Fierce Pharma
JANUARY 22, 2024
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
MedCity News
JANUARY 22, 2024
No matter the outcome, it’s certain that the cost of drugs will not be an issue easily resolved anytime soon even though several other states also have laws allowing for drug imports.
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Fierce Pharma
JANUARY 22, 2024
Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.
MedCity News
JANUARY 22, 2024
Expanding access to telehealth-based treatment programs that include medications for OUD, like buprenorphine or Sublocade, to patients as they leave custody can upend this cycle of incarceration through seamlessly following patients wherever they go next. The TREATS Act creates a legal pathway for this care to continue.
Fierce Pharma
JANUARY 22, 2024
Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Food and Drug Administration’s crosshairs, Reuters first reported. | Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance.
MedCity News
JANUARY 22, 2024
The Medicaid Innovation Collaborative announced five pilot programs in Kentucky, New York and Iowa. Each program addresses the health-related social needs of Medicaid beneficiaries living with a chronic condition, like diabetes.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JANUARY 22, 2024
Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients.
Fierce Pharma
JANUARY 22, 2024
Lucentis biosimilar Cimerli is the best-selling product for Coherus BioSciences, accounting for 54% of its revenue in the third quarter of last year. | Lucentis biosimilar Cimerli is the best-selling product for Coherus BioSciences, accounting for 54% of its revenue in the third quarter of last year. But the Redwood City, California, drugmaker has sold it off to Sandoz for $170 million to focus its efforts on oncology, Coherus said on Monday.
MedCity News
JANUARY 22, 2024
In its Phase 3 test, Ionis Pharmaceuticals drug donidalorsen reduced the frequency of swelling attacks caused by the rare disease hereditary angioedema. If Ionis can commercialize this drug, competition would include products from Takeda Pharmaceutical and BioCryst Pharmaceuticals.
Fierce Pharma
JANUARY 22, 2024
Lundbeck’s Charl van Zyl has about 100 days under his belt as the company’s new CEO. | The new chief aims to strike M&A deals that will fill out Lundbeck's early pipeline as the company leans on growth drivers Rexulti and Vyepti.
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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.
MedCity News
JANUARY 22, 2024
As healthcare continues to evolve, discharge coordination software will play an increasingly important role in bridging the gap between hospital care and home care, ensuring that NICU graduates and their families receive the comprehensive support they need to thrive.
Pharmaceutical Technology
JANUARY 22, 2024
On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.
MedCity News
JANUARY 22, 2024
In an interview last week, Larry Cohen — CEO of Health 2047, the American Medical Association’s venture studio — noted that digital health programs have proven to do a good job of improving patient outcomes — but only for certain groups. As technology continues to advance, he urged healthcare leaders not to underestimate the effectiveness of engaging patients by having boots on the ground.
European Pharmaceutical Review
JANUARY 22, 2024
Researchers have developed two capillary electrophoresis (CE)-based analytical methods : capillary zone electrophoresis (CZE) and imaged capillary isoelectric focusing (iCIEF) to analyse a broad spectrum of monoclonal antibodies (mAbs) and complex mAb formats. Charge heterogeneity analysis of mAbs and complex formats, such as bispecifics, is “crucial” for therapeutic applications, according to the researchers.
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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
pharmaphorum
JANUARY 22, 2024
Sandoz makes its first acquisition since spinning out of Novartis, buying a Lucentis biosimilar from Coherus that will boost its position in the US market.
Pharmaceutical Technology
JANUARY 22, 2024
The UK NICE recommends Pfizer's talazoparib, marketed as Talzenna, to treat a specific type of locally advanced or metastatic breast cancer.
pharmaphorum
JANUARY 22, 2024
A hearing will get underway in Delaware later today in the latest phase of GSK’s attempts to defend itself from allegations that its Zantac drug caused cancer in patients.
MedCity News
JANUARY 22, 2024
Exceptional awareness levels help hospitals improve operational efficiency and can also help health systems increase capacity, improve access to care, achieve higher profitability and improve margins.
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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.
pharmaphorum
JANUARY 22, 2024
AstraZeneca’s Imfinzi plus bevacizumab and TACE improved PFS compared to TACE alone in hepatocellular carcinoma patients in EMERALD-1, but more data may be needed before approval
Pharmaceutical Technology
JANUARY 22, 2024
Sandoz has agreed to acquire Coherus Biosciences' CIMERLI ophthalmology franchise, including proprietary software.
pharmaphorum
JANUARY 22, 2024
End of the line for Roche’s 18-year alliance with Swiss biotech AC Immune, as it returns rights to Alzheimer's antibodies crenezumab and semorinemab
PharmaTimes
JANUARY 22, 2024
Approximately one in five children will be hospitalised to treat measles
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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.
Pharmaceutical Technology
JANUARY 22, 2024
The US FDA has granted fast track designation to Kyverna Therapeutics’ KYV-101 for the treatment of multiple sclerosis (MS).
PharmaVoice
JANUARY 22, 2024
Demand for infectious disease treatments is projected to grow and challenge trials, when done right, could speed drug development.
Pharmaceutical Technology
JANUARY 22, 2024
Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.
PharmaTech
JANUARY 22, 2024
Experic’s latest article looks at new initiatives aimed at fostering the development of biologics delivered via inhalation, an emerging field. While manufacturing technologies have advanced to support this sector, several challenges remain, including an unclear regulatory pathway.
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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
Quantified
JANUARY 22, 2024
In a landscape where customer demands and market dynamics constantly evolve, certified salespersons are better equipped to adapt, innovate, and drive revenue growth for the company. According to a recent Axelos study, 97% of decision-makers and 84% of individuals say certification adds value in the workplace, bringing higher efficiency and employee satisfaction.
Pharmaceutical Commerce
JANUARY 22, 2024
Opdivo (nivolumab) with Yervoy (ipilimumab) showed a 79% drop in the risk of disease progression or death compared to chemotherapy in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.
European Pharmaceutical Review
JANUARY 22, 2024
The global extractable and leachable (E&L) testing services market is projected to value $2.57 million by 2030, according to a report by ResearchAndMarkets. Between 2023 to 2030, this represents a CAGR of 15.13 percent, the authors stated. The report shared that due to the key role of these services for single-use systems and finished formulations, many analytical techniques, “including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis”.
Pharmaceutical Commerce
JANUARY 22, 2024
Phase Ib study evaluated satri-cel in patients with advanced gastric/gastroesophageal cancer or pancreatic cancer who had progressed on or were intolerant of prior systemic therapy.
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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.
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