Mon.Sep 16, 2024

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Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim

Fierce Pharma

Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat. | Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.

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*EVENT* The Silent Edge: October 9 in NYC

Authentic Influence Group

The Silent Edge: How Body Language and Communication Skills Shape Leadership Success October 9, 2024 | 8:00 AM | NYC Free Event | Limited to 30 Seats Enjoy a Breakfast Bagel | Take in the NYC Skyline | Master Leadership Through Body Language Harness the power of what’s not being said. Join Shelly O’Donovan to master body language that transforms your leadership presence, influences decisions, and builds stronger teams.

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Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss

Fierce Pharma

Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. | Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss, or lebrikizumab, to treat atopic dermatitis.

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We’re Overcomplicating Healthcare AI — Here’s How We Achieve Impact Beyond The Hype

MedCity News

It’s important that we focus attention on the areas where AI is already having a significant impact. These are the practical applications that will allow the best and brightest researchers to focus on science rather than data munging. The post We’re Overcomplicating Healthcare AI — Here’s How We Achieve Impact Beyond The Hype 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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ESMO: Despite survival miss, Exelixis presses on with FDA prostate cancer bid as Ipsen scraps EU plan

Fierce Pharma

The same set of clinical data on Cabometyx and Tecentriq in prostate cancer has led to two distinct regulatory plans between Exelixis and its partner Ipsen. | The same set of clinical data on Cabometyx and Tecentriq in prostate cancer has led to two distinct regulatory plans between Exelixis and its partner Ipsen.

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New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds

MedCity News

Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020. The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds appeared first on MedCity News.

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After the Lykos debacle, what’s next for psychedelic therapies?

Pharmaceutical Technology

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

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AbbVie faulted for misleading ad featuring Serena Williams

pharmaphorum

FDA raps AbbVie for 'misleading' ad for migraine drug Ubrelvy featuring tennis star Serena Williams

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Providence Health Plan, American Heart Association Launch Cardiovascular Health Initiative

MedCity News

Providence Health Plan and the American Heart Association will create blood pressure programs in 20 community organizations and clinics over three years. The post Providence Health Plan, American Heart Association Launch Cardiovascular Health Initiative appeared first on MedCity News.

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ESMO: Pfizer drug helps cancer patients gain weight

pharmaphorum

Pfizer's anti-GDF-15 antibody ponsegromab was able to achieve weight gain in cancer patients with cachexia in a phase 2 trial presented at ESMO

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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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Where is Pediatric Innovation Making an Impact?

MedCity News

Pediatric innovation in mental health is the theme of the INVEST Digital Health Pitch Perfect contest at Pegasus Park in Dallas on September 18. The post Where is Pediatric Innovation Making an Impact? appeared first on MedCity News.

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ESMO: NIAGARA backs Imfinzi in bladder cancer, but will FDA?

pharmaphorum

AstraZeneca reveals 'practice changing' data for Imfinzi as peri-operative therapy for bladder cancer, but will the FDA accept the study?

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A Crystal Ball for Cancer Survivors

MedCity News

This test can be thought of as a crystal ball for cancer survivors and research has found it can predict with near certainty whether a patient’s cancer will recur. So why aren’t more patients getting the test? The post A Crystal Ball for Cancer Survivors appeared first on MedCity News.

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Support app for young cancer patients launches in UK

pharmaphorum

Rates of cancer among people aged 24 and below are rising fast, but health systems are often not catering well enough to the specific needs of this age group.A new partnership has been set up between the Ella Dawson Foundation, a UK-based charity for young people with cancer, and digital cancer care company Careology to try to tackle that deficit and improve their treatment and wellbeing.

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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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WHO adds first mpox vaccine to prequalification list

PharmaTimes

The decision is expected to facilitate timely access to Bavarian Nordic’s Imvanex

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Boehringer seeks approval for lung fibrosis drug following Phase III win

Pharmaceutical Technology

The Phase III trial evaluating nerandomilast as a treatment for idiopathic pulmonary fibrosis met its primary endpoint.

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Agility in action: 5 ways to fast-track your clinical trial

PharmaVoice

Five ways to beat study timeline pressures and get medicines to patients faster.

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Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older

Pharmaceutical Technology

Eli Lilly and Company has announced the FDA approval of EBGLYSS for treating atopic dermatitis in adults and children over 12.

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

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ESMO: J&J cues up phase 3 for Rybrevant in colorectal cancer

pharmaphorum

J&J plans phase 3 trials for Rybrevant in colorectal cancer, after reporting positive results for the METxEGFR bispecific antibody at ESMO

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FDA approves Roche’s Ocrevus Zunovo with Halozyme Enhanze delivery tech

Pharmaceutical Technology

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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ESMO: Incyte's PD-1 treads new ground in anal cancer

pharmaphorum

Incyte's first attempt to get FDA approval for its PD-1 inhibitor Zynyz for squamous cell carcinoma of the anal canal (SCAC) was knocked back by the FDA, but new data could get the programme back on track.Zynyz (retifanlimab) is a late entrant to the PD-1/PD-L1 category but picked up its first approval in the rare tumour Merkel cell carcinoma last year.

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Not Your Average Bra: How Bloomer Tech’s Wearable Is Addressing Heart Disease in Women

MedCity News

MIT spinout Bloomer Tech is developing a wearable electrocardiogram device designed to look and feel like a bra. The post Not Your Average Bra: How Bloomer Tech’s Wearable Is Addressing Heart Disease in Women 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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Biopharma prepares to pivot from China as Biosecure Act advances

PharmaVoice

After the House of Representatives passed the Biosecure Act last week, U.S. biotechs could be forced to cut ties with five Chinese contract partners.

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Sanofi Gears Up for RSV Season, Begins Shipping Beyfortus

Pharmaceutical Commerce

The manufacturing line producing the company’s branded form of nirsevimab-alip has been approved by the FDA.

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The hunt for game-changers against the deadliest form of brain cancer

PharmaVoice

Treatments for glioblastoma have fallen short in the face of difficult challenges, but the pipeline is full of renewed attempts.

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The DETECT V Trial: Exploring Chemotherapy-Free Treatment for HER2+/HR+ Metastatic Breast Cancer

Pharmacy Times

Data from the second interim analysis of the DETECT V trial, presented at ESMO Congress 2024, suggest that a chemotherapy-free regimen combining dual HER2-targeted therapy with endocrine therapy, particularly with the addition of ribociclib, may be an effective treatment for patients.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ESMO 2024: Keytruda is key to first-line treatment of HER2+ mGEJ adenocarcinoma

Pharmaceutical Technology

Despite positive KEYNOTE-811 results, Merck & Co’s position in this setting is not devoid of threats from other competitors.

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FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis

PharmExec

Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.

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Disease modifiers may take over PAH landscape, says Cereno CEO

Pharmaceutical Technology

As more drugs approach late-stage development for PAH, Cereno Scientific’s CEO expects more successful disease-modifying therapies.

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FDA Approves Ocrevus Zunovo for Relapsing, Primary-Progressive Multiple Sclerosis

PharmExec

Ocrevus Zunovo is the first and only twice-yearly, 10-minute subcutaneous injection for treating both relapsing multiple sclerosis and primary-progressive multiple sclerosis.

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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