Leqvio Gets Label Update For Earlier Use in Patients with Heart Disease
Drug Topics
JULY 12, 2023
Recent safety data also allowed four adverse events to be removed from the label.
FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label
Pharmacy Times
NOVEMBER 14, 2024
The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.
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FDA Issues New Labeling Changes Clarifying Safety of Testosterone Products Following Clinical Trials
Pharmacy Times
MARCH 4, 2025
The FDA is issuing new changes to labels on testosterone products, clarifying that there are no increases in major cardiac events among men with hypogonadism but noting an increase in blood pressure with the use of such products.
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Biogen admits slow Aduhelm launch, as scientists question label again
pharmaphorum
SEPTEMBER 10, 2021
Some insurers have refused to cover the drug, citing what they claim is unproven efficacy for the anti-amyloid drug, as well as the risk of adverse events, while the FDA has also come under fire over its handling of the review and approval. The post Biogen admits slow Aduhelm launch, as scientists question label again appeared first on.
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AZ drops two trials aimed at expanding Lokelma’s label
pharmaphorum
DECEMBER 1, 2023
The STABILIZE-CKD and DIALIZE-Outcomes studies – part of AZ’s CRYSTALIZE programme for the drug – have been shelved because patients were being enrolled into them more slowly than hoped for, and clinical events were occurring at a lower rate than expected.
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Health Canada expands Orkambi label to include access to infants
Pharmaceutical Technology
APRIL 11, 2023
This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.
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Novo expands Wegovy’s US label to reduce cardiovascular events
Pharmaceutical Technology
MARCH 11, 2024
Wegovy can now be used to reduce the risk of major cardiovascular events in obese or overweight patients with heart disease.
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Pharma Marketers: Drive Registrations for Your Next Event [INFOGRAPHIC]
Pharma Marketing Network
APRIL 28, 2021
With our growing audience of pharma and healthcare professionals, the Pharma Marketing Network (PMN) leverages its experience in helping drive registrations for top-rated events and conferences that attracts diverse populations at scale. Let’s work together to identify the unique needs of your event and produce maximum engagement.
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Novo Nordisk plans label expansion for Rybelsus following Phase III win
Pharmaceutical Technology
OCTOBER 22, 2024
The oral semaglutide reduced the occurrence of major adverse cardiovascular events (MACE) by 14% in patients with type 2 diabetes.
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12 Medications With Off-Label Uses
BuzzRx
JANUARY 27, 2023
The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.
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Sharing oncology trial PROs to build the treatment of the future
pharmaphorum
AUGUST 24, 2020
In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. . Project Patient Voice .
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Major study on DMT shows promise for depression
European Pharmaceutical Review
JANUARY 25, 2023
Participants were enrolled into an open-label phase of the study, which enabled the assessment of durability of antidepressant effect, as well as the comparative efficacy and safety of a one versus two dose regimen of SPL026. No drug-related serious adverse events (SAEs) reported, including no reported suicidal ideation or behaviour.
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STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance
STAT
AUGUST 20, 2024
Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted.
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FDA Expands Label for Inclisiran to Include Adults With High LDL-C, Increased Risk of Heart Disease
Pharmacy Times
JULY 11, 2023
The updated label for inclisiran (Leqvio) includes patients with comorbidities, such as hypertension and diabetes, who have yet to experience a cardiovascular event.
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Can you drink alcohol while taking clonidine?
The Checkup by Singlecare
DECEMBER 6, 2024
Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. When taken together, the risk of these adverse events can increase. In addition, alcohol can increase your blood pressure.
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Rosuvastatin (Crestor) alternatives: What can I take instead of rosuvastatin?
The Checkup by Singlecare
JANUARY 6, 2025
Besides simply lowering LDL, the drug is approved by the Food and Drug Administration (FDA) for reducing the risk of cardiovascular events like heart attacks. Preventing cardiovascular events, such as heart attacks or strokes, from happening or recurring is another salient goal for cholesterol medication.
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FDA grants priority review for Biogen’s tofersen to treat ALS
Pharmaceutical Technology
JULY 27, 2022
The application for the drug comprised data from a Phase I clinical trial in healthy subjects, a Phase I/II trial analysing ascending dose levels, the Phase III VALOR trial and an open-label extension (OLE) trial. It also included the latest one-year combined data from VALOR and the OLE study. Furthermore, 6.7%
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Eliquis vs. Plavix: Key differences, uses, costs, and side effects
The Checkup by Singlecare
NOVEMBER 5, 2024
Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors. Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors.
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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling
The FDA Law Blog
SEPTEMBER 23, 2022
For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.
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Can I take Ozempic if I’m not diabetic?
The Checkup by Singlecare
AUGUST 14, 2024
Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use.
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Eliquis vs. aspirin: Differences & similarities explained
The Checkup by Singlecare
MARCH 20, 2025
The degree of risk of these bleeding events is dependent on an individuals risk factors such as age and frequency of falls. per year Allergic reaction Yes Less than 1% Yes 1%2% Reyes syndrome No N/A Yes Rare Sources: DailyMed Eliquis drug label , StatPearls , and AVERROES trial. per year Yes 3.8%
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6 Digital Tools at the Center of Healthcare Digitalization [INFOGRAPHIC]
Pharma Marketing Network
APRIL 15, 2021
Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.
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Long-Term Outcomes with VMAT2 Inhibitors
Pharmacy Times
FEBRUARY 3, 2025
Panelists discuss how long-term open-label extension studies of VMAT2 inhibitors demonstrated sustained efficacy and tolerability of both deutetrabenazine (ARM-TD and AIM-TD extensions showing durable response over 3 years) and valbenazine (KINECT 4 showing maintained improvements through 48 weeks), with low discontinuation rates due to adverse events (..)
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Therapeutic-first for cold agglutinin disease haemolytic anaemia
European Pharmaceutical Review
NOVEMBER 21, 2022
The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0
What to know about semaglutide weight loss
The Checkup by Singlecare
MARCH 10, 2025
Some are also approved to help lower the risk of heart disease and cardiovascular events in people with diabetes or obesity. Its important to talk to your prescriber about potential adverse events before taking and while using semaglutide. Like Ozempic , Rybelsus is sometimes prescribed off-label for weight loss.
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Stage set for Jardiance to become universal heart failure drug
pharmaphorum
MARCH 3, 2022
The results of the EMPULSE trial showed that adults hospitalised for acute heart failure were 36% more likely to see an improvement on clinical measures – including all-cause mortality, frequency of heart failure events, time to first heart failure event, and symptoms – in the first 90 days after treatment started compared to placebo.
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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine
pharmaphorum
MAY 10, 2021
At the moment, there’s no indication that the cases are linked to the vaccine itself, but the EMA has asked the companies to provide “further detailed data, including an analysis of the events according to age and gender,” as it looks into the signal.
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STAT+: Pharmalittle: Online prescribing prompts scrutiny and concern; FDA is pushed to approve OTC birth control pills
STAT
OCTOBER 25, 2022
Food and Drug Administration regulate drugs, including approved uses and claims made by ads and product labels. Meanwhile, states regulate the actual prescribing events — providers, pharmacies, and medical practice standards. Federal agencies like the U.S. Continue to STAT+ to read the full story…
Sandoz granted novel biosimilars approval
European Pharmaceutical Review
MARCH 6, 2024
Keren Haruvi, President Sandoz North America highlighted that denosumab is a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events. The approval is also accompanied by labelling with safety warnings. Wyost Similarly, Wyost 120 mg/1.7
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Abilify alternatives: What can I take instead of Abilify?
The Checkup by Singlecare
APRIL 4, 2025
Efficacy, fewer adverse events, and convenience sound like an enticing trio of features, but Abilify may not be the best choice among the group. In studies listed on their drug labels, Seroquel XR had a lower incidence of akathisia, an EPS complex with agitation and restlessness, than Abilify did in studies listed on their drug labels.
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Does Aetna cover Ozempic?
The Checkup by Singlecare
APRIL 9, 2025
Though some healthcare providers prescribe it off-label for obesity, Ozempic is not FDA -approved for weight loss. … In my experience, it is not covered for off-label use. … In my experience, it is not covered for off-label use. Does Aetna cover Ozempic for weight loss ? Try a different pharmacy.
STAT+: Pharmalittle: We’re reading about a thumbs down for an Alzheimer’s drug, Pfizer gene therapy struggles, and more
STAT
JULY 26, 2024
Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year. Novo plans to add the prescribing information on the Wegovy label in the EU within about one month. regulator, while the U.S. Continue to STAT+ to read the full story…
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What are the side effects of atorvastatin for older adults?
The Checkup by Singlecare
APRIL 9, 2025
Atorvastatin interactions Atorvastatin interactions, per the Lipitor label, include the following: Strong inhibitors of CYP3A4 : Combining atorvastatin and strong inhibitors of CYP3A4, an enzyme, can increase plasma concentrations of atorvastatin. In the event of an overdose, immediately seek medical attention or call 911. Diarrhea 6.8%
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First patient dosed with HIV gene therapy
European Pharmaceutical Review
SEPTEMBER 22, 2022
The Phase I/II trial ( NCT05144386 ), sponsored by Excision, is an open-label, sequential cohort, single ascending dose study and will enrol nine patients. As a result, HIV can persist in tissue reservoirs for years.
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Insights+ Key Biosimilars Events of March 2023
PharmaShots
APRIL 5, 2023
in bevacizumab with no incidence of treatment-induced neutralizing anti-drug Ab MB02 is a bevacizumab biosimilar that has received approval from the US FDA & EMA which previously showed bioequivalence to reference bevacizumab in 3 PK studies in healthy patients Related Post: Insights+ Key Biosimilars Events of February 2023
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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma
pharmaphorum
MAY 25, 2022
When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Identifying the appropriate code and label. The same cannot be said for online events. The codes still apply.
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Oral penicillin challenge deemed safe and effective in low-risk allergy patients
Hospital Pharmacy Europe
JULY 18, 2023
Removing the label of being allergic to penicillin involves intra-dermal skin testing followed by an oral penicillin challenge. In the five days following the oral penicillin challenge, a total of nine immune-mediated adverse events were recorded in the intervention group and 10 in the control group.
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Developing the EU’s first intestinal microbiota-based biologic
European Pharmaceutical Review
JUNE 12, 2024
This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. MBK-01 demonstrated a greater clinical benefit than fidaxomicin when used as the first choice for treatment of the current CDI episode event without any antibiotic treatment. percent compared to 61.54
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Can you take glimepiride and metformin together?
The Checkup by Singlecare
DECEMBER 31, 2024
It is FDA approved to treat Type 2 diabetes along with diet and exercise in adults and children 10 years and older, but it also has various off-label uses. On top of that, metformin is sometimes prescribed off-label to treat Type 1 diabetes , while glimepiride is only suitable for Type 2. Roman and Morkos.
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Study suggests CTX-009 a promising approach for biliary tract cancer
Hospital Pharmacy Europe
JANUARY 29, 2023
The findings presented at ASCO 2023, relate to an open-label, multi-centre, single arm, Phase II trial, in patients with unresectable, advanced biliary tract cancer. In terms of safety, treatment-emergent adverse events > grade 3 occurred in 95.8% of patients and 6 patients discontinued treatment due to adverse events.
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FDA releases analysis on drug product quality in 2022
European Pharmaceutical Review
JULY 3, 2023
CDER’s analysis stated that the median site inspection score (SIS) of the manufacturing sites with more than one FY2022 recall event was lower (4.96) than the median SIS for sites with one or fewer recall events in FY2022 (7.00).
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Digital Tools at the Center of Healthcare Digitalization
Pharma Marketing Network
MARCH 23, 2021
Get your complimentary copy of "The Publishing Industry: The Soar of Innovation During COVID-19 Fact Sheet". Company Email *.
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Semaglutide weight loss injection launched in UK
European Pharmaceutical Review
SEPTEMBER 5, 2023
Evidence of efficacy for Wegovy In headline data from its landmark trial evaluating cardiovascular outcomes in obese patients released last month, Novo Nordisk announced that semaglutide 2.4mg (Wegovy) demonstrated a 20 percent reduction in major adverse cardiovascular events.
Novartis to Present Five-Year (ALITHIOS) Open-Label Extension Study Results of Kesimpta (ofatumumab) for Relapsing Multiple Sclerosis at AAN 2023
PharmaShots
APRIL 20, 2023
was associated with fewer confirmed disability worsening events vs those who switched later from teriflunomide to Kesimpta ~80% remained free of 6mos. Shots: The (ALITHIOS) OLE study evaluating Kesimpta which showed continuous treatment with Kesimpta for ~5yr. CDW, low brain volume change over 5yr. vs switch group (-0.42%/yr.) vs -0.28%/yr.
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