Bio Pharma Dive

JANUARY 18, 2024

Called Advanced Medicine Partners, the new company will offer specialized cell and gene therapy manufacturing services to biotech and pharma clients.

Gene Therapy 281

Gene Therapy Manufacturing Gene Medicine 281

Pharmaceutical Technology

MARCH 6, 2023

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. It will also establish cGMP manufacturing of a drug product which will be utilised in future clinical trials.

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Manufacturing Clinical Trials Clinical Trials Production 264

Pharmaceutical Technology

JULY 6, 2023

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

Manufacturing 278

Manufacturing Vaccination Vaccine 278

Drug Patent Watch

JANUARY 22, 2025

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. But what exactly does GMP entail?

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Generic Drugs Manufacturing Drugs Production 94

Bio Pharma Dive

SEPTEMBER 12, 2022

The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline.

Manufacturing 260

Manufacturing Medicine Drugs Development 260

Pharmaceutical Technology

NOVEMBER 24, 2023

Bayer announced the launch of a Berlin, Germany-based manufacturing facility to meet future demands from the US, China and Europe.

Manufacturing 264

Manufacturing 264

Pharmaceutical Technology

OCTOBER 17, 2023

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

Manufacturing 264

Manufacturing Compliance Drugs 264

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.

Gene Therapy 264

Gene Therapy Manufacturing Gene Clinical Trials 264

Pharmaceutical Technology

JUNE 27, 2023

Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.

Manufacturing 246

Manufacturing 246

Bio Pharma Dive

AUGUST 25, 2022

The biotech signed a 30-year deal with the University of Pittsburgh to establish a gene and cell therapy manufacturing hub that’s being built with a $100 million grant.

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Manufacturing Gene Gene Therapy 271

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48

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Manufacturing Development Drugs Compliance 96

Pharmaceutical Technology

MARCH 4, 2025

Experts debate whether European manufacturers are preferring domestic operations as the continent competes with Asia and the US.

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Manufacturing 162

Pharmaceutical Technology

JUNE 7, 2023

The manufacturing site will be completed in three phases and will produce anti-bacterial medicines and anti-malarial drugs. Fosun Pharma chairman Wu Yifang stated: “We are glad to be supported by IFC to localise pharmaceutical manufacturing and distribution in Africa.

Manufacturing 240

Manufacturing Drugs Production Medicine 240

Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Yet this is far from straightforward.

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Production Manufacturing Engineer Containment 237

Bio Pharma Dive

JUNE 28, 2024

The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

Gene Therapy 180

Gene Therapy Manufacturing Gene 180

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 24, 2024

Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.

Manufacturing 189

Manufacturing Production Drugs Clinical Trials 189

Pharmaceutical Technology

FEBRUARY 24, 2025

PHARMAP 2025 takes place on 14-15 April 2025 in Berlin, Germany.

Packaging 241

Packaging Packaging Manufacturing 241

Pharmaceutical Technology

FEBRUARY 27, 2025

Eli Lilly has announced plans to expand its domestic medicine production in the US with four new pharmaceutical manufacturing sites.

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Manufacturing Medicine Production 165

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 24, 2024

In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.

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Licensing Licensing Manufacturing Clinical Trials 189

Bio Pharma Dive

APRIL 29, 2024

Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.

Manufacturing 271

Manufacturing Development 271

Bio Pharma Dive

APRIL 22, 2024

The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.

Manufacturing 281

Manufacturing Medicine Drugs 281

Bio Pharma Dive

APRIL 10, 2024

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

Manufacturing 290

Manufacturing Drugs Trials 290

Pharmaceutical Technology

MARCH 7, 2025

Astellas Pharma and Yaskawa have agreed to form a JV that will focus on developing a cell therapy product manufacturing platform.

Manufacturing 147

Manufacturing Production Development 147

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2024

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

Licensing 189

Licensing Licensing Manufacturing Cosmetics 189

Pharmaceutical Technology

SEPTEMBER 24, 2024

Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.

Manufacturing 262

Manufacturing 262

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)

Manufacturing 189

Manufacturing Production Drugs Clinical Trials 189

Bio Pharma Dive

FEBRUARY 8, 2024

The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.

Manufacturing 283

Manufacturing Licensing Licensing 283

Bio Pharma Dive

MARCH 11, 2025

Unveiling of the new factory comes as Merck and other pharma companies face pressure to reshore manufacturing back to the U.S.

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Pharma Companies Vaccination Vaccine Manufacturing 357

Pharmaceutical Technology

NOVEMBER 30, 2023

As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.

Gene Therapy 264

Gene Therapy Gene Manufacturing 264

Pharmaceutical Technology

JUNE 25, 2024

Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.

Manufacturing 246

Manufacturing 246

Bio Pharma Dive

MAY 17, 2022

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

Manufacturing 281

Manufacturing Drugs Containment 281

Bio Pharma Dive

JUNE 20, 2023

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

Gene Therapy 280

Gene Therapy Manufacturing Gene Genetics 280

Pharmaceutical Technology

AUGUST 21, 2024

The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.

Sales 245

Sales Manufacturing 245

Pharmaceutical Technology

JANUARY 22, 2025

Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing for the latters GLPG5101.

Manufacturing 147

Manufacturing 147

Pharmaceutical Technology

FEBRUARY 7, 2025

AI could deliver substantially greater efficiencies in cell and gene therapy manufacturing and enable more patients to benefit.

Gene Therapy 147

Gene Therapy Manufacturing Gene 147

Bio Pharma Dive

MARCH 20, 2023

As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.

Gene Therapy 245

Gene Therapy Gene Development Manufacturing 245