Fri.May 31, 2024

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Despite decline: one death per hour due to smoking in Belgium

Sciensano

Each year, over 9,000 people die in Belgium as a result of smoking. These are the latest findings from Sciensano, Belgium’s public health institute. This represents one death every hour. Despite a clear decreasing trend in the number of smoking-related deaths, inequalities persist, with a greater impact among men and in Brussels and Wallonia. On World No Tobacco Day, Sciensano wants to draw more attention to the consequences of smoking.

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FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Pharmaceutical Technology

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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FDA staff outline shortcomings of Lykos data for MDMA therapy

Bio Pharma Dive

Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.

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European Commission approves Biogen’s QALSODY for ALS treatment

Pharmaceutical Technology

The EC has approved Biogen's QALSODY to treat adults with amyotrophic lateral sclerosis (ALS) linked to SOD1-ALS mutation.

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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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FDA delays decision on Dupixent in COPD; Summit makes a bold claim

Bio Pharma Dive

Regeneron and Sanofi now expect an FDA verdict in September. Elsewhere, Summit claimed victory over Keytruda and Neurocrine’s longtime CEO revealed plans to step down.

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Moderna, with FDA nod for RSV vaccine, grows reach beyond the pandemic

Fierce Pharma

With the FDA nod, Moderna's RSV vaccine becomes the company's second product to secure the FDA's backing.

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More Trending

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ASCO: In surprise, J&J's injectable Rybrevant extends lung cancer patients' lives versus intravenous version

Fierce Pharma

When companies introduce an injectable version of an intravenously infused drug, better convenience with comparable efficacy is typically the goal. | When companies introduce an injectable version of an intravenously infused drug, better convenience with comparable efficacy is typically the goal. But to Johnson & Johnson’s surprise, a subcutaneous formulation of its lung cancer med Rybrevant proved to work better than the original infusion.

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Midland Pharmaceuticals launches to advance spinal injury therapeutics

Pharmaceutical Technology

Midland Pharmaceuticals has launched to focus on the development of a therapeutic for spinal cord injury and cerebrovascular disease.

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NHS platform announced to accelerate personalised cancer vaccine clinical trials

Pharma Times

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

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On National Cancer Survivors Day, celebrating the power of research

Antidote

This Sunday, June 2, is National Cancer Survivors Day , designed to be a celebration for those who have survived cancer and an inspiration for those recently diagnosed. Since 1991, the national cancer death rate has dropped by 33% , partially due to advancements in treatment, early detection, and reduced smoking rates.

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

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Moderna gets FDA okay for RSV vaccine mResvia

pharmaphorum

Moderna has secured FDA approval for its RSV vaccine, setting up a three-way market battle with GSK and Pfizer.

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ASCO: Bristol Myers' confirmatory KRAS data avoid Amgen's flaws but still leave FDA prospects unclear

Fierce Pharma

After Amgen’s KRAS confirmatory trial results were rejected by the FDA as uninterpretable, Bristol Myers Squibb has divulged details of its rival study. | Bristol Myers Squibb has divulged the details of Krazati's confirmatory trial. While the study doesn't share the same design problems as Amgen's rival KRAS program, it still leaves open questions about Krazati's regulatory outlook.

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The Crick announces new partnerships with SMEs and MRC for research

Pharma Times

The projects will focus on a range of research areas, including Down’s syndrome and ALS

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Summit, Akeso's antibody triumphs over Keytruda in China lung cancer trial, sending shares skyrocketing

Fierce Pharma

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival over Keytruda monotherapy.

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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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This week in clinical trials – 27th to 31st May

pharmaphorum

Stay updated with the latest clinical trials news from 27th to 31st May, featuring companies like Arcturus Therapeutics, AZ, Vesper Bio, Ultragenyx, and Incannex. Get insights into their latest developments and advancements in the field.

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Celebrating Asian American, Native Hawaiian and Pacific Islander (AANHPI) Heritage Month

Intouch Solutions

EVERSANA INTOUCH takes pride in championing its employees. This month, we recognized and celebrated Asian American, Native Hawaiian and Pacific Islander (AANHPI) Heritage Month. Employees participated in various activities to spread awareness and honor AANHPI cultures. Jasmine Abraham, Account Supervisor, explained why celebrating AANHPI Heritage Month at EVERSANA INTOUCH is important.

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ASCO: Novartis’ Scemblix aces first-line CML study

pharmaphorum

Novartis’ Scemblix could be headed for first-line use in chronic myeloid leukaemia after outperforming TKI drugs in the ASC4FIRST study presented at ASCO.

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Pharma Pulse 5/31/24: Gen Z’s Passion for Skincare Falls Short on Sun Protection, A Long, But Promising Road Ahead in Clinical Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gilead’s Trodelvy woes rise with failed bladder cancer trial

pharmaphorum

Gilead's TROP2 ADC Trodelvy has missed the target in another clinical trial, this time in urothelial carcinoma.

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New tentative approval for MSN 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… Source

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Fierce Pharma Asia—Takeda plots US layoffs; AZ, Daiichi suffer trial setback; Asahi Kasei strikes buyout deal

Fierce Pharma

Takeda is planning more than 600 layoffs in Massachusetts. AstraZeneca and Daiichi Sankyo's Dato-DXd failed to show an overall survival benefit in a lung cancer study. | Takeda is planning more than 600 layoffs in Massachusetts. AstraZeneca and Daiichi Sankyo's Dato-DXd failed to prove an overall survival benefit in a lung cancer study. Japan's Asahi Kasei is moving to buy rare disease drugmaker Calliditas for about $1 billion.

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New tentative approval for Annora Pharma drug brivaracetam

Drug Patent Watch

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms and, and is included in seven NDAs.

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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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Sterling Pharma Solutions to Invest $3 Million in Germantown, WI Plant

Pharmaceutical Commerce

Financial commitment will go toward expanding the CDMO’s integrated antibody-drug conjugate services.

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Which pharmaceutical drugs have the most drug patents in Czech Republic?

Drug Patent Watch

This chart shows the drugs with the most patents in Czech Republic.

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Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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New patent for Maia Pharms drug ANGIOMAX RTU

Drug Patent Watch

Annual Drug Patent Expirations for ANGIOMAX+RTU Angiomax Rtu is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from three suppliers.

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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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Good news in Europe, bad news in US for Sanofi and Regeneron's COPD bid for Dupixent

Fierce Pharma

A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding | A highly anticipated decision on Sanofi and Regeneron’s Dupixent to become the first biologic to treat chronic obstructive pulmonary disorder (COPD) is on hold in the United States but is speeding along in Europe.

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New patent for Sun Pharm drug WINLEVI

Drug Patent Watch

Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier.

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Healthcare HR: Addressing Key Risks in 2024

XTalks

Mercer and Marsh recently released its “ 2024 People Risk Report ,” which highlights critical areas for healthcare HR professionals. Understanding and addressing these risks is paramount as healthcare organizations navigate evolving challenges. Let’s delve into why these points are crucial for healthcare HR professionals, ensuring resilient and effective management of workforces.

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Overcoming AMR market failure: Three start-up stories

pharmaphorum

As AMR spreads globally, innovative startups are racing to develop solutions. Learn how Revagenix, LimmaTech and Lumen are using novel approaches to overcome AMR market failure.

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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.