Fierce Pharma

OCTOBER 16, 2023

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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Sales 363

PharmaVoice

OCTOBER 19, 2023

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

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Patients 138

MedCity News

OCTOBER 15, 2023

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

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Impetus Digital

OCTOBER 20, 2023

Register for one of Impetus’ upcoming webinars between November 20-24: Digital Learning Programs with a Twist About the webinar Last year, we hosted a series of webinars on virtual learning programs. By popular demand, we are bringing them back in November, featuring all the new best practices, tips, and tricks that we’ve picked up in the last 12 months.

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Education Professional Services Training Healthcare Provider 115

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Fierce Pharma

OCTOBER 16, 2023

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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PharmaVoice

OCTOBER 17, 2023

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

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Pharmaceutical Technology

OCTOBER 18, 2023

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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FDA 145

Fierce Pharma

OCTOBER 18, 2023

Editor's Note: Please check back on Oct. 22 when the full data of EV-302 are presented at ESMO 2023. | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.

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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

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Food and Drug Administration FDA Food Safety 110

MedCity News

OCTOBER 18, 2023

Investing in Friction-reducing tactics such as community building and providing benefits, training, and personalized support to employees will yield compounding long-term benefits while reducing churn rate.

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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.

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Pharmaceutical Technology

OCTOBER 17, 2023

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

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Patients 111

Fierce Pharma

OCTOBER 17, 2023

Editor's note: This is an evolving story. Please check back on Oct. 23 when the full data of MARIPOSA are presented at ESMO 2023. | A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.

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European Pharmaceutical Review

OCTOBER 18, 2023

TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes. Data from the Phase III PROTECT clinical trial , presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. As the primary endpoint, 94.9 percent of participants in the TZIELD group maintained peak C-peptide levels ≥0.2 pmol/mL.

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Medicine Safety Patients Medical 108

MedCity News

OCTOBER 15, 2023

This year’s HLTH conference brought a bevy of news announcements — from partnerships to new product features to acquisitions and more. In this list, MedCity News compiled short summaries for 11 of the conference’s most notable announcements.

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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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Copyright Clearance Center

OCTOBER 18, 2023

Oct. 18, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider, announces Duncan Campbell has joined its Client Engagement and Business Development team as Executive Director. Campbell was most recently Senior Director, Global Sales Partnerships at John Wiley & Sons, where he led teams responsible for licensing and business development, agent relations, collective rights management, and permissions across the range of Wiley’s aca

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Leads Sales Management Marketing 105

Fierce Pharma

OCTOBER 17, 2023

If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.

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FDA 291

European Pharmaceutical Review

OCTOBER 20, 2023

A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.

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Pharmaceutical Management 107

MedCity News

OCTOBER 16, 2023

Microsoft rolled out several AI tools at the HLTH conference last week to enable providers to harness the power of data to be more efficient in their care delivery efforts. The overarching goal is to reduce costs, burnout and improve outcomes. Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly,

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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

PharmaTech

OCTOBER 18, 2023

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

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Fierce Pharma

OCTOBER 20, 2023

Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers. | Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers.

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Competition 270

European Pharmaceutical Review

OCTOBER 17, 2023

In final guidance , the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma. NICE’s recommendation coincides with the Medicines and Healthcare Products Regulatory Agency (MHRA) granting a licence for glofitamab” The bispecific monoclonal antibody (BsAb) treatment is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.

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Medicine Engineering Healthcare Healthcare 105

MedCity News

OCTOBER 18, 2023

FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.

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FDA Marketing Biopharma Pharma 121

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Pharmaceutical Technology

OCTOBER 18, 2023

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

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Medicine 114

Fierce Pharma

OCTOBER 18, 2023

Pfizer will cough up $2 million to settle allegations from the U.S. Department of Labor that it underpaid certain women who were employed at the company’s New York City headquarters. | The accusations centered on the company's compensation of 86 female employees in 2015 and 2016. Under the settlement with the Department of Labor, the company must also set aside $500,000 for potential future salary adjustments.

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Pharmaceutical Commerce

OCTOBER 18, 2023

These components take the burden off drug manufacturers to prep packaging components for sterilization, while helping to enhance the drug filling and packaging process.

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Manufacturing 103

MedCity News

OCTOBER 19, 2023

With its new handheld ultrasound device, Exo is seeking to take point-of-care ultrasound beyond just the emergency medicine field — into areas like urgent care, primary care and the home. Kurt Hammond, Exo’s chief commercial officer, said that the device sets itself apart from other handheld ultrasound devices, such as those sold by GE, Philips and Butterfly Network, because its AI does a better job of making the ultrasound process quick and easy for providers.

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Networking Medicine Medical Healthcare 118

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PharmaVoice

OCTOBER 16, 2023

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

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Fierce Pharma

OCTOBER 16, 2023

Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said. | Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.

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Marketing 263

European Pharmaceutical Review

OCTOBER 19, 2023

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany. There are differences in the appearance between the falsified pen and the original pen.

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Medicine Electronics Safety Manufacturing 96

MedCity News

OCTOBER 20, 2023

Access to oncology-specific interdisciplinary care delivered digitally by a team of nurses, mental health therapists, nutritionists, advanced practice providers, and oncologists is the best option for combatting pain points related to both cost and access.

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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.

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