Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

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FDA Pharmaceutical 287

MedCity News

SEPTEMBER 28, 2023

Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.

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FDA Patients Marketing Biopharma 111

Pharmaceutical Technology

SEPTEMBER 28, 2023

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

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Medgadget

SEPTEMBER 26, 2023

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that is incorporated into a virtual reality headset. The technology can measure brain activity while someone is undergoing an immersive virtual reality experience. The device may assist in enhancing medical virtual reality interventions, such as those used to treat post-traumatic stress disorder or phobias, by revealing brain activity during different tasks or experiences that help clinicians to

Medical 110

Medical 110

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

Copyright Clearance Center

SEPTEMBER 28, 2023

September 28, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces the availability of AI-disambiguated data and enriched metadata, for researchers and institutions, within RightFind Navigate through a pilot for its customers. CCC also announces several powerful new features of the RightFind Suite.

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Pharmaceutical Management 106

Fierce Pharma

SEPTEMBER 28, 2023

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

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FDA Side effects 269

PharmaTech

SEPTEMBER 28, 2023

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

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Patients 104

PharmaVoice

SEPTEMBER 26, 2023

From COTA’s large datasets and AI model assistants to a company guiding patients through cancer care, AI can help — but it’s a long way from human-free.

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Patients 105

Medgadget

SEPTEMBER 26, 2023

Researchers at the University of California San Francisco have developed an implantable bioreactor that may pave the way for artificial kidneys. Dialysis and kidney transplants both have significant disadvantages for patients with kidney failure, and so scientists are trying to develop a lab created kidney that would not require harsh immunosuppression or a donor kidney.

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Patients Medicine 97

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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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

SEPTEMBER 26, 2023

Digital therapeutics will be one of the topics discussed at INVEST Digital Health scheduled for October 26 at Health Wildcatters headquarters in Pegasus Park in Dallas. Register today!

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Medicine 118

European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. Subcutaneous (SC) administration is authorised for US adults with moderate to severe active ulcerative colitis (UC) after induction therapy with ENTYVIO intravenous (IV).

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FDA Food and Drug Administration Patients Physicians 82

PharmaVoice

SEPTEMBER 27, 2023

Despite recent phase 3 setbacks in RSV and COVID-19, CEO Paul Chaplin sees a promising path forward in the travel vaccine market for the Dutch biotech.

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Marketing 98

PharmaTimes

SEPTEMBER 28, 2023

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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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

Fierce Pharma

SEPTEMBER 26, 2023

Amid a global expansion spree at WuXi Biologics, the company's immunization-focused subsidiary has christened its inaugural CDMO site in China. | WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.

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Manufacturing 276

MedCity News

SEPTEMBER 24, 2023

Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.

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Manufacturing Biopharma Pharma 119

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 Pharma Patients 91

PharmExec

SEPTEMBER 26, 2023

Accenture’s global life sciences technology lead discusses how the life sciences industry has embraced artificial intelligence.

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Leads 105

Advertiser: ZoomInfo

Shifting to an account-based marketing (ABM) strategy can be both exciting and challenging. Well-implemented ABM motions build engagement with high-value accounts and drive impactful campaigns that resonate with your audience. But where do you begin, and how do you progress from crawling to running? Watch now as Demand Gen experts delve into the essentials of each stage of the ABM process.

Marketing

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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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 26, 2023

Costco is partnering with Sesame to offer Costco Members discounted pricing on virtual health services, including primary care and mental health. But the move is a little different from other retailers like CVS Health and Walgreens.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

Resminostat (Kinselby) has been clinically proven to postpone disease progression, new data from one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date has revealed. The treatment is an oral small molecule class I, IIb and IV histone deacetylase (HDAC) inhibitor. Data from the RESMAIN resminostat study Findings from the RESMAIN study of the maintenance therapy could significantly change clinical practice in advanced CTCL, according to the company.

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Patients Pharmaceutical Medical Marketing 87

Advertiser: ZoomInfo

One of the biggest challenges for any B2B marketer is understanding your prospects’ next move — who is most likely to buy and when. Without these insights, marketing campaigns can feel more like guesswork, with high investment and little return. We’re here to tell you there’s a better way. By tracking buyers’ digital footprints and online activity, such as website visits, product reviews, and spikes in content consumption, you can engage prospects with a message that really resonates.

Marketing

Pharmaceutical Commerce

SEPTEMBER 28, 2023

How recent advancements in practice and technology have ushered in a new era of pharmaceutical logistics.

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Pharmaceutical 99

Medgadget

SEPTEMBER 29, 2023

Researchers at Oxford University have developed a tiny battery that can power small implantable devices, such as drug delivery technologies. The new battery is inspired by the ionic gradients that electric eels use to generate electricity. It involves tiny droplets of a conductive hydrogel that are placed near each other. Each droplet has a different ionic concentration, meaning that ions will flow from high concentration droplets to low concentration droplets.

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Medicine Safety Medical Networking 67

Fierce Pharma

SEPTEMBER 26, 2023

As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach. | As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach.

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Patients Pharma 265

MedCity News

SEPTEMBER 26, 2023

The advancement of value-based care cannot and should not exist solely in a payvider model, Intermountain Health CEO Rob Allen argued in an interview last week. Having its own health plan made things “a little easier” when Intermountain began getting serious about at-risk contracts, but achieving success in value-based care “is more about your commitment to the approach” and forging strong relationships with payers of all types.

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Advertiser: ZoomInfo

In this eBook, we’ll run through real-world examples that show how RevOps teams can benefit from modern solutions for the access, management, and activation of their GTM data. Whether you need to improve lead response times, boost adoption of core tools, improve lead qualification, or target and automate your GTM motions, you’ll find examples of how revenue teams are solving some of the toughest problems in modern business.

Leads

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

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Food and Drug Administration Patients FDA Medicine 87

PharmaTimes

SEPTEMBER 29, 2023

Review raises concerns about approach taken by the DHSC regarding changes to Statutory Scheme - News - PharmaTimes

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Medicine 86

Medgadget

SEPTEMBER 29, 2023

CraniUS , a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system. The technology is designed to deliver drugs to the brain, and it can bypass the blood-brain barrier. This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease.

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Medicine Patients Medical FDA 65

Fierce Pharma

SEPTEMBER 27, 2023

Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S. in the first half of 2024.

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FDA Pharmacology Sales 255

Advertiser: ZoomInfo

Consolidating your tech stack is an effective cost-saving measure that drives GTM efficiency and adds value to your enterprise. With a cohesive, integrated tech stack, your revenue teams can deliver an excellent customer experience that sets you up to win faster than your competitors.