Fierce Pharma

FEBRUARY 12, 2024

Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection. But the first FDA-approved oral eosinophilic esophagitis therapy comes with a limitation.

FDA 259

FDA 259

Pharmaceutical Technology

FEBRUARY 12, 2024

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

142

142

Fierce Pharma

FEBRUARY 12, 2024

After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S. | After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.

FDA 253

FDA 253

MedCity News

FEBRUARY 12, 2024

By leveraging AI and machine learning, researchers can analyze complex data sets, identify novel biomarkers, and provide more effective and tailored treatment options for cancer patients.

Patients 114

Patients Medicine Biopharma 114

Advertisement

Distribution

Fierce Pharma

FEBRUARY 12, 2024

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. | Following a rejection in 2023, the FDA has accepted the resubmission of Xspray’s application for its leukemia candidate Dasynoc, which is seeking to dethrone Bristol Myers Squibb’s entrenched cancer blockbuster Sprycel (dasatinib).

FDA 233

FDA Pharma 233

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

FDA 110

FDA Leads Pharmaceutical Patients 110

MedCity News

FEBRUARY 12, 2024

The Payer Insights Program at ViVE 2024, in partnership with MedCity News, kicks off day one at the event. This new immersive program will focus on the impact of rising healthcare costs, recent regulatory changes, and innovative payer solutions for optimizing data insights, minimizing costs, and expanding access to care.

Healthcare 109

Healthcare Healthcare 109

Fierce Pharma

FEBRUARY 12, 2024

Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starti | Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starting to take shape.

Pharmaceutical 227

Pharmaceutical 227

MedCity News

FEBRUARY 12, 2024

Who do the California Office of Healthcare Affordability’s cost and market impact review regulations apply to? That depends on three questions, according to a recent webinar.

Healthcare 104

Healthcare Healthcare Marketing 104

Fierce Pharma

FEBRUARY 12, 2024

AbbVie has closed its $10.1 billion buyout of antibody-drug conjugate specialist ImmunoGen. | AbbVie has closed its $10.1 billion buyout of antibody-drug conjugate specialist ImmunoGen. And the good news from an industry perspective is that deal took less than three months to complete.

164

164

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

FEBRUARY 12, 2024

Today, many hope artificial intelligence will be the key that unlocks the value of digitization. Perhaps it will, but the claim that better technology will necessarily improve healthcare is no longer credible. Having lived in both analog and digital worlds, who better than us Oregon Trail doctors to help ensure digital health technologies best serve our workforce, patients, and communities?

Doctors 105

Doctors Healthcare Healthcare Patients 105

PM360

FEBRUARY 12, 2024

This February we celebrate the 16th annual Rare Disease Day , established in 2008, to raise awareness of the more than 7,000 identified rare diseases worldwide. Rare Disease Day is observed annually on the “rarest” day of the year, February 28th or 29th depending on leap years. Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and

Food and Drug Administration 105

Food and Drug Administration Patients Networking Transportation 105

MedCity News

FEBRUARY 12, 2024

Private equity is a way to help achieve scale. Groups that use scale to better serve the stakeholders that matter most, including radiologists, hospitals, referring physicians and—most importantly—patients, will be best positioned to not just survive, but thrive.

Physicians 100

Physicians Patients Healthcare Healthcare 100

pharmaphorum

FEBRUARY 12, 2024

Study finds that monitoring of rheumatoid arthritis patients with an Apple Watch and iPhone and AI algorithm improves on standard practices.

Patients 103

Patients 103

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

MedCity News

FEBRUARY 12, 2024

Acquiring CymaBay Therapeutics gives Gilead Sciences another drug for its liver disease portfolio. CymaBay’s molecule, seladelpar, is under FDA review for treating primary biliary cholangitis, a rare disease affecting the bile ducts of the liver.

FDA 95

FDA Biopharma Pharma 95

pharmaphorum

FEBRUARY 12, 2024

Gilead Sciences has beefed up its pipeline with an agreement to buy CymaBay Therapeutics and its seladelpar drug for primary biliary cholangitis (PBC) for $4.

89

89

MedCity News

FEBRUARY 12, 2024

With the many advantages of robotics, it is time for pediatric patients to garner the same attention and technology development that adult patients have benefitted from for decades.

Patients 96

Patients Physicians 96

pharmaphorum

FEBRUARY 12, 2024

GSK’s antisense-based drug for chronic hepatitis B, bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval

FDA 91

FDA 91

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

MedCity News

FEBRUARY 12, 2024

Adopting consumer strategies from leading retailers can give MA plans an edge in an increasingly competitive market filled with new entities while improving quality, reducing cost, and improving member loyalty.

Retail 82

Retail Management Competition Leads 82

pharmaphorum

FEBRUARY 12, 2024

Biotech giant CSL has seen almost 5% wiped off the value of its shares after one of its most anticipated pipeline products failed a phase 3 trial in heart attack patients

Patients 80

Patients 80

European Pharmaceutical Review

FEBRUARY 12, 2024

Researchers based in France have demonstrated a robust online Raman monitoring model for bioreactors, which combines Raman spectroscopy and machine learning (ML). In the study, the fermentation of alcohol by Saccharomyces cerevisiae ( S. cerevisiae) was used as a benchmark bioprocess. The method was validated across numerous batches and a fed-batch bioreactor.

Pharmaceutical 80

Pharmaceutical Management 80

Pharmaceutical Technology

FEBRUARY 12, 2024

The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.

95

95

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

PharmaTimes

FEBRUARY 12, 2024

The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359

Safety 113

Safety Patients Healthcare Healthcare 113

pharmaphorum

FEBRUARY 12, 2024

At its second attempt, Takeda has won FDA approval for Eohilia, the first and only oral therapy in the US for eosinophilic oesophagitis

FDA 66

FDA 66

PharmaTimes

FEBRUARY 12, 2024

The chip removes cells, which could become tumours, before they are implanted in a patient

Patients 101

Patients 101

PharmaVoice

FEBRUARY 12, 2024

Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.

FDA 59

FDA 59

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

PharmaTimes

FEBRUARY 12, 2024

The platform delivers digitalised patient data to improve clinical trials and development

Patients 100

Patients 100

Contrarian Sales Techniques

FEBRUARY 12, 2024

NAPSRx stands for the National Association of Pharmaceutical Sales Representatives®, and it's basically a cool club for folks who want to rock the pharmaceutical sales world. They offer this certification called CNPR, short for Certified National Pharmaceutical Representative, which is like a golden ticket if you're new to the scene or looking to step up your game in pharma sales.

Sales 52

Sales Pharma Pharmaceutical Sales Ethics 52

PharmaTimes

FEBRUARY 12, 2024

The projects will focus on healthcare in LMICs in the event of extreme weather

Healthcare 102

Healthcare Healthcare 102

ALULA

FEBRUARY 12, 2024

In today’s dynamic work environment, leaders who are goo d at prioritiz ing the total well-being of the workforce also help to improve key business metrics associated with job satisfaction, employee retention, customer loyalty , teamwork, safety, accuracy, and—of course—profitability in the long term.

Safety 52

Safety 52

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