Drug Topics

JANUARY 16, 2023

Pharmaceutical makers, price managers out of control with ‘necessary drug’ for millions, Attorney General says.

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Pharmacy Times

JANUARY 16, 2023

The head of the CAR T cell antibody can recognize and target the growth factor in its tumor microenvironment.

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FDA 162

Drug Topics

JANUARY 16, 2023

In the 3 cases documented by researchers, hepatitis B surface antigen (HBsAG) levels were reduced by more than 50% after Japan began its COVID-19 vaccination program.

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Vaccines Documentation 247

Pharmacy Times

JANUARY 16, 2023

Providers use "Kitchen Sink Approach" because cure proves elusive, symptomatic treatment is sketchy.

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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

Patient Care

Drug Topics

JANUARY 16, 2023

High drug prices, supply chain issues, and inflation are just a few challenges chipping away at prescription drug profits. But enhanced procurement strategies enable pharmacies to drive profitability. Read our latest white paper, “How to Maximize Prescription Drug Profits in Today's Purchasing Environment”. Profitability is how you sustain your business so you can continue to serve patients.

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PharmaVoice

JANUARY 16, 2023

After years of pioneering new methods for using data and technology to improve patient health outcomes, IQVIA’s Christina Mack is on the cusp of a research revolution.

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Pharmacy Times

JANUARY 16, 2023

Significant study results may help inform clinical practice strategies.

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Drug Topics

JANUARY 16, 2023

New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.

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FDA 190

Pharmacy Times

JANUARY 16, 2023

The atypical antipsychotic is an extended-release injectable suspension that is administered bi-weekly.

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FDA 139

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults. Rykindo ® is an atypical antipsychotic developed by Luye Pharmaceutical.

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FDA Labelling 122

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.

Pharmacy Times

JANUARY 16, 2023

Recommendations vary based on age, first vaccination received, and time since the last dose.

Vaccines 139

Vaccines 139

European Pharmaceutical Review

JANUARY 16, 2023

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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FDA 122

Pharmacy Times

JANUARY 16, 2023

Study is the first to examine calciferol in brain tissue, which may help investigators understand dementia and its causes.

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Pharmaceutical Technology

JANUARY 16, 2023

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

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Communication FDA 119

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

Pharmacy Times

JANUARY 16, 2023

Ronna Hauser of the National Community Pharmacists Association and Olin and Scotty Sykes, accountants from Sykes & Company, discuss DIR changes.

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STAT

JANUARY 16, 2023

They’re far too small to be seen by even the most sophisticated medical imaging device. But bits of tumor DNA adrift in a patient’s blood are an important bellwether for whether cancer will return — and, as a new study shows, can predict which treatments are likely to work. Scientists reported in the journal Nature Medicine on Monday that colorectal cancer patients who had tumor DNA in their blood after surgery were far more likely to have their cancer return.

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Chemotherapy 106

Pharmacy Times

JANUARY 16, 2023

Clonidine works on adrenergic receptors in the brain, which are known for their role in fight-or-flight responses and are believed to be activated in post-traumatic stress disorder.

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STAT

JANUARY 16, 2023

SAN FRANCISCO — Invitae, a Bay Area genetic testing company with a mission to use genomic information to improve health care, has struggled to turn that mantra into a solid business model. It’s now trying to turn things around. The company, which offers genetic tests for people who are pregnant or planning to have a child as well as for conditions such as heart disease and hereditary cancers, announced last July that it would lay off more than 1,000 employees , more than a third of

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Pharmacy Management Software

Pharmacy Times

JANUARY 16, 2023

Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.

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Labelling FDA 123

BioPharm

JANUARY 16, 2023

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

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FDA 89

Pharmacy Times

JANUARY 16, 2023

If patients attend their discharge appointments at pharmacist-led heart failure transition of care clinics, they are less likely to be readmitted to the hospital within 30 days.

Hospitals 122

Hospitals 122

Pharmafile

JANUARY 16, 2023

Eli Lilly and AbbVie have announced their departure from the voluntary scheme for branded medicines pricing and access (VPAS), causing worry that NHS patients may miss out on breakthrough drug treatments. VPAS is an agreement which was set up in 2019 between the Government, NHS and medicine manufacturers designed to limit the cost of drugs for the health service while supporting industry innovation.

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Communication 75

Pharmacy Times

JANUARY 16, 2023

Analysis focuses on why some individuals with a genetic predisposition develop AMD, while others are spared.

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pharmaphorum

JANUARY 16, 2023

Hormone replacement therapy (HRT) could cut the risk of Alzheimer’s in some women at elevated risk of the disease, according to researchers in the UK. The study by a team at the Universities of East Anglia and Edinburgh shows that HRT use is associated with better memory, cognition, and larger brain volumes in later life among women carrying the APOE4 gene, a well-established risk factor for Alzheimer’s.

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OctariusRx

JANUARY 16, 2023

This week we are once again providing an update on the most recent drug shortages. Drug shortages currently remain at over 100 different medications, with the Food and Drug Administration (FDA) noting 123 products as being unavailable. Some of these shortages are short term, or limited availability, while others are completely unavailable with unknown release dates.

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Long-Term Care Facilities FDA 74

pharmaphorum

JANUARY 16, 2023

Two top pharma companies have exited the UK’s voluntary medicines pricing agreement in protest at what the industry has said is a “punitive” system of revenue clawbacks, casting doubt on the future of the scheme in its present form. AbbVie and Eli Lilly have left the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), according to an update issued this morning by the Association of the British Pharmaceutical Industry (ABPI), which said the move has “sent a w

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Pharmacy Times

JANUARY 16, 2023

YLB113 (Nepexto) produced significantly lower injection site reactions and injection site erythema compared with etanercept in patients with rheumatoid arthritis.

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Pharmaceutical Technology

JANUARY 16, 2023

While the threat of high inflation is receding, its second-round effects may not quickly abate. Pharma may have to navigate a difficult path through relatively slow-to-fall inflation in regions outside the US. Untamed inflation is a top concern for the pharmaceutical industry globally in 2023. While the impact of underlying inflation is gradually expected to become less severe over the year, there are signs indicating that inflation pressure will be more persistent in some markets than previousl

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Pharmaceutical Companies Pharmaceutical Companies Communication Hospitals 64

Pharma Times

JANUARY 16, 2023

MHRA approval relates to the company’s midlands-based drug development facilities

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Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. Rykindo has also been approved as a single agent or as adjunctive therapy to lithium or valproate to treat bipolar I disorder in these patients. Developed using Luye Pharma’s microsphere technology platform, Rykindo is a bi-weekly long-acting risperidone injection.

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FDA 64

Pharma Times

JANUARY 16, 2023

Major industry names depart leaving UK pricing deal in serious jeopardy

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The FDA Law Blog

JANUARY 16, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive PDF template that: allows for form construction and autofill, complements internal review templates used at CDRH, harmonizes with the Non-In Vitro Diagnostic Devi

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FDA Documentation 59

Outsourcing Pharma

JANUARY 16, 2023

AMR joins a Series C funding raise for BioVersys, which is developing antimicrobials against common drug-resistant bacteria that threaten public health.

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