Fierce Pharma

JANUARY 24, 2024

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.

Safety 228

Safety FDA 228

European Pharmaceutical Review

JANUARY 24, 2024

The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. AI/ML is predicted to be the top technology investment for 60 percent of life sciences companies over the next two years, according to a recent survey 1 from the Pistoia Alliance.

Pharma 127

Pharma Pharmaceutical manufacturing Manufacturing Pharmaceutical 127

Fierce Pharma

JANUARY 24, 2024

It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgoci | It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgocitinib to treat atopic dermatitis. Slowly but surely, Denmark’s Leo Pharma—which gained the rights to develop and commercialize delgocitinib in the rest of the world a decade ago—is working toward its first green light for the topical cream.

Pharma 202

Pharma Patients 202

MedCity News

JANUARY 24, 2024

After experiencing firsthand the shortcomings of existing public and private programs to treat children’s developmental delays, Jen Wirt founded a startup called Coral Care. The company, which announced its official launch on Tuesday, brings pediatric developmental specialty care into families’ homes.

111

111

Advertisement

Distribution

Fierce Pharma

JANUARY 24, 2024

Another prostate cancer trial has hit its main goal, and yet the drug developer can’t immediately file for an FDA approval. | In a similar pattern as Novartis' radiotherapy Pluvicto, Exelixis now has positive prostate cancer data for a combination of Cabometyx and Roche's Tecentriq, and yet the drug developer can't immediately file for an FDA approval.

FDA 177

FDA 177

pharmaphorum

JANUARY 24, 2024

CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.

131

131

MedCity News

JANUARY 24, 2024

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy.

Pharmaceutical 106

Pharmaceutical Biopharma Pharma 106

Fierce Pharma

JANUARY 24, 2024

Over the years, myriad generic drugmakers have had to ante up fines and settlement fees for allegedly colluding on the prices of copycat drugs. | Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017.

164

164

MedCity News

JANUARY 24, 2024

By partnering with a cloud managed service provider, one can overcome cloud staffing and security issues and better align internal resources with the things that make your business special, like developing new apps and features that enhance healthcare services and improve health outcomes for end users.

Management 102

Management Healthcare Healthcare Specialization 102

Fierce Pharma

JANUARY 24, 2024

Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Contr | Dangerously low levels of blood sugar—attributed to potentially counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters.

154

154

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

JANUARY 24, 2024

Virtual reality reduces the cost of training while also improving learning efficiency and knowledge retention. It’s not just universities and medical students that are embracing VR technology for learning. I travel all over the world to work with healthcare teams implementing VR and have observed, that a growing number of hospitals are using it for continuing education.

Healthcare 102

Healthcare Healthcare Education Training 102

PharmaTech

JANUARY 24, 2024

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

Biopharma 98

Biopharma Manufacturing 98

MedCity News

JANUARY 24, 2024

Cherish Health recently launched Cherish Serenity, a device that sits in the home and can detect falls across multiple rooms. If there is an emergency, it will notify a caregiver or response center for help.

Safety 101

Safety 101

PharmaVoice

JANUARY 24, 2024

Executives on the healthcare giant’s full-year earnings call highlighted a strong cash position and incremental dealmaking as a way to get past incoming competition.

Competition 98

Competition Healthcare Healthcare 98

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

JANUARY 24, 2024

In 61% of counties with a PCP shortage, there is a high volume of retail pharmacies. It reveals an opportunity for pharmacists, who have the education and training, and are already providing vaccinations, tests and frontline treatments to amplify the impact they can have on providing accessible care in the communities they serve.

Retail 94

Retail Education Training Physicians 94

Pharmaceutical Technology

JANUARY 24, 2024

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

109

109

pharmaphorum

JANUARY 24, 2024

LEO Pharma's chronic hand eczema drug delgocitinib has outperformed the only approved drug for the condition in a phase 3 trial.

Pharma 95

Pharma 95

Pharmaceutical Technology

JANUARY 24, 2024

The company could be in line for a priority review voucher if 4D-710, currently in Phase I/II clinical trials, is approved.

104

104

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

European Pharmaceutical Review

JANUARY 24, 2024

Topline data from a novel Phase III study show that the biologic TREMFYA ® (guselkumab) facilitated rapid and significant clearance in moderate to severe scalp psoriasis ( PsO ) and significant improvement in scalp itch at 16 weeks, according to Johnson & Johnson. It is the first prospective, large-scale, randomised-controlled clinical trial evaluating people of colour across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment

Medicine 78

Medicine Prospecting Patients Leads 78

pharmaphorum

JANUARY 24, 2024

BenevolentAI’s search for a new chief executive has concluded with the appointment of industry bigwig Dr Jörg Möller to the role, four months after Joanna Shields stepped down and as the company emerges from a restructuring drive. The UK artificial intelligence specialist said in a statement that Möller is “an accomplished R&D leader and champion of the application of AI to drug discovery.

Pharma 78

Pharma 78

Pharmaceutical Commerce

JANUARY 24, 2024

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA).

Pharma 64

Pharma 64

pharmaphorum

JANUARY 24, 2024

BARDA has given $24 million to Locus Bio to support a mid-stage trial of bacteriophage therapy LBP-EC01 for resistant E coli infections.

84

84

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

JANUARY 24, 2024

Patients living with sickle cell disease and thalassaemia will be eligible for the test

Patients 86

Patients 86

pharmaphorum

JANUARY 24, 2024

A consortium led by the Digital Medicine Society (DiMe) has been formed to tackle a thorny problem for digital health product (DHP) developers – how to bring them to market in a way that ensures they are commercially sustainable.

Medicine 67

Medicine Marketing 67

PharmaTimes

JANUARY 24, 2024

The new company will develop novel therapies to benefit the body’s immune system

Pharma 85

Pharma 85

PharmaVoice

JANUARY 24, 2024

The most studied diseases last year included three types of cancer as research into COVID-19 fell sharply in the post-pandemic era.

64

64

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 Commerce

JANUARY 24, 2024

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.

FDA 52

FDA 52

European Pharmaceutical Review

JANUARY 24, 2024

Sanofi has agreed to acquire Inhibrx, Inc. for approximately $1.7 billion, therefore taking on a potential best-in-class treatment for rare lung and liver disease alpha-1 antitrypsin deficiency (AATD). A promising best-in-class rare disease treatment AATD is an inherited rare disease of the lungs and liver, which according to Sanofi, is characterised by low levels of AAT protein, a neutrophil elastase inhibitor.

Safety 52

Safety Patients Pharmaceutical 52

PharmExec

JANUARY 24, 2024

Under the agreement, Bristol Myers Squibb obtains Mirati’s entire portfolio, including Krazati (adagrasib) for the treatment of KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer.

52

52

Pharmaceutical Commerce

JANUARY 24, 2024

The definitive merger agreement was reached in October 2023, with Bristol Myers Squibb acquiring Mirati for $58 per share in cash, for a total equity value of $4.8 billion.

52

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