Roots Analysis

AUGUST 16, 2023

mRNA has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing RNA 52

Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The EC approval follows a positive opinion from the European Medicines Agency’s committee on medicinal products for human use (CHMP) in April 2023.

Vaccination 147

Vaccination Vaccine Marketing Manufacturing 147

Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData. There are fewer EMA-approved sites in the region.

Manufacturing 130

Manufacturing Generic Drugs Contract Manufacturing Production 130

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

JUNE 19, 2023

Oral liquid medicine manufacturer Rosemont Pharmaceuticals has announced the acquisition of Lucis Pharma. UK-based Rosemont hopes that this latest acquisition will bolster its portfolio with a pipeline of innovative products and allow it to serve the UK and overseas markets. Please check your email to download the Report.

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Medicine Marketing Manufacturing Production 130

Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This guidance was previously endorsed by the ICH Assembly in November 2022 and is regarded as an attempt to harmonise regulatory considerations surrounding continuous manufacturing.

Manufacturing 211

Manufacturing Production Drugs Protein 211

XTalks

MARCH 29, 2022

Jazz Pharmaceuticals has broken ground on a new $100 million manufacturing plant for cannabis-based medicines in the UK. The 60,000-square-foot facility was specially designed to support the company’s two regulatory-approved cannabis-based medicines and offer capacity for future drugs currently under development.

Medicine 111

Medicine Manufacturing Sales FDA Approval 111

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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Manufacturing Packaging Packaging Drugs 130

Pharmaceutical Technology

FEBRUARY 3, 2023

The field of genomic medicine has reached a true turning point. In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1]

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Genome Genomics Medicine Gene Therapy 244

Pharmaceutical Technology

APRIL 24, 2023

Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

Pharmaceutical Technology

DECEMBER 9, 2022

Brazil is the largest country in Latin America, with a population of over 212 million, and consequently has the biggest pharmaceutical market in the region. There are also strict price controls, which in some cases can limit profitability for manufacturers. The generics market in Brazil.

Marketing 246

Marketing Sales Production Medicine 246

BioTech 365

OCTOBER 15, 2020

DUBLIN–(BUSINESS WIRE)–The “Nuclear Medicine and Radiopharmaceuticals Manufacturing Market, 2020-2030” report has been added to ResearchAndMarkets.com’s offering.

Manufacturing 40

Manufacturing Medicine Marketing 40

Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. A new frontier in cancer research.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Manufacturing Vaccination Vaccine Packaging 130

Pharmaceutical Technology

JUNE 13, 2023

This will allow the Swiss company to begin ramping up its drug substance manufacturing process with its sister company FinVector Oy in Kuopio, Finland ahead of its planned product launch. Finvector Oy is a Finnish biopharmaceutical company that specialises in current Good Manufacturing Practice (cGMP) manufacturing.

Gene Therapy 246

Gene Therapy Manufacturing Gene FDA Approval 246

Pharmaceutical Technology

FEBRUARY 27, 2023

Manufacturing a drug therapy usually involves several different stakeholders. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. Regulatory decisions by the EMA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

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Manufacturing Drugs Packaging Packaging 130

Roots Analysis

MARCH 9, 2022

Biopharmaceutical Excipient Manufacturing Market. Given the evident benefits of biologics over small molecule drugs (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is poised to witness continued and consistent growth over the next several years. Capacity Analysis.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. EMA and NICE news.

Manufacturing 130

Manufacturing Packaging Packaging Contract Manufacturing 130

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

Marketing 173

Marketing Sales Manufacturing Drugs 173

BioTech 365

DECEMBER 15, 2021

Global Pharmaceutical Contract Manufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com Global Pharmaceutical Contract Manufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com DUBLIN–(BUSINESS (..)

Contract Manufacturing 40

Contract Manufacturing Manufacturing Medicine Marketing 40

STAT News

OCTOBER 27, 2022

Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies.

Medicine 111

Medicine Manufacturing Marketing Drugs 111

Pharmaceutical Technology

MARCH 21, 2023

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). SK Biotek is contracted to manufacture the small molecule API.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

NOVEMBER 23, 2022

Innovations in biotechnology are advancing the biopharmaceutical market, enabling the treatment of complex diseases with next-generation therapeutics synthesised or extracted from a biological source. Hamilton’s position as a historical steel manufacturer means the city has infrastructure assets that are absent elsewhere.

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Marketing Gene Therapy Life Science Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 20, 2022

Contract marketing companies support pharmaceutical companies in creating, improving, and maintaining their brand, as well as reducing risk, and ensuring better product placement in the market. Identifying the top commercial dose (non-sterile) companies in contract marketing.

Marketing 130

Marketing Drug Delivery Systems Production Containment 130

BioPharma Reporter

JUNE 27, 2022

A new âEuropean Union â Latin America and Caribbeanâ partnership aims to boost Latin Americaâs manufacturing capacity.

Manufacturing 96

Manufacturing Medicine Vaccination Vaccine 96

Pharmaceutical Technology

APRIL 27, 2023

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority. billion by 2028.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. GSK owns a majority stake in ViiV Healthcare.

Medicine 130

Medicine Manufacturing Pharma Companies Licensing 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Trends in pharmaceutical contract packaging.

Packaging 130

Packaging Packaging Marketing Containment 130

Pharmaceutical Technology

JANUARY 26, 2023

“With cell and gene therapy, not only does it offer the management of symptoms like other conventional medicines, but it also offers the potential of a cure. RoslinCT began as a spin-out from the Roslin Institute – now part of the University of Edinburgh – in 2006, providing expertise in regenerative medicine.

Gene Therapy 130

Gene Therapy Gene Medicine Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 8, 2022

Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies. Discover the top pharmaceutical compounding companies in contract marketing. Large-scale manufacturing. Large-scale manufacturing.

Marketing 130

Marketing Pharmacy Containment Sales 130

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

Pharmaceutical Technology

MARCH 30, 2023

At the start of this year, the World Health Organisation (WHO) said that more than 300 children had died in The Gambia, Indonesia and Uzbekistan in 2022 in deaths linked to contaminated medicine. The medicines – over-the-counter cough syrup – were contaminated with ethylene glycol (EG) and diethylene glycol (DEG).

Compliance 130

Compliance Manufacturing Contamination Production 130

STAT News

NOVEMBER 28, 2022

A hotly contested provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare $1.5 billion spent by the health care program — on just five medicines during that period, according to a new analysis. billion from 2015 to 2020 — or nearly 5% of the $30.2

Medicine 105

Medicine Branding Manufacturing Marketing 105

Intouch Solutions

NOVEMBER 20, 2023

In the rapidly changing landscape of global markets, staying ahead of the curve is crucial for businesses aiming to expand and thrive. As we step into 2024, the realm of market access undergoes dynamic shifts influenced by technological advancements, policy changes, and evolving consumer behaviors.

Marketing 105

Marketing Manufacturing Genome Genomics 105

Pharmaceutical Technology

SEPTEMBER 14, 2022

More than 100 approved peptide-based therapeutics are currently available in the market. The increasing demand for API peptide products is in turn increasing the demand for peptide API manufacturers who also offer contract marketing services. Discover the top API protein and peptide companies in contract marketing.

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Protein Marketing Manufacturing Reagent 130