Fierce Pharma

MAY 17, 2024

Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.

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Safety Medicine 271

MedCity News

MAY 19, 2024

Saint Luke’s Mid America Heart Institute launched a new solution on its care platform to help patients who have AFib or are at risk of developing the condition. The program, which was developed with digital health startup Story Health, seeks to engage patients between clinic visits. The post Saint Luke’s, Story Health Roll Out New AFib Program appeared first on MedCity News.

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Patients 94

Fierce Pharma

MAY 14, 2024

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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Patients 304

MedCity News

MAY 14, 2024

SmarterDx — an AI startup that provides clinical review and quality audits for medical claims — closed a $50 million Series B funding round, bringing its total funding to date to $71 million. The post SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue appeared first on MedCity News.

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Medical Healthcare Healthcare 126

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pharmaphorum

MAY 17, 2024

Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.

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FDA Medical Patients 109

Scott Burrows

MAY 17, 2024

As a keynote inspirational speaker, I’ve had the privilege of addressing audiences from various industries and backgrounds, but there’s something uniquely invigorating about speaking at sales and leadership conferences. Recently, I had the opportunity to kick off a sales conference for a broker dealer that had just been acquired by the largest independent broker dealer in the U.S.

Leads 104

Leads Sales conference Sales Management 104

MedCity News

MAY 16, 2024

The dangers of polypharmacy and its increasingly wide reach across the American population make it imperative that we enhance the accuracy and efficiency of medication reconciliation processes. The post It’s Past Time to Prevent Polypharmacy in U.S. Healthcare appeared first on MedCity News.

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Healthcare Healthcare Medical 122

pharmaphorum

MAY 14, 2024

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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Pharmaceutical Technology

MAY 16, 2024

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.

Pharmaceutical 98

Pharmaceutical 98

Pharmaceutical Commerce

MAY 17, 2024

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Distribution Biopharma Pharma Marketing 104

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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

Fierce Pharma

MAY 16, 2024

The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. | The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, Q1 came close to matching the final quarter of last year, when 21 of the top 25 companies showed increases.

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Biopharma Pharma 279

MedCity News

MAY 17, 2024

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

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FDA Biopharma Pharma 115

pharmaphorum

MAY 13, 2024

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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Marketing 117

Pharmaceutical Technology

MAY 16, 2024

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Oropharyngeal Cancer.

Pharmaceutical 98

Pharmaceutical 98

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

Integrity Solutions

MAY 14, 2024

For many in sales, negotiation is one of the most challenging aspects of the job. More often than not, these salespeople approach negotiation as a win-or-lose endurance game, a contentious battle that pits two opposing sides against each other. “Winning” means convincing the customer to accept your point of view—even if the outcome isn’t necessarily in the customer’s best interest.

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Sales Training 89

Fierce Pharma

MAY 14, 2024

A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. | With a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that a CDMO industry stabilization is playing out.

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Manufacturing Marketing 285

MedCity News

MAY 15, 2024

This year has been a messy one for virtual care companies, but that doesn’t mean that telehealth is dead, according to Eve Cunningham, Providence’s chief of virtual care and digital health. In her view, virtual care can definitely still be an important part of the care delivery model — but only if it is embedded into the greater healthcare delivery ecosystem.

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Healthcare Healthcare 114

pharmaphorum

MAY 14, 2024

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Safety

Pharmaceutical Technology

MAY 16, 2024

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Laryngeal Cancer.

Pharmaceutical 98

Pharmaceutical 98

Copyright Clearance Center

MAY 15, 2024

The post The Interplay Between Copyright Licensing and Exclusive Rights; AI Edition appeared first on Copyright Clearance Center.

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Fierce Pharma

MAY 14, 2024

It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.

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FDA Pharma 284

MedCity News

MAY 16, 2024

While adopting new technology is obviously a big part of healthcare innovation teams’ work, there are plenty of worthwhile initiatives that don’t involve advanced technologies, pointed out Dan Shoenthal, chief innovation officer at MD Anderson Cancer Center. The post Innovation Doesn’t Always Have To Involve The Latest Tech, MD Anderson Exec Says appeared first on MedCity News.

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

pharmaphorum

MAY 15, 2024

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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FDA 101

Pharmaceutical Technology

MAY 16, 2024

The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.

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Distribution 105

European Pharmaceutical Review

MAY 17, 2024

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union. The recommendation follows a review by the PRAC , which concluded that there is a “possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb.

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Medicine Safety Marketing Medical 75

Fierce Pharma

MAY 14, 2024

When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

pharmaphorum

MAY 15, 2024

House Oversight Committee passes BIOSECURE Act, which would restrict US companies from contracting with Chinese biotechs including WuXi AppTec, MGI and BGI

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Pharmaceutical Technology

MAY 16, 2024

Chenodiol is under clinical development by Leadiant Biosciences and currently in Phase II for Cerebrotendinous Xanthomatosis.

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European Pharmaceutical Review

MAY 17, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug received accelerated regulatory approval based on the “encouraging response rate and duration of response (DoR) observed in clinical studies,” Amgen said.

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Food and Drug Administration FDA Food Patients 74

Fierce Pharma

MAY 17, 2024

Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).

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FDA Medical Patients 254

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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