Fierce Pharma

SEPTEMBER 18, 2024

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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Authentic Influence Group

SEPTEMBER 16, 2024

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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MedCity News

SEPTEMBER 18, 2024

By acquiring Dermavant, Organon gets Vtama, a drug approved for treating plaque psoriasis. An FDA decision for the topical cream in atopic dermatitis is expected by the end of 2024. The post Organon Gets More Skin in the Game by Acquiring Roivant’s Dermatology Subsidiary appeared first on MedCity News.

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Pharmaceutical Technology

SEPTEMBER 19, 2024

An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.

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Fierce Pharma

SEPTEMBER 19, 2024

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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pharmaphorum

SEPTEMBER 18, 2024

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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Pharmaceutical Technology

SEPTEMBER 16, 2024

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

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Fierce Pharma

SEPTEMBER 20, 2024

The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.

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pharmaphorum

SEPTEMBER 15, 2024

Women with HER2-positive breast cancer can be treated with AstraZeneca and Daiichi Sankyo's Enhertu, regardless of whether their cancer has spread to the brain, according to a new study.The results of the open-label DESTINY-Breast12 trial – reported at the ESMO cancer congress in Barcelona – showed that nearly two-thirds (61.6%) of patients with brain metastases at baseline who were treated with the HER2-directed antibody-drug conjugate (ADC) were alive without disease progression at one year.

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MedCity News

SEPTEMBER 19, 2024

During a panel discussion at MedCity News’ INVEST Digital Health conference, three healthcare leaders shared their expert insight on what needs to change in order to improve the industry’s cybersecurity strategy. The post What Will It Take to Improve Healthcare Cybersecurity? appeared first on MedCity News.

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Healthcare Healthcare 115

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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.

Safety

Pharmaceutical Technology

SEPTEMBER 18, 2024

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

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Fierce Pharma

SEPTEMBER 18, 2024

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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pharmaphorum

SEPTEMBER 17, 2024

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.

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FDA 90

MedCity News

SEPTEMBER 19, 2024

Months after 23andMe CEO Anne Wojcicki publicly stated she wants to take the company she co-founded private, all of the company’s independent board directors have resigned. The board letter to Wojcicki stated that its members preferred resigning over continuing to have a difference of view over the direction of the company. The post Mass Board Exodus at 23andMe Leaves Company With Tough Decisions Ahead appeared first on MedCity News.

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Advertiser: ZoomInfo

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

Competition

Pharmaceutical Technology

SEPTEMBER 18, 2024

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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Fierce Pharma

SEPTEMBER 18, 2024

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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Sales 261

pharmaphorum

SEPTEMBER 15, 2024

GSK, iTeos TIGIT drug belrestotug shows efficacy in PD-L1-high NSCLC trial at ESMO, giving some positive news for the beleaguered class

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MedCity News

SEPTEMBER 16, 2024

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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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.

FDA

Pharmaceutical Technology

SEPTEMBER 16, 2024

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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Fierce Pharma

SEPTEMBER 17, 2024

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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pharmaphorum

SEPTEMBER 20, 2024

Astellas is ready to launch its first digital health product in the US, called Digitiva, which provides at-home monitoring of people with heart failure

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MedCity News

SEPTEMBER 18, 2024

While fibrates are proven to lower triglyceride levels, which can serve as a biomarker for cardiovascular disease risk, several major clinical studies from the past 20 years have failed to show a benefit of fenofibrates over and above statins in further reducing heart-related events. The post Millions are Taking a Drug that Falls Short of its Promise to Lower Risk of Heart Attack appeared first on MedCity News.

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Pharmaceutical Technology

SEPTEMBER 16, 2024

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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Fierce Pharma

SEPTEMBER 19, 2024

Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma. | Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.

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Pharma 239

pharmaphorum

SEPTEMBER 16, 2024

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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FDA 95

MedCity News

SEPTEMBER 19, 2024

Doctor’s offices are the front door of the American healthcare system. We owe it to them to support H.R. 2474 and put an end to annual Congressional stop-gap spending bills. The post Medicare Reimbursement for Doctors is in Critical Condition appeared first on MedCity News.

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Safety

Pharmaceutical Technology

SEPTEMBER 16, 2024

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

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Fierce Pharma

SEPTEMBER 20, 2024

Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC). | Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC).

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pharmaphorum

SEPTEMBER 16, 2024

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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Patients 91

MedCity News

SEPTEMBER 20, 2024

Many are already experimenting with AI in narrow settings. But in order to expand deployment, it’s important to understand the most practical AI opportunities with the greatest ROI. Here are four high-impact opportunities that can boost staff efficiency and improve the patient experience. The post From Charting to Patient Intake: The 4 Biggest Opportunities for AI in Healthcare appeared first on MedCity News.

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Advertiser: ZoomInfo

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

Marketing