Fri.Feb 02, 2024

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Brain drug developer Alto Neuroscience prices $129M IPO

Bio Pharma Dive

The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.

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Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status

Pharmaceutical Technology

The US FDA has granted rare paediatric disease (RPD) designation for Tyra Biosciences’ TYRA-300 for treating achondroplasia.

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Arch, a prolific biotech creator, is raising $3B for startup investing

Bio Pharma Dive

A regulatory filing shows the firm is putting together a new multibillion-dollar fund, roughly two years after raising a similar amount.

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Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

Pharma Times

Dopamine neuron senescence is a hallmark of Parkinson’s disease

Medicine 155
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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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IGC Pharma heads towards a Phase I study for Alzheimer’s disease

Pharmaceutical Technology

With TGR-63 advancing towards the clinical stage, IGC Pharma is tackling different small molecule alternatives to treat Alzheimer’s.

Drugs 147
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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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NHS launches BRCA testing programme for people of Jewish descent

Pharma Times

Individuals with Jewish ancestry are six times more likely to carry a genetic fault

Genetics 126
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BMS reports 2% revenue loss in 2023 after Revlimid generics hurt sales

Pharmaceutical Technology

Bristol Myers Squibb has reported a 2% revenue decrease from 2022 as it focuses on business development to counteract patent losses.

Sales 130
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An overview of endometrial cancer

Antidote

Endometrial cancer, also known as endometrial carcinoma or uterine cancer , is a condition that approximately 66,000 individuals are diagnosed with annually, and instances rise roughly 2% in the United States each year. Because it is often caught early, a person’s prognosis is typically good — but it is still a disheartening diagnosis that significantly impacts the lives of those who experience it.

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Scottish company secures £4.2m to advance 3D-printed micro-tumour tech

Pharmaceutical Technology

Carcinotech has gained funding to enter the North American market with the company's pioneering 3D-printed tumours for cancer treatments.

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

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As Humira plummets, AbbVie dials up Rinvoq and Skyrizi estimates to a combined $27B

Fierce Pharma

As AbbVie slogs through sharp revenue declines for Humira, the company is looking to the immunology light at the end of the tunnel. | Sales of Humira—which once sat pretty as the world’s best-selling drug—plunged nearly 41% to $3.3 billion in the third quarter.

Sales 122
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As England’s virus hospitalisations surge flu vaccines evolve

Pharmaceutical Technology

England evaluates vaccine procurement and pandemic preparedness, whilst Moderna’s mRNA vaccine creeps closer to regulatory approval.

Vaccine 130
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Bristol Myers CEO outlines transition strategy featuring 11 key brands, more dealmaking

Fierce Pharma

In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-man | In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a transition period filled with patent cliffs and new government-mandated pricing pressure.

Branding 122
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AbbVie wins UK NICE endorsement for subcutaneous Tepkinly in DLBCL

Pharmaceutical Technology

AbbVie’s Tepkinly has been recommended for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

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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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JP Morgan 2024 – Katherine Stueland

pharmaphorum

Learn more about Katherine Stueland, the CEO of GeneDx, as she discusses her journey, the future of diagnostics, whilst at JP Morgan 2024.

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Protected: Key mistakes in decentralised clinical trials and how to put them right

Pharmaceutical Technology

Common mistakes in decentralised clinical trials (DCTs) are undermining industry confidence in the model. We explore these issues.

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The Path for Prescription Drug Sales

Pharmaceutical Commerce

A dive into this market reveals that the latest numbers yield promising results—a global value of a worldwide $1.6 trillion—but it will continue to be attributed to past, present, and future healthcare spending.

Sales 116
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Biosyngen’s liver cancer therapy receives fast track designation

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) to Biosyngen's T cell therapy BST02 for liver cancer.

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

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FDA Can’t Reclassify Its Way Out of Reviewing 100,000 LDT Submissions

FDA Law Blog

By Steven J. Gonzalez & Allyson B. Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). Most of these reclassified tests will supposedly be infectious disease and companion diagnostic IVDs.

In-Vitro 116
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LimmaTech secures funding for vaccine technology development

Pharmaceutical Technology

LimmaTech announced the closing of a second round of its Series A financing, securing $3m from Tenmile for vaccine technology development.

Vaccine 130
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Hikma will pay $150m in US opioid settlement

pharmaphorum

Indian pharma Hikma has agreed a $150 million settlement to resolve lawsuits claiming that it helped fuel to the opioid crisis in the US

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Regeneron's Eylea HD vs. Roche's Vabysmo: Will the real standard of care please stand up?

Fierce Pharma

One day after Roche said it was starting to establish Vabysmo as th | One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea.

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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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Vera prices $$250m offer, and other biotech financings

pharmaphorum

Our round-up of recent biotech financings is headed by a $250 million public offering for late clinical-stage biotech Vera Therapeutics, with an initial public offering (IPO) filed by CAR-T specialist Kyverna and private rounds for Eyconis, COUR Pharmaceuticals, Basking Biosciences, Enterprise Therapeutics, Halia Therapeutics and NeoPhore.

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Peeking Behind the Curtain: The Current State of Pharma 3PLs and Future Outlook

Pharmaceutical Commerce

Leading experts in the sector explore the value of third-party logistics providers when it comes to fortifying pharmaceutical supply chains.

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The PM Society Careers Conference

pharmaphorum

The PM Society are delighted to be running their fifth Careers Conference that will be taking place on the 21st of February 2024 between 1pm to 6pm at the Royal Society of Medicine. Please share with your colleagues and network, as this is a great opportunity for students to attend and learn more about our industry.

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New Report: How GoodRx Improves the Economics of Healthcare

Drug Channels

Today’s guest post comes from Divya Iyer, SVP of Go-to-Market Strategy at GoodRx. Divya shares highlights from GoodRx’s new research report: The GoodRx Effect: How GoodRx Improves the Economics of Healthcare. She highlights how GoodRx’s integrated pharma copay cards help to improve medication access, therapy adherence, and overall health outcomes. Click here to download the full report and learn more about partnering with GoodRx to drive patient access for your brand.

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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 sets date for Adaptimmune’s sarcoma drug verdict

pharmaphorum

The FDA is due to decide by 4th August whether to approve Adaptimmune’s afami-cel engineered T-cell therapy for advanced synovial sarcoma.

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Which pharmaceutical drugs have the most drug patents in Peru?

Drug Patent Watch

This chart shows the drugs with the most patents in Peru. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Peru? appeared first on DrugPatentWatch - Make Better Decisions.

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Global cancer burden study reveals ‘striking inequity’

pharmaphorum

The World Health Organization (WHO) has said that the burden of cancer on societies around the world is growing at an alarming rate, with a 77% increase in new cases expected by 2050, along with significant gaps in care.

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New patent for Abbvie drug UBRELVY

Drug Patent Watch

Annual Drug Patent Expirations for UBRELVY Ubrelvy is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent for Abbvie drug UBRELVY appeared first on DrugPatentWatch - Make Better Decisions.

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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.