Express Pharma

MAY 15, 2024

For example, AstraZeneca partnered with Adherium Limited to offer a mobile-based smart inhaler linked to a digital portal that tracks medication dosage and enables data sharing with physicians. The goal is for patients to properly adhere to prescription guidance, achieving better patient health outcomes.

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The Guardian - Pharmaceutical Industry

NOVEMBER 5, 2023

Exclusive: Regulator extends part suspension of licence to July 2024 after IT blunder led to incorrect dosage of cancer treatment A private health company paid millions by the NHS has failed to fix safety defects that led to the death of a cancer patient, the Guardian can reveal.

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Express Pharma

JANUARY 17, 2025

As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. In March 2024, Lonza hosted its first digital Responsible Supplier Event which brought together more than 1,100 participants.

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Express Pharma

MARCH 12, 2025

IPA also pointed out that US regulations require adverse events related to any dosage form of a drug to be reported under the same Abbreviated New Drug Application (ANDA) number, even if the product is manufactured at a different facility or outside India. Thus, it cannot be conclusively linked with the manufacturing site or manufacturers.

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Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 66

Express Pharma

OCTOBER 20, 2024

Diltiazem Hydrochloride Extended-Release Capsules USP in the 120 mg, 180 mg, and 240 mg dosages have an estimated market size of US$ 28.2 million for the twelve months ending June 2024, according to IQVIA. The label provides a detailed indication.

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PharmaTech

OCTOBER 9, 2024

Pharmaceutical Technology® Europe sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery.

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Dosage 59

European Pharmaceutical Review

JUNE 4, 2024

Meeting the Divisions at ACHEMA 2024 IMA Active The ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and banding, weight checking, coating, handling and washing. They create the conditions for the next innovation, the next level of flexibility, solutions designed to enhance the value of your product.

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Packaging Customer Service Labelling Dosage 95

Big Molecule Watch

SEPTEMBER 27, 2024

Approval of Accord’s Trastuzumab Biosimilar : On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

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Biosimilars Dosage Diabetes 64

PharmaTech

OCTOBER 9, 2024

Pharmaceutical Technology Europe spoke with Ali Rajabi-Siahboomi, vice president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products.

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Dosage Packaging 52

FDA Law Blog: Biosimilars

JUNE 13, 2024

On June 10, 2024, the District Court of New Jersey issued its Opinion in the case, finding that Teva’s patents were improperly listed. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.

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Dosage 116

European Pharmaceutical Review

MAY 23, 2024

Design of the pill meant that the drug release and dosage timing of individual active materials were controlled by geometrical design, the authors stated. This paper features in the June 2024 issue of the journal Materials Today Advanced. Rivers et al.

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The Thyroid Pharmacist

DECEMBER 29, 2023

I am hoping to feel more settled in 2024. I am wrapping up some projects in early 2024 and I am carving out more time for myself and my own healing. In this article, I share a ton of natural solutions for everyday ailments, how to use each supplement, recommended dosages for each supplement, and precautions to be aware of.

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PharmaTech

OCTOBER 9, 2024

Michelle Logan, vice president of the drug product division for Thermo Fisher Scientific, talked about expanding capability to better serve customers in the OSD market.

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Dosage 45

Big Molecule Watch

JANUARY 26, 2024

On January 17, 2024, Celltrion announced the U.S. ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). Celltrion’s January 2024 announcement indicates that it expects the 20 mg version of YUFLYMA® “to be available in pharmacies in late Q1 2024.” launch of a new, 80 mg/0.8 ml dose and a 20 mg/0.2

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Dosage Biosimilars 64

European Pharmaceutical Review

NOVEMBER 1, 2024

percent between 2024 and 2033. Packaging types generating demand in the market include tamper-proofing drug packaging against counterfeiting, as well as single-dosage packaging, according to the research. The worldwide pharmaceutical container packaging market is expected to rise in revenue from $104.12

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European Pharmaceutical Review

APRIL 9, 2024

The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. billion in 2024. Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The company employs more than 6,500 people, generating revenues of €1.1

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Pharmaceutical Manufacturing Dosage Drug Development 98

Express Pharma

SEPTEMBER 9, 2024

Romaco India inaugurated its Solids Processing Experience Center on the evening of September 4, 2024, in Sultanpur, Hyderabad. The Hyderabad centre is intended to cater to the needs of the Indian market, providing expert solutions for pharmaceutical, nutraceutical, and other industries dealing with solid dosage production.

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Dosage 105

Express Pharma

OCTOBER 7, 2024

On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceutical manufacturing. He also referenced the WHO guidelines included in the Revised Schedule M.

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Dosage Pharmaceutical Manufacturing Packaging 105

Express Pharma

DECEMBER 24, 2024

As per a Future Market Insights report, the global sustainable pharma packaging market size is projected to grow from $ 96 billion in 2024 to $ 410 billion by 2034, reflecting a 15.6 per cent CAGR. For example, consider a tablet of 13.5 mm length and 7.5 To pack 20 such tablets, pharma companies currently use 857.5

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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. AbbVie), for a direct-to-consumer (DTC) TV advertisement for its drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams.

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Labelling Adverse Reactions Dosage 59

The Happy PharmD

SEPTEMBER 15, 2024

The strain on pharmacists can lead to errors, as evidenced by a pharmacist who almost administered the wrong vaccine dosage due to workload pressures. The post State of Well-Being 2023-2024 appeared first on The Happy PharmD. Feel free to check it out! Until then, take care and see you soon!

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Insurance Coverage and Processing Dosage Documentation Communication 52

Express Pharma

SEPTEMBER 24, 2024

On September 22, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 5 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on Water Systems and Qualification.

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Dosage Pharmaceutical Manufacturing 101

Express Pharma

NOVEMBER 26, 2024

.” Dr Veeramani, Chairman, Pharmexcil, said “ The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance.

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Packaging Biosimilars Pharmaceutical Manufacturing Dosage 105

European Pharmaceutical Review

NOVEMBER 25, 2022

If approved, paliperidone palmitate extended-release injectable suspension (LY03010) is primed as a favourable option to treat schizophrenia, due to reduced dosage requirement of a once-a-month, yet it risks being hidden in a crowded long-acting injectable (LAI) market, GlobalData warns. million in 2031, representing 0.6

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Big Molecule Watch

AUGUST 2, 2024

On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” The draft guidance is open for public comment until September 23, 2024. regarding postapproval manufacturing changes.

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Biosimilars Dosage 53

Pharmaceutical Business Review

JULY 5, 2024

According to data from IQVIA, Ivosidenib Tablets have an estimated market size of $114m for the 12 months ending March 2024. Previously, Alembic received tentative USFDA approval for ANDA for Bosutinib Tablets in 100mg and 500mg dosages.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

European Pharmaceutical Review

JANUARY 8, 2025

Every participant was also able to maintained their full EGFRi dosage, enabling them to harness the full therapeutic effect of their EGFRi inhibitor cancer therapy” Every participant was able to maintained their full EGFRi dosage, enabling them to harness the full therapeutic effect of their EGFRi inhibitor cancer therapy.

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Dosage Labelling 52

FDA Law Blog: Biosimilars

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

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Express Pharma

MAY 22, 2024

Published Online: November 3, 2022 at: [link] Accessed April 29, 2024. February 2, 2024. * Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. JAMA Ophthalmology.

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Biosimilars Diabetes Dosage 52

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. PharmaTher and Vitruvias Therapeutics have entered a collaboration deal to commercialise PharmaTher’s Ketarx (racemic ketamine) in the US.

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Hospitals Dosage Labelling 52

RX Note

NOVEMBER 12, 2024

In November 2024, a new Micromedex app was introduced to deliver more efficient access to all Micromedex content, including Drug Reference, Drug Interactions, IV Compatibility and calculators. In my experience, there are increasingly more off-label uses and dosages included in this resource.

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European Pharmaceutical Review

NOVEMBER 8, 2022

Sandoz , a leading antibiotics producer has announced its €50 million investment to increase Europe’s manufacturing capacity of finished dosage form (FDF) penicillin, the most common form of antibiotic worldwide, to enhance global manufacturing capacity of amoxicillin and other major penicillin products.

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Dosage 52

Pharmaceutical Business Review

OCTOBER 21, 2024

The safety profile of Kisqali at the 400mg dosage was also highlighted as well-tolerated, with most adverse events being of low grade. The trial demonstrated that Kisqali, when used alongside endocrine therapy (ET), reduced the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC, compared to ET alone.

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Pharma in Brief

FEBRUARY 28, 2024

The FC’s discussion of the law regarding fixed dosages and schedules was incomplete. The FCA held that, “[t]hough a fixed dosage and schedule may be a good indication that no [professional] skill and judgment would be required, evidence may indicate otherwise.” 2024 FCA 23 Relevance of fixed dosing. v Janssen Inc.

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Dosage 52

Big Molecule Watch

SEPTEMBER 24, 2024

On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product” classification. 2024), the D.C. See Eli Lilly & Co. Becerra et al. , 1:24-cv-01503 (S.D. Becerra , 108 F.4th

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Express Pharma

MARCH 20, 2025

Expanded capabilities across the value chain: India has also enhanced its position in the operations value chain by demonstrating broader capabilities across more complex dosages and large molecules. References BMI, a Fitch solutions company, 2024. United States Food and Drug Administration.

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Generic Medicine Dosage Packaging 66