pharmaphorum

SEPTEMBER 6, 2022

The company’s lead drug PTX-061 is intended to improve the effectiveness of chemotherapy in patients with AML , which at the moment is only effective in around 20% of patients. The company said it will develop the new drug very quickly, and is eyeing regulatory filings with the FDA and EMA “as early as 2024.”

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The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU. With a J-code from the Centers for Medicare & Medicaid Services, PEMRYDI RTU is expected to be launched in the first quarter of 2024.

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pharmaphorum

OCTOBER 4, 2020

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

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Immunization Chemotherapy FDA 98

European Pharmaceutical Review

AUGUST 12, 2024

The deal is anticipated to be finalised in Q3 of 2024. Progress in immunotherapy drug development In June, the US Food and Drug Administration (FDA) authorised an immunotherapy combination to treat endometrial cancer.

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Research Laboratories Chemotherapy FDA 59

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb]. cited 2024Feb].

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European Pharmaceutical Review

DECEMBER 28, 2023

As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.

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Immunization Chemotherapy Medical Schools FDA 84

pharmaphorum

OCTOBER 10, 2022

Immutep claimed fast-track status from the FDA for efti last week as a combination therapy alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) for previously-untreated non-small cell lung cancer (NSCLC), based on the results of the phase 2 TACTI-002 study. month mPFS with Keytruda plus chemo, with fewer side effects.

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Chemotherapy FDA 59

European Pharmaceutical Review

JULY 18, 2024

1,2 This is especially important in forms of cancer where chemotherapy remains the main treatment option. Because ADCs offer a good way to specifically deliver an effective treatment to tumour systems, this could be an improvement on the systemic impact of chemotherapy. References Fu et al. ASCO Educational Book.

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Chemotherapy FDA 59

pharmaphorum

DECEMBER 5, 2022

The trial tested Jemperli given alongside chemotherapy with carboplatin and paclitaxel, followed by Jemperli alone, to a control group given placebo plus chemo followed by placebo.

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PharmaShots

MARCH 29, 2023

Lupin has earned the US FDA approval for the generic version of Banzel as Rufinamide Oral Suspension. It is the only drug in its class of chemotherapy and is developed from the natural substance found in a sea sponge. The exact mechanism of action is uncertain. Glenmark has also released its generic drug version in the US market.

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Hospital Pharmacy Europe

FEBRUARY 15, 2024

They are] administered by the same nurses who would normally give chemotherapy’, Dr Tucker says. The FDA is already talking up what it calls ‘a dizzying array’ of potential formats for multispecific antibodies, which can target multiple antigens simultaneously and, it says, ‘may lead to treatments for diseases with no or few therapies’.

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The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [45] As the intestines are made of smooth muscles, a reduction in the action of these muscles can slow down digestion and cause constipation. freece.com. [11]

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The FDA Law Blog

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). chemotherapy-induced), and pain.

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Controlled Substances Chemotherapy FDA Dosage 69

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

MARCH 29, 2023

In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. Stéphane Thiroloix, CEO of AlgoTx Alongside erythromelalgia, the company is testing ATX01 in a Phase II study in chemotherapy-induced peripheral neuropathy (CIPN). The company expects to have data from both trials ready in mid-2024, says Thiroloix.

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STAT

JULY 31, 2023

… House Republicans have drafted drug-shortage legislation that differs significantly from the approach Democrats propose to stem shortages of chemotherapies and other critical medicines that hospitals typically use , STAT explains. Republicans We value your postcards and telegrams.

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The FDA Law Blog

MAY 5, 2024

Last August, the Food and Drug Administration (“FDA”) and HHS, after considering the eight-factor analysis required by the Controlled Substances Act (“CSA”) for scheduling substances of abuse, recommended DEA reschedule marijuana from schedule I to schedule III. 29, 2023). Letter to DEA Administrator Anne Milgram, from Phil Weaver, et al.

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The FDA Law Blog

FEBRUARY 11, 2024

FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024).

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