The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

Documentation 59

Documentation Labelling FDA Packaging 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

JULY 9, 2021

The updated label for Aduhelm (aducanumab) says it should only be used in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, according to an update from the drug’s developers. Katie Porter (@RepKatiePorter) July 6, 2021. Now, it has backtracked on that decision.

Labelling 59

Labelling FDA 59

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

European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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FDA Labelling 122

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…

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Labelling FDA 127

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.

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Vaccines Labelling Immunization 122

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.

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Labelling Immunization 111

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 .

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FDA Labelling 98

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

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.

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Labelling Compounding 98

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.,

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Labelling FDA 98

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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Labelling 98

European Pharmaceutical Review

NOVEMBER 10, 2022

Medicines Discovery Catapult (MDC) released a report 2 on complex medicines in 2021, proposing narrowing the definition to: ‘medicines requiring the application of novel technologies for their delivery and targeting of drugs, through the modification of an active pharmaceutical ingredient (API) or formulation, or a novel delivery route’.

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Labelling Compounding 105

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.”.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 119

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

IDStewardship

MARCH 12, 2023

” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication. Article 5: A Baker’s Dozen of Top Antimicrobial Stewardship Intervention Publications for Hospitalized Patients in 2021 Find it here.

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Medication Guidelines Documentation Labelling Hospitals 299

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

pharmaphorum

SEPTEMBER 2, 2020

These include handling of decentralised and mutual recognition procedures, how variations to labels will be handled and new assessment routes from 1 January. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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Documentation Labelling 124

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 105

Labelling 105

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.

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FDA Labelling 105

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.”.

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Labelling Communication FDA Medical Schools 97

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

DECEMBER 29, 2021

The FDA’s decision stemmed from a request for additional data relating to a device component of tralokinumab, scuppering Leo’s hopes for a US launch for Adbry in 2021. billion in the first nine months of 2021, helped by additional approvals in severe asthma and chronic rhinosinusitis with nasal polyposis.

FDA 111

FDA Labelling 111

pharmaphorum

JANUARY 26, 2022

At the moment the only other BiTE to reach the US market is Amgen’s CD19-targeting Blincyto (blinatumomab), which has been approved for various types of leukaemia and made $340 million in sales in the first nine months of 2021.

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FDA Chemotherapy Labelling Immunization 124

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 98

Labelling FDA 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

pharmaphorum

SEPTEMBER 24, 2021

The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet to develop any symptoms of the muscle wasting disorder. Evrysdi is also on an upwards trajectory, bringing in around $250 million in the same period.

Labelling 97

Labelling FDA 97

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

Labelling 111

Labelling FDA 111

pharmaphorum

FEBRUARY 21, 2022

DESTINY-Breast03 and 04 as well as data in HER2-positive non-small cell lung cancer (NSCLC) have gone a long way towards building positive sentiment to Enhertu among market watchers, who were nervous about the drug’s prospects when the ILD issue started to emerge.

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Chemotherapy Labelling 132

European Pharmaceutical Review

JANUARY 13, 2023

The CHMP’s opinion does not need a European Commission (EC) decision due to the nature of the Type-II label variation. In July 2021, Tezspire was the first and only biologic to be granted Priority Review in the US for the treatment of asthma by the FDA. Rise of biologics set to continue, says report.

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Labelling FDA 98

The Checkup by Singlecare

FEBRUARY 14, 2024

That’s why even though the medication is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes, it’s also used off-label as a weight-loss medication. For managing blood glucose levels, a 2021 trial found tirzepatide to be slightly more effective than semaglutide (the active ingredient in brand-name Ozempic ).

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Dosage Labelling FDA Pharmaceutical Companies 115

pharmaphorum

JANUARY 7, 2022

billion on the first nine months of 2021, well ahead of Pfizer’s own forecasts. Ionis’ drug has however been held back by a limited label and some safety concerns and Ionis recently sold North American rights to the drug to Sobi.

Labelling 116

Labelling Immunization 116

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

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.

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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