Drugs and Manufacturing - Clinical Research Informer

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Development Compliance Drugs

Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Bio Pharma Dive

AUGUST 21, 2024

Company executives had previously warned investors that a delay was likely due to issues at a facility run by third-party manufacturer.

Manufacturing

Manufacturing Drugs

Novo obesity drug sales lag as manufacturing problems persist

Bio Pharma Dive

NOVEMBER 2, 2022

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

Manufacturing

Manufacturing Sales Medicine Drugs

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Bridging Innovation & Patient Care: The Growing Role of AI

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AI startup Leucine raises $7m for drug manufacturing digital twin platform

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

Manufacturing Compliance Drugs

The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

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?

Generic Drugs

Generic Drugs Manufacturing Drugs Production

California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Insulin

Insulin Manufacturing Contract Manufacturing Production

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

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

Manufacturing

Manufacturing Development Drugs Compliance

Incannex partners with Catalent to manufacture psilocybin

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.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Production

Novartis funnels $300M into early biologic drug manufacturing

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

Manufacturing Medicine Drugs Development

FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns

Bio Pharma Dive

NOVEMBER 17, 2020

Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround.

Manufacturing

Manufacturing Drugs

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

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

Manufacturing Drugs Trials

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

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

Manufacturing Drugs Containment

Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

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

Manufacturing Production Drugs Clinical Trials

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog

APRIL 8, 2025

As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). And DPD was a significant piece of that puzzle. facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

Generic Drugs

Generic Drugs Drugs Bioequivalency Production

Lilly to buy injectable drug plant in manufacturing ramp-up

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

Manufacturing Medicine Drugs

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

MAY 6, 2022

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.

Production

Production Drugs Manufacturing

Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

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

Licensing Licensing Manufacturing Cosmetics

Workshop on ‘Quality Control in Ayurveda Industry’ highlights importance of QC & QA in Ayurveda drug manufacturing

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 14, 2023

The workshop was attended […]

Manufacturing

Manufacturing Drugs Clinical Trials Clinical Trials

CDSCO issues guidance document on export NOC for unapproved, banned and new drugs

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.

Drugs

Drugs Manufacturing Clinical Trials Clinical Trials

Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

MARCH 12, 2025

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

Generic Drugs

Generic Drugs Drugs Manufacturing Branding

Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

Drugs

Drugs Manufacturing Production Marketing

Advanced technologies in unlocking the future of drug manufacturing

Bio Pharma Dive

MARCH 11, 2024

Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.

Manufacturing

Manufacturing Drugs

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

Bio Pharma Dive

OCTOBER 4, 2022

The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

Production

Production Drugs Manufacturing

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development

Development Regulation Manufacturing Drugs

Lilly plans new $2.5B manufacturing plant as obesity drug demand ramps up

Bio Pharma Dive

NOVEMBER 17, 2023

Following the approval of Zepbound, Lilly is adding capacity to avert shortages and restricted access.

Manufacturing

Manufacturing Drugs

Signal: US lays out plan to seize govt-funded drug patents to lower cost

Pharmaceutical Technology

DECEMBER 8, 2023

The newly announced plans would allow third parties to manufacture such drugs if manufacturers make them unaffordable.

Drugs

Drugs Manufacturing

The Future of Generic Drug Development for Emerging Markets: Opportunities and Challenges

Drug Patent Watch

JANUARY 23, 2025

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. Share your thoughts in the comments below! Read the full article here: [link]

Generic Drugs

Generic Drugs Marketing Development Drugs

Resolving challenges with product recovery in biopharma manufacturing

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. More than 100 treatments are currently on the market, with hundreds more on their way.

Production

Production Manufacturing Engineer Containment

Overcoming regulatory challenges in sterile manufacturing

Pharmaceutical Technology

MARCH 25, 2025

Evolving regulations in sterile manufacturing requires innovation, market knowledge, and investment. How can drug manufacturers respond?

Manufacturing

Manufacturing Regulation Marketing Drugs

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

Drugs

Drugs Licensing Licensing Regulation

Cereno partners with CordenPharma to scale up CS1 drug production

Pharmaceutical Technology

JANUARY 12, 2024

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

Production

Production Drugs Manufacturing

CVS launches new venture in biosimilar drug experiment

Bio Pharma Dive

AUGUST 24, 2023

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

Drugs

Drugs Manufacturing Marketing

FDA clears second Novartis plant for gene therapy manufacturing

Bio Pharma Dive

APRIL 5, 2022

The 170,000-square-foot plant located in North Carolina can now fulfill its primary function: producing commercial-grade Zolgensma, which has become one of the Swiss pharma's top-selling drugs.

Gene Therapy

Gene Therapy Manufacturing Gene Drugs

Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

Bio Pharma Dive

OCTOBER 20, 2021

Anticipating regulatory clearance of the pill, the group aims to speed access by investing in the manufacturing of generic versions of the drug.

Drugs

Drugs Manufacturing

Biden proposes subsidizing drug middlemen for insulin

World of DTC Marketing

MARCH 31, 2022

Essentially taxpayers would be subsidizing drug company profits for the price of a product that should have come down a long time ago. With the money it costs us, the Government could encourage a private company to build a manufacturing facility for insulin while offering tax incentives. Los Angeles Times. billion to $5.7

Insulin

Insulin Drugs Pharmacy Manufacturing

Manufacturing delays under-the-skin Tecentriq shot in US

Bio Pharma Dive

SEPTEMBER 8, 2023

Roche says it won’t be able to launch the subcutaneous version of the drug until 2024 as it works with the FDA on manufacturing “updates.”

Manufacturing

Manufacturing Drugs

Cutting losses in drug manufacturing: A new era in fill-finish technology

Pharmaceutical Technology

MAY 20, 2024

Drug product loss is a necessary compromise to manufacture injectable medications. Traditional filling lines often incur losses exceeding one litre…

Manufacturing

Manufacturing Drugs Production

Lilly eczema drug turned back by FDA over manufacturing

Bio Pharma Dive

OCTOBER 2, 2023

The rejection of lebrikizumab is Lilly’s second for an immunology drug this year, following a complete response letter for mirikizumab in April.

Manufacturing

Manufacturing Drugs

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

Manufacturing

Manufacturing Medicine Production Trials

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

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

Manufacturing Production Drugs Clinical Trials

Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 6, 2023

A Single Bench of the Delhi High Court has refused to grant interim injunction in favour of German pharma major Boehringer Ingelheim against the Indian generic manufacturers in a patent litigation on the former’s diabetes drug linagliptin, noting that prima facie the patent is vulnerable to revocation and the company has made an attempt towards […] (..)

Manufacturing

Manufacturing Drugs Clinical Trials Clinical Trials

How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

DECEMBER 11, 2024

The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. This article outlines key considerations and strategies for developing a sustainable generic drug development strategy. “Generics are known for their cost-effectiveness.

Generic Drugs

Generic Drugs Development Drugs Compliance

The Role of Quality Assurance in Generic Drugs

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

Generic Drugs

Generic Drugs Drugs Contamination Manufacturing

Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

JANUARY 14, 2025

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?

Generic Drugs

Generic Drugs Development Drugs Manufacturing

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Webinars

Trending Sources

Novo obesity drug sales lag as manufacturing problems persist

Webinars

AI startup Leucine raises $7m for drug manufacturing digital twin platform

The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

California’s low-cost insulin plans receive $100m manufacturing boost

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Incannex partners with Catalent to manufacture psilocybin

Novartis funnels $300M into early biologic drug manufacturing

FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

Lilly to buy injectable drug plant in manufacturing ramp-up

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

Workshop on ‘Quality Control in Ayurveda Industry’ highlights importance of QC & QA in Ayurveda drug manufacturing

CDSCO issues guidance document on export NOC for unapproved, banned and new drugs

Key Considerations for Generic Drug Stability Testing

Do generics producers have what it takes to tackle complex and specialty drugs?

Advanced technologies in unlocking the future of drug manufacturing

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

FDA rejects two China-developed cancer drugs

Lilly plans new $2.5B manufacturing plant as obesity drug demand ramps up

Signal: US lays out plan to seize govt-funded drug patents to lower cost

The Future of Generic Drug Development for Emerging Markets: Opportunities and Challenges

Resolving challenges with product recovery in biopharma manufacturing

Overcoming regulatory challenges in sterile manufacturing

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

Cereno partners with CordenPharma to scale up CS1 drug production

CVS launches new venture in biosimilar drug experiment

FDA clears second Novartis plant for gene therapy manufacturing

Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

Biden proposes subsidizing drug middlemen for insulin

Manufacturing delays under-the-skin Tecentriq shot in US

Cutting losses in drug manufacturing: A new era in fill-finish technology

Lilly eczema drug turned back by FDA over manufacturing

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

How to Develop a Sustainable Generic Drug Development Strategy

The Role of Quality Assurance in Generic Drugs

Innovative Approaches to Generic Drug Development: Case Studies

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