2026 and Drug Development - Pharmacist Digest

STAT+: Biotech accelerator Curie.Bio raises $340 million for a new seed fund

STAT

JANUARY 29, 2025

Curie.Bio’s new fund will help the organization double its investing over the next two years: The aim is to invest in between 15 and 20 biotechs this year and up to 25 companies in 2026, the founders told STAT exclusively. Continue to STAT+ to read the full story…

Drug Development

Race for approval of first oral GLP-1R drug in obesity intensifies with four in phase III trials: GlobalData

Express Pharma

DECEMBER 2, 2024

With a projected launch in 2026, it represents Eli Lilly’s bid to expand the company’s dominance in the GLP-1R category.” China-based Jiangsu Hengrui’s HRS-9531 is the final Phase III contender and the only one not being developed by pharma giants Novo Nordisk or Eli Lilly.

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BioOrbit eyes 2026 for pre-clinical trials of space manufactured protein crystals

Pharmaceutical Technology

JUNE 19, 2025

BioOrbit aims to kick off pre-clinical trials to study protein crystals for monoclonal antibodies (mAbs) produced in a pharmaceutical factory in space in 2026. Then, we will need to run pre-clinical trials of these crystals, which will be in 2026 or 2027. Image credit: Rini. com/ Shutterstock.

Communication

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

JUNE 26, 2025

13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care , April 2, 2025, [link] www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025.

Drug Pricing

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Lisata collaborates with GATC Health on drug development

Pharmaceutical Technology

JUNE 18, 2025

June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook GATC’s MAT platform identifies potential new drugs and provides comprehensive analytic reports. Lisata Therapeutics has formed a strategic partnership with GATC Health to advance AI-driven drug discovery and development.

Drug Development

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STEERLife announces its solvent-free melt fusion technology

Express Pharma

MAY 15, 2025

STEERLife provides comprehensive development capabilities for complex and potent drugs – including NCEs, hormone therapies, orphan drugs, complex generics (ANDAs) and 505(b)(2) products, assisting global pharma in overcoming development and manufacturing challenges through process-driven innovation.

Drug Development

Locked in a federal stalemate, states take PBM reform into their own hands

PharmaVoice

JUNE 16, 2025

1, 2026, The healthcare giant also said the law would result in Arkansas paying more for prescription drugs. For example, pharma lobbyists are pushing for a fix to the Inflation Reduction Act’s pill penalty that the industry says disincentivizes small molecule drug development.

Drug Pricing

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Acumen and JCR partner on brain delivery therapy for Alzheimer’s

Pharmaceutical Technology

JULY 16, 2025

The first drug developed employing this technology has received approval in Japan for treating a lysosomal storage disorder. Anticipated next steps involve generating preclinical candidate data packages, which will include non-human primate studies expected in early 2026.

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MHRA approves needle-free adrenaline nasal spray for anaphylaxis

Pharmaceutical Technology

JULY 18, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sarepta Therapeutics to cut 500 jobs amid restructuring Thermo Fisher acquires Sanofi’s steriles manufacturing site in US Navamedic completes dne pharma acquisition Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

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After myriad failures, a new wave of ALS drugs approaches

PharmaVoice

JUNE 25, 2025

Few diseases have suffered more drug development disappointment than amyotrophic lateral sclerosis. Two novel readouts in 2026 French biopharma Axoltis Pharma is testing an ALS candidate that targets the integrity of the blood brain barrier and neural circuits. The study is expected to reach its primary completion in July 2026.

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Sanofi concludes Blueprint Medicines acquisition

Pharmaceutical Technology

JULY 21, 2025

It is expected to enhance gross margin and contribute positively to operating income and earnings per share after 2026. The transaction is financed with cash and commercial paper proceeds and will not significantly impact Sanofi’s 2025 financial guidance.

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What Pharma Manufacturers Need to Know About US Trade Policy Changes

PharmaTech

JULY 23, 2025

Bristol Myers Squibb Application for Psoriatic Arthritis Drug Accepted for Review in Four Regions Patrick Lavery July 22nd 2025 Article Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

Dosage

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FDA to review Bristol Myers Squibb’s Sotyktu for psoriatic arthritis

Pharmaceutical Business Review

JULY 22, 2025

The FDA has set a target action date of 6 March 2026. This regulatory step follows similar acceptances in China and Japan, as well as an application validation by the European Medicines Agency. Sotyktu was previously approved by the FDA in 2022 to treat moderate-to-severe plaque psoriasis in adults requiring systemic therapy or phototherapy.

Immunity

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Actio gains $66m to advance small molecule therapeutics pipeline

Pharmaceutical Technology

JUNE 19, 2025

By GlobalData Learn more about Strategic Intelligence The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026. The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations.

Communication

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UK government targets manufacturing as it eyes £41bn life science sector growth

Pharmaceutical Technology

JULY 16, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sino Biopharma spends $951m to acquire China-based LaNova Medicines Otsuka to acquire Cantargia’s CAN10 for autoimmune diseases Vertex and NHS England agree reimbursement for Alyftrek Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

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Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

PharmaTech

JUNE 24, 2025

The LNP-encapsulated small interfering RNA (siRNA) was approved by FDA for the treatment of hereditary transthyretin amyloidosis (ATTR), and this opened the door for mRNA-based drugs in many applications. It is also developing BNT165e, an RNA-based vaccine for the prevention of P. falciparum malaria.

Vaccines

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Aenova Adds Cold Chain Warehouse to Latina, Italy Site

PharmaTech

JUNE 27, 2025

Construction on the new warehouse began in early 2025, and the company expects the facility to be operational in the first quarter of 2026. Accelerating drug development In other Aenova news, the company launched its Aenovation program for the acceleration of drug development in May 2025 (2).

Dosage

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Vertex and NHS England agree reimbursement for Alyftrek

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 (..)

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Health Canada extends Evkeeza approval for children with HoFH

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 (..)

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Organon drug for endometriosis falls short in mid-stage study

BioPharma Dive

JULY 2, 2025

Chief Executive Kevin Ali called the drug a “multibillion dollar opportunity” during the J.P. The company had hoped to kick off Phase 3 research in 2026 and launch the medicine around 2029. Organon acquired the drug in its purchase of Forendo Pharma in 2021. Morgan Healthcare Conference in January.

Drug Pricing

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FDA to review MSD’s doravirine/islatravir NDA for HIV-1

Pharmaceutical Technology

JULY 14, 2025

The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for review to treat adults with virologically suppressed human immunodeficiency virus (HIV)-1. A target action date of 28 April 2026 has been set under the Prescription Drug User Fee Act (PDUFA).

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Draig secures $140m for neuropsychiatric disorder therapies

Pharmaceutical Technology

JUNE 19, 2025

As well as advancing DT-101, the new capital injection will also support the progression of two gamma-aminobutyric acid type A (GABA A ) receptor modulators towards clinical trials in 2026. These compounds have the potential for addressing a spectrum of neuropsychiatric disorders that currently lack adequate treatment options.

Communication

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

Pharmaceutical Technology

JULY 14, 2025

A decision by the FDA is expected in H1 2026. GSK’s Arexvy is already approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk.

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JCR Pharma and Alexion partner on JUST-AAV gene therapy platform

Pharmaceutical Technology

JULY 9, 2025

JCR values its partnership with Alexion, and we are pleased to build on the collaboration we have developed over the years.” The financial impact of this agreement on JCR’s consolidated results for the fiscal year ending 31 March 2026 has already been included in the current earnings forecast.

Insurance Coverage and Processing

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GSK’s Blenrep US comeback hindered by eye safety concerns

Pharmaceutical Technology

JULY 16, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sino Biopharma spends $951m to acquire China-based LaNova Medicines Otsuka to acquire Cantargia’s CAN10 for autoimmune diseases Vertex and NHS England agree reimbursement for Alyftrek Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

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Fangzhou and Novo Nordisk link on chronic disease management

Pharmaceutical Technology

JULY 21, 2025

GERTEIS Alconox Insights Sections Deals Jobs Filings Patents Social Media Latest Immedica to buy Marinus Pharmaceuticals for $151m Private equity deals in pharmaceutical in Canada remained flat in Q3 2024 Q3 2024 update: artificial intelligence related private equity activity in the pharmaceutical industry Companies Sections Company A-Z Company Categories (..)

Diabetes

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

Pharmaceutical Technology

JULY 15, 2025

LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. The company has particular emphasis on antibody-drug conjugates (ADCs) and has built several platforms within this modality. A timeline of 30 business days has been set by the companies to finalise the deal. by market close.

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PEPFAR funding protection offers “hope” for people living with HIV

Pharmaceutical Technology

JULY 16, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sino Biopharma spends $951m to acquire China-based LaNova Medicines Otsuka to acquire Cantargia’s CAN10 for autoimmune diseases Vertex and NHS England agree reimbursement for Alyftrek Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

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WHO endorses Gilead’s Yeztugo for HIV prevention

Pharmaceutical Technology

JULY 14, 2025

Member states of the organisation agreed earlier this year to pay 20% more in membership fees to stopgap the US funding shortfall, though WHO’s overall budget for 2026-2027 will be lower than that for 2024-2025. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.

Vaccines

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Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

JULY 18, 2025

Given the way the Hub is set up, it can closely engage with the rare disease community—biotechs, advocacy organisations, and more—without conflicts since it is not involved with the drug review process. However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal.

Drug Development

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

JULY 14, 2025

While the CRL will delay the potential approval of UX111 to 2026, we are working with urgency to respond and resubmit.” We have been diligently responding to the recent CMC observations and our priority is to resolve them so that we can resubmit the BLA as soon as possible. “We

Insurance Coverage and Processing

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Thermo Fisher acquires Sanofi’s steriles manufacturing site in US

Pharmaceutical Technology

JULY 17, 2025

These sites form part of the company’s Accelerator Drug Development 360° contract development and manufacturing organisation (CDMO) and contract research organisation (CRO) solutions, reforming the pharmaceutical value chain for biopharma and biotech companies to accelerate the delivery of key medicines to patients.

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Astellas and KISED link to support Korean pharma startups

Pharmaceutical Technology

JULY 18, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sarepta Therapeutics to cut 500 jobs amid restructuring Thermo Fisher acquires Sanofi’s steriles manufacturing site in US Navamedic completes dne pharma acquisition Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

Packaging

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

Pharmaceutical Technology

JULY 16, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sino Biopharma spends $951m to acquire China-based LaNova Medicines Otsuka to acquire Cantargia’s CAN10 for autoimmune diseases Vertex and NHS England agree reimbursement for Alyftrek Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

Pharmaceutical Companies

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Scaling smart: how small pharma companies can build resilient supply chains

Pharmaceutical Technology

JULY 14, 2025

Discover our World of High-Value Minerals at CPHI Frankfurt Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Foreign Direct Investment Latest JCR Pharma and Alexion partner on JUST-AAV gene therapy platform Time to Market: EPCM Project (..)

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How to remain a top CDMO in ADC-led oncology

Pharmaceutical Technology

JULY 10, 2025

Adding to these pressures is the surging demand for specialised capabilities as oncology drug development moves towards more complex therapies that require technical manufacturing expertise.

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GSK’s Blenrep faces setback as FDA cancer committee votes against approval

Pharmaceutical Technology

JULY 18, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Sarepta Therapeutics to cut 500 jobs amid restructuring Thermo Fisher acquires Sanofi’s steriles manufacturing site in US Navamedic completes dne pharma acquisition Themes Sections Artificial Intelligence Cloud Corporate Governance Cybersecurity (..)

Communication

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

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.

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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

FDA Law Blog: Biosimilars

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

Drug Development

Sarepta Therapeutics to cut 500 jobs amid restructuring

Pharmaceutical Technology

JULY 17, 2025

Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline reprioritisation, the company anticipates delivering $300m in annual non-personnel cost savings from 2026.

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Sarepta refuses to pull gene therapy despite FDA order

Pharmaceutical Technology

JULY 21, 2025

GERTEIS Alconox Insights Sections Deals Jobs Filings Patents Social Media Latest Immedica to buy Marinus Pharmaceuticals for $151m Private equity deals in pharmaceutical in Canada remained flat in Q3 2024 Q3 2024 update: artificial intelligence related private equity activity in the pharmaceutical industry Companies Sections Company A-Z Company Categories (..)

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STAT+: MA anticipation, and security as a cost of doing business

STAT

MARCH 24, 2025

The dawn of a new risk adjustment era Within the next two weeks, the Trump administration will roll out the final Medicare Advantage policies and payments rates for 2026. You know what to do: Send her all of your tips, gossip, and random musings at tara.bannow@statnews.com.

Drug Development

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Quantum leap or quantum hype: the role of quantum computing in protein modelling

Pharmaceutical Technology

JULY 21, 2025

GERTEIS Alconox Insights Sections Deals Jobs Filings Patents Social Media Latest Immedica to buy Marinus Pharmaceuticals for $151m Private equity deals in pharmaceutical in Canada remained flat in Q3 2024 Q3 2024 update: artificial intelligence related private equity activity in the pharmaceutical industry Companies Sections Company A-Z Company Categories (..)

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FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers.

Drug Development

STAT+: Biotech accelerator Curie.Bio raises $340 million for a new seed fund

Race for approval of first oral GLP-1R drug in obesity intensifies with four in phase III trials: GlobalData

Trending Sources

BioOrbit eyes 2026 for pre-clinical trials of space manufactured protein crystals

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Lisata collaborates with GATC Health on drug development

STEERLife announces its solvent-free melt fusion technology

Locked in a federal stalemate, states take PBM reform into their own hands

Acumen and JCR partner on brain delivery therapy for Alzheimer’s

MHRA approves needle-free adrenaline nasal spray for anaphylaxis

After myriad failures, a new wave of ALS drugs approaches

Sanofi concludes Blueprint Medicines acquisition

What Pharma Manufacturers Need to Know About US Trade Policy Changes

FDA to review Bristol Myers Squibb’s Sotyktu for psoriatic arthritis

Actio gains $66m to advance small molecule therapeutics pipeline

UK government targets manufacturing as it eyes £41bn life science sector growth

Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Vertex and NHS England agree reimbursement for Alyftrek

Health Canada extends Evkeeza approval for children with HoFH

Organon drug for endometriosis falls short in mid-stage study

FDA to review MSD’s doravirine/islatravir NDA for HIV-1

Draig secures $140m for neuropsychiatric disorder therapies

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

JCR Pharma and Alexion partner on JUST-AAV gene therapy platform

GSK’s Blenrep US comeback hindered by eye safety concerns

Fangzhou and Novo Nordisk link on chronic disease management

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

PEPFAR funding protection offers “hope” for people living with HIV

WHO endorses Gilead’s Yeztugo for HIV prevention

Can rare disease research in the US thrive under the new administration?

Ultragenyx receives complete response letter for UX111 BLA

Thermo Fisher acquires Sanofi’s steriles manufacturing site in US

Astellas and KISED link to support Korean pharma startups

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

Scaling smart: how small pharma companies can build resilient supply chains

How to remain a top CDMO in ADC-led oncology

GSK’s Blenrep faces setback as FDA cancer committee votes against approval

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

The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

Sarepta Therapeutics to cut 500 jobs amid restructuring

Sarepta refuses to pull gene therapy despite FDA order

STAT+: MA anticipation, and security as a cost of doing business

Quantum leap or quantum hype: the role of quantum computing in protein modelling

FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived

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