Thu.Feb 13, 2025

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Panel recommends developing comprehensive long-term strategic plan for mental healthcare and research

AuroBlog - Aurous Healthcare Clinical Trials blog

Identifying a significant gap in the Ministry’s actions in addressing the funding and resource challenges in the premier mental health institutions, the Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended various measures including development of a comprehensive long-term strategic plan for mental healthcare, research and infrastructure development.

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A brain biotech launches with Roche’s spare parts

Bio Pharma Dive

Backed by Goldman Sachs, Novo Nordisk’s parent company and others, Newleos Therapeutics debuted Thursday with $94 million and a plan to develop drugs for brain function and health.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

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AbbVie and Xilio to collaborate on antibody-based immunotherapies

Pharmaceutical Technology

AbbVie has entered a partnership and option-to-license agreement with Xilio for tumour-activated, antibody-based immunotherapies.

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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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There’s Never Been a More Dangerous Time to Use Street Drugs. Here’s Why

AuroBlog - Aurous Healthcare Clinical Trials blog

In the early hours of September 14 2021, three men parked in a quiet car park in the southern English market town of Abingdon-on-Thames. The men, returning from a night out, had pulled over to smoke heroin.

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Neumora shakes up its C-suite; Biogen cuts early-stage pipeline

Bio Pharma Dive

Henry Gosebruch, Neumora’s CEO since 2023, will depart. Elsewhere, Biogen dropped two antisense drugs in a pipeline cull and Voyager hit a setback for its ALS gene therapy.

More Trending

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Sanofi to take $250M charge on study failure for E. Coli vaccine

Bio Pharma Dive

The French drugmaker said the vaccine it agreed to develop with Johnson & Johnson a year ago was “not sufficiently effective.

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SmartCella gains rights to advance cell therapy research for Parkinson’s

Pharmaceutical Technology

SmartCella has secured exclusive rights to advance research around cell replacement therapies for the treatment of Parkinson's.

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Illuccix therapy gets approval in the UK

Pharma Times

Imaging agent to improve prostate cancer detection

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US Government actions having a serious impact on global health, WHO chief says

Pharmaceutical Technology

Speaking publicly for the first time about the USAID freeze, WHO director-general Dr Tedros has asked the US to reconsider its position.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Kennedy confirmed as HHS Secretary

pharmaphorum

The US Senate today confirmed Robert F Kennedy Jr as Health and Human Services Secretary, after a vote that largely followed party lines.

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TriNetX and Fujitsu form JV to boost healthcare research in Japan

Pharmaceutical Technology

TriNetX has collaborated with Fujitsu to establish TriNetX Japan KK, a JV aimed at accelerating healthcare research and clinical trials.

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Andembry treatment approved across Europe

Pharma Times

Significant progress for hereditary angioedema condition

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Royalty Pharma pays $250m for rights to Biogen’s lupus drug

Pharmaceutical Technology

Royalty Pharma has signed a deal to pay Biogen $250m to support the development of its late-stage experimental lupus medication litifilimab.

Drugs 147
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Small study finds GLP-1 drug can curb excess alcohol use

pharmaphorum

Novo Nordisk's GLP-1 receptor agonist semaglutide has been shown to help people struggling with alcohol use disorder.

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Pharma Pulse 2/13/25: PwC Report Identifies Top Trends in Pharma, Counseling About Cannabis Use is Crucial & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Ex-DeepMind scientist launches drug discovery company

pharmaphorum

Another AI drug discovery venture has emerged from the Google DeepMind team, Latent Labs, with $50m in funding for its protein design platform.

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Building Confidence in CGT Innovation

Pharmaceutical Commerce

In the fourth part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, explains the value of FDA guidance documents for manufacturers, along with the areas of CGT development that would benefit most from standardization.

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Sanofi, J&J abandon trial of E coli vaccine after poor data

pharmaphorum

Johnson & Johnson and Sanofi's vaccine for preventing invasive disease caused by E coli looks all but defunct after they abandon a phase 3 trial

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Typeform Test

Trialfacts

The post Typeform Test appeared first on Trialfacts.

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FDA changes its mind on Astellas' geographic atrophy drug

pharmaphorum

Astellas has shored up the competitive profile of Izervay for eye disorder geographic atrophy, getting FDA approval for extended treatment.

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Aardvark prices $94.2m IPO to fund development of Prader-Willi syndrome drug

Pharmaceutical Technology

Aardvarks lead candidate ARD-101 is being investigated in a Phase III study for hyperphagia in Prader-Willi syndrome.

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Santhera's DMD drug poised for wider rollout in Germany

pharmaphorum

Santhera has agreed pricing and reimbursement for its Duchenne muscular dystrophy drug Agamree with German health funds representing 90% of patients.

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February 13, 2025: HCSRN Extends Early-Bird Registration Deadline for 2025 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2025 Annual Conference to February 28. The conference will be held from April 8 to 10 in St. Louis, Missouri. The theme of this year’s conference is “Optimizing Collaborations to Advance Health In a Dynamic Research Landscape.” The conference will provide networking opportunities to spur collaboration on research initiatives that improve health and healthcare for individuals a

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Defining, building, and implementing the next wave of biopharma R&D

pharmaphorum

In this podcast interview, learn about defining, building, and implementing strategies in the next wave of biopharma R&D. Stay informed and gain valuable insights from industry experts.

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MedTech M&As in 2025: A Roundup

XTalks

MedTech M&As in 2025 featured an array of transactions from acquisitions that bolster interventional systems and digital testing capabilities to strategic moves in manufacturing and specialized equipment that underscore the sector’s commitment to advancing technology and operational excellence. Stay tuned for Xtalks monthly updates on M&As across the MedTech sector, with the next installment covering March 2025, as we continue to track and analyze emerging trends in MedTech M

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RFK Jr. confirmed by Senate as health secretary

Bio Pharma Dive

All but one Senate Republican voted for Kennedy, a controversial vaccine critic who used a crusade to "Make America Healthy Again" to win one of the most powerful jobs in Washington.

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The Role of Partnerships in Generic Drug Development

Drug Patent Watch

The Unsung Heroes of Generic Drug Development: The Power of Partnerships As we navigate the complex landscape of pharmaceuticals, it's easy to overlook the crucial role that partnerships play in bringing affordable, life-saving medications to market. But the truth is, partnerships are the backbone of generic drug development, and their impact cannot be overstated.

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KalVista Shares New Data on Sebetralstat for Hereditary Angioedema (HAE)

XTalks

The findings shed light on patient adherence to long-term prophylaxis (LTP) treatments for hereditary angioedema (HAE) and highlight sebetralstats efficacy as an on-demand therapy. Dr. Raffi Tachdjian of UCLA presented a US commercial claims analysis revealing that nearly 40% of HAE patients initiating LTP experienced significant gaps in prescription refills over a 12-month period, with more than half discontinuing LTP altogether.

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The continued evidence of AI’s drug discovery value

Drug Discovery World podcast

This is the latest episode of the free DDW narrated podcast, titled The continued evidence of AIs drug discovery value, which covers two articles written for DDW Volume 24 Issue 2, Spring 2023 of DDW. They are called: How generative AI could improve drug discovery and Can artificial intelligence help craft new medicines? Absci is a generative artificial intelligence (AI) drug creation company with goals of bringing better biologics to patients more quickly.

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Trump presidency signals potential downturn in NIH SBIR/STTR grant funding for biopharma drugs

Pharmaceutical Technology

US President Donald Trump kicked off his second term with a series of directives aimed at the US National Institutes of Health (NIH), signalling headwinds in securing NIH grant funding for biopharmaceutical research and development (R7D).

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FDA Approves Gomekli as First NF1 Treatment for Adults & Children

XTalks

The FDA has granted approval to SpringWorks Therapeutics Gomekli (mirdametinib) for the treatment of adult and pediatric patients aged two years and older with neurofibromatosis type 1 (NF1). NF1 is a rare genetic disorder characterized by the development of tumors along nerves in the skin, brain and other parts of the body. According to SpringWorks, in the US, the disease affects approximately 100,000 children and adults.

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Trump Enacts Reciprocal Tariffs on Trading Partners

Pharmaceutical Commerce

These taxes on goodswith the potential to take effect in weeks or monthswill vary by country, but rates could depend on regulations, industry subsidies, and other factors.

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Grand Rounds February 7, 2025: Improving Symptom Control in Pediatric Cancer Patients With SSPedi and SPARK (Lillian Sung, MD, PhD)

Rethinking Clinical Trials

Speaker Lillian Sung, MD, PhD Canada Research Chair in Pediatric Oncology Supportive Care Division of Haematology/Oncology Chief Clinical Data Scientist The Hospital for Sick Children Ontario, Canada Slides Keywords Cancer; Pediatrics; Cancer Symptoms; Symptom Control Key Points Symptom control in pediatric cancer patients is very poor; almost all children undergoing treatment for cancer will experience difficult symptoms, including fatigue, changes in hunger, pain, and n

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