Mon.Jan 22, 2024

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Karuna, Cerevel might be just the start of psychiatry drug M&A

Bio Pharma Dive

New details of the proposed acquisitions show there were multiple interested buyers, which, according to some analysts, could set the stage for more dealmaking.

Drugs 320
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Sandoz to acquire Coherus’ CIMERLI ophthalmology franchise

Pharmaceutical Technology

Sandoz has agreed to acquire Coherus Biosciences' CIMERLI ophthalmology franchise, including proprietary software.

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Gilead ADC medicine misses goal in closely watched lung cancer study

Bio Pharma Dive

Trodelvy didn’t outperform chemotherapy in a large study of people with a common lung tumor, a setback that sent company shares down by double digits.

Medicine 305
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UK NICE recommends Pfizer’s talazoparib for advanced breast cancer

Pharmaceutical Technology

The UK NICE recommends Pfizer's talazoparib, marketed as Talzenna, to treat a specific type of locally advanced or metastatic breast cancer.

Marketing 245
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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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Scientists Think They’ve Figured Out How Cannabis Triggers The Munchies

AuroBlog - Aurous Healthcare Clinical Trials blog

Neuroscientists at Washington State University think they have figured out why cannabis is so notorious for causing the ‘munchies’ among users. Their research on mice is the first to investigate how cannabis impacts the real-time activity of brain regions that control appetite.

Scientist 238
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Bladder cancer-focused CG Oncology files for IPO

Pharmaceutical Technology

On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.

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More Trending

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FDA grants fast track status to Kyverna’s multiple sclerosis therapy

Pharmaceutical Technology

The US FDA has granted fast track designation to Kyverna Therapeutics’ KYV-101 for the treatment of multiple sclerosis (MS).

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Ionis says rare disease drug succeeds in late-stage HAE study

Bio Pharma Dive

The medicine, called donidalorsen, reduced hereditary angioedema-related attacks in the Phase 3 trial. Several competing options to it are already available or in advanced testing, however.

Medicine 182
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IISc develops heat-tolerant vaccine for protection against different strains of SARS-CoV-2 & future variants

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Institute of Science (IISc) is now developing a heat-tolerant vaccine that can offer protection against different strains of SARS-CoV-2 – both current and future variants. The researchers have proved that their vaccine candidate is effective against all current strains of SARS-CoV-2 and can be quickly adapted for future variants as well.

Vaccine 181
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Processa shoots for breast cancer label expansion for capecitabine combo

Pharmaceutical Technology

Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.

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

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January 22, 2024: Your Pragmatic Trial Has Ended. Now What?

Rethinking Clinical Trials

What happens to a pragmatic trial intervention after the study ends? In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program's completed pragmatic clinical trials summarize the posttrial interpretation of their trials' results and consider the factors that influenced the sustainment or de-implementation of the studies' interventions.

Trials 162
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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

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NHS catch up campaign launched for missed MMR vaccines

Pharma Times

Approximately one in five children will be hospitalised to treat measles

Vaccine 135
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Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

Fierce Pharma

Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.

Antibody 139
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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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Bayer in artificial intelligence: theme innovation strategy

Pharmaceutical Technology

How many patents did Bayer submit related to artificial intelligence last quarter, and how many were granted? Discover the latest information here.

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Eli Lilly's troubled NJ manufacturing site in hot water again over maintenance, quality control lapses

Fierce Pharma

Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Food and Drug Administration’s crosshairs, Reuters first reported. | Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance.

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F. Hoffmann-La Roche in cybersecurity: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to cybersecurity last quarter, and how many were granted? Discover the latest information here.

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Sandoz makes its first post-spinout acquisition

pharmaphorum

Sandoz makes its first acquisition since spinning out of Novartis, buying a Lucentis biosimilar from Coherus that will boost its position in the US market.

Marketing 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A ‘sense of urgency’ swirls in the UK pharma regulatory landscape

Pharmaceutical Technology

The UK government adopted a series of updates to pharmaceutical laws, governing the medication landscape in 2023.

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Legislative Proposals to Tackle Improper Pharmaceutical Patents in the Orange Book

Drug Patent Watch

A recent article published in Health Affairs, delves into the Federal Trade Commission’s (FTC) concerns regarding the inclusion of improper patents in the FDA’s Orange Book by pharmaceutical manufacturers. The… The post Legislative Proposals to Tackle Improper Pharmaceutical Patents in the Orange Book appeared first on DrugPatentWatch - Make Better Decisions.

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NS Pharma gains EC orphan drug designation to treat EGPA

Pharmaceutical Technology

NS Pharma has received orphan drug designation from the European Commission for NS-229 for eosinophilic granulomatosis with polyangiitis.

Drugs 130
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Pharma waste management: Balancing cost, compliance, and environmental responsibility

pharmaphorum

Pharma waste management is crucial for balancing cost, compliance, and environmental responsibility in the healthcare industry. Explore strategies and best practices for effectively managing pharmaceutical waste, while ensuring regulatory compliance and minimising environmental impact.

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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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Obesity drugs could fuel the next pharma CMO gold rush

Pharmaceutical Technology

Obesity drugs are in such high demand in developed markets that there is a shortage of Novo Nordisk’s Wegovy and Ozempic, and Eli Lilly’s Mounjaro and Trulicity,

Drugs 130
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J&J's Balversa gets mixed approval in bladder cancer as FDA ratchets up scrutiny on subgroup data, patient survival

Fierce Pharma

When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand. | When the FDA converts an accelerated approval into a full nod, it's typically associated with a wider label for the drug at hand. But in the case of Johnson & Johnson’s Balversa, the FDA narrowed the use of the first-in-class bladder cancer drug in two ways and expanded it in another.

Drugs 110
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NHS to ramp up MMR vaccine drive amid surging measles cases in England

Pharmaceutical Technology

More than 3.4 million children are unprotected against the disease, as NHS urges more people to book missed MMR vaccinations.

Vaccine 130
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Virtual reality training to help NHS doctors spot signs of sepsis

Pharma Times

Approximately 48,000 deaths in the UK occur from sepsis every year

Doctor 109
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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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OSE shares pipeline updates and plans Phase III trial for Tedopi

Pharmaceutical Technology

The French company will start the confirmatory trial for its cancer vaccine Tedopi as a second-line lung cancer therapy in Q2 2024.

Trials 130
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Roche ducks out of AC Immune Alzheimer antibody alliance

pharmaphorum

End of the line for Roche’s 18-year alliance with Swiss biotech AC Immune, as it returns rights to Alzheimer's antibodies crenezumab and semorinemab

Antibody 106
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At least three oncology 2023 brand launches have blockbuster potential

Pharmaceutical Technology

An analysis of GlobalData’s analyst consensus sales and forecast database reveals that three out of 12 novel oncology brands that launched globally from November 2022 to December 2023 have the potential to reach blockbuster sales.

Branding 130
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Next stage in GSK’s Zantac defense gets underway today

pharmaphorum

A hearing will get underway in Delaware later today in the latest phase of GSK’s attempts to defend itself from allegations that its Zantac drug caused cancer in patients.

Drugs 105
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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.