The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

Labelling 45

Labelling FDA 45

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

Labelling 59

Labelling FDA 59

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

Labelling 52

Labelling 52

pharmaphorum

JANUARY 12, 2021

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

Labelling 71

Labelling FDA 71

STAT

JANUARY 8, 2024

Cure Ventures , a Boston-based venture capital firm founded in 2021 by a trio of veteran biotech investors, has brought in two former executives from Sage Therapeutics to prepare them for investing in neuroscience startups. Continue to STAT+ to read the full story…

Labelling 89

Labelling FDA 89

Pharmaceutical Technology

JANUARY 23, 2023

However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021.

Labelling 111

Labelling Immunization 111

STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

Labelling 82

Labelling FDA 82

European Pharmaceutical Review

FEBRUARY 8, 2023

Research from data and analytics company GlobalData shows that the use of CD19 chimeric antigen receptor T-cell (CAR-T) agents for blood cancer is set to significantly increase between 2021-2031. GlobalData predicts Bristol-Myers Squibb’s Breyanzi and Gilead’s Yescarta are set to have high annual sales in the forecast period.

Labelling 96

Labelling Compounding 96

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

FDA 89

FDA Labelling 89

STAT

OCTOBER 4, 2023

Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. The treatment, which is called Lumakras and made by Amgen, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. Now, Amgen needs to prove it works.

FDA 87

FDA Labelling 87

pharmaphorum

JUNE 22, 2021

Labelling software firm has implemented six new software systems in the last few months in a sign that the market is now rebalancing after the upheavals of the last 12 months. The first few months of 2021 have been extremely busy for us as it is clear that the legacy of COVID-19 has focused people’s minds.

Labelling 52

Labelling 52

pharmaphorum

JULY 1, 2021

The two firms are collaborating to create a unique, end-to-end labeling solution tailored for medical device organizations. Wokingham, United Kingdom — 22 nd June 2021 — Labeling software specialist PRISYM ID has joined the Siemens Digital Industries Software Solution Partner Program.

Labelling 52

Labelling 52

pharmaphorum

MAY 10, 2021

Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

Vaccines 122

Vaccines Labelling Immunization 122

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

Labelling 105

Labelling 105

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 *.

Labelling 98

Labelling 98

The Checkup by Singlecare

JANUARY 26, 2024

Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity. It received FDA approval for weight management in June 2021.) Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects.

Labelling 111

Labelling FDA 111

The FDA Law Blog

AUGUST 23, 2022

Instead of simply denying authorization, FDA responded by authorizing these tests with a requirement in the labeling for serial testing. For example, labeling stated: This test is authorized “when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.”.

Labelling 97

Labelling Communication FDA Medical Schools 97

The Checkup by Singlecare

FEBRUARY 8, 2024

Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Mounjaro (tirzepatide) is gaining popularity as a treatment for Type 2 diabetes mellitus and off-label for weight management. Cases of diabetic retinopathy with tirzepatide use were noted in a 2021 study.

Labelling 98

Labelling Adverse Reactions Mayo Clinic FDA 98

Pharmaceutical Technology

JULY 20, 2022

While the label expansion will likely increase avenues for patients to access the antiviral, Ganio adds one caveat: due to burnout and turnover seen across the healthcare field, including pharmacy staff, there are going to be sites that just don't have the resources to dedicate a pharmacist to do some of this work.

Labelling 111

Labelling Community Pharmacies Medical Records FDA 111

The Checkup by Singlecare

FEBRUARY 1, 2024

Keep a regular schedule : Taking ibuprofen as directed by the label or a healthcare provider can help ensure the drug is taken effectively and safely. Read labels on nonprescription products: Check the labels of OTC cold and pain medications. Harvard Health (2021) Caldolor highlights of prescribing information , U.S.

Labelling 98

Labelling Dosage FDA 98

European Pharmaceutical Review

JANUARY 18, 2023

In 2021, Peter Kohut, Director of Drug Safety at Arriello shared with EPR how European medical cannabis market lacks a common regulatory framework. “… there is a lack of standardisation in the manufacturing of medical cannabis products , their ingredients and labelling.”.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Labelling 110

pharmaphorum

JUNE 10, 2021

The latest version of the PRISYM 360 cloud-based labeling solution has achieved certification for the GS1 standards utilized by the medical device and life science industries. GS1 oversees a system of globally recognized open standards for unique identifiers that can be used throughout the supply chain to enhance traceability.

Labelling 52

Labelling Patient Care 52

European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. in November 2021. The primary endpoint assessed in this study was RBC-TI for 12 weeks, with a mean haemoglobin increase ? The company will also discuss results with health authorities.

Labelling 101

Labelling 101

pharmaphorum

OCTOBER 14, 2022

It was first approved for five-year contraception back in 2000, and had that extended to seven years in 2021. Now, the label says it “should be removed or replaced after eight years at the latest,” according to Bayer.

Labelling 59

Labelling FDA 59

Pharmaceutical Technology

MAY 19, 2023

The company’s NDA was supported mainly by the data obtained from the Phase I clinical trial completed in June 2021, and the Phase III ASCEND trial. In the long-term, open-label, safety ASCEND trial, 446 participants with more than 9,000 migraine attacks were treated with more than 10,500 STS101 doses for up to 18 months.

FDA 59

FDA Labelling 59

European Pharmaceutical Review

AUGUST 16, 2022

The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia. In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialise BeiGene’s tislelizumab in North America, Europe, and Japan.

Labelling 98

Labelling Immunization 98

pharmaphorum

MARCH 3, 2022

The findings – published today in the journal Nature Medicine – come after Jardiance was approved for chronic heart failure with reduced ejection fraction (HFrEF) last year, with the label expanded to include patients with heart failure with preserved ejection fraction (HFpEF) last month. It has been used to treat type 2 diabetes since 2014.

Labelling 98

Labelling Hospitals 98

pharmaphorum

MAY 5, 2021

After an indifferent period Novo Nordisk has kicked off 2021 on the front foot, raising its financial forecast after posting better than expected Q1 earnings and sales. He added: “The solid financial performance in the first three months of 2021 has enabled us to raise our outlook range for the full year.” billion DKK ($2.04

Labelling 72

Labelling FDA 72

The Checkup by Singlecare

NOVEMBER 3, 2023

Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. “Fruits are and should be one of the main components in our daily meals,” says Dr. Makhija. Fruit is a power-packed food and provides nutrients beyond the ‘sweet’ component of it.” Added sugar can go by many names.

Labelling 116

Labelling Packaging Immunization 116

European Pharmaceutical Review

OCTOBER 31, 2022

An ongoing Phase III, open-label, randomised trial ( 04628494 ) is currently evaluating epcoritamab as a monotherapy for patients with these cancers. Data from the dose escalation section of the investigation was published in The Lancet in 2021. The primary endpoint for the expansion part was overall response rate (ORR).

Labelling 89

Labelling FDA 89

The Checkup by Singlecare

DECEMBER 5, 2023

California Florida New York Texas Illinois New Jersey Colorado North Carolina Ohio Washington Additionally, a separate study by Trilliant found that cities in the states mentioned above had the highest percentage change in Ozempic use from 2021 to 2022. It should not be prescribed to patients who want to lose just a few pounds.

Insurance 105

Insurance Prescription Filling FDA Dosage 105

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Customer Service 52

Customer Service Labelling Packaging 52

pharmaphorum

FEBRUARY 17, 2021

An additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in Q2. The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million, with the potential to increase to 600 million if the commission takes the option on a further 100 million doses.

Vaccines 64

Vaccines Labelling 64

The Checkup by Singlecare

DECEMBER 1, 2023

Red Dye 40 is among the most commonly used artificial food dyes in the United States, and you might see it labeled under a different name on the products you consume. Regardless of what manufacturers label it as, there have been ties to specific negative side effects when ingested too frequently. 40 Aluminum Lake, and FD&C Red No.

Labelling 52

Labelling FDA Documentation 52

The Checkup by Singlecare

NOVEMBER 9, 2023

A recent study showed dieting patients lost up to a quarter of their body weight while taking Zepbound (when combined with diet and exercise)—more than Wegovy’s 15% of body weight during their 2021 study. Zepbound is a once-weekly injection for chronic weight management in adults with obesity (a body mass index of 30 kg/m 2 or greater).

FDA 120

FDA Insurance Labelling 120

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

Chemotherapy 59

Chemotherapy Labelling FDA 59

The Checkup by Singlecare

FEBRUARY 8, 2024

for 30, 10 mg tablets of cetirizine (must present prescription to apply SingleCare savings) Free coupons Zyrtec coupons Cetirizine coupons What are the off-label uses for Zyrtec? Off-label prescribing or off-label uses are when a medication is prescribed or used for an indication that is not approved by the FDA.

Dosage 52

Dosage Labelling FDA Hospitals 52