Putting Patients First Blog

JUNE 26, 2025

This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. A minimum 60-day window for public input should be established, with outreach to affected patient groups. July 2, 2024. link] 2027_07.02.24.pdf. 51 National Health Council. April 14, 2023.

Drug Pricing

Pharmaceutical Technology

JULY 29, 2025

The FDA’s approval for adults with GHD was based on the findings from the Phase III parallel-arm, randomised, active-controlled (open-label) and placebo-controlled (double-blind) foresiGHt trial. This therapy is administered subcutaneously once a week, ensuring a sustained release of active, unmodified somatropin.

Packaging

Pharmaceutical Technology

JULY 7, 2025

The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. KalVista will receive an upfront payment of $11m, with an additional $11m contingent upon achieving a regulatory milestone anticipated by early 2026. Sign up for our daily news round-up!

Packaging

Express Pharma

AUGUST 13, 2025

Greenspace provides comprehensive regulatory support, including claims substantiation and compliant labelling guidance for international markets. The products are not intended to diagnose, treat, cure, or prevent any disease. The post Greenspace Herbs unveils Quantum Ayurveda technology platform appeared first on Express Pharma.

Documentation

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

BioPharma Dive

JULY 16, 2025

The company expects the two moves together will result in more than $400 million in annual cost savings in 2026. On Wednesday, Sarepta shared that the FDA is adding a black box warning about the risk of liver failure or injury to Elevidys’ label, which Sarepta said should resolve any agency concerns with the therapy’s use in that group.

Drug Pricing

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

Pharmaceutical Technology

JULY 14, 2025

Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. A decision by the FDA is expected in H1 2026. MAXSHOT.PL via Shutterstock.

Labelling

Pharmaceutical Technology

JULY 22, 2025

It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”

Insurance Coverage and Processing

Pharmaceutical Technology

JULY 15, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest WHO endorses Gilead’s Yeztugo for HIV prevention Illimis secures funding for GAIA-based Alzheimer’s therapeutics GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients Themes Sections Artificial Intelligence Cloud Corporate (..)

Packaging

Pharmaceutical Technology

JULY 16, 2025

This can be achieved by taking responsibility for warehousing, packing and labelling, order management, distribution, freight audit, and transportation trend management of pharma materials. 3PLs can unlock cost savings that their customers might find harder to achieve.

Pharmaceutical Companies

Pharmaceutical Technology

AUGUST 1, 2025

Eli Lilly is attempting to join fellow pharma companies with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) – drugs originally approved for treating diabetes – gaining expanded label expansions in cardiovascular indications.

Packaging

Pharmaceutical Technology

JULY 15, 2025

Danish dermatology leader LEO Pharma has bought the rights to Boehringer Ingelheim’s psoriasis drug Spevigo (spesolimab) for €90m ($105m), strengthening its portfolio ahead of a possible public listing in 2026.

Packaging

Pharmaceutical Technology

JULY 17, 2025

July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. With its pipeline reprioritisation, the company anticipates delivering $300m in annual non-personnel cost savings from 2026.

Insurance Coverage and Processing

Pharmaceutical Technology

JUNE 13, 2025

By GlobalData Learn more about Strategic Intelligence Moderna said it plans to have mRESVIA available for both both younger adults and older adults in the US in time for the 2025-2026 respiratory virus season. This usually begins around November and peaks in the mid-Winter months.

Vaccines

Pharmaceutical Technology

JULY 21, 2025

“This guides every decision we make, as evidenced by our conservative decision to pause shipments of Elevidys for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure (ALF).”

Labelling

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

Documentation

Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day. billion for Blincyto.

Labelling

BioPharma Dive

JULY 10, 2025

The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season. The shot was previously available for these individuals under emergency use authorization. In May, Health and Human Services Secretary Robert F. Kennedy Jr.

Vaccines

Beckers Hospital Review

JULY 16, 2025

That will be an implementation that takes place in October of 2026, and fundamental to laying that foundation upon which we can build. Q: You’ve led efforts to label inequity and disrespect as preventable harm. So that’s a great place for us to be starting.

Cerner

FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ).

Labelling

Pharmaceutical Commerce

FEBRUARY 21, 2025

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on other concepts that are powering the companys 2025 Supply Chain Trends Report, and how they could possibly change in 2026.

Labelling

pharmaphorum

OCTOBER 14, 2022

” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum.

Labelling

European Pharmaceutical Review

FEBRUARY 8, 2023

Breyanzi is approved for DLBCL, and a label expansion is anticipated for expansions into marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) in 2026 and 2028, respectively. This allows for a large total eligible patient population despite capturing less patient share relative to other CD19 CAR-T agents.

Labelling

Express Pharma

SEPTEMBER 18, 2024

Following its acquisition of Fusion Pharmaceuticals, AstraZeneca has taken responsibility of FPI-2265-202, which has its Phase II/III trial in PSMA-positive mCRPC patients slated for primary completion in 2026.

Chemotherapy

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

Pharmaceutical Manufacturing

Putting Patients First Blog

JULY 2, 2024

1 And we appreciated CMS’ thorough responses to comments for IPAY 2026 and hope the Agency will replicate this for this comment opportunity. These elements were previously highlighted in our comments in response to the IPAY 2026 guidance, and we continue to stress their importance for the 2027 draft guidance.

Drug Pricing

Pharmaceutical Technology

JULY 26, 2022

There are two branded miglustat therapies available across the 3MM, with the US market having Johnson and Johnson’s (J&J, US) Zavesca and also generic miglustat available, but neither of these are approved for the treatment of NPC, so physicians prescribe this therapy off-label.

Labelling

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. link] duals-rfi/.

Insurance Coverage and Processing

pharmaphorum

AUGUST 27, 2020

Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients who have received at least four prior therapies. billion in 2026.

Labelling

pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell.

Labelling

pharmaphorum

APRIL 23, 2021

At the moment, IgAN is controlled using blood pressure medication to limit damage to the kidney, with immunosuppressants such as corticosteroids used off-label in some cases to suppress the autoimmune response. It is usually diagnosed after patients see blood in their urine and undergo a kidney biopsy.

Labelling

pharmaphorum

OCTOBER 1, 2020

Undeterred, CTI argued that it should move ahead with a filing based on additional data from an open-label study called PAC203, whilst also starting another phase 3 trial – PACIFICA – to bolster the data. Shortly after, Shire (now part of Takeda) ducked out of a $172 million partnership for the drug. Jakafi had sales of more than $1.1

Packaging

Pharmaceutical Technology

MAY 9, 2023

The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031). None of the three are currently publicly reimbursed.

Diabetes

Big Molecule Watch

DECEMBER 28, 2023

Coya later reported its 48-week clinical data for a proof-of-concept open-label study in 4 patients with amyotrophic lateral sclerosis (ALS) demonstrating that treatment with COYA 302 appeared to ameliorate disease progression. Dr. Reddy’s will have exclusive rights to the same in areas outside of these territories.

Biosimilars

Pharmaceutical Technology

MARCH 7, 2023

Zulresso contains brexanolone, which is chemically identical to allopregnanolone, as per the drug’s label. With an estimated completion date of May 2026, the study strives to utilise the endocrine biology of perimenopause to explain the behavioural and neurobiological features of depression in perimenopausal women.

Labelling