Sciensano

MAY 31, 2024

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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Pharmaceutical Technology

MAY 31, 2024

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

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Bio Pharma Dive

MAY 31, 2024

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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Pharmaceutical Technology

MAY 31, 2024

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

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Bio Pharma Dive

MAY 31, 2024

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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Pharmaceutical Technology

MAY 31, 2024

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

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Development 130

Pharmaceutical Technology

MAY 31, 2024

Bristol Myers Squibb (BMS) has received FDA approval for Breyanzi to treat adults with relapsed or refractory mantle cell lymphoma.

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FDA Approval 130

Antidote

MAY 31, 2024

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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Research 119

Fierce Pharma

MAY 31, 2024

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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Trials 116

pharmaphorum

MAY 31, 2024

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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Fierce Pharma

MAY 31, 2024

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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Antibody Trials Regulation Drugs 115

pharmaphorum

MAY 31, 2024

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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Drugs 115

Intouch Solutions

MAY 31, 2024

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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Fierce Pharma

MAY 31, 2024

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

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Pharma Times

MAY 31, 2024

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

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Vaccination Vaccine Clinical Trials Clinical Trials 130

pharmaphorum

MAY 31, 2024

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

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Vaccination Vaccine FDA Approval Marketing 119

Pharma Times

MAY 31, 2024

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

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Research 123

pharmaphorum

MAY 31, 2024

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

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Trials Clinical Trials Clinical Trials 110

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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.

Clinical Trials

Drug Patent Watch

MAY 31, 2024

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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Drugs Branding Marketing 80

Fierce Pharma

MAY 31, 2024

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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Trials 59

Drug Patent Watch

MAY 31, 2024

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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Drugs Branding Marketing 80

Drug Discovery World

MAY 31, 2024

Jaguar Health’s out-licensing agreement with Magdalena Biosciences to develop novel, natural prescription medicines derived from plants for mental health indications, has been expanded. The agreement now includes the ethnobotanical know-how related to development of a prescription drug compound from a specified medicinal plant for possible schizophrenia and psychoses indications and for development with potential corporate partners.

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Licensing Licensing Drugs Medicine 59

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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

Clinical Research

Drug Patent Watch

MAY 31, 2024

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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Drugs Marketing 59

Pharmaceutical Commerce

MAY 31, 2024

The latest news for pharma industry insiders.

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Clinical Trials Clinical Trials Trials 104

pharmaphorum

MAY 31, 2024

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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Fierce Pharma

MAY 31, 2024

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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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.

Clinical Trials

Drug Discovery World

MAY 31, 2024

News round-up for 27-31 May by DDW Senior Digital Content Editor Diana Spencer. The selected news highlights this week report breakthrough findings from early phase research and development, mainly preclinical studies and Phase I clinical trials, including a drug that can prevent sepsis deaths, a microbiome based immuno-oncology candidate, and a plant-based therapy for diarrhoea.

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Drugs Clinical Trials Clinical Trials Trials 52

XTalks

MAY 31, 2024

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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Drug Channels

MAY 31, 2024

Today’s guest post comes from Jan Nielsen, Patient Solutions Division President at AssistRx. Jan discusses the challenges facing life sciences organizations’ patient support program reverification processes. Jan then highlights how the right vendor can help overcome these challenges for both pharmacy and medical benefit products. She offers real-world examples how of AssistRx implements these solutions for clients.

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Life Science Pharmacy Production Drugs 52

XTalks

MAY 31, 2024

Allecra Therapeutics, a clinical-stage biopharma company focused on combating antibiotic resistance, received approval from the US Food and Drug Administration (FDA) for Exblifep (cefepime/enmetazobactam). This novel combination antibiotic treatment is approved for complicated urinary tract infections (cUTIs), including pyelonephritis (a urinary tract infection when one or both kidneys become infected). “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the

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Bacteria FDA Approval Trials Pharma Companies 52

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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