Fierce Pharma

SEPTEMBER 25, 2023

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

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FDA 277

MedCity News

SEPTEMBER 25, 2023

Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.

Manufacturing 115

Manufacturing FDA Biopharma Pharma 115

Fierce Pharma

SEPTEMBER 25, 2023

After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug unt | Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight.

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Distribution Sales Patients 259

MedCity News

SEPTEMBER 25, 2023

Novo Nordisk is paying Valo Health $60 million up front to gain three preclinical cardiovascular disease programs. Milestone payments for those programs and others covered under the artificial intelligence drug discovery pact could reach up to $2.7 billion.

Biopharma 114

Biopharma Pharma 114

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Distribution

Fierce Pharma

SEPTEMBER 25, 2023

While GSK’s Arexvy was first out the gate in this summer’s respiratory syncytial virus (RSV) vaccine race, Pfizer has kept the pressure up with its rival shot Abrysvo. | While GSK’s Arexvy was first out the gate in this summer’s respiratory syncytial virus (RSV) vaccine race, Pfizer has kept the pressure up with its rival shot Abrysvo. Now, as the RSV season creeps up, Pfizer’s vaccine has received a formal endorsement from the CDC to be used during pregnancy to protect infants.

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MedCity News

SEPTEMBER 25, 2023

Issues around healthcare affordability, mental health challenges and worsening chronic conditions are all top of mind for Ellen Kelsay, president and CEO of Business Group on Health.

Healthcare 108

Healthcare Healthcare 108

MedCity News

SEPTEMBER 25, 2023

The Supreme Court’s recent summer decision in Health and Hospital Corporation of Marion County, Indiana, et al. v. Talevski has raised the stakes for nursing homes by ruling that private litigants may bring civil claims against facilities to recover damages for violations of certain provisions of the Federal Nursing Home Reform Act (FNHRA). This decision provides powerful incentives for nursing homes and other facilities subject to the FNHRA to enhance their monitoring and compliance processes.

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Fierce Pharma

SEPTEMBER 25, 2023

In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. | In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing is starting back up. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.

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Manufacturing 214

MedCity News

SEPTEMBER 25, 2023

Although employee stress and burnout are critical issues in all industries, the healthcare industry offers numerous examples of the impact on staff as well as ways to provide short and long-term solutions. These topics will be part of the discussion at the HLTH event October 8-11 in Las Vegas. Register today to join the conversation!

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Healthcare Healthcare 105

Fierce Pharma

SEPTEMBER 25, 2023

GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26

Manufacturing 239

Manufacturing 239

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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.

Safety

MedCity News

SEPTEMBER 25, 2023

A new study found that MA beneficiaries have more than 50% fewer inpatient stays and 22% fewer emergency department visits than traditional Medicare enrollees.

Medical 105

Medical 105

Fierce Pharma

SEPTEMBER 25, 2023

The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. | The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. Now, the FDA found a fresh problem at a clinical trial site for Coherus’ Junshi Biosciences-partnered toripalimab.

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FDA 177

European Pharmaceutical Review

SEPTEMBER 25, 2023

Nuclear magnetic resonance (NMR) relaxation techniques traditionally used in the food and chemical industries are becoming more relevant to pharmaceutical applications as well. The measured relaxation rate constants resulting from fast chemical exchange between water and exposed NH and OH protons on proteins can be selective to biologics. This has led to applications with biopharmaceutical formulations and protein investigations.

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Pharmaceutical Manufacturing Food Electronics 96

Fierce Pharma

SEPTEMBER 25, 2023

A who’s who of biopharma companies have backed a push to rai | A who’s who of biopharma companies have backed a push to raise awareness about lung cancer among Hispanic and Latino Americans, funding a project that has enlisted a Mission: Impossible star to educate the community about risk factors, early warning signs and screening.

Biopharma 180

Biopharma Education Pharma 180

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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

Distribution

European Pharmaceutical Review

SEPTEMBER 25, 2023

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. Specifically, it described how ERP systems clarify every aspect of operations in a business for drug serialisation compliance. The authors highlighted that this is helpful when setting up infrastructure to implement drug track and trace systems.

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Pharmaceutical Pharmacology Safety Manufacturing 94

PharmaVoice

SEPTEMBER 25, 2023

Despite high rates of disease in older populations, systemic issues are keeping them out of research studies.

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PharmaTech

SEPTEMBER 25, 2023

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

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Manufacturing 98

European Pharmaceutical Review

SEPTEMBER 25, 2023

The European Commission (EC) has approved TEVIMBRA ® (tislelizumab) as monotherapy for adults with oesophageal cancer. The humanised IgG4 anti-PD-1 antibody is indicated for unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurren

Food and Drug Administration 91

Food and Drug Administration Manufacturing Safety Medicine 91

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Safety

PharmaTimes

SEPTEMBER 25, 2023

Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes

Patients 117

Patients 117

European Pharmaceutical Review

SEPTEMBER 25, 2023

Novartis’ Phase III NETTER-2 trial for its radioligand therapy ( RLT ) Lutathera ® (INN: lutetium ( 177 Lu) oxodotreotide /lutetium Lu 177 dotatate) has demonstrated an ability to offer significant improvement in progression-free survival (PFS) in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The radioligand therapy is the first to demonstrate clinically meaningful benefit in a first line setting” As a first line treatment, in combination with long-acting octreotide, Lutathera

Manufacturing 88

Manufacturing Patients Medical Pharmaceutical 88

PharmaTimes

SEPTEMBER 25, 2023

Trial involves the use of Padcev and Keytruda among patients with certain types of urothelial cancer - News - PharmaTimes

Patients 102

Patients 102

PM360

SEPTEMBER 25, 2023

Life sciences professionals can now easily and quickly obtain industry payments to any healthcare professional (HCP) in the U.S. by simply entering their National Provider Identifier (NPI) into a newly launched ChatGPT plugin from Klick Health. Built on OpenAI, KlickRx ChatGPT is the first ChatGPT plugin available for life sciences companies in the U.S.

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Medical Media Competition Healthcare 75

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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.

Specialization

Pharmaceutical Technology

SEPTEMBER 25, 2023

Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.

Medical 84

Medical 84

Pharmaceutical Commerce

SEPTEMBER 25, 2023

CDMO purchases branded sachet-packaging machine for commercial manufacturing.

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Manufacturing 105

PharmaVoice

SEPTEMBER 25, 2023

Scientific discovery through new, breakthrough modalities is essential to solve current and future global health challenges – but the path is not easy nor well-defined.

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PharmaTech

SEPTEMBER 25, 2023

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Patients 52

Patients 52

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

LEVO Health

SEPTEMBER 25, 2023

Medical information is often dense and inaccessible. The intricate jargon, overwhelming details, and frequently changing best practices can make healthcare topics challenging to decode. Fortunately, explainer videos provide a powerful tool to simplify large swathes of medical information quickly and easily. They are transforming the way decisions are made in healthcare by breaking down healthcare complexities into digestible, visual content.

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Medical Education Healthcare Healthcare 52

Pharmacy Times

SEPTEMBER 25, 2023

Physical symptoms of burnout can include headaches, digestive problems, sleep disturbances, and increased susceptibility to illnesses due to a weakened immune system.

Management 66

Management 66

PharmaVoice

SEPTEMBER 25, 2023

In today’s Biopharma landscape, considering Gross-to-Net is essential for effectively designing and optimizing patient support programs.

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Biopharma Patients 52

Pharmacy Times

SEPTEMBER 25, 2023

For community pharmacists, cooler temperatures, school buses on the roads and Friday night football are not just signs of a changing season – they are indicators that patients will soon be seeking vaccinations for the 2023-2024 respiratory illness season.

Patients 59

Patients 59

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management