Tue.Dec 12, 2023

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Tome Biosciences debuts with $213M and a new way to edit the genome

Bio Pharma Dive

Based on the work of MIT scientists, the well-funded startup is developing ways to insert large sizes of genetic material anywhere in the genome without damaging or breaking DNA.

Genome 334
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December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups , analyses from the Distributed Research Network , and study designs and results from the NIH Collaboratory Trials.

Trials 147
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FTC, in unusual move, leads Sanofi to terminate a drug research deal

Bio Pharma Dive

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.

Licensing 309
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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

Medicine 144
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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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AstraZeneca to acquire vaccine maker Icosavax for up to $1.1B

Bio Pharma Dive

The deal signals the pharma company’s continuing interest in vaccine development and hands it a combination shot aimed at two respiratory viruses.

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Babies born early have an increased risk of developmental disorders

Pharma Times

Around 240 million children worldwide are living with these types of disorders - News - PharmaTimes

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More Trending

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Imeik Technology Development sees highest patent filings and grants during July in Q3 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Imeik Technology Development here.

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Pfizer reveals reorganization, executive departure as it gets ready to close $43B Seagen buyout

Fierce Pharma

To complete its acquisition of Seagen, what did Pfizer need to do to satisfy antitrust concerns of the Federal Trade Commission? | By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday.

Sales 126
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Bicara raises $165m to advance cancer therapy  

Pharmaceutical Technology

The funding will advance Bicara’s lead candidate BCA101, with the EGFR/TGF-β inhibitor currently being evaluated in Phase II clinical trials.

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10 achondroplasia facts to note

Antidote

Achondroplasia, a term meaning “without cartilage formation,” is a genetic disorder leading to disproportionate short stature. Sometimes called achondroplastic dwarfism or ACH , this condition has few treatment options and no known cure. However, individuals diagnosed with this condition can typically lead fulfilling, healthy lives with proper management.

Genetics 121
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Sanofi bows to FTC demands and ends Maze licensing deal

Pharmaceutical Technology

The license of Maze’s GYS1 program, including MZE-001, was the subject of FTC opposition, leading to Sanofi terminating the agreement

Licensing 130
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Genentech elevates interim CEO Ashley Magargee to full-time leadership position

Fierce Pharma

Genentech’s brief leadership interregnum is coming to an end as the company’s interim chief executive, Ashley Magargee, prepares to take a permanent place on the throne. | Genentech veteran Ashley Magargee, who was tapped to temporarily steer the Roche subsidiary in November, will don the mantle of full-time CEO on Jan. 1, 2024. The executive move comes amid a period of C-suite fluidity for Roche and its large pharma group.

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Coaching and Medical Affairs: The View from the Frontline

pharmaphorum

Coaching and Medical Affairs: The View from the Frontline Mike.

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Troubled Evofem, marketer of contraceptive gel Phexxi, sells itself to Aditxt in $100M deal

Fierce Pharma

Evofem has struggled to gain commercial traction with Phexxi. Now, it's selling itself after shares crashed dramatically over the last few years.

Marketing 115
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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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Can China’s biotech industry weather frosty US relations?

pharmaphorum

Can China’s biotech industry weather frosty US relations? Mike.

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Grifols’ Innovation Strategy in the Plasma Medicine Space

XTalks

Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin. These components make plasma an invaluable resource for treating various medical conditions, especially those that are rare and chronic.

Medicine 111
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Is the future of pharmaceutical drugs in the delivery?

pharmaphorum

Is the future of pharmaceutical drugs in the delivery? Mike.

Drugs 111
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Navigating Neuroscience Trials: Biomarkers, Imaging and CRO Strategies

XTalks

The world of neuroscience trials is rapidly evolving, presenting new challenges and opportunities for researchers and clinicians. The worldwide market for neurology clinical trials stood at a valuation of $5.24 billion in 2022. It’s projected to grow at a compound annual growth rate (CAGR) of 5.6 percent between 2023 and 2030. This growth is primarily being driven by a rise in neurological diseases like stroke, dementia and peripheral neuropathy, coupled with increased R&D funding for neurol

Trials 111
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BMS bolts on SystImmune bispecific ADC in $8.4bn deal

pharmaphorum

BMS bolts on SystImmune bispecific ADC in $8.4bn deal Phil.

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Ferring trims US workforce by 134 with layoffs in New Jersey, Minnesota

Fierce Pharma

As waves of layoffs continue to hit the biopharma industry, Ferring Pharmaceuticals is trimming its headcount by 134 across its two U.S. locations. | The drugmaker will lay off 79 at its New Jersey headquarters and 55 at its microbiome subsidiary Rebiotix in Minnesota as a result of a "revised business strategy.

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ASH: Sanofi’s Sarclisa carves out a multiple myeloma niche

pharmaphorum

ASH: Sanofi’s Sarclisa carves out a multiple myeloma niche Phil.

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Trade & Channel Strategies 2023: An Interview with Bayer's Spencer Miller

Pharmaceutical Commerce

Bayer executive talks Enable Holistic Hub and Provider Services panel.

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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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Genentech confirms Magargee as permanent CEO

pharmaphorum

Genentech confirms Magargee as permanent CEO Phil.

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National Resilience lines up 440 new jobs at former AstraZeneca plant in Ohio

Fierce Pharma

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a | Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday.

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Digitised pathology resource will speed HIV cancer R&D

pharmaphorum

Digitised pathology resource will speed HIV cancer R&D Phil.

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White Claw Enters Non-Alcoholic Beverage Market

XTalks

White Claw is entering the non-alcoholic beverage space with its latest innovation, the White Claw 0% Alcohol seltzers. Offering a new twist on traditional flavors, these drinks come in black cherry cranberry, mango passionfruit, peach orange blossom and lime yuzu. Designed to mirror the taste of the original White Claw Hard Seltzers, these 12-ounce beverages contain only 15 calories per can and are infused with electrolytes for added hydration benefits.

Marketing 104
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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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Sanofi abandons Maze Pompe deal after FTC lawsuit

pharmaphorum

Sanofi abandons Maze Pompe deal after FTC lawsuit Phil.

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ASH: After Imbruvica's stumble in mantle cell lymphoma, AbbVie and J&J eye possible combo comeback

Fierce Pharma

With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to sta | With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to stage a comeback in mantle cell lymphoma.

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AZ agrees $1.1bn deal to buy RSV jab developer Icosavax

pharmaphorum

AZ agrees $1.1bn deal to buy RSV jab developer Icosavax Phil.

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Trade & Channel Strategies 2023: An Interview with Cheryl Allen of Curatio Scientia

Pharmaceutical Commerce

Founding Partner of Curatio Scientia speaks on her upcoming panel at Trade & Channel Strategies 2023.

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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.