Sat.Aug 03, 2024 - Fri.Aug 09, 2024

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A Breadcrumb of Serialized Data

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the Drug Supply Chain Security Act, along with opportunities for improvement.

Pharma 105
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BioNTech posts €808M loss as company continues to come to grips with seasonal COVID vaccine market

Fierce Pharma

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

Marketing 363
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Trending Sources

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Wearable Tech is Empowering Patients To Be Proactive in Their Health

MedCity News

This potential for self-management can reduce the burden on the healthcare system, resulting in fewer doctor visits, lower hospitalization risks, and fewer diagnostic tests as patients can take corrective action earlier or identify issues sooner. The post Wearable Tech is Empowering Patients To Be Proactive in Their Health appeared first on MedCity News.

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Sales Team Management: 24 Practical Strategies You Need to Know

Spotio

Let’s be honest, managing a high-performance sales team is hard. Especially when you consider that 91% of sales reps missed their sales quotas last year. How can anyone be expected to lead a group of sellers effectively when almost all of them are likely to underperform in some way? Missed quotas aren’t even the worst of it. The average annual turnover rate for sales teams is a whopping 35%.

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

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BioMarin keeps but scales down Roctavian gene therapy ops

pharmaphorum

BioMarin Pharma has decided not to divest its haemophilia A gene therapy Roctavian but is reining back its ambitions for the business, for now

Pharma 117
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Bavarian Nordic scores $157M contract to replenish US supplies of smallpox/mpox vaccine Jynneos

Fierce Pharma

Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.

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Pharma execs react to final drug price negotiations with Medicare

PharmaVoice

Here’s what the leaders of the companies with the 10 drugs in the first wave of price negotiations with Medicare said about how the new prices will impact their portfolio.

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BMS ducks out of $1.56bn TIGIT alliance with Agenus

pharmaphorum

Bristol-Myers Squibb has handed back rights to a TIGIT drug partnered with Agenus, ending an alliance that could have been worth up to $1.56 billion to the biotech.Agenus revealed BMS' decision in a Securities & Exchange Commission (SEC) filing (PDF), saying it was a result of a "broader strategic realignment of their development pipeline which involves other licensed products.

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Novartis and Viatris sued by estate of Henrietta Lacks, whose cells were extracted for research in 1951

Fierce Pharma

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

Medical 363
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An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

MedCity News

The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. The post An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs appeared first on MedCity News.

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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.

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Purdue receives clearance for opioid overdose injector for younger individuals

Pharmaceutical Technology

Coming in response to a rise in teenage overdoses across the US, the Purdue auto-injector device is designed to be used by anyone.

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Biopharma, finance vets launch $600m life science loan firm

pharmaphorum

There's a new source of funding for life science companies, Symbiotic Capital, which is providing credit as an alternative to other financing routes

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Servier snags FDA approval for Voranigo, the 1st targeted therapy for a common type of brain tumor

Fierce Pharma

Servier has expanded its IDH drug armamentarium with the FDA approval for an IDH1/2 dual inhibitor. | Servier's Voranigo, or vorasidenib, is now the first systemic therapy for low-grade IDH-mutant brain cancer.

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Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain  Cancer

MedCity News

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. The post Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer appeared first on MedCity News.

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How to Stay Competitive in the Evolving State of Martech

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

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Pharma Pulse 8/8/24: Addressing Maternal Health Disparities and Driving Change, Abacavir Increases Cardiovascular Risk in Patients With HIV & more

Pharmaceutical Commerce

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

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Lilly's tau drug for Alzheimer's flunks phase 2 test

pharmaphorum

Eli Lilly's oral tau drug fails to show efficacy in a phase 2 trial in Alzheimer's disease in another setback for the class

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Pfizer to create 500 new jobs as it upgrades Australia manufacturing plant to help fight antimicrobial resistance

Fierce Pharma

Warning of a "silent pandemic" spreading across the globe, Pfizer is taking the fight against antimicrobial resistance (AMR) Down Under. | Pfizer announced Tuesday that it has invested 150 million Australian dollars (about $98 million) to build a new manufacturing facility at its Australian site in Melbourne, where the company will help produce new antimicrobial treatments aimed at addressing the rising tide of antimicrobial resistance.

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Biotech Financing Roundup: Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

MedCity News

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. The post Biotech Financing Roundup: Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More appeared first on MedCity News.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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BioMarin Adjusts Sales Plan for Severe Hemophilia A Gene Therapy

Pharmaceutical Commerce

ROCTAVIAN will only be sold to the United States, Italian, and German markets, as the company eyes its profitability by 2025.

Sales 105
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AI biotechs Exscientia and Recursion agree $688m merger

pharmaphorum

Recursion Pharma has agreed to merge with rival AI-powered drug discovery firm Exscientia in an all-stock deal valued at $688 million

Pharma 117
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Bristol Myers telegraphs layoffs in New Jersey, trimming 117 jobs in staggered wave of cuts

Fierce Pharma

Bristol Myers Squibb, while working its way through a major restructuring, has unveiled another round of layoffs in New Jersey. | Bristol Myers Squibb, while working its way through a major restructuring, has unveiled another round of layoffs in its home state of New Jersey.

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Startup Red Queen Therapeutics Unveils $55M and Tech to Defeat Elusive Viral Pathogens

MedCity News

Apple Tree Partners’ latest startup is Red Queen Therapeutics, developer of stapled peptide drugs that block viral fusion. Its lead program is on track for Phase 2 testing in immunocompromised Covid-19 patients; a preclinical pan-influenza program is in development under a BARDA contract. The post Startup Red Queen Therapeutics Unveils $55M and Tech to Defeat Elusive Viral Pathogens appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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US FDA approves Novartis’ Fabhalta in IgAN treatment

Pharmaceutical Technology

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

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Wegovy slowdown rattles Novo Nordisk investors

pharmaphorum

Weaker sales of obesity drug Wegovy cause a dip in Novo Nordisk's share price, but CEO says volume growth is strong and will accelerate in second half

Sales 109
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Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

Fierce Pharma

With Gilead's stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. | The HIV-focused drugmaker looks to position its long-acting Sunlenca as a prime PrEP option after the med aced a phase 3 study.

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The Quiet Epidemic Affecting Vascular Health

MedCity News

Peripheral IV insertion and blood collection are two of the most prevalent inpatient procedures in U.S. hospitals. Here’s how clinicians can advocate for a better, more compassionate care experience without extra “sticks.” The post The Quiet Epidemic Affecting Vascular Health appeared first on MedCity News.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Malaysia approves Antengene’s XPOVIO NDA for multiple myeloma

Pharmaceutical Technology

Antengene received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO NDA for two multiple myeloma indications.

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Bayer CEO says recovery on track as key drug products shine

pharmaphorum

Bayer has joined its peers among European drugmakers with a hike in pharma forecasts for the year, as it recorded a rise in group sales but lower profits for the second quarter.Total revenues came in at €11.1 billion ($12.2 billion) in the quarter, ahead of analyst consensus estimates, with pharma leading the charge as it recorded sales up 4.5% to €4.61 billion.

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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection

Fierce Pharma

As Purdue Pharma attempts to restore its image following its role in | As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.

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Cigna Distributes Grants to 22 Nonprofits Focused on Youth Mental Health

MedCity News

Cigna is distributing about $3 million to 22 nonprofits addressing youth mental health. Over the next three years, the company is allocating $9 million total. The post Cigna Distributes Grants to 22 Nonprofits Focused on Youth Mental Health appeared first on MedCity News.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.