pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. That status goes to Johnson & Johnson’s Spravato (esketamine), which was approved in March 2019 and is administered as a nasal spray twice a week for four weeks.

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. thalassemia.

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Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.

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FDA Labelling 98

pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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FDA Chemotherapy Labelling 98

pharmaphorum

DECEMBER 22, 2021

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The post Amgen builds Otezla’s psoriasis label as rival BMS looms large appeared first on.

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Labelling FDA 59

The FDA Law Blog

SEPTEMBER 15, 2022

For both draft guidances, it is unclear what induced FDA to publish these draft guidances now. FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products.

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Labelling FDA 45

pharmaphorum

AUGUST 16, 2021

Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 billion takeover of Peloton Therapeutics in 2019 – for a family of rare tumours. Merck paid $1.05 billion upfront to secure rights to Welireg, and also pledged another $1.15

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Labelling FDA 98

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. Lilly acquired Retevmo as part of its $8 billion takeover of Loxo Oncology in 2019.

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Labelling FDA 59

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

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

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post FDA holds back from action over Xeljanz safety study appeared first on.

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pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. GSK’s problems with Trelegy, developed in partnership with Innoviva, stem from the phase 3 CAPTAIN study , which reported findings in May 2019.

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Labelling FDA 105

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

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FDA Labelling 72

pharmaphorum

AUGUST 18, 2021

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. billion takeover of Tesaro in 2019. The post GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli appeared first on.

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Labelling FDA 52

pharmaphorum

FEBRUARY 23, 2021

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. The post FDA to quickly review Incyte’s Jakafi in chronic GVHD appeared first on.

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FDA Labelling 66

pharmaphorum

JULY 26, 2021

Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of the main assets behind the $39 billion merger. Ultomiris was approved by the FDA for use in paediatric PNH last month.

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Labelling FDA 52

pharmaphorum

JULY 9, 2021

According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots. . The therapy hasn’t yet been approved by the FDA.

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Vaccines Labelling FDA Immunization 105

pharmaphorum

SEPTEMBER 2, 2021

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. The post FDA firms up JAK inhibitor warnings after Xeljanz review appeared first on.

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FDA Labelling 52

The Checkup by Singlecare

DECEMBER 21, 2023

But since its FDA approval for the treatment of Type 2 diabetes back in 1994, metformin has emerged as something of a “miracle drug” thanks to its effectiveness in treating other common health conditions, like infertility, obesity , and heart disease. Metformin is a medication commonly used to treat people with Type 2 diabetes.

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Health and Personal Care Stores Labelling Dosage FDA 105

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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pharmaphorum

JANUARY 29, 2021

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. Xeljanz isn’t the only drug in the class to be affected by toxicity concerns of course.

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Labelling Patient Care FDA 135

pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. Belsomra’s first-to-market advantage hasn’t translated into big annual sales, which have stayed planted just over the $300 million mark since 2019.

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FDA Labelling 52

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

The Checkup by Singlecare

MARCH 12, 2024

If you see medications labeled “Advil” and others labeled “ibuprofen,” you may ask yourself: “Is Advil the same as ibuprofen?” NSAIDs are FDA-approved pain medications that can decrease fever and inflammation. You may also want to know: Does Advil have ibuprofen in it? What does Advil and ibuprofen treat?

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Labelling FDA Medication Labelling 97

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. billion in 2019, and will be hoping for a swift uptake in the US to get a return on its big investment. It has a long way to go.

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Labelling FDA 105

pharmaphorum

OCTOBER 25, 2021

The new approval is the first breast cancer indication for Keytruda in Europe, although elsewhere Merck has already started to expand the label for its cancer immunotherapy in TNBC. The US and Japanese regulators approved the Keytruda plus chemo regimen for first-line TNBC treatment earlier this year.

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Chemotherapy FDA Labelling 87

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA Documentation Communication Labelling 105

The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. See 21 CFR 807.81(a)(3)

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FDA Documentation Labelling 98

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. and Miriam B. Morkos , Pharm.D.

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Labelling Dosage Insurance Coverage Insurance 52

The Checkup by Singlecare

JUNE 28, 2024

It’s in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, approved by the Food and Drug Administration (FDA) to manage blood sugar levels in adults with Type 2 diabetes when combined with diet and exercise. In fact, the drug often sees shortages due to high demand for off-label prescriptions for weight loss.

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Insurance Insurance Coverage Labelling Medical Records 96

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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FDA Labelling 52

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”

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FDA Labelling Documentation Communication 52

The Checkup by Singlecare

JUNE 7, 2024

However, it is still only approved for certain conditions, with other conditions being potential off-label uses. FDA-approved Farxiga uses Farxiga, known by its generic name dapagliflozin, first received approval from the Food and Drug Administration (FDA) in 2014. Weight loss Farxiga is not FDA-approved to promote weight loss.

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Labelling FDA Hospitals Dosage 80

The FDA Law Blog

FEBRUARY 16, 2023

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.

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Labelling Packaging FDA 64

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. February 2019.

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Labelling FDA 98

pharmaphorum

SEPTEMBER 11, 2020

billion in 2019 with more growth predicted this year. But Kesimpta (ofatumumab), a repurposed cancer drug approved last month by the FDA, is seen as strong competition for Ocrevus thanks to a comparatively lower price and an injector pen that allows for home administration instead of in a clinic.

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Labelling FDA 87

The FDA Law Blog

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Valentine & Frank J.

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