Pharmaceutical Commerce

DECEMBER 18, 2023

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

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STAT

MARCH 8, 2024

The drug, donanemab, succeeded in its Phase 3 trial , resulting in a 35% slowing of Alzheimer’s disease progression versus placebo.

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PharmaTech

OCTOBER 12, 2023

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

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Documentation 52

Pharmacy Times

JANUARY 9, 2024

Berdazimer topical gel, 10.3% (Zelsuvmi; Ligand Pharmaceuticals Inc) has been approved for the treatment of molluscum contagiosum in individuals aged 1 year and older.

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Pharmaceutical Commerce

DECEMBER 20, 2023

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

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pharmaphorum

MARCH 10, 2024

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.

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STAT

APRIL 18, 2023

Over the past five years, digital mental health has risen from a niche topic to a global health priority. Two companies that came to embody this potential were Mindstrong for smartphone monitoring of mental health and Pear Therapeutics for FDA-approved apps and digital interventions. billion evaluation.

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Pharmaceutical Technology

JANUARY 8, 2024

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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STAT

DECEMBER 1, 2022

The first FDA-approved fecal microbiome drug. We cover all these topics and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We also discuss the FDA approval of a microbiome drug for the treatment of a bowel disorder and the potential for a big acquisition of Horizon Therapeutics.

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Drug Pricing 183

Pharmacy Times

DECEMBER 19, 2023

This approval makes birch triterpenes the first treatment for wounds associated with junctional epidermolysis bullosa to be approved by the FDA.

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Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

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Controlled Substances 64

Express Pharma

SEPTEMBER 27, 2023

Winlevi has been approved by the United States Food & Drug Administration (US FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older. Winlevi has become the most prescribed branded topical acne drug in the US.; million in 2021 to $1,297.0 million in 2028.

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Pharmacy Times

MARCH 18, 2024

The FDA-approved topical and oral agent is currently indicated for adult patients with patterned alopecia.

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Chemotherapy 52

FDA Law Blog: Biosimilars

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic. By Allyson B. Mullen & Jeffrey N.

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Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

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Labelling 116

LifeProNow

DECEMBER 22, 2023

In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. Pharmasol is under contract with multiple pharmaceutical companies.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 130

LifeProNow

MAY 4, 2023

FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The FDA has long considered the benefits of decentralized clinical trials. Califf, M.D.

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Packaging 130

Eye on FDA

AUGUST 17, 2022

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Soon, we may have a new dominating topic in Monkeypox. So let’s take a look: Volume – Let’s look first at the numbers of releases issued by FDA for the first six months of the year.

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Communication Labelling 75

Pharmaceutical Business Review

DECEMBER 18, 2023

ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. In the hair-bearing areas, applying topicals such as creams, gels, and ointments becomes difficult.

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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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Labelling 98

Pharmaceutical Business Review

MARCH 5, 2024

This marks a significant advancement in ophthalmic care, introducing the first FDA-approved ophthalmic formulation of clobetasol propionate, a corticosteroid and the first new steroid in the ophthalmic market in over one and half decades.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% to treat the signs and symptoms of dry eye disease.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. Walsh brings to the table an unparalleled depth of FDA regulatory expertise. More notably, Ms.

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Pharma Leaders

APRIL 20, 2023

The FDA has updated emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to allow individuals 65 years and older to receive a second booster dose at least four months after the first bivalent dose. The FDA also authorized use of the current bivalent vaccines for everyone six months of age and older.

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Vaccines 52

Pharma Leaders

APRIL 7, 2023

The FDA has identified undisclosed deficiencies in Ascendis Pharma’s new drug application (NDA) for TransCon PTH (palopegteriparatide) for treatment of hypoparathyroidism, an uncommon condition in which the body produces low levels of the parathyroid hormone. Related Topics

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Labelling 52

FDA Law Blog: Biosimilars

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. FDA Law Blog readers can use discount code S10-866-866L24.S HP&M is proud to have our professionals participating in these important events.

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Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

HPM”), as well as other experts from FDA, DOJ, and the private sector. Walsh is a nationally recognized expert on FDA enforcement matters across all sectors and has held numerous leadership positions with FDLI and with the Women’s White Collar Defense Association.

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Communication 59

Pharma Leaders

MAY 8, 2023

The FDA sent a complete response letter (CRL) to Novo Nordisk on April 24, requesting more information on the company’s hemophilia drug concizumab, the company announced in its first quarter earnings report. Novo Nordisk also said it is evaluating the content of the CRL and will work with the FDA to provide the requested data.

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pharmaphorum

OCTOBER 26, 2022

Topicals — creams, ointments, foams, and lotions applied directly to the affected areas of the skin — don’t get nearly as much TV time as their systemic biologic counterparts, the self-injectables with catchy theme songs, where the smiley and sleeveless walk confidently down the street and/or swim. First in class. In May, the U.S.

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Immunity Immunization Adverse Reactions 98

Safe Biologics

NOVEMBER 12, 2023

This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation. The FDA will be accepting comments on the draft guidance through Nov. Read the new FDA’ Guidance here. Read the full letter here.

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Pharma Leaders

MAY 3, 2023

The FDA has placed a partial clinical hold on Sun Pharma’s IND application for Deuruxolitinib (CTP-543), which was being studied in patients with alopecia areata, an autoimmune disease that includes hair loss. Related Topics

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Labelling 52

RX Note

FEBRUARY 11, 2024

Topical teething gels*. UpToDate does not recommend OTC (including homeopathic remedies) or prescription-strength topical analgesics (e.g., Says, 2016 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit, 2018 Chewing on a chilled [not frozen] teething ring.

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Adverse Reactions Labelling Community Pharmacies 52

European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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Labelling 92

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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Packaging 85

Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. Consider “FDA in Brief” releases as a sort of press release-lite.

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Labelling Communication Vaccines 93

Pharmaceutical Business Review

MAY 1, 2023

The next generation topical phosphodiesterase-4 (PDE4) inhibitor Zoryve is also indicated to treat psoriasis in the intertriginous areas. This approval marks the first topical PDE4 inhibitor to receive approval outside of the US.

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Adverse Reactions Immunity Immunization 52