AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 13, 2023

The Indian Council of Medical Research (ICMR) has issued list of technologies supported under ICMR-Medical Device and Diagnostics Mission (MDMS) Secretariat to foster indigenous manufacturing of medical devices and diagnostics.

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Manufacturing Research Clinical Trials Clinical Trials 178

Pharmaceutical Technology

DECEMBER 1, 2024

The HIV vaccine space has seen dwindling research activity as drug manufacturers turn to PrEP therapies for preventive treatment.

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Vaccine Vaccination Manufacturing Drugs 264

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

Pharmaceutical Technology

DECEMBER 16, 2022

The report, Pharmaceutical Manufacturing ESG Survey – Towards a Sustainable Supply Chain (November 2022), reveals that most pharma industry insiders believe the sector is not doing enough to limit harm to the environment. This is a particular problem for highly potent drugs such as antibiotics.

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Manufacturing Pharma Companies Drugs Development 162

Bio Pharma Dive

APRIL 15, 2024

Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.

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Contamination Manufacturing Production Research 264

Bio Pharma Dive

APRIL 27, 2023

The cell and gene therapy developer will also cut back on manufacturing and certain research in California as it redirects resources to three priority programs.

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Gene Therapy Gene Manufacturing Development 278

Bio Pharma Dive

MAY 18, 2023

The biotech joins a score of other cell and gene therapy developers that, on the heels of a historic market downturn, have been forced to cut costs.

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Gene Therapy Manufacturing Gene Research 147

Pharmaceutical Technology

MAY 16, 2023

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. This will include pairing up indications with manufacturers amongst the BGTC’s partners.

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Gene Therapy Gene Research Clinical Trials 227

Pharmaceutical Technology

MAY 2, 2023

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

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Manufacturing Gene Therapy Gene Development 130

Fierce Pharma

AUGUST 1, 2024

Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. Like many other biopharma companies, Kyowa Kirin is in restructuring mode.

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Manufacturing Research Drugs 93

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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In-Vitro Manufacturing Licensing Licensing 241

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 6, 2024

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. crore. […]

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Manufacturing Drugs Clinical Trials Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 11, 2024

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.

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Manufacturing Sales Drugs Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.

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Drugs Manufacturing Clinical Trials Clinical Trials 245

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. In April 2023, Forge Biologics received a qualified person (QP) declaration for the manufacture of AAV gene therapies at its facility in Columbus, Ohio, US.

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Gene Therapy Gene Development Manufacturing 256

Pharmaceutical Technology

MAY 9, 2023

BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries. It will become an independent, end-to-end contract development and manufacturing organisation, as a separate company and in collaboration with Warburg Pincus and Advent International.

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Contract Manufacturing Manufacturing Clinical Research Development 243

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2023

Indian pharma’s mainstay in the areas of CRAMS (contract research and manufacturing services), product development, regulatory protocol adherence, and dossiers submissions in the required CTD (Common Technical Document) format are big growth opportunities, said Suresh Khanna, chairman, Karnataka Drugs and Pharmaceutical Manufacturers Association and (..)

Manufacturing 189

Manufacturing Marketing Production Research 189

World of DTC Marketing

MARCH 31, 2022

With the money it costs us, the Government could encourage a private company to build a manufacturing facility for insulin while offering tax incentives. Dr. Jing Luo says the list price of insulin — the price set by manufacturers but not necessarily what patients or providers pay — has increased between 300% to 500%. billion to $5.7

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Insulin Drugs Pharmacy Manufacturing 240

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

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Clinical Research Research Gene Therapy Drugs 226

XTalks

APRIL 7, 2025

For manufacturers developing GLP-1s or in the market, its invaluable to understand the nuances of how real-world evidence (RWE) can be harnessed to demonstrate the clinical and economic value of weight loss medications. Optum Life Sciences researchers stay up-to-date on the latest in research and how it may affect access for patients.

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Life Science Research Trials Manufacturing 52

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 31, 2024

The Indian Council of Medical Research (ICMR) has announced an Expression of Interest (EoI) inviting eligible organizations, companies, and manufacturers to participate in the ‘Transfer of Technology’ for a CRISPR Cas-based TB detection system.

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Manufacturing Research Clinical Trials Clinical Trials 189

Bio Pharma Dive

OCTOBER 23, 2020

The rare disease drug developer is betting it can create a better DMD treatment by combining Solid's research with its manufacturing and gene delivery technology.

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Gene Therapy Gene Manufacturing Development 204

Roots Analysis

JANUARY 27, 2025

It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.

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Manufacturing Contamination Production Gene Therapy 40

Drug Patent Watch

MARCH 12, 2025

Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts. For generic drug manufacturers, stability testing is a critical step in the development process. It's not just a matter of copying a formula and slapping a new label on it.

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Generic Drugs Drugs Manufacturing Branding 97

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 8, 2024

The shortage is due to higher-than-expected demand and manufacturing issues. Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution).

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Manufacturing Medicine Clinical Trials Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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Production Clinical Trials Clinical Trials Compliance 188

Roots Analysis

JANUARY 27, 2025

DYNAMICS OF RADIOPHARMACEUTICAL MANUFACTURING A COMBINATION OF RADIOISOTOPES AND PHARMACEUTICALS Radiopharmaceutical manufacturing is a highly specialized field that involves the production of radioactive drugs used in medical imaging and treatment procedures.

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Manufacturing Production Medicine Contract Manufacturing 40

pharmaphorum

APRIL 26, 2024

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

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Research Manufacturing Development Drugs 111

Bio Pharma Dive

APRIL 11, 2023

Founded by University of Pennsylvania researchers, VintaBio will manufacture the viral vectors that are essential in cell and gene therapy production, but which have been in shorter supply as more companies entered the space.

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Gene Therapy Gene Production Manufacturing 173

Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Gene Therapy Manufacturing Gene Production 244

Pharmaceutical Technology

MAY 31, 2023

Source: GlobalData © GlobalData The respondents also remarked that various aspects of the UK’s healthcare sector have worsened post-Brexit, and over 70% of them thought that the UK would not remain an attractive destination for healthcare research and manufacturing after Brexit.

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Life Science Manufacturing Regulation Medicine 55

Bio Pharma Dive

JULY 26, 2023

The startup is the latest young company to emerge with plans to make production of cell-based medicines easier for researchers and biotechs.

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Manufacturing Medicine Production Research 130

Pharmaceutical Technology

JUNE 6, 2023

The project is a partnership with Inspirevax and the National Research Council of Canada (NRC). Using the advanced manufacturing platform of NRC, these vaccine antigens are expected to be quickly deployable in next-generation vaccine formulations. SynergiQC, the Quebec-based funding programme created by CQDM, has awarded the funding.

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Vaccine Vaccination Development Manufacturing 231

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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FDA Approval Manufacturing Development RNA 105

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Association […]

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Licensing Licensing Manufacturing Clinical Trials 189

FDA Law Blog

APRIL 8, 2025

About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research. Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers.

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Generic Drugs Drugs Bioequivalency Production 141

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 22, 2022

Drug manufacturers have hailed the Drugs (Eighth Amendment) Rules, 2022 mandating barcode or quick response (QR) code on the label of top 300 brands of formulations from August 1, 2023, saying that QR codes will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing.

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Branding Drugs Manufacturing Medicine 189