Sat.Jul 30, 2022 - Fri.Aug 05, 2022

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ICYMI: Patients across the country are sharing concerns about government price setting

PhRMA

As members of Congress continue to push forward misguided government price-setting policies under the guise of “negotiation,” patient advocates across the country have been speaking out in local media outlets about the potential consequences.

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Updated NCCN Breast Cancer Screening Guidelines Help Clarify Risk for Patients

Pharmacy Times

Patients can better understand the most current recommendations for breast cancer screening with the new NCCN Guidelines for Patients®: Breast Cancer Screening and Diagnosis.

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Myth vs. Fact: The Senate’s latest price setting proposal

PhRMA

The narratives being built around the Senate’s latest price setting proposal frame it as a bill intended to lower drug prices for patients and address rising inflation. But those narratives aren’t the facts. Here, we bust those myths.

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Resistant Starch in Foods Can Reduce Hereditary Cancer by 50%

Pharmacy Times

Findings in a new trial show that dietary supplementation of resistant starch has the potential to decrease people’s risk of certain types of gastrointestinal cancers.

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Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

pharmaphorum

Roche’s Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial. The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

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Celebrating Medicare’s 57th anniversary

PhRMA

In case you missed it, Saturday, July 30, marked the anniversary of Medicare. For 57 years, Medicare has helped pay for medical care for Americans over the age of 65, as well as younger Americans with certain medical needs. To celebrate, we are reflecting on the history of the program that benefits more than 60 million Americans. Unfortunately, some members of Congress are considering significant changes to Medicare that could have a devastating effect on millions of Americans.

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Notable Revisions in Diabetes Treatment According to ADA Guidelines

Pharmacy Times

American Diabetes Association updates recommendations regarding SGLT-2 inhibitors, GLP-1 RA, and finerenone for cardiovascular and renal comorbidities.

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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year. That was followed by Europe, which saw a 0.6 year-on-year percentage point change in machine learning roles.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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An open letter to Congress: Stand with patients and future cures

PhRMA

I recently joined PhRMA board members in penning the letter below to Congress, urging them to abandon their latest drug pricing proposal.

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Overdose Deaths Increased in Wave 4 of the Opioid Crisis, Coinciding with the COVID-19 Pandemic

Pharmacy Times

The suggested wave 4 of the opioid crisis saw high opioid-involved overdose death rates in urban counties and high acceleration of overdose deaths in rural counties, indicating that the opioid crisis worsened during the COVID-19 pandemic.

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Sarepta says early filing for DMD gene therapy is back on

pharmaphorum

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023. The US biotech – which already has three antisense drugs for DMD on the market – had said earlier it was planning to delay the application into 2023, so the new announcement marks an acceleration of its plans.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

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The Senate’s latest price setting proposal will undermine U.S. economic growth

PhRMA

Last week, we examined ways the latest drug pricing proposal will undermine patient access to medicines , American medical innovation and our health care system as a whole. But there is another consequence that we can’t leave out: the impact this proposal will have on the biopharmaceutical industry’s contributions to American jobs and the economy.

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Facilities in Non-Hispanic Black, Rural Counties Less Likely to Administer Early COVID-19 Vaccines

Pharmacy Times

Health care facilities in counties with higher Black populations and in rural areas were less likely to serve as COVID-19 vaccination facilities during May 2021, indicating disparities in vaccine distribution.

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How the WHO hepatitis strategy measures up in the field

pharmaphorum

According to the World Health Organization (WHO), approximately 296 million people globally live with hepatitis B, with most unaware of their infection. Africa is the worst impacted region for hepatitis B with a prevalence of 7.5 percent compared to 0.5 percent in the Americas. Hepatitis C impacts an estimated 58 million people across the globe. Again, Africa is the worst-impacted region with a prevalence of 0.8 percent while the Americas see a prevalence of 0.5 percent.

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Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work?

PharmaVoice

Companies like Cost Plus Drugs and DiRx can bring generics directly to consumers at a fraction of the price, but whether it’s enough to fix the inflated U.S. healthcare system is yet to be seen.

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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

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Deep Brain Stimulation System May Help Manage Severe Depression

Pharmacy Times

Abbott will work with the FDA to expedite the review of their deep brain stimulation system to treat the life-threatening disease of treatment-resistant depression.

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Gilead Sciences’ push into oncology is paying off, as Veklury falters

pharmaphorum

Gilead Sciences’ investment in oncology has started to provide a solid return, with sales of cancer therapies breaching the $500 million threshold for the first time in the second quarter. Cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) for lymphoma and leukaemia together brought in $368 million, up 68%, while antibody drug conjugate Trodelvy (sacituzumab govitecan) rose 79% to $159 million thanks to increased uptake in triple-negative breast canc

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

The FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services et al. , July 25, 2022.

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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Is There Such Thing as Work-Life Balance in Pharmacy?

Pharmacy Times

Many companies overlook the power that workplace culture can have on employee wellness and instead, focus relentlessly on financial metrics.

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-h

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A glimpse inside Bristol Myers Squibb’s integration with Celgene

PharmaVoice

Catherine Owen, senior vice president of major markets, discusses the hurdles — and successes — of bringing the two ‘powerhouses’ together.

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.

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Computationally Developed Cocktail for HIV Therapy Significantly Reduces Chance of Viral Rebound

Pharmacy Times

Using computational methods, the development of an HIV therapy cocktail based on the virus’ genetics was found to increase the efficacy of treatment.

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Gilead snaps up MiroBio and its checkpoint agonists for $405m

pharmaphorum

Less than three years after being spun out of Oxford University, privately-held biotech MiroBio is heading for a takeover by Gilead Sciences in a $405 million deal. MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

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Blending human knowhow, artificial intelligence aids drug discovery

Outsourcing Pharma

A leader from pharmaceutical firm Astellas discusses how the company has put to use a discovery platform that combines human expertise, AI, and robotics.

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Governments and pharma relationships and implications for antimicrobial resistance

Pharmaceutical Technology

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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FDA Approves First Therapy for New HER2-low Breast Cancer Subtype

Pharmacy Times

The FDA approved a new drug that treats unresectable and metastatic HER2-low breast cancer, giving patients with this new subtype a treatment beyond chemotherapy.

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Sanofi looks east with €300m Innovent cancer alliance

pharmaphorum

Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as possible to patients in the world’s second-largest pharma market. The deal – which includes an option on a second €400 million investment – will see the two companies jointly develop tusamitamab ravtansine (SAR408701), a CEACAM5-targeting antibody-drug conjugate (ADC), as well as a pegylated formulation of interleukin-2 codenamed SAR444245 in Chi

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