MedCity News

OCTOBER 1, 2022

The speaker identified workforce training, patient experience, healthcare facilities and medical manufacturing as the main areas poised for disruption. The metaverse holds promising potential to transform healthcare delivery for the better, according to a keynote talk delivered at MedCity’s Invest Digital Health conference.

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MedCity News

JULY 19, 2022

Aside from rallying for more patient-oriented reimbursement and removing the red tape involved so that providers can provide home-based dialysis care, medical device manufacturers must also offer a turnkey solution for home-based therapy that includes servicing the device in a door-to-door model.

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European Pharmaceutical Review

NOVEMBER 12, 2024

To boost AstraZeneca’s research and manufacturing footprint by the end of 2026, it is dedicating $3.5 AstraZeneca’s investment in manufacturing In August, AstraZeneca announced its single biggest investment in its Sweden Biomanufacturing Center in Södertälje, since the facility opened in 2021. The post New $3.5b

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Fierce Pharma

APRIL 23, 2024

As doctors and patients in the U.S. | As doctors and patients in the U.S. grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines.

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MedCity News

AUGUST 21, 2024

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. The post FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma appeared first on MedCity News.

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MedCity News

JULY 12, 2024

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news.

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World of DTC Marketing

MARCH 23, 2022

Do patients care? Do patients care? If you’re a cancer patient and your oncologist is prescribing a drug approved via accelerated Approval, are you going to refuse treatment? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”? Of course not.

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MedCity News

JANUARY 17, 2024

How we discuss overweight and obese diagnoses and how we treat those patients is slowly starting to improve. However, there’s still a lot of work to be done – in how we manufacture, market, and manage life-changing weight care medications, as well as how we expand access and improve adherence to them.

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European Pharmaceutical Review

APRIL 10, 2025

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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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.

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European Pharmaceutical Review

FEBRUARY 21, 2023

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

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European Pharmaceutical Review

JANUARY 18, 2023

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. Thus, the MHRA’s approval supports improved regulation of medical cannabis manufacturing.

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European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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European Pharmaceutical Review

JUNE 10, 2024

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. During the earlier announcement for its French facility, Orano Med highlighted one key challenge of developing lead-212 based radioligand therapies is manufacturing then on an industrial scale.

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European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said. “The

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Fierce Pharma

OCTOBER 9, 2023

Dorothy Gemmel, the Chief Commercial Officer for manufacturer solutions business within GoodRx, identifies two exciting opportunities in pharma marketing today: personalization and partnerships.

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Fierce Pharma

OCTOBER 12, 2023

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 C | A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said.

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European Pharmaceutical Review

APRIL 23, 2024

Bristol Myers Squibb (BMS) and Cellares have announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. The agreement will see BMS use Cellares’ fully automated cell therapy manufacturing platform for the clinical and commercial-scale manufacturing of select CAR T cell therapies.

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European Pharmaceutical Review

NOVEMBER 10, 2023

Novo Nordisk has announced plans to invest over 42 billion Danish kroner (nearly £5 billion) starting in 2023, to expand its manufacturing facilities in Kalundborg, Denmark. According to the pharma company , the financing will add to global capacity: from manufacturing of active pharmaceutical ingredients (API) through to packaging.

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European Pharmaceutical Review

NOVEMBER 23, 2023

Following the UK government’s recent announcement of a £520 million funding boost for UK manufacturing, a new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland will develop innovative and sustainable techniques for these medicines. There is a massive gap in the supply and demand for this innovative technology.

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European Pharmaceutical Review

FEBRUARY 2, 2023

While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients.

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European Pharmaceutical Review

OCTOBER 22, 2024

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.

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European Pharmaceutical Review

OCTOBER 11, 2023

As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned.

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European Pharmaceutical Review

MARCH 17, 2023

In a first-of-its-kind commercial agreement, Great Ormond Street Hospital NHS Foundation Trust (GOSH) will work with Leucid Bio to manufacture LEU011, a lateral Chimeric Antigen Receptor (CAR) targeting NKG2D ligands. It will provide quality assurance (QA) services required for manufacture for the LEU011 first-in-human study.

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European Pharmaceutical Review

FEBRUARY 7, 2024

AstraZeneca has announced a $300 million investment in a US-based manufacturing facility in Rockville, Maryland, which will focus initially on T-cell therapies for oncology indications. Currently, AstraZeneca’s manufacturing sites in the US focus on producing small molecules and biologics, the company highlighted.

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European Pharmaceutical Review

DECEMBER 27, 2023

2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.

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European Pharmaceutical Review

FEBRUARY 12, 2024

‘From bench to bedside’ is a well-known aphorism that merely hints at the arduous journey drug treatments must undergo from their position as a candidate molecule or soon to be explored pathway, to becoming a tablet, injection, or infusion administered to patients worldwide. How does it do this?

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Infuse Medical

MAY 2, 2024

In the healthcare Operations field, achieving the best possible patient outcomes is paramount. This means ensuring patients not only understand their diagnosis but are also empowered to participate actively in their treatment plan. It utilizes computer-generated simulations to create realistic and interactive environments.

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European Pharmaceutical Review

SEPTEMBER 28, 2023

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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European Pharmaceutical Review

JANUARY 12, 2024

New technologies at the facility will support the increased manufacturing capacity, the company stated on X. The post Boehringer plans €120m European manufacturing expansion appeared first on European Pharmaceutical Review. The expansion will boost exports of medicines from Greece to the US market.

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European Pharmaceutical Review

JUNE 15, 2023

This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures. Importantly, they identify potential sources of microbial contamination and assess their risk to patients. Medical devices are essential tools for diagnosing, monitoring and treating a variety of conditions.

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PM360

APRIL 4, 2025

Maximizing the Impact of Patient Support Programs through Strategic Branding A pharmaceutical company is powered by their portfolio of product brands, but can reach new heights by servicing patients, engaging prescribers, and driving better health outcomes. Today, nearly all product brands offer some degree of customer service.

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Fierce Pharma

APRIL 10, 2024

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)

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Fierce Pharma

MARCH 14, 2024

After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy (..)

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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%.

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Fierce Pharma

SEPTEMBER 13, 2023

After securing approval at the end of last year for a potential alternative to bladder removal in certain bladder cancer patients, Ferring Pharmaceuticals has given the gene therapy Adstiladrin to | While it scales up manufacturing, the company is rolling out its Adstiladrin through an early, focused program at certain clinics.

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European Pharmaceutical Review

FEBRUARY 27, 2024

It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen.

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