Fierce Pharma

APRIL 23, 2024

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Pharma 349

MedCity News

APRIL 24, 2024

More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.

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Healthcare Healthcare 128

Pharmaceutical Technology

APRIL 24, 2024

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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pharmaphorum

APRIL 24, 2024

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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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

Distribution

Pharmaceutical Commerce

APRIL 23, 2024

In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.

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Pharma 93

Fierce Pharma

APRIL 23, 2024

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

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Pharmaceutical Technology

APRIL 22, 2024

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Patients 103

pharmaphorum

APRIL 24, 2024

Roche chief executive Thomas Schinecker said today that one in five of the pharma division’s pipeline of new molecular entities (NMEs) has been culled in the last few months as part of a shift in focus on “high impact” projects.

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Pharma 96

European Pharmaceutical Review

APRIL 22, 2024

The USP Microbiology Expert Committee is due to vote on the proposed Chapter <86> to approve bacterial endotoxin testing using non-animal derived reagents between 21 June and 1 July 2024. Jaap Venema , Chief Science Officer, USP shared with EPR that the chapter is helping to guide manufacturers how to the adopt these methods and provides “a path to wider adoption”.

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Fierce Pharma

APRIL 23, 2024

Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.

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FDA Patients 290

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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

MedCity News

APRIL 24, 2024

Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. The post It’s Time to Give Patients a Seat at the Table appeared first on MedCity News.

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Patients 122

Pharmaceutical Technology

APRIL 22, 2024

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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pharmaphorum

APRIL 23, 2024

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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PharmaVoice

APRIL 22, 2024

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

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Medical 124

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

Fierce Pharma

APRIL 24, 2024

It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. | How much impact has the approval of high-dose Eylea had on the upward trajectory of Roche’s Vabysmo? Not much, according to sales figures released by Roche.

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Sales 279

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

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European Pharmaceutical Review

APRIL 25, 2024

Research on the global pharmaceutical parenteral packaging market by InsightAce Analytic Pvt. Ltd. has predicted that the sector will value $18.85 billion by 2031. This is aligned with a CAGR of 4.47 percent between 2024 and 2031. Main drivers for the market were reported to be rising popularity of generics together with blockbuster and other small-molecule drugs going off-patent globally.

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Marketing Pharmaceutical Medicine Manufacturing 79

pharmaphorum

APRIL 22, 2024

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Pharmaceutical Technology

APRIL 22, 2024

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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Fierce Pharma

APRIL 24, 2024

While Biogen’s Chris Viehbacher figures the company is “turning the corner” after several recent setbacks—thanks in large part to accelerating launches of new drugs like Leqembi and Skyclarys—the C | While Biogen’s Chris Viehbacher figures the company is “turning the corner” after several recent setbacks, the CEO admitted Wednesday that there’s still “a lot of work to do” as the biotech plugs ahead with its “Fit for Growth” savings initiative.

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MedCity News

APRIL 24, 2024

Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception. The post When Investment Rhymes with Canada appeared first on MedCity News.

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European Pharmaceutical Review

APRIL 26, 2024

A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This method enables the number of administrations of the drug evaluated to be minimised, the researchers found. The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination.

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Medicine Pharmaceutical Pharmaceutical products Medical 71

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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.

Specialization

pharmaphorum

APRIL 23, 2024

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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FDA 87

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.

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Pharmaceutical 95

Fierce Pharma

APRIL 22, 2024

The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. | The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.

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Prospecting Pharmaceutical 276

MedCity News

APRIL 21, 2024

Solera Health added Ciba Health, Digbi Health and Wondr Health to its HALO platform. The companies treat conditions like hypertension and diabetes. The post Solera Health Expands Platform To Address Cardiometabolic Conditions appeared first on MedCity News.

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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

European Pharmaceutical Review

APRIL 23, 2024

Bristol Myers Squibb (BMS) and Cellares have announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. The deal is valued at up to $380 million in upfront and milestone payments. The agreement will see BMS use Cellares’ fully automated cell therapy manufacturing platform for the clinical and commercial-scale manufacturing of select CAR T cell therapies.

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pharmaphorum

APRIL 24, 2024

An oral therapy that can allow children and adolescents with an aggressive form of brain cancer to be treated at home rather than in hospital has been recommended for use by the NHS in England and Wales.

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Patients 83

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.

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Pharmaceutical 97

Fierce Pharma

APRIL 25, 2024

Facing pressure from the Inflation Reduction Act (IRA) and falling sales for CAR-T therapy Abecma, Bristol Myers Squibb CEO Chris Boerner, Ph.D., still says the Breyanzi-maker h | Facing pressure from the Inflation Reduction Act and falling sales for CAR-T therapy Abecma, Bristol Myers Squibb CEO Chris Boerner says the Beyenzi-maker had a "good start" with the first quarter.

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Sales 244

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients