Wed.Feb 07, 2024

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Venture firm Scion Life Sciences launches with $310M to back new biotechs

Bio Pharma Dive

The new firm intends to carefully select its startups and fund them for the long haul. “We're not a company formation factory,” said Aaron Kantoff, the firm’s co-founder.

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Gilead Sciences posts $5.61bn net income in FY 2023

Pharmaceutical Technology

Gilead Sciences has announced a 22.9% increase in net income of $5.61bn for FY23 as against $4.56bn in FY22.

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Bipolar Disorder Linked to a Higher Risk of Early Death Than Smoking

AuroBlog - Aurous Healthcare Clinical Trials blog

People with bipolar disorder are four to six times more likely to die prematurely than those without the condition, according to a study that compared data on thousands of people with and without the disorder.

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AstraZeneca invests $300m to build new facility in US

Pharmaceutical Technology

AstraZeneca is investing $300m in a facility in Rockville, US - a significant step in launching its cell therapy platforms in the country.

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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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Kyverna IPO adds to biotech momentum with $319M fundraise

Bio Pharma Dive

The company, a leading developer of cell therapies for autoimmune diseases, is the fifth drug startup to go public in 2024. All of them raised at least $100 million.

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Avadomide hydrochloride by Bristol-Myers Squibb for Follicular Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Follicular Lymphoma.

More Trending

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Ligelizumab by Novartis for Food Allergy: Likelihood of Approval

Pharmaceutical Technology

Ligelizumab is under clinical development by Novartis and currently in Phase III for Food Allergy.

Allergies 187
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BridgeBio sells partial rights to dwarfism drug for $100M

Bio Pharma Dive

The deal hands Kyowa Kirin rights in Japan to the drug, which is emerging as a potential rival to BioMarin’s marketed medicine Voxzogo.

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(Sacubitril + valsartan) by Novartis for Hypertrophic Cardiomyopathy: Likelihood of Approval

Pharmaceutical Technology

(Sacubitril + valsartan) is under clinical development by Novartis and currently in Phase II for Hypertrophic Cardiomyopathy.

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February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.

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

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Enfortumab vedotin by Astellas Pharma for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval

Pharmaceutical Technology

Enfortumab vedotin is under clinical development by Astellas Pharma and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC).

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AstraZeneca to invest $300M in US cell therapy plant

Bio Pharma Dive

The UK drugmaker is adding a facility in Rockville, Maryland, after a spate of dealmaking in the therapeutic field.

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Irinotecan hydrochloride by Ipsen for Neuroendocrine Carcinoma: Likelihood of Approval

Pharmaceutical Technology

Irinotecan hydrochloride is under clinical development by Ipsen and currently in Phase II for Neuroendocrine Carcinoma.

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Obesity drug mania takes over Amgen’s earnings call

Bio Pharma Dive

Analysts pressed company executives Tuesday on the potential of its GLP-1 drug for weight loss, early-stage results for which were published this week.

Drugs 145
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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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FDA clear Veru’s IND for GLP-1 RA-associated muscle loss drug

Pharmaceutical Technology

Veru’s Ostarine has previously been investigated in five clinical studies in patients with muscle wastage caused by advanced cancer.

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Brainomix’s AI-enabled stroke software endorsed by NICE

Pharma Times

The HTA reported that Brainomix 360 improved access to treatment for stroke patients

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Immunome wins Ayala’s Phase III desmoid tumour candidate for $50m

Pharmaceutical Technology

The acquisition, which also includes Phase II asset AL101, closes gap to SpringWorks’ FDA-approved Ogsiveo.

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Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)

Rethinking Clinical Trials

            Speaker Susan C. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Jazz Pharmaceuticals to acquire Redx’s KRAS inhibitor programme

Pharmaceutical Technology

Jazz Pharmaceuticals has agreed to acquire rights for a KRAS inhibitor programme from Redx Pharma, in a deal totalling $880m.

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ALTURiX acquires exclusive UK rights to three new products

Pharma Times

The new products are in the areas of gastrointestinal and respiratory medicines

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Stalicla secures funds for late-stage assets amid CNS buzz

Pharmaceutical Technology

Stalicla closes a successful Series B financing round and sets sights on Series C as interest stirs for CNS disorder deals.

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JP Morgan 2024 – Simon Arkell

pharmaphorum

In this interview, Simon Arkell, co-founder and CEO of Ryght, discusses his vision whilst at JP Morgan 2024 and how generative AI is transforming the industry.

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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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Eli Lilly reports 13% increase in Q4 2023 income

Pharmaceutical Technology

Eli Lilly has announced $2.19bn as net income on a reported basis for the fourth quarter of 2023, marking a 13% rise.

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Jazz buys KRAS inhibitors from Redx in $880m deal

pharmaphorum

Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.

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Five ways disconnected consent is impacting patient experiences

Pharmaceutical Technology

When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences.

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Gilead plots long-term cell therapy growth, maintains confidence in Trodelvy despite trial miss

Fierce Pharma

Despite markedly slower cell therapy growth from the third to the fourth quarter of 2023—and a recent setback for Trodelvy—historically HIV-focused Gilead Sciences is not discouraged amid its | Despite a tame level of fourth-quarter growth, recent advances should drive long-term cell therapy sustainability, Gilead execs said. Overall, the company is pushing to generate 30% of its revenues from oncology by 2030.

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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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FDA accepts GSK’s RSV vaccine for adults aged 50-59 for review

Pharmaceutical Technology

The US FDA has accepted for review an sBLA to expand the usage of GSK’s RSV vaccine, Arexvy, in adults aged 50-59 years.

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Brighter times ahead for biotech in 2024?

pharmaphorum

As the pandemic recedes and the global economy stabilises, are there promising signs for the biotech industry's financial outlook in 2024? Learn more about the potential for recovery, reducing bankruptcies, and attracting investors.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

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This week in clinical trials: 15th-19th January 2024

pharmaphorum

Stay updated on the latest clinical trials happening from January 15th to January 19th, 2024. Explore trials by ExeVir, NurixTx, Synendos Therapeutics, and Oxford BioTx.

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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.