STAT

DECEMBER 22, 2023

“I do not believe this particular change will have any bearing on patient care,” said Saad Usmani, a myeloma physician and cell therapist at Memorial Sloan Kettering who has also studied Carvykti.

Labelling 125

Labelling Chemotherapy FDA Patient Care 125

pharmaphorum

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post FDA holds back from action over Xeljanz safety study appeared first on.

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FDA Communication Labelling Patient Care 78

Outsourcing Pharma

JUNE 25, 2024

Last week, OSP had the pleasure of speaking with Ginny Beakes-Read at the DIA Global conference.

Patient Care 52

Patient Care FDA 52

pharmaphorum

APRIL 6, 2021

UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed. . The company says it will focus on deployment into skilled nursing facilities, of which there are around 15,500 in the US providing long-term care for more than 1.35

FDA 59

FDA Long-Term Care Facilities Nursing Homes Assisted Living 59

Pharmacy Times

OCTOBER 25, 2024

Panelists discuss how the FDA approval of daratumumab and hyaluronidase-fihj combined with VRd (bortezomib, lenalidomide, and dexamethasone) for induction and consolidation in transplant-eligible newly diagnosed multiple myeloma patients is changing treatment approaches while also considering how recent evidence suggesting reduced observation time (..)

Patient Care 65

Patient Care FDA 65

The FDA Law Blog

JULY 24, 2023

After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

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FDA Patient Care 52

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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FDA Adverse Reactions Chemotherapy Patient Care 52

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA 52

FDA Packaging Patient Care 52

The FDA Law Blog

NOVEMBER 29, 2022

Before starting opioid therapy for subacute or chronic pain, clinicians should discuss with patients the realistic benefits and known risks of opioid therapy, should work with patients to establish treatment goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks.

Patient Care 52

Patient Care Dosage Controlled Substances Insurance 52

Pharmaceutical Technology

MAY 18, 2023

Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI).

FDA 52

FDA Patient Care 52

pharmaphorum

AUGUST 3, 2021

The FDA has approved an artificial intelligence-based imaging software developed by Abbott that is used to help physicians carry out procedures like implanting stents to open up narrowed blood vessels in the heart. . ” The post Abbott bags FDA okay for AI-based heart imaging software appeared first on.

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FDA Hospitals Patient Care 52

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

FDA 95

FDA Communication Insurance Patient Care 95

pharmaphorum

SEPTEMBER 29, 2021

The finalists are: AIVA , a startup that has developed a voice operating system for patient care. The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud.

Hospitals 138

Hospitals Patient Care FDA 138

pharmaphorum

JANUARY 29, 2021

There was also no difference between the 5mg and 10mg doses of Xeljanz tested in the trial, said Pfizer, which said the data will “further clarify the benefit and risk profile of tofacitinib to help inform medical decision making and patient care.”. There were however warning signs all wasn’t well with the trial.

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Labelling Patient Care FDA 135

Pharmaceutical Technology

NOVEMBER 7, 2022

“We are very impressed with the Parkinson’s Foundation’s holistic approach towards improving patient care and supporting cutting-edge research. “We We are confident that they will be a great partner for us as we bring our treatment for Parkinson’s disease to the clinic in 2023.”.

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Labelling Patient Care FDA 98

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

Medical Schools 97

Medical Schools FDA Patient Care 97

The Checkup by Singlecare

MARCH 20, 2025

With a growing demand for GLP-1 agonists, pharmacists may help guide healthcare providers and patients about proper use, potential side effects, and what to expect. Current approved uses of GLP-1 agonists GLP-1 receptor agonists have gained FDA approval for several medical conditions.

FDA 52

FDA Chemotherapy Patient Care 52

pharmaphorum

SEPTEMBER 12, 2022

“Across LabCorp , we innovate through science and technology, with access to approximately 2,500 [doctors] and PhDs and over 700 patients. This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states.

Immunization 105

Immunization Hospitals FDA Patient Care 105

European Pharmaceutical Review

DECEMBER 21, 2022

This US pathway offers early-phase benefits, including greater FDA collaboration. This US pathway is usually leveraged at later stages in drug development and permits sponsors to use surrogate endpoints to get faster FDA approval. Thus they, too, are taking an evolutionary approach to encourage psychedelic research. Priority review.

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Compounding Controlled Substances FDA Patient Care 119

ISPE

SEPTEMBER 15, 2023

This fusion has the potential to revolutionize patient care, offering novel solutions that were once beyond reach. Through open dialogue and the sharing of insights, these stakeholders can collectively overcome challenges and pave the way for a brighter future for patients.

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FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

European Pharmaceutical Review

OCTOBER 24, 2022

AGB-Pharma CEO Fredrik Lindberg added: “It is hoped that now a licensed medication for children and adolescents is available, shared care agreements between primary and secondary care will be possible in more cases, streamlining the patient care pathway.”.

Labelling 75

Labelling Pharmaceutical Companies Pharmaceutical Companies Patient Care 75

pharmaphorum

DECEMBER 17, 2020

The company’s lead candidate Tenapanor is a targeted, small molecule therapy currently under FDA review. As the pandemic surged this year, the disruption of healthcare systems posed a significant challenge for patients receiving kidney care. Patients who undergo dialysis are some of the most fragile.

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FDA Documentation Patient Care 104

pharmaphorum

OCTOBER 12, 2018

Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care.

Communication 52

Communication Labelling Patient Care FDA 52

The Checkup by Singlecare

JANUARY 11, 2024

As a pharmacist, it’s always a good idea to stay in the know on upcoming FDA approvals. That way, you can avoid any confusion or surprise if a patient inquires about a new medication for their condition or a healthcare provider recommends something different. and hepatic fat by up to 38.6% over 52 weeks, compared to a placebo.

FDA 52

FDA Immunization Patient Care Packaging 52

The FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Patient Care 59

Patient Care FDA 59

pharmaphorum

SEPTEMBER 25, 2020

The new data – presented at this year’s ESMO meeting – reinforce the massive improvement in patient care that Keytruda has achieved in previously-untreated NSCLC, which had a five-year survival rate of just 5% before the drug was approved in 2016.

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Chemotherapy Labelling Patient Care FDA 75

pharmaphorum

APRIL 12, 2022

“So many more drugs are coming to market, and if you look at what the FDA has done over the last five years with approvals versus the actual pool of individuals to speak with, there’s a vast change in the need and the demand,” Lapolla states. Influential individuals. “It’s about digging deeper.

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Communication Patient Care FDA 98

pharmaphorum

MARCH 2, 2021

So efficiency, compliance, and patient care have been compromised. And the FDA has been encouraging the use of cloud-based solutions to streamline the clinical trial process. That means there’s a high risk of errors, not getting vital data, and for there to be bottlenecks in the process.

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Patient Care FDA 116

PharmaShots

MAY 16, 2023

the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023. Data from CheckMate –76K show that treatment with Opdivo in the adjuvant setting reduced the risk of recurrence or death and may help address the unmet need that these patients currently face. Gina Fusaro: The U.S. In the U.S.,

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FDA Patient Care 40

pharmaphorum

JANUARY 12, 2023

Top of the list is the Verily Value Suite analytics platform – designed to help health systems deliver personalised patient care – and various early-stage programmes, including “remote patient monitoring for heart failure and micro needles for drug delivery.”

Patient Care 69

Patient Care FDA 69

pharmaphorum

SEPTEMBER 1, 2022

According to the FDA, one must also meet specific requirements before being approved to take these drugs, which include having no known or suspected severe renal impairment and no known or suspected severe hepatic impairment.

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Vaccines FDA Insurance Patient Care 98

pharmaphorum

DECEMBER 21, 2021

By analysing prescription data across multiple sources, augmented analytics can look at the medical conditions, patient demographics, and specialty areas for which drugs are most widely prescribed. One example of this use case is a pharmaceutical company that recently gained FDA approval for a rare cancer treatment.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Communication 115

The Checkup by Singlecare

MAY 8, 2024

Healthcare providers call upon Remicade for patient care if they fall into the moderate to severe categories. Because the drug suppresses the immune system, the FDA warns specifically about the risk of serious infections, such as tuberculosis and fungal infections.

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Dosage Immunization Vaccines FDA 96

BuzzRx

JANUARY 27, 2023

Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. Given to a patient population for which they do not have FDA approval.

Labelling 52

Labelling FDA Dosage Pharmaceutical Companies 52

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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Independent Pharmacies FDA Documentation CPhT 52

OctariusRx

DECEMBER 27, 2022

Very few drug shortages have such a widespread impact on patient care as this one. It’s important to keep safe injection practices and patient safety in the forefront of your planning when handling these shortages. Food and Drug Administration (FDA). Drugs shortages continued to plague us in 2022.

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FDA Patient Care Compounding 84

The Checkup by Singlecare

AUGUST 8, 2024

A medication shortage occurs when the demand for a drug is greater than the supply, according to the Food and Drug Administration (FDA). The FDA tracks drug shortages at the national level by obtaining information from drug manufacturers about their ability to produce medications. Many factors cause medication shortages.

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Compounding FDA Compounding Pharmacies Community Pharmacies 52