Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder.

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Drug Discovery World

SEPTEMBER 14, 2023

Excluding Covid-19 medicines, total revenue increased 16% and product sales increased 15%. For Sanofi, second quarter 2023 sales growth of 3.3% Moreover, the FDA approved Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). Specialty care grew 11.8%

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43

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XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. More potential patients equal more prescriptions which equals higher sales and bigger profits.

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Pharmacy Checkers

OCTOBER 2, 2020

Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. company, such as a wholesale pharmacy or retail pharmacy imports commercial quantities for re-sale. Wholesale importation is when a U.S.

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XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. Part J is written in three sections. J)(2) Waiver authority.

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pharmaphorum

MAY 24, 2021

While there are plenty of EGFR-targeting drugs on the market for NSCLC, Rybrevant is the first to be FDA-approved for patients with exon 20 mutations, and also represents Janssen’s first lung cancer therapy. billion last year from its approved indications in EGFR-mutated NSCLC.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. Key results include: Total revenues increased 5% to $6.5

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Camargo

FEBRUARY 4, 2021

Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive. Report Shows that Most Drugs Fall Short of Sales Forecasts. Camargo has extensive experience in assisting clients navigate these challenges.

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pharmaphorum

JUNE 2, 2021

The additional capacity will also allow Moderna to prepare for full regulatory approval of the vaccine, which would be its first registered product and likely a source of blockbuster revenue in the coming years as COVID-19 switches from pandemic to endemic status.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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XTalks

DECEMBER 29, 2022

As of December 16, 2022, there are seven US Food and Drug Administration (FDA) approved gene therapies. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. In 2023, a number of gene therapies are expected to get the FDA green light.

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Pharmacy Checkers

JANUARY 4, 2020

It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation. Wholesale drug importation is when people or companies import drugs for re-sale, usually described as commercial quantities. What about personal drug importation ?

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. FOOTNOTES. (1)

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The Pharma Data

NOVEMBER 4, 2020

Such promotion builds on the important outreach to healthcare professionals made by our direct sales team, the size of which doubled near the start of 2020. In the process of hiring select people with extensive commercial experience in Europe and preparing for post-approval market access negotiations. million and $8.9

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The Pharma Data

OCTOBER 29, 2020

Net product sales were $1,588.3 SOLIRIS net product sales were $1,042.3 ULTOMIRIS net product sales were $289.3 STRENSIQ net product sales were $189.4 KANUMA net product sales were $28.4 ANDEXXA/ONDEXXYA net product sales were $38.9 GAAP cost of sales was $144.7 GAAP cost of sales was $144.7

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The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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The Pharma Data

JANUARY 5, 2021

In addition, Radius may pay sales-based milestone payments and a tiered, high single-digit effective royalty. based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C.

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The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Source link.

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The Pharma Data

APRIL 26, 2021

Q1 net sales declined -2% (cc¹, +1% USD), due to prior year COVID-19 related forward purchasing (approximately USD 0.4 Kesimpta sales reached USD 50 million. Adakveo sales reached USD 37 million. Sandoz sales declined -13% (cc, -9% USD), with Retail -18% (cc) and Biopharmaceuticals growing +7% (cc). Operating income.

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The Pharma Data

FEBRUARY 4, 2021

on a GAAP Basis, Inclusive of a Non-cash Charge for Skyrizi Contingent Consideration Revaluation Based on Higher Estimated Future Sales; Adjusted Diluted EPS of $2.92. AbbVie recently provided new long-term sales guidance. The company expects continued strong total company sales growth leading up to the U.S. Recorded a $4.7

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The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. Scientists at Charité, University Medicine Berlin , have been able to use daratumumab to successfully treat two female patients who have systemic lupus erythematosus.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. Cost of Sales (1). previously $59.4

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FDA Law Blog

JANUARY 9, 2024

However, before the state can start importing drugs, it must first submit for FDA approval a pre-import request for each eligible prescription drug it plans to import into the United States. This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. See 21 C.F.R. 251.5; § 251.6(c).

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FDA Law Blog

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products. January 29, 2024).

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