Fierce Pharma

DECEMBER 21, 2023

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. |

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The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Labelling Communication FDA 59

Fierce Pharma

OCTOBER 11, 2023

Dermavant has presented evidence that Vtama provides immediate and long-term relief from the severe itch condition pruritus, the most prevalent symptom of atopic dermatitis. The trial results bolster Dermavant's effort to win a label expansion for the drug.

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Labelling FDA 97

pharmaphorum

FEBRUARY 17, 2022

The drugmaker was supposed to hear back from the FDA on mavacamten at the end of January, but the regulator delayed its deadline to 28 April to allow more time to look at BMS’ risk evaluation and mitigation strategy (REMS) for the drug, which is vying to become the first cardiac myosin inhibitor on the market.

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Labelling FDA 59

The FDA Law Blog

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. Further, FDA, in its ministerial role, only looks at the use code and approves a carve-out based on the use code.

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Labelling FDA 40

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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pharmaphorum

DECEMBER 5, 2022

A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

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Pharmaceutical Technology

MAY 16, 2023

Dutch biopharmaceutical company Byondis has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for [vic-]trastuzumab duocarmazine (SYD985).

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FDA Labelling 52

European Pharmaceutical Review

DECEMBER 2, 2022

has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Rigel Pharmaceuticals, Inc. Clinical safety data of Rezlidhia for AML.

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FDA Labelling 77

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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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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The FDA Law Blog

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter

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Labelling FDA Controlled Substances 59

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). Supporting information is critical to illustrate the specific points of regulatory misconduct.

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pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

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FDA Documentation Labelling 59

Pharmaceutical Technology

NOVEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Dyne Therapeutics’ DYNE-251 to treat Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping. At present, DYNE-251 is being analysed in the international Phase I/II DELIVER trial.

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FDA Labelling 52

Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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pharmaphorum

JUNE 20, 2022

Nuplazid (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson’s disease, but Acadia’s hope to expanding that use to the Alzheimer’s population were shot down by a complete response letter (CRL) from the regulator last year. At one point it had been tipped as a future blockbuster.

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FDA Labelling 52

PharmaShots

MAY 8, 2023

Shots: The P-III open-label study (ECOSPOR IV) evaluating Vowst, the US FDA-approved orally administered microbiota-based therapeutic to prevent recurrence in 263 patients, showed that 91.3% of patients achieved clinical response @8wks. maintained a response through 24wk. achieved a clinical response @8wk.; 94.4% & 94.6%

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Labelling FDA 40

pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Meanwhile, those with levels below 150 cells/µL – a group with no biologic treatment options at present – the AAER dropped by 39%.

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FDA Labelling 52

The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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FDA Labelling 78

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

European Pharmaceutical Review

MARCH 5, 2024

Conference, forums and highlights Parallel to the fair, the renowned analytica conference takes place in the ICM – International Congress Center Messe München, covering the breadth of modern analysis with around 180 presentations. ” Additionally, environmentally friendly alternatives to chemicals and consumables are presented.

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Labelling FDA 84

Pharmaceutical Technology

DECEMBER 11, 2022

Richter’s transformation (RT) is a rare blood cancer arising in up to 10% of patients with chronic lymphocytic leukemia (CLL) and presenting as aggressive lymphoma, typically as diffuse large B-cell lymphoma (DLBCL). Among the enrolled patients, 68 were previously treated and seven were newly diagnosed.

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Labelling FDA 59

European Pharmaceutical Review

NOVEMBER 21, 2022

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). The syndrome accounts for half of all heart failure cases globally. The first bioengineered HFpEF human heart models.

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Labelling FDA 122

The Checkup by Singlecare

FEBRUARY 8, 2024

Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. The first generic of prescription Zyrtec, cetirizine, was approved by the FDA in 2008, around the time the medication became available over the counter. for 30, 10 mg tablets of Zyrtec (must present prescription to apply SingleCare savings) $3.24

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Dosage Labelling FDA Hospitals 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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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union. Keep thorough records of approvals for future reference.

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Packaging Labelling Communication Pharmaceutical Companies 52

Pharmaceutical Technology

MARCH 6, 2023

While the data will be presented at an upcoming meeting, a previous analysis of the two arms for OS showed an HR of 0.59, which could lead to a modest but clinically meaningful improvement in OS. The case of Tuoyi presents a very interesting case in global development and commercialisation efforts. versus 1.4%). versus 1.4%).

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Chemotherapy FDA Labelling Immunization 52

The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR. 860.230.

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FDA Documentation Labelling 52

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.

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Labelling FDA Documentation 52

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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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. We do not know if tirzepatide is associated with MTC in humans.

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European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. The Phase III data will be presented at an upcoming medical meeting. The PSMAfore study. No unexpected safety findings were observed in PSMAfore.

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PharmaShots

APRIL 21, 2023

Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)

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FDA Labelling 40

Hospital Pharmacy Europe

JUNE 12, 2023

Dystrophic epidermolysis bullosa is caused by a gene mutation, and the recent FDA approval of the corrective gene therapy VYJUVEK represents the first specific treatment to become available. Dystrophic epidermolysis bullosa (DEB) is a rare genetic, blistering skin disorder that is usually present from birth. Rod Tucker finds out more.

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