05 billion in cash for Halda Therapeutics, gaining access to an innovative new type of oral therapy for prostate cancer. His remarks come as J&J continues to reshape itself following the spin off of its Kenvue consumer health business.
The U.S. Food and Drug Administration approved GSK’s oral antibiotic to treat complicated urinary tract infections, giving patients a new treatment option against drug-resistant infections, Pharmaphorum notes. While the pill, called Utebzi, does not offer a novel mechanism of action, it provides an alternative to the current intravenously administered carbapenems, which are often used as a last resort for infections resistant to other antibiotics. GSK acquired rights to Utebzi in a $591 million licensing deal in 2022 with Spero Therapeutics, just a few months after the FDA rejected Spero’s first marketing application for the antibiotic with a request for an additional clinical trial.
And so, another working week will soon draw to a close — at least on this side of the pond where we have a holiday tomorrow. This means we are staring down a longer-than-usual agenda to fill. So far, we plan to manicure the Pharmalot campus and promenade extensively with the official mascots, and we hope to hold still another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The great outdoors, as always, is beckoning, which could mean a jaunt to the beach or perhaps a hike in the woods. Or maybe a stroll along city streets with an iced drink in hand. If the weather fails to cooperate, the great indoors also provides comfort — you can cook a favorite meal, curl up with an e-book, or binge-watch the telly. Well, whatever you do, have a grand time. But be safe, enjoy, and see you soon. And if dad is still around, remember to say hello. …
Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Bloomberg News writes. This sets J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight loss drugs from Eli Lilly and Novo Nordisk. J&J chief executive officer Joaquin Duato said the company aims to become the world’s leading cancer company, with oncology as one of its core growth pillars. Last year, J&J paid $3.05 billion in cash for Halda Therapeutics, gaining access to an innovative new type of oral therapy for prostate cancer. His remarks come as J&J continues to reshape itself following the spin off of its Kenvue consumer health business.
The U.S. Food and Drug Administration approved GSK’s oral antibiotic to treat complicated urinary tract infections, giving patients a new treatment option against drug-resistant infections, Pharmaphorum notes. While the pill, called Utebzi, does not offer a novel mechanism of action, it provides an alternative to the current intravenously administered carbapenems, which are often used as a last resort for infections resistant to other antibiotics. GSK acquired rights to Utebzi in a $591 million licensing deal in 2022 with Spero Therapeutics, just a few months after the FDA rejected Spero’s first marketing application for the antibiotic with a request for an additional clinical trial.
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Ebola cases increase almost 40% in a week as death toll passes 200
DAKAR, Senegal — The Ebola outbreak in Congo and Uganda has claimed more than 200 lives in its first month and is the worst known outbreak at this stage, with up to 35,000 suspected potential contacts, Africa’s Centres for Disease Control and Prevention said on Thursday.
With 894 confirmed cases so far, the current outbreak is three times worse than a previous outbreak in Uganda in 2000, which had 281 cases at the same point, said Dr. Wessam Mankoula, a medical epidemiologist at Africa CDC.
DAKAR, Senegal — The Ebola outbreak in Congo and Uganda has claimed more than 200 lives in its first month and is the worst known outbreak at this stage, with up to 35,000 suspected potential contacts, Africa’s Centres for Disease Control and Prevention said on Thursday.
With 894 confirmed cases so far, the current outbreak is three times worse than a previous outbreak in Uganda in 2000, which had 281 cases at the same point, said Dr. Wessam Mankoula, a medical epidemiologist at Africa CDC.
IDBS, which provides cloud software for biopharma, and Alchemi, an applied AI company, partnered to connect AI agents to data captured and contextualized in the IDBS Polar platform across the drug development lifecycle. By capturing such data at the point of creation within a single governed backbone, Polar delivers the data foundation that makes agentic AI viable in regulated environments, explains IDBS in a statement.
Preparing regulatory filings remains one of biopharma’s most persistent bottlenecks. CMC teams spend months assembling data, drafting reports, and reconstructing process histories, while current AI tools often break the compliance chain by pulling data out of validated systems, according to an IDBS spokesperson, adding that connecting Alchemi’s purpose-built agents to Polar’s AI-ready data foundation keeps validated data traceable and auditable.
CMC technical reports, clinical study reports, and submission dossiers can be drafted faster and routed through human-in-the-loop workflows for review and sign-off, maintaining compliance, points out the IDBS official. According to Alchemi, in customer deployments across biopharma, teams have produced documents of this type up to 70% faster using Alchemi’s agents.
“A regulatory filing that takes a team weeks, our agents draft in minutes, at submission-ready quality, with the compliance trail intact, because they work straight from governed data in Polar,” reports Anuj Chadha, co-founder, Alchemi.
“Our mission is to accelerate life-changing therapies to patients, and as part of Danaher, that means turning ideas into impact with speed and certainty,” says Pietro Forgione, general manager, IDBS. “[Our company] delivers a governed data backbone that makes AI-ready data available across the biopharma lifecycle. By partnering with Alchemi, we can accelerate critical regulatory milestones using high-quality, compliant AI agents,” said Pietro Forgione, general manager, IDBS.
The post IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings appeared first on GEN – Genetic Engineering and Biotechnology News.
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cAMPfield lands $180M to build gut disease drug
The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.
The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Ebola cases increase almost 40% in a week as death toll passes 200
IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings
cAMPfield lands $180M to build gut disease drug
At FDA, ‘caretaker mode’ is better than power trip mode
New biotech cAMPfield emerges with $180M to reshape IBD treatment
STAT+: Shingles vaccine may lower dementia risk, new study finds
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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