pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved,” said Gad, who is chairman and president of Y-mAbs. “I

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FDA Chemotherapy Labelling 105

pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

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Labelling FDA 76

pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

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FDA Chemotherapy Labelling 111

STAT

OCTOBER 4, 2023

Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. But in reviewing the study, the FDA found potential data and protocol problems that could jeopardize the entire trial. Now, Amgen needs to prove it works.

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FDA Labelling 106

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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FDA Labelling 98

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 129

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). By Sophia R.

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Labelling FDA 45

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. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021. Broad label questioned. — Brad Loncar (@bradloncar) June 7, 2021.

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FDA Labelling 98

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Labelling FDA Vaccines Communication 40

pharmaphorum

SEPTEMBER 23, 2022

The FDA has granted accelerated approval the RET inhibitor for all adults with locally advanced or metastatic solid tumours with a RET fusion mutation, two years after giving it a green light for RET-positive thyroid and lung cancers. The post Lilly bags label extension for RET drug Retevmo in US appeared first on.

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Labelling FDA 59

pharmaphorum

MAY 27, 2021

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids. . The post FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash appeared first on.

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FDA Labelling 98

pharmaphorum

JUNE 11, 2021

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs.

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FDA Immunization Labelling 96

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October.

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FDA Labelling Immunization 105

The FDA Law Blog

AUGUST 23, 2022

By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices. As FDA would acknowledge, the antigen tests are the fastest and most practical method for distributing testing in the general population. That could happen again.

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Labelling Communication FDA Medical Schools 97

The Checkup by Singlecare

DECEMBER 12, 2024

In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it.

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Compounding Compounding Pharmacies FDA Insurance 52

The FDA Law Blog

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021.

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Labelling Compounding Payment Processing Vaccines 105

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.

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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

The FDA Law Blog

AUGUST 7, 2024

But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements.

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Labelling FDA Hospitals 59

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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The FDA Law Blog

NOVEMBER 29, 2023

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. FDA considers these guiding principles as complimentary to their recent efforts around PCCPs including their proposed draft guidance on PCCPs.

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FDA Communication Labelling 115

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. 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.

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FDA Labelling 59

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. Costs and profits worldwide are shared with CRISPR Therapeutics.

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Labelling FDA 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.,

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Labelling FDA 98

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. AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in the first half of 2023. Rise of biologics set to continue, says report.

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Labelling FDA 98

pharmaphorum

SEPTEMBER 15, 2021

The two FDA-approved oral GnRH antagonists – AbbVie and Neurocrine Biosciences’ Oriahnn (elagolix) and Myovant’s Pfizer-partnered Myfembree (relugolix) – are both combined with hormonal drugs. If approved, ObsEva’s drug will add another once-daily competitor to the ring.

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FDA Labelling 98

pharmaphorum

MARCH 1, 2022

The US Food and Drug Administration (FDA) has approved a new cell-based therapy for blood cancer, developed by Janssen and China’s Legend Biotech to treat multiple myeloma. Following the FDA decision, CARVYKTI is now Legend’s first product to be approved for use in the US.

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FDA Labelling 59

pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. billion in sales from it in 2021, while Novartis made $2.2

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FDA Labelling 59

Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).

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FDA Labelling Immunization 59

pharmaphorum

DECEMBER 16, 2020

An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with preserved ejection fraction (HFpEF), which accounts for around half of all heart failure cases but proves highly resistant to drug treatment. The post Entresto set for big sales hike after FDA panel endorsement appeared first on.

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FDA Labelling 52

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

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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Chemotherapy FDA Labelling 98

European Pharmaceutical Review

OCTOBER 31, 2022

Additionally, Danish biotech Genmab has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for epcoritamab for adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The submissions are supported by Phase II trial data.

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Labelling FDA 98

pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. As Vidaza is a standard first-line therapy for AML the new indication makes Tibsovo an option for a wider range of patients, although the drug has reportedly been used off-label in this setting.

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FDA Chemotherapy Labelling 52

The Checkup by Singlecare

JANUARY 26, 2024

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

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Labelling FDA 111

The FDA Law Blog

NOVEMBER 14, 2022

2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. FDA will not refund any fees that have been incurred already). 31, 2021 is subject to the fee for FY 2022. (In

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FDA Packaging Labelling Dosage 52

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.

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Labelling FDA 97