Fri.Oct 11, 2024

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Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months

Fierce Pharma

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

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From Crawling to Caring: The Evolution of Clinical Practice with AI and Its Transformative Impact on Healthcare

MedCity News

As clinicians begin to rely more on AI, they will also need to cultivate new skills, particularly around critical interpretation of AI-generated insights, to fully leverage its potential in patient care. The post From Crawling to Caring: The Evolution of Clinical Practice with AI and Its Transformative Impact on Healthcare appeared first on MedCity News.

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Sanofi enters talks with private equity firm to sell controlling stake in consumer health unit Opella

Fierce Pharma

With reports swirling about potential interest in Sanofi’s consumer health business, the French pharma has confirmed that a deal is indeed brewing. | Sanofi has entered negotiations with private equity outfit Clayton, Dubilier & Rice to potentially sell a 50% controlling stake in its consumer health business, Opella. Sanofi first telegraphed plans to separate its consumer health arm last October.

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Establishing Better Health Care Outcomes through AI

MedCity News

The scaling power of AI can simultaneously remove barriers to access, drive costs down system-wide and elevate the role of the human clinician so they can focus on human touch that their patients need. The post Establishing Better Health Care Outcomes through AI appeared first on MedCity News.

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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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Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics

Fierce Pharma

A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed. | Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.

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Lawmaker asks FTC to probe Novo/Catalent deal

pharmaphorum

US Senator Elizabeth Warren asks FTC to scrutinise $16.5bn Novo Holdings/Catalent merger and sale of manufacturing plants to Novo Nordisk.

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Roche gets FDA green light for breast cancer drug Itovebi

pharmaphorum

FDA gives Roche the first approval for PI3K inhibitor Itovebi, clearing the drug for certain types of advanced breast cancer

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Fierce Pharma Asia—AstraZeneca-CSPC heart med deal; Astellas' gene therapy pact, new cell therapy site

Fierce Pharma

AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. | AstraZeneca has bagged a cardiovascular disease candidate from China's CSPC Pharma in a deal potentially worth $2 billion. Astellas is shuffling its cell therapy research team and investing in a dementia gene therapy candidate.

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Medicare Advantage Star Ratings Drop Again

MedCity News

For 2025, the average star rating for Medicare Advantage Prescription Drug contracts was 3.92, compared to 4.07 for 2024, 4.14 for 2023 and 4.37 for 2022. The post Medicare Advantage Star Ratings Drop Again appeared first on MedCity News.

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Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

Pharmaceutical Commerce

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

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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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Sanofi in talks to sell stake in consumer health spinout

pharmaphorum

Rumours that Sanofi was in discussion with private equity groups over the sale of its consumer health business Opella have been confirmed – at least partially.The French pharma group confirmed this morning that it has entered into talks with US-based Clayton Dubilier & Rice to sell a controlling 50% stake in the unit for what has been estimated by Reuters to be in the region of €15 billion ($16.4 billion).

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CPHI Milan 2024: Pharma Industry Growth and Investment

PharmaTech

Pharmaceutical Technology Europe spoke with John McQuaid, president and managing director at Almac Pharma Services, at CPHI Milan 2024, held October 8–10, in Milan, Italy, about how the pharmaceutical industry is growing and what might drive investment in the future.

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Aiming to Outdo Rivals in Severe Asthma, Upstream Bio Upsizes IPO to $225M

MedCity News

Upstream Bio will use its IPO haul to continue clinical testing of verekitug, which it contends be a better treatment option for severe asthma compared to a commercialized Amgen and AstraZeneca drug. CAMP4 Therapeutics and Ceribell also priced IPOs to join the public markets. The post Aiming to Outdo Rivals in Severe Asthma, Upstream Bio Upsizes IPO to $225M appeared first on MedCity News.

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Vaccines “essential” for addressing AMR, says WHO

European Pharmaceutical Review

A new report by the World Health Organization (WHO) has emphasised the importance of vaccines in addressing antimicrobial resistance (AMR) globally. For example, the report explained that “vaccines against 24 pathogens could reduce the number of antibiotics needed by 22 percent or 2.5 billion defined daily doses globally every year”. Vaccines are a key part of helping to reducing AMR because they “prevent infections… and slow the emergence and spread of drug-resistant pathogens”, WHO explained.

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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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Workforce Shortages? Attract and Retain Top Talent With Employer Branding

Healthcare Success

Are you struggling to fill critical positions in your healthcare organization? You’re not alone. With competition for top talent at an all-time high, hospitals and health systems must prioritize employer branding to attract and retain skilled professionals. Why Employer Branding Matters Employer branding isn’t just a marketing buzzword—it’s a critical strategy for healthcare organizations.

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Activist investor Starboard cries foul play in exec U-turn at Pfizer

Pharmaceutical Technology

Starboard has accused Pfizer of “coercive conduct” after executives who initially backed the hedge fund retracted their support.

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Pharma Pulse 10/11/24: Leverage AI to Lower Cost, Barriers to Cell Therapies & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

Pharmacy Times

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a pre-filled, auto-injector pen.

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

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Buy, Sell, Hold: Cell and Gene Therapy

PharmaTech

In episode 1, cell and gene therapy experts Dr. Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

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Study: Risk Factors Associated With Developing Ocular Complications Following Shingles Diagnosis

Pharmacy Times

Female and older patients had a greater incidence of herpes zoster ophthalmicus and were more likely to develop ocular complications.

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Improve Patient Care or Keep Data Secure in Healthcare? Yes.

Salesforce

The rapid evolution of the healthcare landscape is nothing short of revolutionary. Technological innovations such as mobile health apps, wearable devices, and AI are transforming how care is delivered. Regulatory shifts, changing consumer demographics, cutting-edge research, landmark policies like the Patient Protection and Affordable Care Act, and the push towards outcomes-based reimbursement have raised the stakes for healthcare organizations.

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Facing Industry Disruptions, FDA Grants Temporary Exemption From DSCSA Requirements For Trading Partners

Pharmacy Times

The exemption allows more time for partners to adhere to enhanced distribution security requirements in the Food, Drug, & Cosmetics Act and prevents possible supply chain disruptions.

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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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EMA and HMA Publish Network Strategy for Public Consultation

PharmaTech

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

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The Evolving Role and Importance of Pharmacists in the Health Care System

Pharmacy Times

Amelia Arnold, PharmD, reflects on the growing recognition of pharmacists as valuable clinical providers.

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AaviGen, SK pharmteco Announce Manufacturing Agreement for Heart Failure Gene Therapy

PharmaTech

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

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LogiPharma USA 2024: Confronting Conflicting Priorities Between Supply Chain Partners

Pharmaceutical Commerce

Lucy Alexander, capabilities lead, global supply chain and strategy, AstraZeneca, discusses how to handle opposing concerns between supply chain teams and offers communication solutions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Evonik Wins Award at CPHI Milan for Plant-based Parenteral Drug Delivery Adjuvant

PharmaTech

Evonik won the CPHI Excellence in Pharma Award in the “Sustainability” category in recognition of its plant-based squalene, PhytoSquene, used in parenteral drug delivery applications.

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FDA Approves Roche’s Itovebi for Endocrine-Resistant, PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

PharmExec

Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

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South Korean company Dong-A ST wins FDA approval for Stelara biosimilar

Pharmaceutical Technology

Imuldosa is the latest FDA-approved biosimilar of J&J’s blockbuster therapy for the treatment of certain autoimmune diseases.

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How to Rally a Team Around Building a New Business

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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