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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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.

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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.

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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.

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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.

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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.

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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.

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK.

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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.

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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.

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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.

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 14, 2023

The workshop was attended […]

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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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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.

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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.

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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.

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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.

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Bio Pharma Dive

NOVEMBER 17, 2023

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

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Pharmaceutical Technology

DECEMBER 8, 2023

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

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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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]

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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.

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Pharmaceutical Technology

MARCH 25, 2025

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

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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.

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Pharmaceutical Technology

JANUARY 12, 2024

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

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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.

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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.

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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.

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Pharmaceutical Technology

MARCH 11, 2025

The multi-year manufacturing deal with CordenPharma will secure future supply of VK2735 if it goes to market.

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Pharmaceutical Technology

OCTOBER 25, 2024

A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.

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Pharmaceutical Technology

DECEMBER 22, 2022

The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American. Fentanyl was first synthesised in 1959 and introduced to markets in the 1960s as a pain relief drug.

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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

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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.”

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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…

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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.

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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.

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