Drug Pricing, Labelling and Vaccines

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

JUNE 23, 2025

This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. The 505(j) pathway is how you get a multisource generic.

Pharmacy Technician

Pharmacy Technician Compounding Pharmacies Dosage Hospitals

Pharmacy Policy Updates for June 2025

Pharmacy Times

JUNE 16, 2025

According to Trump, patients could see cost reductions of 30% to 80%, but experts question the feasibility and practicality of implementing such a policy within the complex United States drug pricing and supply system. Kennedy Jr, is permitted to develop a new rule that ties American drug prices to those of other nations.

Pharmacy Technician

Pharmacy Technician Drug Pricing Insurance Coverage and Processing Compounding Pharmacies

Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

JUNE 17, 2025

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety.

Health and Personal Care Stores

Health and Personal Care Stores Insurance Coverage and Processing Hospitals Drug Pricing

FDA approves KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

JULY 7, 2025

How will RFK Jr’s American dream for vaccines play out? The positive results from the KONFIDENT trial were further supported by findings from the real-world KONFIDENT-S open-label extension study. Ekterly has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it.”

Packaging

Packaging Communication Hospitals Drug Pricing

FDA takes major step to ease access to CAR-T therapy

BioPharma Dive

JUNE 27, 2025

Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment. You can unsubscribe at anytime. Most Popular Incyte replaces CEO Hoppenot with dealmaker Meury FDA takes major step to ease access to CAR-T therapy RFK Jr.-appointed

Drug Pricing

Drug Pricing Hospitals Immunity Immunization

Swissmedic approves Novartis’ malaria medicine for babies

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Hospitals Communication Drug Pricing

Torrent Pharmaceuticals to acquire stake in JB Pharma for $3bn

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? of equity shares from JB employees at the same price per share as offered to KKR.

Packaging

Packaging Communication Hospitals Drug Pricing

Vertex and NHS England agree reimbursement for Alyftrek

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Communication Hospitals Vaccines

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

BioPharma Dive

JULY 16, 2025

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. You can unsubscribe at anytime. Please select at least one newsletter. Registered in England and Wales.

Drug Pricing

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Labelling

Health Canada extends Evkeeza approval for children with HoFH

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Communication Hospitals Vaccines

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

JULY 14, 2025

How will RFK Jr’s American dream for vaccines play out? Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. MAXSHOT.PL via Shutterstock. A decision by the FDA is expected in H1 2026.

Labelling

Labelling Vaccines Insurance Coverage and Processing Packaging

FDA removes safety programme for CAR-T therapies to boost uptake

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? The agency said that safety information can be adequately conveyed using drug product labelling. This includes a boxed warning for the risks of CRS and neurological toxicities.

Insurance Coverage and Processing

Insurance Coverage and Processing Packaging Labelling Communication

US trade tariffs and the potential impact on pharma supply chains

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? But this goes both ways, meaning retaliatory measures from the EU will also impact drug prices in the US. Unfortunately, there could be more in store. 39% of imported medicinal and pharmaceutical products consumed in the EU are made in the US.

Health and Personal Care Stores

Health and Personal Care Stores Packaging Drug Pricing Pharmaceutical Manufacturing

Vetter breaks ground on $285m US clinical manufacturing site

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Hospitals Compounding Communication

Chugai and Gero link on antibody drugs for age-related conditions

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out?

Immunity

Immunity Immunization Packaging Hospitals

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Communication Hospitals Drug Development

EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma

Pharmaceutical Technology

JULY 11, 2025

How will RFK Jr’s American dream for vaccines play out? With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.”

Packaging

Packaging Hospitals Biosimilars Communication

Why global 3PL providers are essential to easing supply chain challenges

Pharmaceutical Technology

JULY 16, 2025

How will RFK Jr’s American dream for vaccines play out? 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 Companies Pharmaceutical Companies Vaccines Drug Pricing

J&J eyes prostate cancer label expansion for Akeega

Pharmaceutical Technology

JULY 7, 2025

How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference.

Labelling

Labelling Packaging Communication Hospitals

AstraZeneca’s Imfinzi approved in Europe for muscle-invasive bladder cancer

Pharmaceutical Technology

JULY 4, 2025

How will RFK Jr’s American dream for vaccines play out? Tensions escalated in late January when the company scrapped a £450m plan to turn its Speke-based facility into a major vaccine hub, after failing to reach an agreement with government ministers over the level of state support.

Chemotherapy

Chemotherapy Packaging Labelling Communication

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Dive

JUNE 11, 2025

Based on conversations with physicians, it “could be positioned well, and ahead of Augtyro,” he wrote, adding that Wednesday’s sell off in shares was “overdone on any potential launch and label optics concerns.” You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.

Drug Pricing

Drug Pricing Immunity Immunization Drug Development

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Pharmaceutical Technology

JULY 15, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Communication Hospitals Vaccines

Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

JULY 17, 2025

How will RFK Jr’s American dream for vaccines play out? 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. Credit: luchschenF/Shutterstock.com.

Insurance Coverage and Processing

Insurance Coverage and Processing Labelling Communication Packaging

Pulmonary arterial hypertension market to reach $9.35bn across 7MM by 2034

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Hospitals Compounding Communication

CTO East Coast 2025: Global oncology cell therapy market to hit $25bn by 2031

Pharmaceutical Technology

JULY 10, 2025

How will RFK Jr’s American dream for vaccines play out? Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

Packaging

Packaging Hospitals Compounding Communication

Moderna COVID vaccine gets full approval for children

BioPharma Dive

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

Vaccines

Vaccines Drug Pricing Labelling Drug Development

STAT+: The long game for weight loss drugs

STAT

JUNE 26, 2025

Today, we uncover the extent of low-quality generic cancer medicines disseminated globally, see ACIP prepare to raise new questions about vaccines approved long ago, and more. Sign up to get our biotech newsletter in your inbox. Bill Meury was appointed Incyte’s new CEO. Others contained too much.

Chemotherapy

Chemotherapy Labelling Vaccines Drug Pricing

Merck to buy Verona and its lung drug in $10B deal

BioPharma Dive

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Drug Pricing

Drug Pricing Labelling Pharmaceutical Companies Pharmaceutical Companies

WHO accuses China of withholding Covid-19 genetic data

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out? This includes understanding how different modalities of vaccines work, which has knock-on effects for supply chain logistics and manufacturing coordination. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.

Packaging

Packaging Communication Hospitals Vaccines

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. covered insulin product or vaccine).

Labelling

Labelling Drug Pricing Compounding Payment Processing

Inflation, drug pricing and reimbursement constraints will challenge pharma sector

Pharmaceutical Technology

JANUARY 5, 2023

The swift development of COVID-19 vaccines was an unprecedented scientific and collaborative achievement by government, regulators, research institutions, and the pharmaceutical industry. The pharmaceutical industry has long been labelled as a recession-proof—stable demand for medicines and new treatment options acts as a protective barrier.

Drug Pricing

Drug Pricing Vaccines Labelling Communication

GSK acquires efimosfermin alfa from Boston Pharma for $2bn

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging

Packaging Chemotherapy Hospitals Communication

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog: Biosimilars

JUNE 2, 2023

Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drug price transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drug price transparency reporting.

Labelling

Labelling Vaccines Drug Pricing Immunity

Leading medical groups sue RFK Jr and HHS over ‘hostile’ vaccine policies

Pharmaceutical Technology

JULY 8, 2025

How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 8, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The lawsuit marks the first legal challenge posited to RFK Jr and the HHS since his remodelling of vaccine regulation in the US.

Vaccines

Vaccines Packaging Communication Hospitals

US government plans proposal to push down Medicaid drug prices

Pharmaceutical Technology

MAY 24, 2023

The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drug prices under Medicaid as part of a new proposal.

Drug Pricing

Drug Pricing Vaccines Labelling Communication

Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Dive

JULY 18, 2025

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. Many, however, were already on the record holding similar views as Makary on the warning label.

Labelling

Labelling Drug Pricing Vaccines Medical Schools

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

BioPharma Dive

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

Drug Pricing

Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing

India is rising from a CDMO perspective when it comes to biologics

Express Pharma

FEBRUARY 10, 2025

India trends: The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development. India’s robust IT infrastructure and strong technology sector play a key role in streamlining clinical trial data.

Documentation

Documentation Drug Pricing Biosimilars Labelling

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Policy Updates for June 2025

Trending Sources

Building Intelligent Pharma Supply Chain Management with Real-World Data

FDA approves KalVista’s Ekterly for hereditary angioedema

FDA takes major step to ease access to CAR-T therapy

Swissmedic approves Novartis’ malaria medicine for babies

Torrent Pharmaceuticals to acquire stake in JB Pharma for $3bn

Vertex and NHS England agree reimbursement for Alyftrek

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

Health Canada extends Evkeeza approval for children with HoFH

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

FDA removes safety programme for CAR-T therapies to boost uptake

US trade tariffs and the potential impact on pharma supply chains

Vetter breaks ground on $285m US clinical manufacturing site

Chugai and Gero link on antibody drugs for age-related conditions

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma

Why global 3PL providers are essential to easing supply chain challenges

J&J eyes prostate cancer label expansion for Akeega

AstraZeneca’s Imfinzi approved in Europe for muscle-invasive bladder cancer

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Sarepta Therapeutics to cut 500 jobs amid restructuring

Pulmonary arterial hypertension market to reach $9.35bn across 7MM by 2034

CTO East Coast 2025: Global oncology cell therapy market to hit $25bn by 2031

Moderna COVID vaccine gets full approval for children

STAT+: The long game for weight loss drugs

Merck to buy Verona and its lung drug in $10B deal

WHO accuses China of withholding Covid-19 genetic data

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Inflation, drug pricing and reimbursement constraints will challenge pharma sector

GSK acquires efimosfermin alfa from Boston Pharma for $2bn

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Leading medical groups sue RFK Jr and HHS over ‘hostile’ vaccine policies

US government plans proposal to push down Medicaid drug prices

Panel urges FDA to remove warnings on hormonal menopause therapy

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

India is rising from a CDMO perspective when it comes to biologics

Stay Connected