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The FDA approved insulin aspart-xjhz (Kirsty) 100 units/mL as the first and only interchangeable biosimilar to insulin aspart (NovoLog). 1 The FDA approves Kirsty, an interchangeable biosimilar insulin, enhancing diabetes treatment options and accessibility for patients. Kirsty [package insert]. News release. Biocon Biologics.
From 1980 to 2024, the National Centers for Environmental Information reported 403 confirmed natural disaster events impacting weather or climate, totaling economic losses over $1 billion. Planning ahead is key,” Phillips said.
Dispensing data can also help identify patients who are good candidates for pharmacogenomic testing, for packaging services for pharmacy care at home, and even weight loss programs. By keeping the patient at top of mind and prioritizing this engagement, reviews are also becoming a more essential part of driving traffic to the pharmacy.
4 Stocking eco-conscious products, such as items with recyclable packaging or low-waste formulations, can help your customers meet their sustainability goals while strengthening their connection to your brand.
Ozempic and Wegovy are also used to reduce the risk of major cardiovascular events. Food and Drug Administration (FDA). Their purpose is to meet an individual patients specific needs when an FDA-approved drug doesnt. The FDA has a drug shortage list, and injectable semaglutide is currently in low supply.
While the company touted Perry’s 30 years of leadership in consumer packaged goods, it said an executive search firm has been hired to lead the quest for its next permanent CEO. Jazz sings new tune with CEO switch Jazz Pharmaceuticals made history by scoring the first FDA approval for a CBD-based drug in 2018.
Buy Reports Newsletters PT News FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer Vepdegestrant is an investigational, oral bioavailable PROteolysis TArgeting Chimera (PROTAC) medication. Credit: Gorodenkoff/Shutterstock.com. Give your business an edge with our leading industry insights.
Launches DSai™ — AI-Powered Digital Sign-In to Modernize HCP Event Compliance in L… From Groupize.ai Company Announcements View all | Post a press release ActiGraph rebrands as Ametris to reflect expanded clinical evidence generation capabilities From Ametris June 25, 2025 Groupize.ai
The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.
Omnichannel Marketing Strategies Omnichannel marketing ensures consistency across all platforms—whether it’s an email, social media post, or in-person event. Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries.
The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH), a prodrug of somatropin or human growth hormone (HGH), to treat adults with growth hormone deficiency (GHD). Credit: Andrei Kuzmik / Shutterstock.com.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Credit: design_cam/Shutterstock.com. Icotrokinra was co-discovered and is currently being developed through a licensing and collaboration agreement between Protagonist and J&J.
This follows the ODD granted by the US Food and Drug Administration (FDA) and highlights MP1032’s potential as a first-in-class therapy that may reduce the need for high-dose corticosteroids, which can lead to serious side effects such as growth stunting, osteoporosis and metabolic issues.
MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.
Despite the potential efficiencies and the FDA encouraging manufacturers to make the switch from batch processing, the pharmaceutical industry has been slow to adopt continuous manufacturing due in large part to general conservatism and the cost implications of such investments. “Those are through the FDA,” he said.
For some patients, experiencing a serious adverse event from a drug can be a harrowing, or even life-threatening, event. To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs.
Seasonal events like picnics, cookouts, and camping increase the chances of improper food handling. Outdoor events like barbecues, tailgates, and picnics often involve long periods where perishable foods sit out unrefrigerated. Choose piping-hot, freshly cooked meals when available; otherwise, choose pre-packaged foods.
The safety profile remained consistent with previous studies, with no unexpected events observed. Efficacy was demonstrated across the full spectrum of axSpA, including both radiographic (r-axSpA) and non-radiographic (nr-axSpA) forms. Rinvoq also beat Jyseleca to the market in axSpA, having gained approval in the indication in 2022.
The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. Communication between the manufacturing plant and retail stores. as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients to the biopharma and pharmaceutical industries.
Annabel Kartal Allen July 31, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA has appointed George Tidmarsh as the temporary director of CBER after Vinay Prasad’s sudden exit. Image credit: -Oxford- via Getty Images. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
Despite worried hand-wringing over a potential slowdown in FDA approvals under the new administration, the agency has been giving the go-ahead to drugs at a near record-setting clip. Meanwhile, the decision-making production has come during a major upheaval inside the FDA. Please let us know if you have feedback.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
These may either be specific to the production process itself (such as pyroglutamination of the N-terminus as is frequently seen in monoclonal antibodies (mAbs) or may be the result of purification processes (such as amino acid oxidation or deamidation events) and may indicate that process change is required. Specifications.
As a multifactorial condition influenced by both genetic predisposition and lifestyle factors, hypertension is a leading risk factor for serious health outcomes including microvascular complications (retinopathy and nephropathy) and macrovascular events (myocardial infarction and stroke). mg/d, 1 mg/d, 2 mg/d, and placebo for 12 weeks.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
Takeda has informed the FDA that the manufacturing of Gammagard S/D will cease in December 2027. The new formulation is contraindicated in patients with severe hypersensitivity to immunoglobulin products, requiring careful monitoring.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Meanwhile, the US Food and Drug Administration (FDA) has extended the review period for the biologics licence application (BLA) submitted by the company for Blenrep combinations for the same indication.
Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Credit: Volha_R/Shutterstock.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Give your business an edge with our leading industry insights.
This is what the FDA requires for botanical drug approval: evidence, consistency, and repeatability. A Market Ready For Change In this way, a botanical drug is not a supplement with better packaging. It is a pharmaceutical, developed within a rigorous regulatory framework.
FDA guidance documents illustrate labeling salt drugs and associated active moieties. The secondary label will specify the Drug ZA-ion amount per capsule and the equivalent Drug Z-salt amount consistent with FDA labeling guidance. Additional mole calculations are needed only for drug-name labeling per FDA guidance ( Figure 5b above).
What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.
Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. In a bid to chase competitiveness, the EU is advancing its most drastic revision of pharmaceutical law in 20 years.
Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies. Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies. Here’s how one company built its own.
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. Concerningly, preventable adverse events due to medication errors cause an estimated 44,000 to 98,000 hospital deaths annually, more than the number attributed to motor vehicle accidents.
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