Fierce Pharma

JULY 2, 2024

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

FDA 333

FDA 333

MedCity News

JULY 2, 2024

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

Competition 107

Competition FDA Patients Biopharma 107

Fierce Pharma

JULY 2, 2024

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

Medical 244

Medical Government 244

Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

Patients 111

Patients 111

Advertisement

Fierce Pharma

JULY 2, 2024

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

Biopharma 242

Biopharma 242

MedCity News

JULY 2, 2024

Primary care physicians are generally pretty optimistic about AI’s potential to make care delivery more efficient, according to new survey results. In the past few years, automated dictation and scribing tools were the AI technologies that have been most impactful for primary care providers. The post Why Are Primary Care Physicians Optimistic About AI?

Physicians 94

Physicians 94

MedCity News

JULY 2, 2024

The Supreme Court made several recent decisions that impact healthcare, including overturning the Chevron deference and upholding access to the abortion pill mifepristone. The post 3 Recent Supreme Court Decisions that Affect Healthcare appeared first on MedCity News.

Healthcare 92

Healthcare Healthcare 92

Fierce Pharma

JULY 2, 2024

In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.

Patients 222

Patients 222

pharmaphorum

JULY 2, 2024

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.

Medicine 91

Medicine Pharma Leads Marketing 91

Fierce Pharma

JULY 2, 2024

While certain other drugmakers have relented in the face of the U.S. | The FTC has launched an investigation into Teva over the Israeli-American drug giant's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents.

217

217

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

JULY 2, 2024

BARDA is contributing funding for a Phase 3 clinical test of a Moderna messenger RNA vaccine that could protect against the strains of bird flu virus now spreading in U.S. dairy cows. The Moderna vaccine is currently in Phase 1/2 testing. The post Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine appeared first on MedCity News.

Biopharma 91

Biopharma Pharma 91

Fierce Pharma

JULY 2, 2024

The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.

206

206

MedCity News

JULY 2, 2024

A multifaceted solution that involves three complementary and overarching strategies The post Transforming Hospital Discharge Processes Drives Better Patient Outcomes appeared first on MedCity News.

Patients 89

Patients 89

Fierce Pharma

JULY 2, 2024

As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. | As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.

Pharma 186

Pharma 186

Advertisement

Distribution

pharmaphorum

JULY 2, 2024

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

FDA 103

FDA Marketing 103

Fierce Pharma

JULY 2, 2024

It's been nearly seven years since former Mylan President Rajiv Malik was first implicated in an industrywide generic drug price-fixing investigation. | Mylan and its former president Rajiv Malik are no longer considered to be "subjects of interest" in a federal generic industry antitrust probe, Viatris said in a release. Mylan has since merged with another company to form Viatris.

176

176

Pharmaceutical Technology

JULY 2, 2024

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

95

95

Fierce Pharma

JULY 2, 2024

Just two months after telegraphing plans to lay off 641 staffers at two of its Massachusetts sites, Takeda is parting ways with another group of its workforce with more layoffs in the state. | Takeda will cut 220 staffers across two of its Massachusetts sites, while Merck KGaA's EMD Serono plans to lay off an unspecified number of employees as it moves its headquarters to the Boston area.

188

188

Advertisement

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

JULY 2, 2024

Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.

FDA 105

FDA Marketing 105

European Pharmaceutical Review

JULY 2, 2024

Researchers have developed a technique to optimise drug delivery using nanoparticles. They applied computer simulations based on blood flow dynamics, to investigate the effects of blood flow on the adhesion and retention of nanoparticle drug carriers. Studies investigating drug delivery via the bloodstream to diseased tissues “have been effective” when “using mouse models and in vitro tissue models”, yet these have used nanoparticles designed “mostly by trial and error”, the researchers emphasis

Engineering 80

Engineering Transportation Medicine Pharmaceutical 80

pharmaphorum

JULY 2, 2024

The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book

91

91

MedCity News

JULY 2, 2024

Health systems need to leverage new approaches to healthcare staffing to make sure patients receive the care they need, when and where they need it. The post Beating Healthcare Growth Challenges Depends on a New Nurse Staffing Approach appeared first on MedCity News.

Healthcare 73

Healthcare Healthcare Patients 73

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

PharmaTimes

JULY 2, 2024

Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children

88

88

pharmaphorum

JULY 2, 2024

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

Medicine 62

Medicine 62

PharmaTech

JULY 2, 2024

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA 64

FDA 64

PharmaTimes

JULY 2, 2024

According to WHO, around 15% of pregnant women will develop an obstetric complication

Medical science 89

Medical science Medical 89

Advertisement

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

Pharmaceutical Technology

JULY 2, 2024

Utilising innovative digital tools and access to real-time data, the pharmaceutical industry could offer invaluable support to the NHS’s preventative care mission.

Pharma 59

Pharma Pharmaceutical 59

PharmExec

JULY 2, 2024

Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies.

Patients 52

Patients 52

Pharmaceutical Technology

JULY 2, 2024

On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin gene-related proteins (anti-CGRP mAbs) to onabotulinumtoxinA (BoNT-A) for chronic migraine prevention.

52

52

PharmExec

JULY 2, 2024

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

Pharmacology 52

Pharmacology Safety Patients FDA 52

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