pharmaphorum

JUNE 22, 2021

AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . The FDA removed the boxed warning for those risks last year but the product hasn’t recovered commercially.

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pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug.

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pharmaphorum

JUNE 1, 2021

Novo Nordisk – which is already active in stem cell therapies with a candidate in early development for type 1 diabetes – is on the hook for up to $598 million in total licensing and milestone payments plus royalties on sales if HS-001 reaches the market. Other readouts give grounds for optimism.

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pharmaphorum

FEBRUARY 17, 2022

Bristol-Myers Squibb has new data backing up the value of mavacamten for obstructive hypertrophic cardiomyopathy (HCM), as it waits for a delayed verdict on its marketing application for the drug, acquired as part of its $13.1 billion takeover of MyoKardia in 2020.

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pharmaphorum

AUGUST 18, 2021

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. Sales have rocketed ever since, climbing 30% to almost $2 billion last year, and 60% to $1.36 billion in the first half of 2021.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021. Additionally, it has been submitted for marketing authorization in China, as well as multiple other countries worldwide. Kenilworth, NJ, USA).

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pharmaphorum

FEBRUARY 10, 2022

Asundexian (also known as BAY2433334) will be given a speedy review by the US regulator as a secondary preventative treatment for people with ischaemic stroke, specifically those with non- cardioembolic risk factors like narrowed arteries.

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pharmaphorum

JANUARY 5, 2021

An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed. The market access lever is more heavily applied in Europe than the US.

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Delveinsight

JULY 22, 2021

The decision gave Bayer complete control of BlueRock’s cell therapy pipeline, headed by DA01 and spanning various diseases in the neurology , cardiology , and immunology categories. To do so, Omniscient will utilize the financing to expand market access for its existing brain-mapping platforms, in part by increasing its global sales team.

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pharmaphorum

JANUARY 12, 2021

The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.

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The Pharma Data

OCTOBER 15, 2020

15, 2020 — CBD has been widely marketed as a cure-all for whatever ails you, and a new study finds many Americans are buying the sales pitch. The wave of marijuana legalization in the United States has led to a massive surge of CBD products being marketed across the nation, researchers said. THURSDAY, Oct. © 2020 HealthDay.

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XTalks

JUNE 11, 2024

Market Dynamics: Understanding Agent DCB’s Competitors Boston Scientific’s Agent DCB operates in an extremely competitive market. This hybrid approach demonstrates the versatility and potential overlap in technology between DES and DCB markets.

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The Pharma Data

DECEMBER 12, 2020

It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

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The Pharma Data

OCTOBER 14, 2020

“The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years.

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The Pharma Data

NOVEMBER 11, 2021

When NO binds to sGC, the enzyme catalyses the conflation of intracellular cyclic guanosine monophosphate (cGMP), a alternate runner that plays a part in the regulation of vascular tone, cardiac contractility, and cardiac redoing. MSD has the marketable rights to vericiguat in theU.S. About Vericiguat Vericiguat2.5

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XTalks

JULY 10, 2023

Xtalks spoke with Kaushik Gune, Head of Healthcare (US) at Huma, a global digital health technology company, to learn more about SaMD and what it looks like to create a regulated health app. What are some examples of software as a medical device (SaMD) and how is this software regulated? Tier one devices represent the low risk.

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The Pharma Data

SEPTEMBER 29, 2021

Finerenone has also been submitted for marketing authorization within the European Union (EU) and China, also as multiple other countries worldwide and these applications are currently under review. They also control how much water and electrolytes are in the body, regulating blood pressure.

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The Pharma Data

NOVEMBER 4, 2020

Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. This press release and further information about Alexion can be found at: www.alexion.com.

Antibody 52

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XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. It’s been widely marketed and is considered a leading medication in the SGLT2 inhibitor class. percent in the fourth quarter and decreased 56.7

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The Pharma Data

AUGUST 30, 2021

Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC). There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time.

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The Pharma Data

AUGUST 29, 2020

Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials.

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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. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

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Cloudbyz

AUGUST 16, 2024

By automating many of the processes that were once manual and error-prone, eCRFs allow research teams to focus on what truly matters: advancing scientific knowledge and bringing new treatments to market more efficiently. FDA regulations that establish the criteria for electronic records and electronic signatures.

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The Pharma Data

JANUARY 12, 2021

Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. This press release and further information about Alexion can be found at: www.alexion.com.

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The Pharma Data

NOVEMBER 4, 2020

Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand. Securities and Exchange Commission Regulation G.

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The Pharma Data

APRIL 26, 2021

(USD 789 million, +34% cc) sustained strong growth with increased patient share across markets, driven by demand as the essential first choice therapy for heart failure patients. USD 319 million, +81% cc) had a strong quarter with growth driven by Europe and Emerging Growth Markets, as well as ongoing geographic expansion.

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The Pharma Data

OCTOBER 29, 2020

Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. Marketable securities. Received U.S. Germany & Japan. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences.

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The Pharma Data

AUGUST 17, 2021

Following a topline presentation at the ESC Heart Failure Congress in June, the updated European Society of Cardiology and Heart Failure Association Guidelines on Acute and Chronic Heart Failure will also be presented during the ESC Congress and made available for use. FDA has approved finerenone for marketing authorization in the U.S.

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Pharma Marketing Network

MARCH 19, 2025

Introduction In the highly regulated pharmaceutical industry, audience engagement is more than just a marketing goalit is a necessity for building trust with healthcare professionals (HCPs) and patients. This article explores effective audience engagement strategies tailored for pharma marketers, focusing on both HCPs and patients.

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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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