Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

European Pharmaceutical Review

JANUARY 4, 2023

WuXi STA , a subsidiary of WuXi AppTec, has announced that its first continuous manufacturing ( CM ) line for oral solids is in operation at its drug product site in Wuxi city, China. Unit operations including dispensing, blending, lubrication, tablet compression, and coating. Oral solids. billion by 2030.

Dosage 52

Dosage 52

ISPE

MARCH 30, 2023

or the “Smart Factory”, as applied to the Pharmaceutical Industry) have reaped the benefits of data connectivity – including improved quality, productivity, and profitability. These solutions enable progress for the industry as a whole, with considerations for all aspects of development from raw material to the final product.

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Documentation 98

European Pharmaceutical Review

AUGUST 2, 2023

These can facilitate rapid testing and release of products manufactured in a good manufacturing practice (GMP) environment. Real-time monitoring and control of the biomanufacturing processes through product quality insights continues to be a key area of focus in the biopharmaceutical industry, the paper reported.

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ISPE

SEPTEMBER 7, 2023

Numerous pharmaceutical companies are diversifying their portfolios, while some are taking a leap into the ATMP (Advanced Therapy Medicinal Product) era. The commercialisation of an ATMP product has always been under the spotlight. The emergence of new therapies leads to the need for multi-modal manufacturing facilities.

Hospitals 98

Hospitals Pharmaceutical Companies Pharmaceutical Companies 98

STAT

AUGUST 23, 2023

The Danish drugmaker is scrambling to boost output of the drug to meet soaring demand in the United States and after production problems at the factory in Belgium operated by its first contract manufacturer, Catalent. The company had previously said it had enlisted a second contract manufacturer, but had not identified it.

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European Pharmaceutical Review

DECEMBER 6, 2023

In the interview, conducted at CPHI Barcelona, Krishna Venkatesh, Global Head, Sterile Manufacturing Operations at Dr Reddy’s Laboratories explores industry’s growing focus on achieving end-to-end connectivity, as well as the potential of automation and track and trace solutions. What trends are you seeing in the pharma space?

Packaging 83

Packaging Vaccines 83

European Pharmaceutical Review

NOVEMBER 14, 2023

The report called for all political parties to unite around this long-term vision to support sustainable regional and national economic growth. Leading the UK’s manufacturing In the UK, the M5 sectors, including life sciences, employ nearly one million people in roles that are 46 percent more productive than the national average.

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pharmaphorum

FEBRUARY 3, 2022

Novartis chief executive Vas Narasimhan has downplayed any chances of swift decision on the future of its generics business Sandoz, saying that a decision on the possible sale of the unit may not come until the last quarter of the year. billion bid from EQT and the German Struengmann family.

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ISPE

APRIL 13, 2023

Primary benefits include acceleration of the steps for design, scale-up, and regulatory approval for all process unit operations, in support of bringing new drugs to market in a timely manner. This in turn nurtures process understanding, 2 motivating companies to establish modeling as a key enabler for process design.

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Compounding FDA 98

The FDA Law Blog

AUGUST 14, 2023

One inspection resulted in FDA’s securing a consent decree to restrict or shut down operations, and two resulted in an “untitled letter,” which is not available to the public on FDA’s website. Of those facilities manufacturing essential medicines deemed to be the product of complex manufacturing processes, 68% were located in the U.S.,

FDA 52

FDA Dosage Compounding 52

pharmaphorum

DECEMBER 29, 2022

The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. Digital workflows also facilitate collaboration along the product lifecycle, enabling data-driven decision making and improving inspection readiness.

Vaccines 107

Vaccines 107

PharmaShots

JUNE 29, 2023

The company focuses on developing organic spirulina and microalgae products under its Nutraceutical division as a type of dietary supplement. The business sells nutraceutical products under categories, including Children's Health Supplements, Skin, Hair & Nails Supplements, and Immune Supplements. Revenue: $277.2M

Immunization 40

Immunization 40

The FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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FDA Documentation Labelling 59

pharmaphorum

FEBRUARY 9, 2022

GlaxoSmithKline’s COVID-19 products – antibody drug Xevudy and a vaccine adjuvant – helped drive a 5% increase in 2021 revenues to £34 billion ($46 billion), ahead of what chief executive Emma Walmsley says will be a “landmark year” for the company. billion, but still came in ahead of analyst expectations.

Vaccines 101

Vaccines 101

The FDA Law Blog

MARCH 3, 2024

Instead, the final NDAA directed the DoD to determine whether Chinese biotechnology companies should be identified as Chinese military companies operating in the United States. On January 31, the DoD issued an updated list of Chinese military companies operating in the U.S.,

Packaging 102

Packaging FDA 102

European Pharmaceutical Review

MAY 29, 2023

As these products are parenteral and according to the GMP are sterile, the costs associated with their manufacturing are high. Therefore, the industry has worked to successfully develop unit operations capable of handling continuous stream processing, stated Tanzini et al.

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Process Improvement Packaging Vaccines FDA 75

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Dosage Packaging Compounding Labelling 81

pharmaphorum

SEPTEMBER 8, 2021

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. ” Fewer staff will therefore be asked to cover more ground with fewer resources, all whilst operating under a pay freeze, they claim.

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European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. For example, it was advised to establish appropriate control strategies for both active substances and drug products. Cioc et al.

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PharmaShots

JUNE 14, 2023

Moreover, the company’s Diagnostic Business discovers, develops, and manufactures in vitro diagnostic products and devices for hospital and clinical use. In Nov 2022, Bio-Rad entered into an exclusive license and product development agreement with NuProbe to enhance Bio-Rad’s product pipeline through a Digital PCR application.

FDA 56

FDA Hospitals Documentation Patient Care 56

ISPE

NOVEMBER 2, 2022

Vice President, Hospital Business Unit Global Supply Chain. Tom Cheslock, Vice President, Hospital Business Unit Global Supply Chain at Pfizer presented on “Integrated Manufacturing Excellence–Leading thru Uncertainty.” Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!”

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

ISPE

MAY 18, 2023

However, we face a steep learning curve in understanding the diversity and specifics of the manufacturing chain that make this new generation of RNA drug products completely different from traditional biologics (e.g. The revision of PIC/S Annex 2A in 2021 addressed mRNA as a medical product within the ATMPs for the very first time.

Vaccines 98

Vaccines 98

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. A device means a product that’s used in the diagnosis of disease and intended to affect the structure and function of the body of humans,” Faget said.

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FDA Documentation 132

pharmaphorum

MARCH 10, 2022

Biologics product development has increased steadily over the past decade, with the volume of business forecast to double by 2030. Accordingly, pharmaceutical companies are expected to up their investment in this area, both in terms of production infrastructure and expertise.”. Investing in biological production facilities.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Packaging Immunization 98

pharmaphorum

MARCH 14, 2022

Novartis may be planning to sell off its generics business Sandoz, but that hasn’t stopped it investing in the unit ahead of a decision on its future later this year. Sandoz already markets six respiratory products, with almost a dozen in clinical development, according to the generic drugmaker.

Generic Medicine 98

Generic Medicine 98

Pharmaceutical Technology

DECEMBER 14, 2022

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA). Outside of the US region, Novartis will have sole rights to the products.

Compounding 59

Compounding FDA 59

DiversifyRx

JUNE 2, 2023

Here are my favorite OTC products that create additional profit for you while relieving patient pain. Hollywog WiFi TENS Unit AMS Nitric Oxide CBD Products Nudora Probiotics Hollywog WiFi TENS Unit: The Hollywog WiFi TENS Unit utilizes Transcutaneous Electrical Nerve Stimulation (TENS) therapy to alleviate pain.

Independent Pharmacies 52

Independent Pharmacies 52

PharmaShots

MAY 10, 2023

Medical Device Revenue: $5.21B Founded Year: 1896 Total Employees: ~19,000 Headquarters: Hertfordshire, United Kingdom Market Cap: $13.9B Stock Exchange: LON Smith + Nephew is a medical technology company that develops products focusing on the repair, regeneration, and replacement of soft and hard tissues.

Nursing Homes 40

Nursing Homes Hospitals FDA Communication 40

Omnicell

JANUARY 10, 2023

Greg Haas Senior Manager, Product Marketing For nearly two decades, Sentara used central pharmacy robotics to automate medication distribution and enable top-of-license practice. to learn how upgrading central pharmacy automation technology has helped Sentara Healthcare to enhance their central pharmacy operations. PDT | 1:30 p.m.

Medication Dispensing 52

Medication Dispensing Omnicell Cart Fill Hospitals 52

pharmaphorum

NOVEMBER 11, 2021

KNUTSFORD, United Kingdom — Fishawack Health welcomes FIDE, an independent organization providing its clients with insight from clinical key opinion leaders in inflammatory dermatology. Richard Warren, MD, Professor and Director of the Dermatopharmacology Unit at the University of Manchester in the UK. November 10, 2021, UK.

Pharmaceutical Companies 96

Pharmaceutical Companies Pharmaceutical Companies Patient Care 96

ISPE

MAY 10, 2023

Sanat’s organization oversees a complex and large network of manufacturing, commercialization, and distribution operations across four different platforms of pharmaceuticals, vaccines, biologics, and animal health with over 20,000 employees in over 22 countries. The whole manufacturing footprint will look different.

Vaccines 52

Vaccines 52

pharmaphorum

JUNE 22, 2022

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap.

Generic Medicine 106

Generic Medicine FDA Vaccines 106

European Pharmaceutical Review

JUNE 27, 2022

Alexion , AstraZeneca’s Rare Disease group, will invest €65 million to enhance its production capabilities in Ireland. The €65 million investment follows a €341 million investment in the Blanchardstown facility last year to establish a next generation active pharmaceutical ingredient manufacturing unit on the site.

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Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

Vaccines 52

Vaccines 52

Roots Analysis

OCTOBER 24, 2023

HPAPIs, due to their selective mode of action, are effective in much smaller quantities than other therapeutic products. This has led to their widespread production and extensive use in the treatment of various indications including hormonal imbalances, oncological disorders and respiratory disorders.

Compounding 40

Compounding Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 40

European Pharmaceutical Review

MAY 17, 2023

QMS are the integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured and distributed in compliance with regulatory requirements and meet the desired quality standards. The data observed the global pharmaceutical quality management systems (QMS) market is expected to reach a value of $4.44

Pharmaceutical Companies 84

Pharmaceutical Companies Pharmaceutical Companies FDA 84