Thu.Sep 26, 2024

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How to Conduct Effective Generic Drug Market Analysis

Drug Patent Watch

The generic drug market is a complex and dynamic environment where multiple factors influence the availability, quality, and pricing of generic drugs. Conducting an effective market analysis is crucial for pharmaceutical companies, policymakers, and healthcare professionals to understand the market dynamics and make informed decisions.

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Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

Bio Pharma Dive

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

Drugs 334
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Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services 

Pharmaceutical Technology

West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.

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Arch raises another $3B biotech fund in pursuit of ‘coolest’ new science

Bio Pharma Dive

Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.

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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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Some Coffee And Tea Drinkers Could Be Lowering Their Risk of Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

(juanma hache/Getty Images) A new study has investigated whether drinking coffee or tea can reduce the risk of developing dementia, and the findings help explain some murky past results. Researchers at Ningxia Medical University in China have found that some coffee or tea drinkers are lowering their risk of dementia.

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Pfizer to pull sickle cell drug from market, shut down trials

Bio Pharma Dive

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.

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More Trending

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Lawmakers call for investigation of former FDA device director

Bio Pharma Dive

The letter follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

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Union plans Phase III trial for atopic dermatitis after Phase IIb win

Pharmaceutical Technology

The company has also reported positive data for PDE4 inhibitor, orismilast, in psoriasis, hidradenitis suppurativa, and ulcerative colitis.

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Oxford drug design secures funding to combat cystic fibrosis lung infections

Pharma Times

£3m programme to accelerate new antimicrobial treatment

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Boehringer Ingelheim opens $66.8m new cancer research facility

Pharmaceutical Technology

The Angelika Amon research building will house 150 employees across 11 floors researching cancer therapies.

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

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Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

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How can the UK’s Labour government transform health and care?

Pharmaceutical Technology

Lord Darzi’s independent report of the NHS and the Labour conference in Liverpool got leaders at HETT 2024 to discuss the UKs healthcare sector.

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Sheffield A&E to implement life-saving HIV and hepatitis testing

Pharma Times

New government scheme to offer routine opt-out blood tests

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MHLW approves MSD’s KEYTRUDA for lung and urothelial cancers

Pharmaceutical Technology

The Japanese MHLW has granted approval for MSD’s KEYTRUDA (pembrolizumab) for lung and urothelial cancer indications.

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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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AstraZeneca’s Tagrisso follows up ASCO standing ovation with key lung cancer FDA nod

Fierce Pharma

In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tag | In June at the ASCO conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer blockbuster Tagrisso, the presentation received a standing ovation.

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Orion and Aitia partner for AI-driven oncology drug discovery

Pharmaceutical Technology

Orion has entered a partnership with Aitia to leverage artificial intelligence in drug discovery and simulation in the oncology field.

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Vicebio raises $100m for vaccines and other bio financings

pharmaphorum

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

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Pfizer to withdraw sickle cell treatment OXBRYTA from market

Pharmaceutical Technology

Pfizer has announced the withdrawal of all lots of OXBRYTA approved for treating sickle cell disease (SCD) from worldwide markets.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MSD hits a hurdle with its LAG-3 programme

pharmaphorum

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

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AskBio and Belief BioMed partner to advance gene therapies

Pharmaceutical Technology

AskBio has entered a strategic partnership with China-based Belief BioMed (BBM) to advance the development of new gene therapies.

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AZ gets sought-after lung cancer approval for Tagrisso

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

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Roche looks to grow Gazyva's reach with phase 3 lupus nephritis win

Fierce Pharma

After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur

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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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Mirai Bio launches with plan to help genetic med developers

pharmaphorum

Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.

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World Heart Day 2024: Use Heart for Action

XTalks

September 29 is World Heart Day 2024, an initiative by the World Heart Federation to raise awareness about cardiovascular diseases (CVDs) and the importance of heart health. As one of the leading causes of death globally, CVDs claim over 20 million lives each year. Despite this, many countries fail to prioritize heart health, with national strategies often lacking or entirely absent.

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Obesity drug developer BioAge raises $198m in IPO

pharmaphorum

BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.

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Bristol Myers Squibb's Karuna buyout pays off with FDA approval for novel schizophrenia med Cobenfy

Fierce Pharma

After decades of stagnation in the schizophrenia field, Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a promising new drug. | Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a promising new schizophrenia drug.

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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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Second Niemann-Pick approval brings more hope to patients

pharmaphorum

IntraBio claims FDA approval for its Aqneursa therapy for Niemann-Pick type C, the second new drug for the disease in four days

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Oncology expert reveals the impact of biomarker testing on the outcomes of targeted therapies for cancer

BioPharma Reporter

David Carbone, Director of the James Thoracic Oncology Center and Professor of Internal Medicine at The Ohio State University Comprehensive Cancer Center, has dedicated his career to researching and treating lung cancer, with over 300 scientific publications on topics including lung cancer genetics, cancer immunotherapy and tumor-associated immunosuppression mechanisms.

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Part 1: Accelerating the medical, legal and regulatory (MLR) review leveraging AI

pharmaphorum

Discover how AI is revolutionising the medical, legal, and regulatory review process in the first part of this series. Explore the benefits and strategies for accelerating MLR review.

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Pfizer withdraws sickle cell disease drug Oxbryta amid safety concerns

Outsourcing Pharma

The US big pharma company Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinical trials of the drug as data indicate a high risk of severe adverse events.

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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.