Thu.Jun 20, 2024

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

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 360
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6 Steps for Success in the Medical Sales Field

David Bagga

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.

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In fight against knockoff weight loss meds, Eli Lilly accuses sellers of 'deceptive' advertising

Fierce Pharma

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.

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Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage

MedCity News

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.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Fierce Pharma

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.

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Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks

MedCity News

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.

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More Trending

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Semi-automation of manual interventions in high-speed filling lines

European Pharmaceutical Review

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.

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Johnson & Johnson blueprints €125M plant upgrade as part of 5-year Italy investment

Fierce Pharma

After plugging nearly 50 million euros into its Italy operations in the first half of the decade, Johnson & Johnson Innovative Medicine is significantly upping its commitment to the country.

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Three Healthcare Challenges Overcome by Virtual Specialty Care — And Why Employers Should Take Note

MedCity News

Virtual first models can address a brutal trifecta of challenges – access, cost, and quality. The post Three Healthcare Challenges Overcome by Virtual Specialty Care — And Why Employers Should Take Note appeared first on MedCity News.

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Vanda rejects buyout offers, pans 'opportunistic attempts' at securing its shares at a discount

Fierce Pharma

A series of increasing buyout offers has failed to convince Vanda's board of directors that the company should sell itself. | Vanda is turning away buyout offers from Future Pak and Cycle Pharma. In a statement, Vanda said its revenue base, cash position and efficient operations position the company "for significant long-term growth and value creation far in excess of the" other firms' offers.

Pharma 255
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Big potential for small molecule drugs in cancer treatment

European Pharmaceutical Review

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

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Samsung Biologics upgrades another production pact, this time with Baxter for $223M

Fierce Pharma

On a revised dealmaking spree this year, Korea’s Samsung Biologics is re-tooling its long-running drug manufacturing pact with Baxter Healthcare. | The revised deal, first established back in July of 2017, will now see Baxter pay Samsung upwards of $223 million for its manufacturing services through end of 2034. Previously, Baxter was on the hook to pay just $15 million for Samsung’s production assistance.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

PharmaVoice

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.

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No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval

Fierce Pharma

Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. | The med is the first new chemical entity to win FDA approval specifically to treat primary axillary hyperhidrosis, or excessive underarm sweating. It's also Botanix's first approved product.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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Can Providers Scale Value-Based Care Sustainably?

MedCity News

Value-based care results in a lot of added administrative tasks for physicians — so much so that one health system leader believes value-based care will never reach true scale unless providers figure out how to ease that burden. The adoption of new technology, coupled with workflow training from fellow physicians, can help address this issue, population health experts say.

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AbbVie's rising star Skyrizi nabs key ulcerative colitis FDA approval

Fierce Pharma

AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. | Since its original nod in 2019, AbbVie's IL-23 inhibitor has added several new uses over the years. Now, its fourth approved disease area is ulcerative colitis.

FDA 204
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AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

pharmaphorum

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 109
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Fierce Pharma Asia—BioNTech's ADC clinical hold; Takeda's leukemia bet; China NMPA's meeting with FDA

Fierce Pharma

BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. | BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sarepta bags key expansion to DMD gene therapy label in US

pharmaphorum

Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.

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NIH-funded trials fall flat on diversity goals

PharmaVoice

Many clinical trials aren’t meeting enrollment inclusion checkpoints — and some aren’t even setting targets, according to a recent OIG report.

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Infectious disease group ISID names six global priorities

pharmaphorum

International Society for Infectious Diseases (ISID) publishes six priorities focusing on challenges faced by low- and middle-income countries (LMICs).

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FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars

MedCity News

FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching studies add time and expense to the development of biosimilars, delaying them from reaching patients. The post FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars 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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Sanofi: NICE would reject Sarclisa even if it cost nothing

pharmaphorum

After rejection of its multiple myeloma therapy Sarclisa by NICE, Sanofi claims the drug would not have been deemed cost-effective 'even at zero price'

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US study suggests BMS’ cancer drug could target Parkinson’s-causing protein

PharmaTimes

The progressive neurodegenerative condition affects more than ten million people worldwide

Medicine 107
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Vanda bats away unwanted Cycle, Future Pak takeover bids

pharmaphorum

Vanda Pharma is unimpressed with takeover offers from Cycle Pharma and Future Pak, saying they both substantially undervalue the company

Pharma 100
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Lab-grown ‘mini guts’ to help identify treatment for Crohn’s disease

PharmaTimes

The lifelong inflammatory bowel disease affects around one in every 350 people in the UK

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Prostate drugs may find role in dementia, say US scientists

pharmaphorum

Common alpha-blocker prostate drugs linked to lower risk of dementia with Lewy bodies in large-scale observational study.

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Pharma Pulse 6/20/24: Talkspace and FitOn Team Up, The Potential of CAR-T Therapies & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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How engaging providers enhances value-based care

Clarify Health

Recently, Clarify Health ‘s CEO Terry Boch moderated a panel during an event at AHIP 2024 , focused on engagement between health plans and providers. Formerly known as America’s Health Insurance Plans, AHIP is a professional advocacy association for providers of health care coverage, services, and solutions; its annual flagship conference has been a destination for industry leaders for decades.

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Leverage the Power of Recipe-Driven Execution and Standardization

PharmaTech

Standardized manufacturing through a Recipe-Driven Execution environment and digital twins minimizes effort duplication while simplifying operations, harmonizing production processes, and accelerating speed to patient.

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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.