Thu.Mar 07, 2024

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Boehringer Ingelheim cuts monthly out-of-pocket inhaler prices to $35 for US patients

Fierce Pharma

As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.

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Answering 7 Key Questions About Change Healthcare’s Cyberattack

MedCity News

The aftermath the cyberattack on Change Healthcare remains messy, with patients across the country still struggling to obtain their prescriptions. The federal government has even stepped in to help address the fallout of the attack, urging payers to quickly alleviate the digital bottlenecks that providers and pharmacies are facing.

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Trending Sources

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After withdrawal, GSK touts another Blenrep combo win as analysts build blockbuster case for the myeloma ADC

Fierce Pharma

GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. | GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. And analysts are already assigning blockbuster sales figures to the medicine.

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Blue Shield of California CEO on PBM Shakeup: ‘It’s Going to Become the Norm’

MedCity News

During a fireside chat hosted by MedCity News at ViVE, Blue Shield of California CEO Paul Markovich discussed the company’s decision to largely move away from CVS Caremark as its PBM and partner with several other companies.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

Fierce Pharma

With the swelling popularity of Eli Lilly’s diabetes med Mounjaro and its weight loss counterpart Zepbound, unauthorized copycats continue to emerge, posing a growing safety risk. | The company republished an open letter reiterating its commitment to taking legal action against scam sellers after discovering bacteria and impurities in some of the fraudulent meds.

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Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

MedCity News

Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed.

Biopharma 117

More Trending

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Sleep Meds Don’t Work for 9 out of 10 People with Chronic Insomnia – Here’s What Does

MedCity News

As we approach Sleep Awareness Week® 2024, which emphasizes the importance of sleep as a major contributor to a person’s overall health, it is also an important reminder to prioritize getting enough quality sleep.

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Despite pharma growth, Merck KGaA's CDMO slowdown plays into company's overall sales decline

Fierce Pharma

After posting revenue increases for six straight years, including double-digit growth in 2021 and 2022, Merck KGaA took a hard fall last year, with its global sales

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Cellares Innovates With Automated Cell and Gene Therapy Platform

PharmaTech

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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Fierce Pharma Asia—Eisai's Leqembi outlook; Sumitomo's downsizing; Kyowa Kirin's expansion

Fierce Pharma

In separate updates from Japanese drugmakers, Eisai presented new projections for its Biogen-partnered Alzheimer's disease med Leqmebi, while Sumitomo Pharma initiated a round of layoffs | Eisai presented updated projections for Alzheimer's disease drug Leqembi. Sumitomo Pharma initiated a round of layoffs in the U.S. Kyowa Kirin is building a new biologics facility in North Carolina.

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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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Navigating the Current Funding Slowdown While Securing Capital

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, discusses the biggest roadblocks to the widespread adoption of novel modalities, and how new biotech companies can navigate the current funding slowdown while securing the capital crucial for their success.

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UK manufacturing and R&D to benefit from new £360m investment

European Pharmaceutical Review

On 4 March, ahead of the Spring Budget , the UK Chancellor of the Exchequer, Jeremy Hunt, announced a significant investment package for the UK life sciences and manufacturing sectors. A total of £360 million is set to boost UK manufacturing and R&D. Joint government and industry investment of £92 million will help to expand facilities to manufacture life-saving medicines and diagnostics products.

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Gilead and MSD say weekly oral therapy controls HIV

pharmaphorum

Gilead and MSD showcase once-weekly oral HIV regimen at CROI congress, as ViiV presents new data on injectable Cabenuva in patients with low adherence to daily oral therapy

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Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing

European Pharmaceutical Review

A paper published in Frontiers in Microbiology has described an innovative strategy for microbial identification and contamination investigation during sterile manufacturing of drugs. The approach utilised matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for microbial identification. Over a period of three months, two hundred ninety-two samples were collected covering multiple critical components of raw materials, personnel, environment, and production

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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GSK scores again with Blenrep in multiple myeloma

pharmaphorum

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug conjugate (ADC), given in a regimen with pomalidomide plus dexamethasone (PomDex), was shown to be more effective at preventing disease progression or death than Johnson & Johnson’s $10 billion-a-year anti-CD38 antibody Darzalex (daratumumab) with PomDex in the head-to-head DREAMM-8 trial.

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Indian Institute based research boosting pharmaceutical industrial R&D and revenue

Pharmatutor

Indian Institute based research boosting pharmaceutical industrial R&D and revenue admin Thu, 03/07/2024 - 14:23 Pharmaceutical research conducted by institutes plays a crucial role in boosting industrial research and development (R&D) in the pharmaceutical sector. These institutes, often affiliated with universities or independent research organizations, contribute significantly to advancing scientific knowledge, discovering new drugs, and fostering innovation.

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Final Analytical Procedures Guidance Published

PharmaTech

FDA has published final guidance documents regarding validation and development of analytical procedures.

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UK access disparity resolved as NICE backs RCC therapy

pharmaphorum

NICE decision on Ipsen’s Cabometyx and MSD’s Keytruda in first-line kidney cancer ends a disparity in access within the UK.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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NHS to ensure people eligible for very high-risk breast screening are referred

PharmaTimes

Secondary breast cancer is an important risk factor after receiving radiotherapy for Hodgkin lymphoma

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Boundless Bio files IPO, and other biotech financings

pharmaphorum

Boundless Bio made a play to become the seventh US biotech to seek a public listing in 2024, ending a brief hiatus in IPO activity after a busy start to the year.

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US researchers develop algorithm test to identify aggressive ovarian cancers

PharmaTimes

Ovarian high-grade serous carcinoma is the most common form of aggressive ovarian cancer

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J&J’s growing rare disease focus brings a potential multi-use treatment to the table

PharmaVoice

The head of J&J’s autoantibody programs believes nipocalimab is unique among potential rare disease drugs because it can harness a common thread among them.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Pharma Pulse 3/7/24: Rite Aid Enters into APA, S.E.C. Investigates OpenAI & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Sionna raises $182m to double down in cystic fibrosis drug development

Pharmaceutical Technology

Sionna could have four candidates in clinical trials in 2024, amidst a cystic fibrosis landscape that is dominated by Vertex.

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Overcoming Veteran Employment Hurdles: Webinar with AdvaMed

MedTechVets

On January 31st we co-hosted a live webinar with AdvaMed titled “Overcoming Veteran Employment Hurdles” We had 30 participants register for the event where our three Med Tech industry panelists talked about the need for understanding how instrumental and valuable military service is, to continue to propel companies forward. Military service members and Veterans are often faced with an uphill battle as they transition to the civilian world.

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Gilead and Merus enter trispecific antibody discovery deal

Pharmaceutical Technology

Gilead Sciences has entered an agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

PharmExec

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

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FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

Legacy MEDSearch

On March 5, the U.S. Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Following this announcement, Dexcom’s shares experienced a 2.2% increase in extended trading. Known as Stelo , this device is tailored for individuals aged 18 and older who do not require insulin, who are managing diabetes via oral medications or individuals without diabetes seeking to understand how diet an

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The Biggest Challenges Facing Broader Adoption of Novel Cell and Gene Therapies

PharmExec

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses the biggest challenges facing the broader adoption of novel cell and gene therapies from IQVIA's Global Trends in R&D 2024 report.

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Why Paper Forms Aren’t Cutting it in 2024

Penrod

Digital patient forms offer a superior solution for the healthcare sector, swiftly supplanting traditional paperwork. Here’s why. Paper Forms are Inefficient Manually filling out, sorting, and storing paper forms is a time-consuming task that hampers the efficiency and productivity of healthcare professionals. Each form requires a significant amount of time to complete, followed by the need for manual transcription.

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Accelerating Clinical Supply Through Integrated Drug Development

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.