PharmaShots

MARCH 31, 2023

PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular (..)

FDA 40

FDA 40

PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

FDA 40

FDA 40

PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

FDA 40

FDA 40

PharmaShots

JUNE 23, 2023

Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)

FDA 40

FDA 40

PharmaShots

FEBRUARY 24, 2023

Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive

FDA 40

FDA Vaccines 40

Digital Pharmacist

MARCH 28, 2024

Educate Your Staff on Parkinson’s Disease Pharmacists are a constant in the lives of patients living with Parkinson’s Disease. Parkinson’s patients and their caregivers are going to be frequent customers at your pharmacy, so it is important for your staff to understand the disease they’re faced with and the medications used to treat it.

Health and Personal Care Stores 68

Health and Personal Care Stores Hospitals 68

The Checkup by Singlecare

JANUARY 11, 2024

Read more about treatments for skin tags , hidradenitis suppurativa , and shingles. Growths “Growths such as cysts, skin tags, and moles can also cause pain when they’re inflamed,” says Brendan Camp, MD , a dermatologist with MDCS Dermatology in New York. Painful lumps are almost always associated with an infection,” Dr. Ganz says. “A

Mayo Clinic 52

Mayo Clinic Vaccines Immunization 52

pharmaphorum

JANUARY 11, 2022

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Breakthrough designations can speed up the development of new therapies, making them available to patients sooner.

FDA 64

FDA Chemotherapy Hospitals 64

pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

FDA 72

FDA Chemotherapy 72

Pharmaceutical Technology

NOVEMBER 9, 2022

Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. The program was put on hold in December 2020 following a patient report, but this was lifted in April 2021. million price tag.

FDA 111

FDA 111

pharmaphorum

JUNE 12, 2022

The panel voted 13 to 0 on the question of whether beti-cel’s benefits outweighed the risks of the gene therapy in patients with beta thalassaemia who are dependent on blood transfusions, in a dream result for the biotech which just a few weeks ago was expressing doubts about its ability to continue as an operating concern.

FDA 59

FDA 59

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

Immunization 52

Immunization Vaccines 52

pharmaphorum

NOVEMBER 19, 2021

The agreement has been hailed by patient associations, as it adds to current treatment options for the progressive muscle wasting disease – Biogen’s injectable Spinraza (nusinersen) and one-shot gene therapy with Novartis’ Zolgensma (onasemnogene abeparvovec) – which are also backed by NICE.

98

98

Pharmaceutical Technology

JULY 14, 2022

Historically, the pharmaceutical industry has failed to meet the needs of this patient population. Most famously, the US passed its Orphan Drug Act in 1983, providing innovators with financial motivation to develop orphan drugs and meet the needs of these forgotten patients. Efforts have been made to change this.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies Hospitals 59

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. ICER points to brain swelling and potential bleeding seen in approximately 30% of patients treated with aducanumab. Broad label questioned.

FDA 98

FDA Labelling 98

pharmaphorum

JULY 25, 2022

J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Most patients diagnosed with myeloma will relapse over the course of their disease, so the disease is still considered incurable.

FDA 52

FDA 52

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Of these patients, seven have been treated at the recommended phase II dose (RP2D) and regimen.

Immunization 52

Immunization Hospitals Vaccines 52

PharmD Live

DECEMBER 21, 2021

Virtual care, normalized by the pandemic, is now common practice for providers and patients, especially at the primary care level–a boon in 2021 for underserved chronic care populations. With an annual price per patient of nearly $56,000 per year, patients’ families are looking for solutions for their loved ones–with a huge price tag.

FDA 52

FDA Hospitals 52

pharmaphorum

JANUARY 18, 2022

Researchers at Almirall have identified several proteins whose abnormal function is associated with inflammatory immune skin diseases. Dr Thomas Huber, Almirall’s head of research, says the collaboration underlines the firm’s R&D commitment to provide innovative treatment options to patients suffering from severe skin diseases. “It

Immunization 52

Immunization 52

Pharmaceutical Technology

JUNE 29, 2022

Others judge its success based on the fact that 95% of rare diseases still have no available therapies and patient needs remain unmet. For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

FEBRUARY 22, 2021

Last week, Bluebird said it was pausing its Zynteglo (betibeglogene autotemcel) programme in Europe after a phase 1/2 trial in patients with sickle cell disease (SCD) – another red blood cell disorder – turned up two cases of blood cancers, one of acute myeloid leukaemia (AML) and another of myelodysplastic syndrome (MDS). million in Europe.

Immunization 52

Immunization 52

pharmaphorum

AUGUST 18, 2022

bluebird bio’s Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require regular blood transfusions. An FDA advisory committee recommended approval of Zynteglo on the strength of that data in June.

FDA 52

FDA Insurance 52

The Checkup by Singlecare

MARCH 21, 2023

Pain is subjective and is defined by the International Association for the Study of Pain (IASP) as “an unpleasant sensory and emotional experience associated with, or resembling, actual or potential tissue damage.” It is a personal experience, and access to pain management is a basic right. RELATED: Belbuca side effects 2.

Dosage 52

Dosage Controlled Substances Labelling Packaging 52

pharmaphorum

JUNE 2, 2021

NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a surprise to patient association SMA UK. The post NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group appeared first on.

Documentation 52

Documentation Communication 52

European Pharmaceutical Review

AUGUST 24, 2022

The antibody is chosen based on its high selectivity and affinity for the tumour-associated antigen and its ability to facilitate internalisation or endocytosis, wherein molecules such as proteins are engulfed by the cell membrane and drawn into the cell. The culmination of two decades of learning.

Compounding 86

Compounding Pharmaceutical Companies Pharmaceutical Companies 86

The Checkup by Singlecare

NOVEMBER 2, 2023

So how do you know if they’re right for your patients (even those who aren’t diabetic)? As awareness grows, patients seek out GLP-1s: Social media and direct-to-consumer advertising are also playing a role in fueling the popularity of GLP-1s. Their usage is skyrocketing because they’re effective—for several different health conditions.

Insurance 52

Insurance FDA Adverse Reactions Hospitals 52

pharmaphorum

NOVEMBER 27, 2022

Fully integrated and automated ingredient to consumer batch tracking using barcoding, RFID tagging, or IoT temperature logging and timestamping significantly reduces the chance of these mix-ups, providing complete traceability records from ingredient manufacturer to patient, and ensures the safety of the product.

Communication 105

Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

PharmaShots

MARCH 9, 2023

She has also been appointed as the president of the American Pancreas Association (APA). An elected member of Association of American Physicians (AAP) and the American Society for Clinical Investigation (ASCI), she also serves fellow of the American Gastroenterological Association. LinkedIn Total experience: 26 yrs.

FDA 40

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

pharmaphorum

JUNE 2, 2022

When asked by pharmaphorum why product sales are expected to be so high in this area, a spokesperson for Evaluate explained: “For many rare diseases, there is high unmet need which results in high levels of use of orphan products in the eligible patient groups, and these groups are often larger than anticipated once treatments become available.

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

JANUARY 25, 2023

When asked about the risk factors associated with cancer, the respondents associated certain skin types with a higher likelihood of skin cancer. More than one-fifth of the respondents (23%) hadn’t heard of any of the cancers mentioned in the survey.

Documentation 52

Documentation Insurance FDA 52

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective.

FDA 98

FDA 98

pharmaphorum

AUGUST 26, 2022

Roctavian delivers a working copy of the Factor VIII gene into cells via an adeno-associated virus (AAV) vector, and offers a one-shot, potentially curative therapy for haemophilia A. million spread over five years.

FDA 111

FDA 111

pharmaphorum

FEBRUARY 16, 2021

NICE is assessing Zynteglo (betibeglogene autotemcel), a one-off gene therapy for the condition, which can have life-threatening consequences and is associated with a curtailed life expectancy. NICE said that data came from a small sample of patients and is using its standard discount rate of 3.5% million in Europe.

91

91

The Checkup by Singlecare

MAY 8, 2023

The Centers for Disease Control and Prevention (CDC) have committed to fighting the opioid overdose epidemic in many ways, including by aiding providers, healthcare systems, and payers with data, tools, and evidence-based guidance to support improved opioid prescribing and patient safety.

Controlled Substances 52

Controlled Substances Dosage Labelling FDA 52

European Pharmaceutical Review

MAY 11, 2023

What were the main findings presented at the 2023 Muscular Dystrophy Association Conference (MDA)? Notably, data from LT-001, a 15-year ongoing observational study following the Phase I START patients, showed that children treated after presenting symptoms of SMA maintained all previously achieved milestones up to 7.5

FDA 73

FDA 73

pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time.

Documentation 105

Documentation Data Entry HIPAA Insurance 105

The Checkup by Singlecare

MARCH 7, 2024

Patients typically start on a low dose of 0.25 Ozempic cost Unfortunately, like many new drugs, Ozempic comes with a hefty price tag. Makhija says Novo Nordisk, the manufacturer of Ozempic, may offer coupons or rebates as well as patient resources and support for finding a lower cost of the medication.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Packaging Insurance Coverage 52