pharmaphorum

FEBRUARY 11, 2022

Privately-held Mayoly Spindler is a specialist in gastroenterology and dermato-cosmetic products that has set itself the target of becoming a top 10 European OTC medicines company in the next 10 years. billion takeover of Clementia Pharma in 2019. billion of its revenues last year.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Section II at 2. Draft Guidance III.B.2(e)

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The Pharma Data

APRIL 1, 2021

Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the launch of SkinMedica ® Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. The skin of the neck is also thinner, similar to the skin on eyelids.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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Pharma in Brief

JANUARY 10, 2024

Changes in Canada’s pricing and market access regimes This year saw major developments in the drug price and reimbursement space, including at the Patented Medicine Prices Review Board ( PMPRB ), the pan-Canadian Pharmaceutical Alliance ( pCPA ), and the Canadian Agency for Drugs and Technologies in Health ( CADTH ). CDA announced.

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The Pharma Data

FEBRUARY 5, 2021

CoolSculpting ® has been an industry-leader, creating the market for non-invasive fat reduction over 10 years ago. ” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. “The number one aesthetic concern for consumers is excess body fat 1.

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FDA Law Blog

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, In other words, it’s a get-what-you-pay-for type situation.

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Pfizer

DECEMBER 13, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. Herbal Products: St. AUTHORIZED USE . IMPORTANT SAFETY INFORMATION

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pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA interprets “pattern” to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. Criterion 2.

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The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. There is also substantial interest, from major industry players, in the Company’s proprietary Tauri-Gum product line.”. . ABOUT TAURIGA SCIENCES INC. .

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Pharmacy Checkers

SEPTEMBER 25, 2020

As a quick reminder, pursuant to Section 804 of the Food, Drug and Cosmetic Act, the FDA issued a proposed new rule to allow wholesale imports of lower-cost drugs from Canada, subject to many conditions and excluding expensive biologics. Biologics, medical products derived from living organisms, are much more expensive than regular drugs.

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FDA Law Blog

JUNE 21, 2022

For those unfamiliar with the hearing aid industry, the industry faces regulations on all fronts: FDA regulates the devices while states regulate their distribution and impose conditions of sale via their licensing authority over “hearing health professionals” including audiologists or hearing aid dispensers.

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Pfizer

DECEMBER 20, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. Herbal Products: St. AUTHORIZED USE. IMPORTANT SAFETY INFORMATION.

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FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(B). chemotherapy-induced), pain, and post-traumatic stress disorder.

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Pfizer

NOVEMBER 23, 2022

Voluntary Licensing : Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

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FDA Law Blog

NOVEMBER 22, 2021

This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). It does not apply to software-related documentation that may be needed to evaluate post market software device issues (e.g.,

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The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. Global Botox Cosmetic net revenues were $493 million , an increase of 9.1 Refer to the Key Product Revenues schedules for further details. percent on a reported basis, or 45.0

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The global revenue for Invega products was $4.14 Pfizer Inc.

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