Wed.Feb 14, 2024

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FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Fierce Pharma

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

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Positive results for MAIA’s SCLC treatment published in Nature Communications

PharmaTimes

The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide

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Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite

Fierce Pharma

Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. | The FDA has approved the first medicine for severe frostbite. The U.S. regulator has signed off on Johnson & Johnson’s Aurlumyn (iloprost), an injected treatment to reduce the risk of amputation of the fingers or toes.

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FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

MedCity News

Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Blueprint boosts Ayvakit peak sales estimate to $2B as key rare disease expansion accelerates

Fierce Pharma

With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion. | With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion.

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Despite Price Transparency Laws, Americans Are Nowhere Near Able to Shop for Care. How Can This Change?

MedCity News

Most hospitals and payers have publicly posted their pricing information, but experts think that data will remain mostly useless for consumers for at least another five years. Now that the data is available, healthcare software companies must step in and build tools that are personalized and easy to use. That way, consumers can eventually use price transparency data to shop for care.

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From Buzzword to Action: Addressing SDOH to Advance Health Equity

MedCity News

When striving for health equity, organizations need to adopt new methods and a new mindset in order to steer clear of using SDoH as a buzzword, and instead hit the mark of health equity results.

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After Vifor buyout, CSL CEO sees 'dampened' outlook for the unit as hurdles mount

Fierce Pharma

Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted. | Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted.

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Omada Expands GLP-1 Care Track To Include Exercise Plans, Member Level Reporting

MedCity News

Omada’s newly expanded GLP-1 Care Track provides tailored exercise plans, support for getting off of GLP-1s and calorie tracking. It also offers insight into who is responding to GLP-1s and who is engaging in Omada’s program.

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After FDA's mixed approval decisions, Sage now says it's 'highly encouraged' by Zurzuvae launch

Fierce Pharma

Sage Therapeutics and Biogen may not have the broad label that they had hoped for with Zurzuvae, but the two companies are still touting the med’s initial launch performance in postpartum depressio | Sage Therapeutics and Biogen may not have the broad label that they had hoped for with Zurzuvae, but the two companies are touting the med’s initial launch performance in postpartum depression.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Episode 1: Debunked (audio): Slaughtering Myths, Bad Practices and Sacred Cows in Healthcare

MedCity News

Here’s the audio of Episode 1 of the newly-launched show Debunked: Slaughtering Myths, Bad Practices and Sacred Cows in Healthcare.

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First drug therapy for frostbite has been cleared by FDA

pharmaphorum

Eicos Sciences' Aurlumyn has become the first FDA-approved drug treatment to prevent amputations in cases of severe frostbite

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Top 5 Strategic Focus Areas for Global Pharma Marketers in 2024

MedCity News

2024 presents an exciting yet challenging landscape for global pharma marketers. Prioritizing digital transformation, adopting patient-centric strategies, navigating regulatory complexities, investing in innovative content marketing, and fostering global collaboration position pharmaceutical marketers to make a lasting impact in an ever-evolving industry.

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Onivyde gets ‘practice-changing’ FDA OK in pancreatic cancer

pharmaphorum

Ipsen has won FDA approval for first-line use of its pancreatic cancer therapy Onivyde, saying it is now part of a potential new “standard-of-care” for patients

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Downside of One-Size-Fits-All: Rethinking Weight-Loss Medications Strategy

MedCity News

A comprehensive approach to obesity management goes beyond prescribing medications for a quick fix.

Medical 111
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Gilead plans $4.3 billion deal to advance liver portfolio

European Pharmaceutical Review

Gilead Sciences has agreed to acquire CymaBay Therapeutics for a total equity value of $4.3 billion. Gilead confirmed that CymaBay’s lead product candidate seladelpar has a best-in-disease profile for second-line primary biliary cholangitis (PBC). This is based on data from the Phase III RESPONSE trial. The company shared that seladelpar is an oral, selective peroxisomeproliferator-activated receptor delta (PPARδ) agonist.

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New report urges UK policymakers to take urgent action on declining child health

PharmaTimes

The report includes five recommendations for the government to address these issues

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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics. It is the uniqueness of the strain and perceived inter-cellular variations (sub-populations) resulting from high viable cell densities during growth (fermentation) and the subsequent harvest and d

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

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US lawmakers urge administration to take action against Wuxi

Pharmaceutical Technology

A bipartisan group of lawmakers is seeking an investigation and sanctions against WuXi given alleged connections to the Chinese military.

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Pharmaceutical suspension market to witness accelerated growth

European Pharmaceutical Review

A report by Allied Market Research predicts that the global pharmaceutical suspension market will reach $83.8 billion by 2032. Having valued $55.5 billion in 2022, the research expected that the market will reach a CAGR of 4.2 percent between 2023 and 2032. Factors driving the global pharmaceutical suspension market One of the main factors anticipated to propel the growth of the pharmaceutical suspension market is the availability of generic pharmaceutical suspensions, the research asserted.

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UK patients very concerned about access to diagnostics

pharmaphorum

UK patients very concerned about access to diagnostics Phil.

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Increased Development of RSV Immunoprophylaxis Inhibited by Cost and Acquisition Barriers

Pharmacy Times

Despite the growth in vaccine and antibody development for combatting RSV, lower income countries may not reap the benefits.

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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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VC Earlybird Health raises €173m for healthtech companies

pharmaphorum

Venture capital group Earlybird has launched its second health fund with $185 million to fund companies in the health technology area

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BMS signs $674m GenAI drug discovery deal with VantAI

Pharmaceutical Technology

The partnership will focus on designing molecular glues for unspecified therapeutic targets.

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Common Osteoporosis Treatment May Reduce Risk of Incident Diabetes

Pharmacy Times

Continued doses of denosumab reduced the incidence of diabetes by more than 1000 patients compared to an initial dose alone.

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FDA cracks down on online retailers selling unapproved GLP-1 agonists

Pharmaceutical Technology

The FDA has issued warning letters to two online sellers for selling unapproved versions of semaglutide and tirzepatide.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Natural Food Preservative May Harm Beneficial Gut Bacteria

Pharmacy Times

Researchers will continue to research how lantibiotic’s antimicrobial effects can be harnessed for good.

Food 55
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FDA grants fast track status to Edgewise’s Duchenne treatment

Pharmaceutical Technology

The US FDA has granted fast track designation to Edgewise Therapeutics’ EDG-5506 aimed at treating Duchenne muscular dystrophy.

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Exscientia CEO sacked for 'inappropriate' staffer relations

pharmaphorum

Exscientia has fired its founder and CEO Dr Andrew Hopkins over “inappropriate relationships” with employees, as chair David Nicholson resigns

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FDA Approves Irinotecan Liposome for Metastatic Pancreatic Adenocarcinoma

Pharmacy Times

The approval of irinotecan liposome offers an improved first-line treatment option for individuals diagnosed with metastatic pancreatic adenocarcinoma.

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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