September, 2024

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AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg

Fierce Pharma

AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.

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Digital Transformation in Healthcare: Mastering Efficiency and Innovation

Pharma IQ

Explore how digital transformation, particularly cloud technology and AI enhances efficiency and patient outcomes.

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The FTC Is Suing PBMs Over Insulin Prices. Will It Be Successful?

MedCity News

The Federal Trade Commission has sued CVS Caremark, Express Scripts and Optum Rx, alleging that they engage in “anticompetitive and unfair rebating practices” as it relates to insulin. One legal expert believes the FTC might win this legal battle. The post The FTC Is Suing PBMs Over Insulin Prices. Will It Be Successful? appeared first on MedCity News.

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China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

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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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*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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“PBMs favour high list prices”- Novo Nordisk CEO targets PBMs in US Senate hearing

Pharmaceutical Technology

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

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Behind the rise BMS’ KarXT, the first new schizophrenia drug in decades

PharmaVoice

KarXT’s approval demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.

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Providers and Payers Are Increasing Their Tech Spend — Where Are They Investing the Most?

MedCity News

Three-quarters of U.S. providers and payers say they have increased their IT spending over the past year, according to a new report from Bain & Company and KLAS Research. Both providers and payers are investing in cybersecurity technology, as well as AI tools. The post Providers and Payers Are Increasing Their Tech Spend — Where Are They Investing the Most?

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PBM strikes back at FTC over drug pricing report

pharmaphorum

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

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Digital Solution Implementation

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

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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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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

Marketing 340
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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

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J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing

Fierce Pharma

After putting on a strong performance in preventing disease progression in the earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’ Carvykti has once again mounted a maj | After putting on a strong performance in preventing disease progression, Johnson & Johnson and Legend Biotech’s Carvykti has once again demonstrated a major benefit—this time in prolonging patients’ lives.

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

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After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned

Fierce Pharma

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows

Fierce Pharma

After experiencing a series of ups and downs in recent years, the biopharma contracting business is gearing up for a rebound in 2025. | Ahead of the CPHI conference in Milan, the events group has teased new research signaling an expected rebound for the CDMO industry—and a rejection of the BIOSECURE Act.

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New migraine drugs less effective than previous generation of triptan meds: BMJ study

Fierce Pharma

A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

Fierce Pharma

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

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Sanofi, Regeneron look to seize major opportunity with Dupixent's COPD approval

Fierce Pharma

After more than a decade without any therapeutic advancements in chronic obstructive pulmonary disorder (COPD), people with the progressive disease suddenly have two new options, with more likely o | Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD. With the nod, Dupixent becomes the first biologic treatment for COPD patients in the U.S.

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Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Fierce Pharma

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals

Fierce Pharma

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Novo Nordisk CEO prepares to defend Ozempic, Wegovy US pricing at Senate hearing

Fierce Pharma

After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.

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In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Fierce Pharma

Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

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GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales

Fierce Pharma

This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

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AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease

Fierce Pharma

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

Fierce Pharma

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

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ESMO: Even after unique trial win, Incyte CEO views PD-1 drug Zynyz as pipeline aide

Fierce Pharma

Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.

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Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

Fierce Pharma

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.

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Bluebird bio lays off 25% of workforce as gene therapy pioneer struggles to stay afloat

Fierce Pharma

After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%. | After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%, or nearly 100 employees.

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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