European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

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European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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FDA Compounding Documentation 52

Hospital Pharmacy Europe

MARCH 21, 2024

Supporting the successful compounding of drugs with 3D printing processes has the potential to not only fulfil unmet patient needs but also drive efficiencies in hospital pharmacies. 2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015.

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Hospitals Compounding Dosage FDA 111

The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Important note: Like Mounjaro, many of these drugs are in demand—and as of early 2024, some are in short supply, so they could be difficult to get.

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Insurance Compounding Pharmacies Compounding Insurance Coverage 59

The FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Roots Analysis

AUGUST 1, 2024

Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA. Examples of some partnerships in this domain include: In May 2024, Sciwind Biosciences and HK inno.N

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Insurance Coverage Insurance Packaging Compounding 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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pharmaphorum

JANUARY 23, 2023

There has been little to report on the programme in the intervening period, other than confirmation that Janssen paid Morphic $10 million in upfront fees, followed by another $5 million in February 2021, and was due to generate revenues to the Waltham, Massachusetts-based biotech until 2024.

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Compounding FDA 52

pharmaphorum

APRIL 10, 2022

10,808,039) covering ADCs that include auristatin compounds coupled to an antibody via a linker molecule. Seagen hailed the outcome of the lawsuit, saying it will now seek royalties on all future US sales of Enhertu through the remaining lifespan of the patent, which expires in November 2024. That could be a sizeable sum.

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Compounding FDA 52

Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. Among other plans, the company hopes to start a Phase I trial of its compound NNI-351 depending on their funding plans.

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Compounding FDA 52

PharmaShots

FEBRUARY 22, 2023

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026).

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Insurance Compounding Dosage Communication 64

Pharmaceutical Technology

JANUARY 10, 2023

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. However, Invokana is likely to continue to lose market share (forecast 9MM CAGR decline of 14.6%), due to an FDA boxed warning regarding diabetic ketoacidosis and increased risk of lower limb amputations.

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The Thyroid Pharmacist

NOVEMBER 15, 2024

17] Ozempic is a once-weekly injection that was approved by the FDA in 2017 for use in adults with type 2 diabetes. Compounding pharmacies will sometimes repackage these drugs, or create lower or different concentrations than what’s typically available. June 25, 2024. Accessed November 13, 2024 [link] [20] Tirrell M.

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PharmaShots

APRIL 3, 2023

The IND application for APB-102 has been approved by the US FDA & the therapy also received ODD & FTD. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. ORR (41.8%

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The Checkup by Singlecare

MARCH 21, 2024

Its active ingredient, semaglutide, is FDA approved for weight loss under the brand name Wegovy , which has a dosing progression of 0.25 has said they expect the shortage to last at least until March 2024. The limits for 2024 are $22,590 for individuals and $30,660 for married couples. mg, 1 mg, 1.7 mg, and 2.4

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Insurance Coverage Insurance Dosage Mail-Order Pharmacies 98

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. Accessed September 6, 2024. Accessed September 17, 2024. It enhances intestinal fluid secretion, thus aiding in constipation. Accessed June 6, 2023.

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Pharmaceutical Technology

MARCH 29, 2023

AlgoTx remains on track to start enrolling subjects of a Phase II study of its compound ATX01 for the rare condition erythromelalgia in Q2 2023, says CEO Stéphane Thiroloix. In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. Free Report How is the Biopharmaceutical industry evolving?

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Chemotherapy Compounding Communication FDA 52

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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