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.

Safety 247

Safety Medicine 247

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.

FDA 112

FDA Biopharma Pharma 112

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.

Patients 283

Patients 283

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.

Medical 126

Medical Healthcare Healthcare 126

Advertisement

Distribution

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

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.

FDA 103

FDA Medical Patients 103

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

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.

Marketing 112

Marketing 112

Pharmaceutical Commerce

MAY 17, 2024

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

Distribution 104

Distribution Biopharma Pharma Marketing 104

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.

FDA 258

FDA Pharma 258

Advertisement

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

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.

Healthcare 113

Healthcare Healthcare Medical 113

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

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).

100

100

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.

Sales 89

Sales Training 89

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

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.

255

255

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.

Healthcare 114

Healthcare Healthcare 114

Pharmaceutical Technology

MAY 16, 2024

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

Distribution 105

Distribution 105

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

FDA 98

FDA 98

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

Copyright Clearance Center

MAY 15, 2024

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

98

98

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.

Biopharma 241

Biopharma Pharma 241

MedCity News

MAY 14, 2024

Healthcare devices must be exempted from general right to repair legislation. The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News.

Safety 112

Safety Healthcare Healthcare 112

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 95

Pharmaceutical 95

Advertisement

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

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

99

99

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.

Medicine 74

Medicine Safety Marketing Medical 74

Fierce Pharma

MAY 13, 2024

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.

253

253

MedCity News

MAY 13, 2024

The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry. The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? appeared first on MedCity News.

Healthcare 113

Healthcare Healthcare 113

Advertisement

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

Pharmaceutical Technology

MAY 16, 2024

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

98

98

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

97

97

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.

Food and Drug Administration 73

Food and Drug Administration FDA Food Patients 73

Fierce Pharma

MAY 15, 2024

Though Galapagos has undergone plenty of staff shakeups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following | Galapagos has teamed up with the largest blood supply network in the U.S. to help establish decentralized CAR-T production on a national scale.

Manufacturing 237

Manufacturing Networking 237

Advertisement

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.

Management