Wed.Jul 03, 2024

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GSK goes all-in on CureVac’s mRNA vaccines

pharmaphorum

GSK has upgraded its longstanding alliance with CureVac on mRNA-based vaccines for respiratory infections, paying €400 million ($429 million) upfront for global rights to its influenza and COVID-19 jabs.

Vaccine 113
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5 FDA decisions to watch in the third quarter

Bio Pharma Dive

Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.

Marketing 321
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Left in limbo: When pharma halts rare disease research

Pharmaceutical Technology

Academic institutions and nonprofit organisations are jumping in to save access to complex gene therapies.

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CureVac cuts jobs, licenses out vaccines to GSK

Bio Pharma Dive

The mRNA specialist plans to eliminate 30% of its workforce as part of a restructuring that will prioritize “high-value” projects like its cancer vaccines.

Vaccine 182
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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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EMA approves Sanofi’s Dupixent for COPD treatment in adults

Pharmaceutical Technology

The EMA has granted approval to Sanofi's Dupixent for adults with uncontrolled chronic obstructive pulmonary disease (COPD).

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Beacon raises $170M for eye gene therapy; J&J confirms Carvykti survival benefit

Bio Pharma Dive

Forbion led the startup’s Series B round. Elsewhere, Vertex got an FDA decision date for its “vanza triple” and Dupixent won a marketing green light in Europe for COPD.

More Trending

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Study reveals cardiovascular health could be biggest risk factor for dementia

Pharma Times

Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK

Research 127
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Beacon secures $170m to advance ophthalmic gene therapies

Pharmaceutical Technology

Beacon’s lead candidate AGTC-501 is currently in a Phase II/III clinical trial for the treatment of X-linked retinitis pigmentosa (XLRP).

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Study finds headache drug could prevent overuse of acute migraine medications

Pharma Times

Chronic migraine is a neurological condition estimated to affect up to 2.

Drugs 126
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Emergent scores US medical countermeasure contracts worth over $250m

Pharmaceutical Technology

Emergent will supply vaccines for anthrax and smallpox, VIV for treating smallpox vaccine complications, and a botulism antitoxin.

Vaccine 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Sanofi and Regeneron's Dupixent scores in Europe as the first biologic to treat COPD

Fierce Pharma

After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week. | After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week.

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Biogen completes $1.15bn HI-Bio acquisition to expand immunology presence

Pharmaceutical Technology

The takeover, which includes the candidate felzartamab, for immune-mediated diseases, diversifies Biogen’s scope.

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Frontiers Health 2024: The foundational pillars

pharmaphorum

Frontiers Health, a prominent event in health innovation, has unveiled the foundational pillars that will define its legacy and future trajectory. The announcement of these pillars precedes their global conference, scheduled for the 17th and 18th of October in Berlin.

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Protecting your drug products: Strategies for preventing metal contamination in powders

Pharmaceutical Technology

Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.

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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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Lilly gets FDA OK for Alzheimer’s drug, cites cost advantage

pharmaphorum

Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.

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GSK and CureVac restructure mRNA vaccine development deal

Pharmaceutical Technology

GSK and CureVac have announced the restructuring of their existing partnership into a new licensing agreement for mRNA vaccine candidates.

Vaccine 130
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Beacon lights up with $170m for retinal disease gene therapy

pharmaphorum

Beacon Therapeutics raises $170m for a pivotal trial of its gene therapy for X-linked retinitis pigmentosa, an inherited cause of blindness

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Moderna’s mRNA influenza vaccine receives $176m boost

Pharmaceutical Technology

Moderna has received a grant of $176m through the RRPV Consortium to expedite the development of mRNA-based pandemic influenza vaccines.

Vaccine 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EU first to approve Dupixent for COPD

pharmaphorum

EU is first to approve Sanofi and Regeneron's Dupixent for COPD, ending a 10-year hiatus in new therapies

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FDA Foods Program: Key Priority Guidance Updates for 2024

XTalks

The US Food and Drug Administration (FDA) Foods Program has released an update on its priority guidance topics for 2024. The update includes a list of draft and final guidance documents that the agency aims to complete this year. Since January, the FDA has issued several important guidelines on this list, providing crucial insights for industry stakeholders.

Genomics 105
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ASCO 2024 - Andree Amelsberg

pharmaphorum

ASCO 2024 interview with Andree Amelsberg providing insights and perspectives on the latest trends and developments in the industry.

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Verona’s COPD Drug Ohtuvayre (ensifentrine) Gets FDA Nod

XTalks

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis. According to the World Health Organization (WHO), COPD is the third leading cause of death worldwide with 3.23 million deaths in 2019 alone.

Drugs 105
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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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FH24 Foundational Pillars

pharmaphorum

Frontiers Health, a prominent event in health innovation, has unveiled the foundational pillars that will define its legacy and future trajectory. The announcement of these pillars precedes their global conference, scheduled for the 17th and 18th of October in Berlin.

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Eli Lilly’s Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi

XTalks

Eli Lilly’s anti-amyloid therapy Kisunla (donanemab-azbt) finally meets success as it received full approval from the US Food and Drug Administration (FDA) for the treatment of individuals with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease (AD). The once-monthly injection for intravenous (IV) infusion is specifically approved for adults with early symptomatic AD, which includes people with MCI as well as people with the mild dementia stage of AD, with confirmed am

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Advantage J&J in multiple myeloma CAR-T tussle with BMS

pharmaphorum

J&J’s multiple myeloma CAR-T Carvykti improves survival when used as a second-line or later therapy, raising the pressure on BMS’ rival Abecma

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Which pharmaceutical drugs have the most drug patents in Norway?

Drug Patent Watch

This chart shows the drugs with the most patents in Norway. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

Drugs 59
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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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New Frontiers in MASH and Chronic Liver Diseases with Aligos CEO Dr. Lawrence Blatt

XTalks

In this episode, Ayesha spoke with Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos Therapeutics , a company developing targeted therapies for liver diseases like MASH (metabolic dysfunction-associated steatohepatitis) and viral diseases to address important unmet medical needs. Prior to co-founding Aligos Therapeutics, Dr. Blatt served as the Global Head of Infectious Diseases and Vaccines at Janssen Pharmaceutical Companies of Johnson & Johnson from 2014 to 2018.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

Drugs 59
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Apple Packs a Punch at WWDC: A Pocketful of Power With Apple Intelligence

Intouch Solutions

This year’s Worldwide Developers Conference (WWDC) wasn’t just about the next iPhone. Apple unveiled a range of exciting developments, including visionOS 2 for enhanced augmented reality, intuitive AirPod gestures and even personalized Genmoji (generative Emojis) you can create at will. But the true star of the show was Apple Intelligence, a significant investment in on-device AI that promises to transform how we interact with our Apple devices.

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New patent for Janssen Biotech drug AKEEGA

Drug Patent Watch

Annual Drug Patent Expirations for AKEEGA Akeega is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug.

Drugs 59
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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.