Mon.May 06, 2024

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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint

Fierce Pharma

As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.

Sales 330
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FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay

MedCity News

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process. The post FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay appeared first on MedCity News.

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Amneal agrees to $272.5M settlement to resolve opioid lawsuits

Fierce Pharma

Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.

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The Promise of RFID for Improving Medication Inventory Management

Pharmaceutical Commerce

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

Medical 111
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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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Pfizer hires Citi analyst Andrew Baum to manage portfolio strategy, business development

Fierce Pharma

“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.

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Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures

MedCity News

Is a widened enforcement net squeezing physicians unfairly? That’s the belief of one high-profile author and health policy expert. The post Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures appeared first on MedCity News.

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“Landmark” genetic blindness CRISPR trial outcomes released

European Pharmaceutical Review

New results from a Phase I/II clinical trial of a CRISPR/Cas9 gene editing therapy show that around 79 percent of patients with a rare form of inherited blindness experienced “measurable improvement”. The BRILLIANCE trial included 14 participants (12 adults and two children) who received an injection of EDIT-101 in one eye. These individuals had a form of Leber Congenital Amaurosis (LCA) caused by mutations in the centrosomal protein 290 (CEP290) gene.

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How Pharma Can Harness Education to Transform the Health Journey

Fierce Pharma

As patients increasingly drive their own healthcare journeys, many rely on educational resources to figure out what actions to take. | Discover how effective education empowers patients and drives healthier outcomes in healthcare.

Education 206
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Alternative methods for mycobacterial testing in biological products

European Pharmaceutical Review

Following a review on the suitability of different technologies, researchers have determined that “[nucleic acid amplification techniques] NATs combined with an efficient extraction method” is the fitting alternative for compendial mycobacterial testing in biological products. The current challenge in mycobacterial testing information on using mycobacterial testing for the quality control of biologicals is limited, the paper noted.

Media 98
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CDMO Nucleus RadioPharma links up with ARTBIO to help produce prostate cancer candidate for clinical trials

Fierce Pharma

Following Nucleus RadioPharma’s 2022 debut, the GE HealthCare- and Mayo Clinic-backed radiopharmaceuticals CDMO is ready to put its production thesis to the test. | Nucleus on Tuesday revealed that it has signed its first manufacturing partnership with clinical-stage radiopharma player ARTBIO. The production deal will support ARTBIO’s planned phase 1 and 2 clinical trials of its lead program in prostate cancer, AB001.

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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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As drug shortages reach record highs, regulators float next steps

PharmaVoice

With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.

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Biden Administration Extends ACA Coverage Eligibility to DACA Recipients

MedCity News

Under a new final rule, eligible DACA recipients will be able to enroll in a Qualified Health Plan through the ACA Marketplace or through a Basic Health Program. The post Biden Administration Extends ACA Coverage Eligibility to DACA Recipients appeared first on MedCity News.

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Top charities team up with $300m for climate, health equity

pharmaphorum

The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.

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There’s Still Time to Register for MedCity INVEST

MedCity News

The conference is the premier boutique healthcare investment event in the U.S. and is scheduled for May 21-22 in Chicago at the Ritz Carlton hotel. The post There’s Still Time to Register for MedCity INVEST appeared first on MedCity News.

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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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Boehringer raises hope of diabetic macular ischaemia therapy

pharmaphorum

Boehringer drug shows promise in diabetic macular ischaemia (DMI), a common and irreversible complication of the eye in people with diabetes with no approved therapies

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FDA’s new diagnostic rules draw pharma criticism

PharmaVoice

Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.

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Citi analyst Andrew Baum to head Pfizer strategy team

pharmaphorum

Pfizer has named Citi analyst Andrew Baum as its chief strategy and innovation officer, taking point on portfolio management and capital deployment

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UK MHRA approves ViiV Healthcare’s cabotegravir formulations for HIV-1

Pharmaceutical Technology

The UK MHRA approved two formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for HIV-1 infection.

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

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Activist investor urges changes to Novavax board

pharmaphorum

Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.

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LogiPharma Europe 2024: Tower Cold Chain Global Head of Product Development Discusses the Future of Cell & Gene Therapy and Cold Chain Storage

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Martin Hawes, Global Head of Product Development, Tower Cold Chain offers insights on the future of cell & gene therapies when it comes to cold chain storage.

Pharma 59
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FDA Accepts Bristol Myers Squibb’s Biologics License Application for Opdivo’s Subcutaneous Formulation Across All Previous Indications

PharmExec

Acceptance of the application was based on promising results from the Phase III CheckMate -67T study, which displayed noninferiority between the oral and intravenous formulations of Opdivo.

FDA 52
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Pharma Pulse 5/6/24: Are Smartphones Driving Teens to Depression? Does Pharma Know What Their Customers Really Want? & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

PharmExec

Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

FDA 52
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Lantern Pharma and Oregon partner to develop cancer treatment

Pharmaceutical Technology

Lantern Pharma has entered into a partnership with Oregon for optimising the development of XCE853, through an AI-driven approach.

Pharma 59
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Phase II Apa-RP Study of Erleada Shows Promise in Treatment of Patients with High-Risk Localized Prostate Cancer Who Have Undergone Previous Radical Prostatectomy

PharmExec

Significant findings included a 100% biochemical recurrence-free rate at 24 months post-surgery in patients with high-risk localized prostate cancer.

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A 340B Compromise at Last? Draft Federal Legislation May Provide a Clear Path Forward

Pharmacy Times

In an ambitious effort to address the ongoing uncertainty within the 340B Program space, 6 senators released a draft discussion bill earlier this year titled the SUSTAIN Act.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NJ Doctor Becomes First In State to Use PathKeeper Surgical Navigation System on Patient

PharmExec

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

Doctors 52
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Sentynl acquires Eiger’s Zokinvy for progeria treatment

Pharmaceutical Technology

Sentynl Therapeutics has announced the acquisition of Zokinvy programme from Eiger BioPharmaceuticals for the treatment of progeria.

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Pharma Pulse 5/6/24: Tips to Rescue a Clinical Trial Before It’s Too Late, What You Need to Know About the UnitedHealth Hack & more

PharmExec

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

Pharma 52
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FDA Accepts Biologics License Application for Subcutaneous Formulation of Nivolumab

Pharmacy Times

The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients.

FDA 57
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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