BioPharma Reporter

JULY 22, 2021

Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.

Manufacturing 98

Manufacturing Life Science Clinical Research Research 98

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 124

Clinical Trial Podcast

AUGUST 24, 2023

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either.

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Clinical Research Research Gerontology Clinical Trials 40

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The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the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

In-Vitro 179

In-Vitro Manufacturing Licensing Licensing 179

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 233

BioTech 365

SEPTEMBER 16, 2021

United States Vaccine Transport Market Report 2021: Focus on Hospitals, Epidemic Prevention Station, Pharmaceutical Manufacturers & Distributors, & Clinical Research Organizations – ResearchAndMarkets.com United States Vaccine Transport Market Report 2021: Focus on Hospitals, Epidemic Prevention Station, Pharmaceutical Manufacturers (..)

Clinical Research 40

Clinical Research Manufacturing Vaccination Vaccine 40

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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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

Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in this domain.

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Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in this domain.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Outsourcing Pharma

SEPTEMBER 22, 2022

Epicâs Life Sciences program is released with the aim to connect providers, pharmaceutical companies, and medical device manufacturers to recruit research participants, expand clinical trial access, and to speed up therapy development.

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Clinical Research Life Science Research Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 12, 2024

Currently, there are around six major manufacturers of […] This is particularly significant in the development of targeted therapies for conditions like cancer, where precise delivery of medication to specific cells or tissues is crucial.

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Manufacturing Development Drugs Clinical Trials 145

pharmaphorum

MARCH 3, 2022

The UK biopharma industry has welcomed a new tranche of funding from the government aimed at bolstering manufacturing of medicinal products and developing the national health data infrastructure. The post UK govt pledges £260m to health data, manufacturing appeared first on.

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Manufacturing Life Science Clinical Trials Clinical Trials 52

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.

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Manufacturing Clinical Trials Clinical Trials Production 89

Roots Analysis

MARCH 24, 2022

You may also be interested in the following titles: Continuous Manufacturing (Small Molecules and Biologics) Market Subcutaneous Biologics, Technologies and Drug Delivery Systems Market Antibody Discovery Services and Platforms Market. Our Social Media Platform. Web: [link]. LinkedIn: [link]. Twitter: [link].

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Clinical Research Development Research Drug Delivery Systems 52

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 (..)

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Manufacturing Marketing Production Research 161

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.

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Cosmetics Manufacturing Drugs Clinical Trials 150

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 7, 2024

Association of Indian Medical Device Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices covering all types of […]

Manufacturing 150

Manufacturing Clinical Trials Clinical Trials Clinical Research 150

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 168

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 9, 2023

In an effort to ensure a stable and cost-effective supply chain for active pharmaceutical ingredients (APIs) in the country, the Department of Pharmaceuticals (DoP) may look at tapping the potential of international collaborations for sourcing of raw materials and manufacturing of ingredients in the country.

Manufacturing 163

Manufacturing Clinical Trials Clinical Trials Clinical Research 163

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 21, 2022

The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, (..)

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Cosmetics Manufacturing Drugs Clinical Trials 163

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Association […]

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Licensing Licensing Manufacturing Clinical Trials 175

BioPharma Reporter

OCTOBER 24, 2022

The company opens a bioanalytical lab in the US, which offers an additional 59,000-square-feet of space to the overall facility, making it âone of the largest laboratories of its kind.â.

Clinical Research 52

Clinical Research Research Contract Manufacturing Manufacturing 52

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 31, 2023

It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious. The Central Drugs Standard Control Organisation (CDSCO) has declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality (NSQ). The central […]

Drugs 160

Drugs Manufacturing Clinical Trials Clinical Trials 160

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 16, 2023

On the occasion of National Ayurveda Day, the Ayurveda Medicine Manufacturers Association of India (AMMOI) has called upon the state governments that the constructive steps being taken by the Union Ayush Ministry to make Ayurveda system of treatment as an alternative treatment method for the world population should be taken forward by all state governments (..)

Manufacturing 139

Manufacturing Medicine Clinical Trials Clinical Trials 139

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 10, 2023

Ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest group, and healthcare providers, have jointly demanded to the Union health minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 that is listed to be tabled in (..)

Cosmetics 154

Cosmetics Drugs Manufacturing Clinical Trials 154

Drug Discovery World

OCTOBER 3, 2023

In pharmaceutical development, collaborating with multiple Contract Development and Manufacturing Organisations (CDMOs) and Contract Research Organisations (CROs) poses potential hurdles – from poor communication to delays, errors, and inconsistent feedback during the progression from preclinical to formulation optimisation and clinical trials.

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Development Drugs Manufacturing Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2023

The Union health ministry has issued a notification prohibiting the manufacture, sale and distribution of pain killers, ketoprofen and aceclofenac and their formulations for animal use with immediate effect, as they are likely to involve risk to animals.

Sales 145

Sales Manufacturing Clinical Trials Clinical Trials 145

Drug Discovery World

OCTOBER 3, 2023

In pharmaceutical development, collaborating with multiple Contract Development and Manufacturing Organisations (CDMOs) and Contract Research Organisations (CROs) poses potential hurdles – from poor communication to delays, errors, and inconsistent feedback during the progression from preclinical to formulation optimisation and clinical trials.

Development 52

Development Drugs Manufacturing Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.

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Manufacturing Production Clinical Trials Clinical Trials 154

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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Pharma Companies Licensing Licensing Sales 140

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. Collaboration and integrated manufacturing. Streamlined clinical trial design with integrated manufacturing can ensure that gene and cell therapies are developed much faster.

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Gene Therapy Gene Marketing Manufacturing 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing 154

Licensing Licensing Drugs Manufacturing 154

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

Drugs 150

Drugs Licensing Licensing Manufacturing 150

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 16, 2023

The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.

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Regulation Manufacturing Drugs Clinical Trials 148

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 27, 2022

Indian Ayurveda propels its growth supported by the industry guidelines of Good Agricultural and Collection Practice (GACP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), said Dr. Rangesh Paramesh, director – Intellectual Property, Himalaya Wellness Company.

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Manufacturing Drugs Clinical Trials Clinical Trials 167

Outsourcing Pharma

MAY 3, 2023

Rich Christie is chief medical officer at AiCure LLC. He is a firm believer in diigtal biomarkers and the audio and visual biomarkers that can be captured through a front-facing camera. OSP inteviewed him to find about more about the changing landscape and what those not entering the digital world are potentially missing out on.

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Clinical Research Research Contract Manufacturing Manufacturing 52