Wed.Dec 20, 2023

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After Amryt buyout, Chiesi scores with FDA nod for rare skin disease treatment Filsuvez

Fierce Pharma

Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. | Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit.

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How Are AI Companies Reacting to HHS’ New Transparency Requirements?

MedCity News

Last week, HHS finalized a new rule that requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Some AI leaders believe the new guardrails are a step in the right direction, and others are skeptical about whether the new rules are necessary or will be effective.

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Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo

Fierce Pharma

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has

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What Will Digital Health Investment Look Like in 2024?

MedCity News

Healthcare’s share of the global PE and VC deal count will likely continue decreasing in 2024, according to a new Pitchbook report. The report also predicted that generative AI and surgical robotics will continue to be hot areas of interest for investors, and that there will be at least three digital health IPOs next year.

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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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Palatin sells female libido drug Vyleesi to Cosette for $12M, plus more in potential milestones

Fierce Pharma

In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. | In 2020, Palatin paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market.

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NourishedRx, ProHealth Connect Team Up To Expand Access to Nutrition Support

MedCity News

NourishedRx is joining ProHealth Connect’s network, meaning its nutrition offerings are accessible for members of 46 payers with food benefits through a ProHealth Connect OTC or flex card. These members will be able to receive NourishedRx’s food delivery services and its wraparound support.

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GSK Expands Again in Cancer, Paying Hansoh $185M for Another ADC

MedCity News

GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024.

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Argenx's Vyvgart Hytrulo comes up short again, this time in the rare disease pemphigus

Fierce Pharma

Less than one month after reporting a trial fail for Vyvgart Hytrulo in a rare bleeding disorder, argenx has swung and missed in a group of chronic blistering diseases. | After a swing and miss in a rare blood disorder last month, argenx's Vyvgart Hytrulo missed its primary and secondary endpoints in a phase 3 in patients with two types of pemphigus.

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Key Parkinson’s protein could offer new potential targets for treatment

PharmaTimes

The findings could lead to new treatments to target the mTOR and ease PD symptoms - News - PharmaTimes

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After Xiidra deal with Bausch, Novartis divests Indian eye care brands to J.B. Pharma for $116M

Fierce Pharma

Last year, reports surfaced that Novartis—hot off the heels of a planned restructuring and spinoff of generics giant Sandoz—was further weighing a sale for its ophthalmology business. | In a deal worth around $116 million, Novartis is handing over a portfolio of “select ophthalmology brands” to Mumbai’s J.B. Chemicals & Pharmaceuticals. The sale is expected to go into effect in January 2027.

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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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BioNTech wins round in CureVac mRNA patent dispute

pharmaphorum

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

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2023 Pharmacovigilance Industry Survey: Unveiling Transformation Trends

Fierce Pharma

In the dynamic realm of healthcare, ensuring drug safety stands as an absolute priority for life sciences companies. | Explore the 2023 PV Industry Survey and learn about the pivotal shifts in drug safety practices, from automation to the emergence of Gen AI. Read now.

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What are pharma’s next blockbusters?

PharmaVoice

In a shifting market focused on targeted therapeutics, drugs that generate big profits are still a priority.

Marketing 119
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The Importance of Data in 2024: Q&A With Christoph Bug, Vice President of Global Medical at Veeva

PharmExec

Data will continue to grow in importance in 2024.

Medical 116
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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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Hello Alpha, TrestleTree Partner To Support Weight Loss

MedCity News

In a new partnership, patients in need of weight loss support can receive primary care, mental health and chronic condition management through Hello Alpha. In between Hello Alpha visits, patients can access health coaching services from TrestleTree.

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Defining Biotech Success in a Challenging Fundraising Environment

PM360

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. After a promising start to the year on the merger and acquisitions (M&A) front, the third quarter was a disappointment for those hoping that the challenging commercial situation was coming to an end.

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3 Ways To Cut Employer Costs in Auto Immune Diseases And Promote Long-Term Employee Health

MedCity News

Spending on prescription drugs for autoimmune diseases has increased by 459% over the past decade, even surpassing cancer drugs. Yet despite driving around 30% of employers’ entire prescription spend, autoimmune diseases have remained completely overlooked in employer health spend.

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Audio Prime—Taking Audio Marketing to the Next Level

PM360

I asked two friends of mine who know media and healthcare marketing and are wizzes when it comes to audio for input on this story. Alas, they were busy. Life, right? So, I asked Professor Scott Galloway’s AI for some words I could use in this story. Because if you can’t rely on an AI trained to think like a marketing prof you follow on LinkedIn, then, well, I have no idea how you can call yourself a modern marketer.

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

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Effective Communication Strategies in Senior Care: Empowering Residents, Families, and Caregivers

MedCity News

Effective communication in senior care is necessary for important interactions that happen within this complex healthcare environment. It’s not just about exchanging words; it’s about creating a nurturing, compassionate, and supportive environment for residents and the loved ones who visit them.

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GSK taps Hansoh for another cancer ADC candidate

pharmaphorum

GSK has turned to China’s Hansoh for another antibody-drug conjugate (ADC), licensing B7-H3-targeting HS-20093 for $185 million upfront.

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4 Biotech Executives Share Strategies Behind Successful Fund Raises

PM360

How can biotech companies successfully raise funds in an environment where investment in the industry is headed for a third straight year of decline? At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. listed on the stock exchanges, is up 13%, according to Leerink Partners’ “Navigating the Complex

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FDA OKs test to spot patients at risk of opioid use disorder

pharmaphorum

FDA OKs test to spot patients at risk of opioid use disorder Phil.

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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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Content Supply Chain: From Craftsmanship to the Industrialization of Marketing

PM360

For thousands of years, everything that people used was created and produced by craftsmen. The quality of the output highly relied on their skills and, as a result, varied greatly. The time to produce and costs associated with production were significant, too. The industrial revolution that started in the 18 th century changed it completely. The industrial production process reduced cost, time to market, and in most cases, improved quality.

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Aclaris slashes staff as it trims its pipeline

pharmaphorum

Aclaris will cut 46% of its workforce after stopping development of MK2 inhibitor zunsemetinib (ATI-450) for immuno-inflammatory diseases.

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Everything You Need to Know About Market Access in China

PM360

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. With its rapidly evolving healthcare system, limited transparency of public information, and language barriers, China has never proven to be an easy market for overseas pharmaceutical companies to enter.

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Argenx dealt another blow as Vyvgart Hytrulo fails again

pharmaphorum

Argenx's subcutaneous version of Vyvgart has failed a second phase 3 trial, this time in autoimmune disease pemphigus vulgaris

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Nordisk Foundation establishes new vaccine initiative worth $260m

PharmaTimes

NIVI aims to create new or improve vaccines to combat deadly airborne infections - News - PharmaTimes

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FDA grants priority review to omalizumab for food allergies

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The drug, a monoclonal antibody, could be used in adults and children over 1 year of age for reduction of allergic reactions, including anaphylaxis, that may occur following accidental exposure to one or more foods.

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Roche and Novartis’ Xolair set for FDA priority review in food allergies

Pharmaceutical Technology

The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation. 1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The proposed changes to EU pharmaceutical legislation broadly aim to: Support innovation and boost attractiveness of EU market Ensure timely and equitable access to medicines for patients across the EU Address other ongoing issues, including antimicrobial resist

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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