Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

FDA 145

FDA 145

Fierce Pharma

JUNE 20, 2024

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

FDA 359

FDA 359

David Bagga

JUNE 20, 2024

Medical Device Sales Academy 6 Steps for Success in the Medical Sales Field The medical representative works to deliver the company’s ideas and messages to the healthcare reps in the most efficient, understandable, and intelligible way. The best way to help improve their service is to provide all necessary information, equipment, and opportunities to enhance […] The post 6 Steps for Success in the Medical Sales Field appeared first on.

Medical sales 130

Medical sales Medical Sales Healthcare 130

MedCity News

JUNE 17, 2024

Two senators recently introduced a bill that seeks to regulate private equity firms’ involvement in the healthcare industry. If passed, the act would establish a criminal penalty of up to six years in prison for private equity executives whose business decisions result in a patient’s death. The post If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement appeared first on MedCity News.

Healthcare 139

Healthcare Healthcare 139

Advertisement

PharmaVoice

JUNE 18, 2024

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

Pharma 119

Pharma Consulting 119

Fierce Pharma

JUNE 18, 2024

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Safety 364

Safety 364

MedCity News

JUNE 21, 2024

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top biologics official, reviewed the same data and reached a different conclusion. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

FDA 122

FDA Biopharma Pharma 122

Impetus Digital

JUNE 17, 2024

A version of this article was previously published in the Journal of mHealth. The days of cookie-cutter medical education sessions and unengaging, didactic data presentations are–mostly–over. These days, medical education and training programs are all about customization, personalization, and innovation. In this article, we take a look at 10 of the hottest trends in medical education and learning programs. 1.

Education 108

Education Medical Media Training 108

Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

FDA 310

FDA 310

European Pharmaceutical Review

JUNE 20, 2024

Researchers have developed a novel, gloveless intervention method with remote robotic interventions for high-speed pharmaceutical isolator filling lines. While these high-speed lines are currently fully automated, Dekker et al. noted that operator interventions are still done manually. For example, a common intervention is the removal of erroneous plungers or stoppers.

Pharmaceutical 105

Pharmaceutical Manufacturing 105

Advertisement

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

JUNE 16, 2024

Palliative care provided by video was equivalent to in-person visits with a clinician, according to study results presented during the recent annual meeting of the American Society of Clinical Oncology. Investigators say these results indicate telehealth can make palliative care accessible to more cancer patients. The post Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study appeared first on MedCity News.

Patients 120

Patients Biopharma 120

pharmaphorum

JUNE 18, 2024

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

FDA 99

FDA 99

Fierce Pharma

JUNE 20, 2024

Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.

Sales 295

Sales Medical 295

European Pharmaceutical Review

JUNE 18, 2024

The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Merck (MSD outside of the US and Canada)’s KEYTRUDA (pembrolizumab) is authorised alongside treatment with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, for these patients.

Food and Drug Administration 105

Food and Drug Administration Patients Food Medicine 105

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

MedCity News

JUNE 20, 2024

Under the Affordable Care Act, most private health insurance plans are required to cover birth control methods approved by the FDA without out-of-pocket costs. But not all plans are doing this, Bernie Sanders declared in a letter. The post Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage appeared first on MedCity News.

Insurance 112

Insurance FDA 112

Scott Burrows

JUNE 18, 2024

In the dynamic world of business, how we approach challenges can define our path to success. Instead of being bogged down by adversity, we have the power to transform it into opportunity simply by changing the way we ask questions. From “Why” to “What” During tough times, it’s natural to ask ourselves, “Why is this happening to us?

Management 98

Management Leads Marketing 98

Fierce Pharma

JUNE 20, 2024

There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

FDA 290

FDA Patients 290

European Pharmaceutical Review

JUNE 21, 2024

Gilead Sciences ’ twice-yearly injectable HIV-1 capsid inhibitor enabled 100 percent efficacy for investigational use of HIV prevention in cisgender women. This is according to interim analysis topline results of the Phase III PURPOSE 1 trial. Lenacapavir showed superiority to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

Safety 98

Safety Medical Pharmaceutical 98

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

MedCity News

JUNE 20, 2024

A proactive cybersecurity stance can maintain the integrity of healthcare, ensuring that care remains both continuous and secure. The post Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks appeared first on MedCity News.

Patients 106

Patients Healthcare Healthcare 106

Pharmaceutical Technology

JUNE 18, 2024

Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.

FDA 113

FDA 113

Fierce Pharma

JUNE 18, 2024

While AstraZeneca’s Truqap bears the distinction of being the first AKT inhibitor to pass muster with the U.S. | In the late-stage CAPItello-290 study, Truqap plus the chemotherapy paclitaxel failed to help extend the lives of patients with locally advanced or metastatic triple-negative breast cancer (TNBC) over paclitaxel and placebo alone, AstraZeneca said Tuesday.

Patients 286

Patients 286

European Pharmaceutical Review

JUNE 20, 2024

Small molecule drugs have been a critical part of the pharmaceutical toolbox for over a century. Most can be taken orally and pass through cell membranes to reach intercellular targets, however, recent advancements in areas such as AI and machine learning have seen the potential for new small molecule-based therapeutics grow exponentially. One example of this is Takeda’s small molecule drug, fruquintinib, which has been shown to be an effective treatment for heavily pretreated metastatic colorec

Medicine 98

Medicine Patients Pharmaceutical Marketing 98

Advertisement

Distribution

MedCity News

JUNE 16, 2024

During a fireside chat at AHIP 2024, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, said she sees a bright future for retail in healthcare. The post Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare appeared first on MedCity News.

Retail 107

Retail Healthcare Healthcare 107

pharmaphorum

JUNE 20, 2024

AbbVie’s Skyrizi is approved by the FDA for ulcerative colitis, making it the first IL-23 inhibitor indicated for both major types of inflammatory bowel disease.

FDA 102

FDA 102

Fierce Pharma

JUNE 20, 2024

In May, Johnson & Johnson touted the success of its intraven | After touting the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease, Johnson & Johnson has shown the success of a subcutaneous (SC) version of Tremfya in another Crohn's disease study.

280

280

European Pharmaceutical Review

JUNE 19, 2024

A non-chemotherapy multi-drug therapy enabled complete remission in 38 percent of evaluable patients with aggressive B-cell lymphoma, a Phase Ib/II clinical trial shows. This was observed in individuals who had experienced a return of their cancer or who were unresponsive to standard treatments. Venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR) were used together in a treatment regimen in 50 patients with diffuse large B-cell lymphoma (DLBCL).

Side effects 98

Side effects Patients Medicine Pharmaceutical 98

Advertisement

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

MedCity News

JUNE 16, 2024

One emerging model brings hope for independent primary care in a rapidly transforming healthcare landscape. The post Is Corporatization Killing Primary Care? appeared first on MedCity News.

Healthcare 105

Healthcare Healthcare Physicians 105

PharmaVoice

JUNE 20, 2024

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Patients 96

Patients 96

Fierce Pharma

JUNE 17, 2024

Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all. | Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all.

Sales 277

Sales Marketing 277

European Pharmaceutical Review

JUNE 17, 2024

Johnson & Johnson Innovative Medicine is planning to invest a total of €580 million in Italy over the next five years. A portion of the investment, €125 million, is intended to support greater production capacity at its Latina site, which is a key part of the firm’s worldwide supply chain network, the company stated. For example, the plant produces over four billion tablets every year, spanning approximately 30 different products, J&J confirmed.

Medicine 97

Medicine Manufacturing Management Government 97

Advertiser: ZoomInfo

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

Marketing