FDA Law Blog

MAY 3, 2021

DEA’s Diversion Control Division is the dedicated unit responsible for regulating legitimate controlled pharmaceuticals and regulated chemicals. Attorney’s Offices, civil or criminal action, against registrants who fail to comply with the CSA and its regulations. DEA can seek administrative action, and working with U.S.

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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

MAY 3, 2021

DEA’s Diversion Control Division is the dedicated unit responsible for regulating legitimate controlled pharmaceuticals and regulated chemicals. Attorney’s Offices, civil or criminal action, against registrants who fail to comply with the CSA and its regulations. DEA can seek administrative action, and working with U.S.

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The Pharma Data

JANUARY 24, 2021

This press release contains “forward-looking information” within the meaning of applicable securities legislation. Persons”, as such term is defined in Regulations under the U.S. Forward-looking information contained in this press release is expressly qualified by this cautionary statement.

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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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pharmaphorum

JANUARY 5, 2022

Oral agents will be a useful adjunct, but vaccination will remain the primary lever to contain the pandemic, with innovations in COVID-19 vaccines appearing in 2022. Aduhelm’s Q3/2021 sales were $300k; investors will expect strong ramp-up in H1/2022. CNS’s moment of truth. Other competitors, including Roche’s gantenerumab, may follow.

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. billion in 2022, a 23.43

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XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Sales of Ozempic were up by 28 percent in Q3 of 2022, driven by high demand for GLP-1-based diabetes treatments.

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The Pharma Data

JANUARY 18, 2021

This pioneering research led to the clinical development of a humanized anti-VEGF Fab (Ranibizumab, Lucentis ® ), which has also been approved as a therapy for neovascular age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular edema. Lucentis ® and Avastin ® collectively achieved over $9 billion in sales in 2019.

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The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

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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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Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Thermo Fisher states on its website that “Given the ongoing conflict, we have paused sales and manufacturing operations in Russia and Belarus.

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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.

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pharmaphorum

MARCH 4, 2021

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis.

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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

JANUARY 27, 2021

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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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

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

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

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

JANUARY 13, 2021

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. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

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The Pharma Data

OCTOBER 28, 2020

Free cash flow , which also reflects capital expenditures and proceeds from asset sales, was JPY 425.5 billion in reported revenue represented 24% of sales, spearheaded by exceptional growth through expanded patient share of gut-selective ENTYVIO in the U.S., Takeda’s reported net profit was JPY 86.5 billion, a 15.8% to JPY 392.0

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The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. But what actually is “Red Light Therapy”?

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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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