Fierce Pharma

JANUARY 10, 2024

In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | Morgan Healthcare Conference.

Labelling

Pharmaceutical Technology

SEPTEMBER 18, 2024

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

Labelling

Pharmaceutical Technology

DECEMBER 16, 2022

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% The figure below summarises the endometriosis market growth across the 7MM from 2020 to 2030. At the end of 2030, the US will contribute approximately 81.3% of 7MM sales.

Compounding

European Pharmaceutical Review

FEBRUARY 8, 2023

Yescarta for blood cancer Yescarta is targeting expansions into the first line for diffuse large B-cell lymphoma (DLBCL) and second line for follicular lymphoma in 2030. It is set to retain its market-leading position as the most lucrative CD19 CAR-T agent in NHL, with annual sales reaching $1.7

Labelling

Pharmaceutical Technology

JUNE 7, 2023

In addition, Mounjaro is estimated to gain sales of around $20bn by 2030 and become the leading GLP-1 in the obesity market, as well as in T2D. Mounjaro’s approval in 2022 for T2D has already led to many prescribers providing the therapy off-label to their patients to help them lose weight.

Pharmaceutical Companies

European Pharmaceutical Review

DECEMBER 1, 2022

Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. In alignment with the World Health Organization (WHO) Neglected Tropical Diseases Roadmap strategy, which aims to eliminate sleeping sickness by 2030.

Labelling

pharmaphorum

JANUARY 19, 2023

.” A recent report from Clarivate highlighted ritlecitinib as one of 14 potential blockbusters to watch this year, pointing to its rapid onset of action and expected label for both adults and adolescents – Olumiant is so far only approved for use in adults. The report predicts that the alopecia areata market will grow to as much as $2.5

Labelling

European Pharmaceutical Review

JULY 31, 2024

billion in 2023 for its obesity and diabetes blockbuster drugs Ozempic (off-label for obesity) and Wegovy respectively, facilitated the growth. Mounjaro, Zepbound, and Ozempic are expected to surpass Merck & Co’s Keytruda in global analyst consensus sales by 2030″ This is despite an “overall 1.6 Global sales of $13.9

Labelling

Pharma Marketing Network

MARCH 25, 2022

By 2030, it is estimated there will be only 4 potential family caregivers per older adult and some are also caring for children of their own. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services.

Labelling

pharmaphorum

MARCH 8, 2022

He is giving Trodelvy a 40% chance of approval and launch with a third-line label in HR+/HER2- breast cancer in 2024, with $900 million in potential sales from the indication, if TROPiCS-02 is positive at the final readout. The company said it “remains confident in that goal.” appeared first on.

Chemotherapy

The FDA Law Blog

JULY 2, 2025

altering drug facts labels) Late payment triggers penalties, interest accrual, and regulatory consequences, including being barred from submitting OMORs or meeting with FDA on monograph issues. adding new ingredients or indications) $111,955 for Tier 2 changes (e.g., What’s to come?

FDA

Roots Analysis

NOVEMBER 27, 2023

Challenges and Restructuring Strategies The surge in demand for Novo Nordisk’s Wegovy has presented challenges, including off-label prescribing of Ozempic and limitations in the stable supply of the drugs.

Pharmaceutical Companies

Pharmaceutical Technology

DECEMBER 22, 2022

By 2030, JCAs will be carried out on all medicinal products with an EMA-issued MA. However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations. As part of the decision-making process, they may request further evidence.

Pharmaceutical Companies

ISPE

MARCH 15, 2023

Transforming Our World: The 2030 Agenda for Sustainable Development.” query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. Accessed 3 December 2022.

Packaging

pharmaphorum

FEBRUARY 22, 2022

The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more than a million more patients. More than 6.2

FDA

ISPE

SEPTEMBER 29, 2023

By 2026, the site will produce 80% of its electricity consumed on-site and aims to be a net-zero greenhouse gas emissions site by 2030. Over the past five years the entire Lessines production site has reduced its operational carbon footprint by 45% or the equivalent of 5,500 tons of CO2.

Pharmaceutical Companies

Pharmacy Friday Pearls

MARCH 9, 2022

2001;161(16):2030-6. vs 10.3% • p < 0.05, NNT = 5 Gerardo CJ, 2017 RCT in 18 ED in the US (n = 74) Crofab ® versus placebo to measure limb function 14 days after envenomation using Patient-Specific Functional Scale Crofab reduced limb disability measured by the Patient-Specific Functional Scale 14 days after copperhead envenomation. •

Immunization

pharmaphorum

NOVEMBER 10, 2022

With 90% of adolescents that should be vaccinated by 2030, Luppi deems it an opportunity. Everyone has a mobile: now is the age of electronic patient information; now is the time for electronic labelling. Nonetheless, with regards to research, we are living in a renaissance age, she argued, in terms of prevention, as much as treatment.

Vaccines

The Checkup by Singlecare

DECEMBER 14, 2022

The World Obesity Federation predicts the number of school aged children and adolescents with obesity will rise from 150 million worldwide to over 250 million by 2030. Long-term metformin treatment in adolescents with obesity and insulin resistance, results of an open label extension study , Nutrition & Diabetes. CDC , 2021) .

Hospitals

pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.

Vaccines

PharmaShots

APRIL 3, 2023

of revenue in 2023 from its four in-line therapies & bringing Pfizer $10B+ in risk-adjusted revenues by 2030. 4 approved medicines across solid tumors & hematologic malignancies, incl. 3 ADCs: Adcetris, Padcev & Tivdak.

FDA

The Checkup by Singlecare

MARCH 10, 2025

BuSpar vs. buspirone BuSpar was a former brand-name version of buspirone, but the BuSpar brand was discontinued in 2009, so its no longer sold under that label. Here are all the details on potential interactions, side effects, and other precautions you need to know.

Dosage

European Pharmaceutical Review

JANUARY 20, 2025

Digital innovation is a critical piece of the response to this challenge, and as part of our ongoing commitment to the environment, AstraZeneca has begun the transition to electronic product information (ePI) , with the goal of introducing ePI across all products by 2030.

Communication