Mon.Jan 22, 2024

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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

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.

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Breaking the Cycle: Telehealth Treatment for People in Custody is Key to Recidivism Disruption

MedCity News

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.

Medical 110
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Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

Fierce Pharma

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.

Patients 313
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Optimised method could facilitate analysis of complex biologics

European Pharmaceutical Review

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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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Eli Lilly's troubled NJ manufacturing site in hot water again over maintenance, quality control lapses

Fierce Pharma

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.

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Medicaid Innovation Collaborative Announces 5 Pilot Programs To Improve Outcomes for Medicaid Patients

MedCity News

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.

Patients 107

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Sandoz makes its first post-spinout acquisition

pharmaphorum

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.

Marketing 109
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Coherus sells Lucentis biosim to Sandoz for $170M to focus on oncology

Fierce Pharma

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.

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Bladder cancer-focused CG Oncology files for IPO

Pharmaceutical Technology

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.

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Lundbeck CEO eyes deals to bolster pipeline, complement growth drivers ahead of patent losses

Fierce Pharma

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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

MedCity News

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.

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Next stage in GSK’s Zantac defense gets underway today

pharmaphorum

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.

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Ionis Rare Disease Drug Is Headed to FDA, But Forthcoming Data Will Decide Competitive Profile

MedCity News

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.

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Trial data raises questions about Imfinzi in liver cancer

pharmaphorum

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

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Empowering Families and Enhancing Care Coordination: The Role of Discharge Coordination Software in the NICU

MedCity News

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.

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UK NICE recommends Pfizer’s talazoparib for advanced breast cancer

Pharmaceutical Technology

The UK NICE recommends Pfizer's talazoparib, marketed as Talzenna, to treat a specific type of locally advanced or metastatic breast cancer.

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Health2047 CEO: As Tech Advances, the Power of Community Engagement Can’t Be Forgotten

MedCity News

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.

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Sandoz to acquire Coherus’ CIMERLI ophthalmology franchise

Pharmaceutical Technology

Sandoz has agreed to acquire Coherus Biosciences' CIMERLI ophthalmology franchise, including proprietary software.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Roche ducks out of AC Immune Alzheimer antibody alliance

pharmaphorum

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

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Achieving Operational Improvement Through Improved Awareness Levels [Sponsored]

MedCity News

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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FDA grants fast track status to Kyverna’s multiple sclerosis therapy

Pharmaceutical Technology

The US FDA has granted fast track designation to Kyverna Therapeutics’ KYV-101 for the treatment of multiple sclerosis (MS).

FDA 81
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NHS catch up campaign launched for missed MMR vaccines

PharmaTimes

Approximately one in five children will be hospitalised to treat measles

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Why It’s So Essential to Build Credibility and Trust in Sales

Integrity Solutions

Trust is the cornerstone of any successful business relationship, and it’s particularly crucial in sales. What is the role of trust in sales? Buyers want to know that they can trust what you’re telling them, that you have their best interests in mind, that you’ll stand behind what your product or service promises to deliver, and that you’ll make things right if any problems do come up.

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Processa shoots for breast cancer label expansion for capecitabine combo

Pharmaceutical Technology

Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.

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Controversial challenge trials offer unparalleled innovation — with ethical bumps

PharmaVoice

Demand for infectious disease treatments is projected to grow and challenge trials, when done right, could speed drug development.

Ethics 65
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Inhaled Biologics from Zero

PharmaTech

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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Certification in the Digital Age: How Tech Accelerates the Process

Quantified

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.

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Opdivo Plus Yervoy Shows Significantly Improved Progression-Free Survival in Metastatic Colorectal Cancer

Pharmaceutical Commerce

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.

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Single-use systems to drive E&L testing market growth

European Pharmaceutical Review

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”.

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Satri-Cel CAR T-Cell Therapy Shows Promising Safety, Efficacy in Gastric, Pancreatic Cancer

Pharmaceutical Commerce

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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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A