Fierce Pharma

SEPTEMBER 24, 2024

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.

Manufacturing 296

Manufacturing Pharmaceutical 296

pharmaphorum

SEPTEMBER 24, 2024

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.

Leads 116

Leads Patients 116

Fierce Pharma

SEPTEMBER 24, 2024

After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.

Healthcare 268

Healthcare Healthcare 268

MedCity News

SEPTEMBER 24, 2024

The integration of AI into mental healthcare is more advanced than many realize because it’s not always obvious; frequently, it’s providing support to free up clinicians to spend more time with their patients or to get more patients into treatment. The post How AI Humanizes Mental Healthcare appeared first on MedCity News.

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Healthcare Healthcare Patients 105

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Fierce Pharma

SEPTEMBER 24, 2024

Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. | PCI has “heavily invested” in new drug delivery tech at its Philadelphia headquarters, laid plans for a 545,000-square-foot expansion in Rockford, Illinois, acquired a new packaging and device assembly plant near Dublin, Ireland, and broken ground on another at its CityNorth Dublin campus.

Manufacturing 222

Manufacturing Pharma 222

MedCity News

SEPTEMBER 24, 2024

Carrot Fertility has partnered with Priority Health to offer two design solutions for fully-funded and self-funded employer groups. These solutions include support for fertility treatment, pregnancy, postpartum care, gestational surrogacy, adoption, menopause and low testosterone. The post Carrot Fertility, Priority Health Strike Partnership for Reproductive Health Support appeared first on MedCity News.

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Pharmaceutical Technology

SEPTEMBER 24, 2024

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

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Fierce Pharma

SEPTEMBER 24, 2024

The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol | The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb, Merck & Co. and BeiGene.

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FDA Patients 203

pharmaphorum

SEPTEMBER 24, 2024

Roche launches 12 in one test for respiratory virus, using its 'revolutionary' TAGS tech, that can be used in regular clinical labs

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Fierce Pharma

SEPTEMBER 24, 2024

Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the c | Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.

Marketing 223

Marketing 223

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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 24, 2024

The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).

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Fierce Pharma

SEPTEMBER 24, 2024

As CDMOs across the industry continue to face pressure from a fluctuating biopharma business environment, AGC Biologics is charting another round of staff cuts and pumping the brakes at one of its | As part of the new restructuring push, AGC will lay off 68 employees at its cell and gene therapy plant in Longmont, Colorado, 17 employees at its commercial mammalian plant in Boulder, Colorado, and 10 employees in Bothell, Washington, according to a Worker Adjustment and Retraining Notification ale

Biopharma 202

Biopharma 202

MedCity News

SEPTEMBER 24, 2024

Many great ideas fail because of a fundamental misunderstanding or underestimation of the unique barriers entrenched within healthcare. Here are some key considerations that innovators from non-healthcare backgrounds need to be prepared for. The post The Long Road to Adoption: What Founders Need to Know Before Breaking into Health Tech appeared first on MedCity News.

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Healthcare Healthcare FDA 86

Fierce Pharma

SEPTEMBER 24, 2024

When government officials and politicians scrutinize high U.S. drug prices, the role of insurers and pharmacy benefit managers (PBMs) often commands at least some of the attention. | At the Senate committee hearing on Novo Nordisk's prices for Ozempic and Wegovy, debate around insurance coverage and pharmacy benefit managers took up much of the conversation.

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Insurance Government Management 167

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MedCity News

SEPTEMBER 24, 2024

Vertex Pharmaceuticals is known for its cystic fibrosis drugs, but the company aims to diversify with a pipeline that reaches more therapeutic areas. CEO Reshma Kewalramani explained Vertex’s strategy during the World Medical Innovation Forum in Boston. The post Pain Meds, Cell Therapies & More: Vertex Pharma CEO Talks About What’s Next After Cystic Fibrosis appeared first on MedCity News.

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Pharma Pharmaceutical Medical Biopharma 85

Pharmaceutical Technology

SEPTEMBER 24, 2024

The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.

Pharma 98

Pharma Marketing 98

pharmaphorum

SEPTEMBER 24, 2024

UCB and Biogen say their first phase 3 trial of their systemic lupus erythematosus (SLE) candidate dapirolizumab pegol was a success, and a second is now expected to start before the end of the year.Data from the PHOENYCS GO study in moderate to severe SLE patients isn't available yet, but the partners say dapirolizumab pegol achieved a "clinical improvement" in the primary and secondary endpoints, including measures of disease activity and flares.

Patients 76

Patients 76

Pharmaceutical Technology

SEPTEMBER 24, 2024

Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.

Manufacturing 104

Manufacturing 104

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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

pharmaphorum

SEPTEMBER 24, 2024

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory pilot.

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Medical Medicine Healthcare Healthcare 64

Pharmaceutical Technology

SEPTEMBER 24, 2024

Discover the leading Pharmaceutical Packaging Companies, Suppliers & Solutions. Download the free Buyer's Guide today for full details.

Pharmaceutical 88

Pharmaceutical Manufacturing Leads 88

MedCity News

SEPTEMBER 24, 2024

Less than a year after its launch, microbiome profiling startup Jona has already given its user interface a makeover as a result of the user feedback it received. If you’re running a successful consumer- or patient-facing startup, acting on user feedback in a timely manner is “absolutely essential,” said Jona CEO Leo Grady. The post Listening to End Users Is Essential — Here’s How One Digital Health Startup Used Feedback to Revamp Its Platform appeared first on MedCity News.

Patients 66

Patients 66

PharmaVoice

SEPTEMBER 24, 2024

Alicia Zhou brings startup bona fides to the nonprofit Cancer Research Institute to promote defragmentation of the cancer research effort.

Biopharma 72

Biopharma 72

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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

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Healthcare Success

SEPTEMBER 24, 2024

AI is flooding the internet with low-quality healthcare content that hasn’t been medically reviewed for accuracy. While this can (and should) be viewed as a big problem, it’s also a unique opportunity for hospitals and healthcare systems to stand out as trusted patient resources. We recently sat down with Ed Bennet, Founder of MarTech.Health and a respected voice in healthcare marketing, to discuss how hospitals can use AI tools strategically to outrank unverified AI content.

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Medical Healthcare Healthcare Physicians 58

pharmaphorum

SEPTEMBER 24, 2024

EU follows Japan and GB in approving Astellas' claudin 18.

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eMediWrite

SEPTEMBER 24, 2024

Marketers in the fiercely competitive pharmaceutical sector of today face a particular difficulty: cutting through the harsh din of a crowded market. Pharma marketers must use innovative, strategic, and data-driven approaches to differentiate their brand from the many others competing for consumers’ attention. These are 5 top strategies for making a name for yourself in the congested pharmaceutical market.

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Marketing Pharma Ethics Healthcare 52

PharmaTech

SEPTEMBER 24, 2024

The next-generation IRO platform was found to significantly outperform the legacy Prodigy system, showing improvements in cell growth, CAR+ cell yield, and overall efficiency.

Manufacturing 52

Manufacturing 52

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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

Referral MD

SEPTEMBER 24, 2024

Healthcare has come a long way since doctors made house calls and gave out lollipops to children. Artificial Intelligence (AI) now plays a vital role in helping people find healthcare solutions. One significant factor in determining a city’s quality of life is its access to healthcare. AI Chatbots that connect people to care, whether in urban or rural areas, will improve quality of life, patient engagement, and access to care.

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Healthcare Healthcare Patients Doctors 52

ALULA

SEPTEMBER 24, 2024

Ever feel like you're running on empty? Like you've given 110% to everything and everyone, but somehow, it's still not enough? Welcome to the club, fellow leaders. We've all been there, and let's face it—burnout is a real B.

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Pharmaceutical Commerce

SEPTEMBER 24, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Mark Karhoff, supply chain & DSCSA consultant, National Association of Boards of Pharmacy, discusses the NABP's PULSE program and how it will support supply chains.

Consulting 52

Consulting Pharma 52

European Pharmaceutical Review

SEPTEMBER 24, 2024

The European Microbiome Innovation for Health ( EMIH ) and the Microbiome Therapeutics Innovation Group ( MTIG ) have agreed to collaborate to advance the development of microbiome -based products and drugs, broadening patient access to approved microbiome therapeutics. A key priority of the agreement is harmonising regulatory frameworks from different regions, so that a broad range of perspectives are collated.

Pharma 52

Pharma Pharmaceutical Patients Medical 52

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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.

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