Thu.Jan 04, 2024

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A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

Bio Pharma Dive

Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.

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Shock Result Reveals The Fruit You May Want to Leave Out of Smoothies

AuroBlog - Aurous Healthcare Clinical Trials blog

The next time you make yourself a berry smoothie, you might want to hold off on the banana. Sure, this fruit is full of potassium and makes a drink deliciously thick and creamy, but according to researchers from the University of California Davis (UCD), there’s something in bananas that might overpower the antioxidants in berries.

Research 245
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Allogene to shift strategy in bid to reposition CAR-T

Bio Pharma Dive

The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.

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Pfizer receives Health Canada approval for haemophilia B therapy

Pharmaceutical Technology

Pfizer Canada has received Health Canada approval for gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of haemophilia B.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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5 FDA decisions to watch in the first quarter

Bio Pharma Dive

The agency could soon clear important new drugs from Eli Lilly and Merck, as well as the first treatment for a common liver disease.

Drugs 317
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Tonabersat by Inflammx Therapeutics for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Wet (Neovascular / Exudative) Macular Degeneration.

More Trending

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Tonabersat by Inflammx Therapeutics for Diabetic Macular Edema: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Diabetic Macular Edema.

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Intellia to lay off staff, cut some early research

Bio Pharma Dive

The CRISPR specialist joins some of its genetic medicine peers in trimming staff, announcing an “organizational streamlining” to focus resources on prioritiy drug programs.

Genetics 195
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DDCDA devises strategies to differentiate their service with improved customer experience

AuroBlog - Aurous Healthcare Clinical Trials blog

Dharwad District Chemists & Druggists Association (DDCDA) is devising strategies to differentiate their service with improved customer experience. These span attention to details like patient education to manage their medication, ensure fair business practices in pricing and dispensing medicines efficiently among others.

Medicine 182
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Novo taps Flagship startups to develop drugs for obesity, MASH

Bio Pharma Dive

The research deals with Omega Therapeutics and Cellarity are the first under a broad alliance Novo struck with Flagship last spring.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Tonabersat by Inflammx Therapeutics for Dry (Atrophic) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Dry (Atrophic) Macular Degeneration.

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Risk model predicts response and survival of cancer patients treated with ICIs

Pharma Times

Metastatic cancer is estimated to be responsible for 90% of cancer deaths

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BridGene and Galapagos partner for oncology drugs discovery

Pharmaceutical Technology

BridGene has entered into a strategic partnership and licensing deal with Galapagos for the discovery of drug candidates for oncology targets.

Drugs 147
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Disrupted sleep could be associated with cognitive function changes

Pharma Times

High amounts of disrupted sleep were found to affect memory and thinking performance

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Novo Nordisk, Eli Lilly's weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Fierce Pharma

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. | Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

Drugs 137
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Why amplifying the patient voice is crucial to clinical trial success

pharmaphorum

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

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Agios’s mitapivat meets endpoints in Phase III thalassemia trial

Pharmaceutical Technology

Agios plans to file regulatory approval for mitapivat by the end of the year after it met primary endpoint in the Phase III trial.

Trials 130
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Bluebird bio's Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Fierce Pharma

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. | Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio has signed a second outcomes-based reimbursement agreement for its sickle cell gene therapy Lyfgenia.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CVS to remove Humira from reimbursement lists in biosimilar push

Pharmaceutical Technology

In a move to drive down customer costs, CVS will replace AbbVie’s blockbuster with more affordable biosimilars.

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2024 forecast: As CDMOs come off pandemic's highs and lows, employment and funding hitches persist

Fierce Pharma

Even after the heady highs of the COVID-19 era, the contract development and manufacturing organization (CDMO) realm remains one of biopharma's buzziest fields. | Even after the heady highs of the COVID era, the CDMO realm remains one of biopharma's buzziest fields. In 2024, CDMOs can advance their priorities on three fronts, a group of experts said during a recent Evaluate webinar on the state of the industry.

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Esperion and Daiichi Sankyo Europe amend partnership

Pharmaceutical Technology

Daiichi Sankyo Europe (DSE) has amended its existing collaboration with Esperion Therapeutics valued at $125m.

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AGC extends CDMO expansion spree, plans second manufacturing facility in Japan

Fierce Pharma

Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. | Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. The Seattle-based CDMO has unveiled its plan to construct a four-story complex, which will cover 20,000 square meters (215,000 square feet) and is expected to become operational in 2026.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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ENYO Pharma raises €39m Series C funding to advance Vonafexor

Pharmaceutical Technology

ENYO Pharma has secured €39m Series C funding to advance Vonafexor for the treatment of the kidney disease Alport syndrome.

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CVS Caremark to kick AbbVie's Humira off some formularies in favor of cheaper biosimilars

Fierce Pharma

This year, CVS Health plans to employ the classic "out with the old, in with the new" mantra when it comes to AbbVie’s Humira. | The changes to major commercial formularies will take effect April 1 and favor Humira biosimilar options over the branded drug as part of CVS' efforts to ramp up U.S. biosimilar adoption.

Branding 115
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Beqvez Becomes Pfizer’s First Approved Gene Therapy After Nod from Health Canada

XTalks

Pfizer has kickstarted the new year with its first-ever gene therapy approval, awarded by Health Canada to the company’s Beqvez (fidanacogene elaparvovec) for the treatment of hemophilia B. The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the a

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Roche antibiotic tackles serious drug-resistant pathogen

pharmaphorum

Scientists at Roche and Harvard University have discovered a new class of antibiotic that can kill carbapenem-resistant Acinetobacter baumannii (CRAB), a major public health threat

Scientist 111
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Bain Capital eyes potential €1B sale of Dutch antibiotics manufacturer Centrient: report

Fierce Pharma

As bankers predict a rise in private equity exits this year, one of 2024’s M&A moves could come from the drug manufacturing realm. | Investment giant Bain Capital is weighing a potential sale of its Dutch antibiotics and active pharmaceutical ingredients (API) specialist Centrient Pharmaceuticals, which could be valued as high as €1 billion ($1.09 billion), Bloomberg reported Wednesday, citing people close to the talks.

Sales 111
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Click bags FDA breakthrough tag for schizophrenia DTx

pharmaphorum

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

Drugs 111
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Merck settles with insurance companies over $1.4B claim tied to 2017 cyberattack: report

Fierce Pharma

Merck has reportedly settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017. | Merck has settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017, Bloomberg Law reports. With the settlement—terms of which were not disclosed—the insurance companies avoided a ruling that would have provided precedent for other cases involv

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AbbVie hit as CVS says it will cut Humira from formularies

pharmaphorum

CVS Health will remove AbbVie’s immunology blockbuster Humira from national lists of reimbursable products, and offer biosimilars of the drug instead

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.