Pharmaceutical Technology

AUGUST 3, 2023

Oramed Pharmaceuticals and Hefei Tianhui Biotech (HTIT) have entered an agreement to form a joint venture to advance oral drug products.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

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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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Pharmaceutical Technology

JULY 14, 2023

After a call to action on social media, J&J has allowed the generic production of its tuberculosis drug bedaquiline.

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CTTI (Clinical Trials Transformation Initiative)

MAY 7, 2024

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a hybrid public workshop on the use of AI in drug and biological product development.

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Camargo

AUGUST 5, 2020

Whether you plan to out-license or commercialize your product, getting the label right matters. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo.

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Fierce Pharma

FEBRUARY 20, 2024

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08

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pharmaphorum

NOVEMBER 19, 2023

Lilly to invest $2.5bn for obesity, diabetes drug production Phil.Taylor Sun, 19/11/2023 - 20:55 Bookmark this

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Pharmaceutical Technology

APRIL 13, 2023

The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets. The extension of the agreement beyond its original Covid-19 focus will accelerate development timelines, increase productivity, and lower manufacturing costs, according to Dyadic’s CEO Mark Emalfarb.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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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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World of DTC Marketing

APRIL 5, 2022

The old model of looking at performance in the first six months of product launch isn’t relevant. Today, colossal budget product launches are not returning the same ROI as before. Product launches are going to need to be micro-targeted to specific audiences. What is the definition of a successful pharma product launch?

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Fierce Pharma

APRIL 25, 2024

Where innovation meets obstacles and the cost of drug development skyrockets, the key to unlocking success of groundbreaking products in the biopharma industry will rely heavily on strategic | Collaborative partnerships key to clearing the path for new biopharma products

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Bio Pharma Dive

APRIL 22, 2024

A new initiative backed by Takeda, Astellas and Sumitomo Mitsui Banking aims to combat a decade-long decline in drug R&D productivity in Japan.

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Pharmaceutical Technology

NOVEMBER 1, 2022

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. What are Product Launches? The Product Launches category recognises companies that have launched notable new products or services into the market.

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Camargo

JUNE 3, 2020

The post Patient-Centered Drug Development for Oncology Products appeared first on Camargo. Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes.

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Pharmaceutical Technology

MAY 2, 2023

Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.

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Outsourcing Pharma

DECEMBER 19, 2023

The US contract development and manufacturing organization (CDMO) Agno Pharma has taken over compatriot firm Lubrizol Particle Sciences to increase its drug product formulation offerings.

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Pharma Mirror

JANUARY 24, 2023

Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development. billion by 2026, up from $186 billion in 2019 according to the Evaluate Pharma report.

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Pharmaceutical Technology

OCTOBER 18, 2023

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

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Pharmaceutical Technology

MAY 23, 2023

Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. The plentiful supply of QS-21 enables the production of next-generation adjuvant systems for new vaccine development.”

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Bio Pharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

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Pharmaceutical Technology

OCTOBER 12, 2023

Leading parenteral packaging company Datwyler has extended its range of coating options with UltraShield™, a high-performance film-coated solution for safely storing innovative drugs.

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Pharmaceutical Technology

AUGUST 16, 2023

AGC has entered into an agreement with Asahi Kasei to produce clinical drug substance for antibody-based therapies at its Seattle site.

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Bio Pharma Dive

JANUARY 24, 2023

The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.

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Bio Pharma Dive

APRIL 25, 2024

The layoffs will impact some 2,200 employees, the company said, as it repositions its business ahead of looming patent expirations for top-selling products.

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BioPharma Reporter

MARCH 19, 2024

With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.

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Drug Discovery World

MAY 7, 2024

Where the bottlenecks of achieving higher cell density and higher titers were once thought to be issues of the past, hurdles have now shifted to achieving speed and scale in mAb production without sacrificing quality. DC: Antibodies have and remain a large product class within the biopharmaceutical market.

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Bio Pharma Dive

APRIL 30, 2024

Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Fierce Pharma

NOVEMBER 22, 2023

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victo | Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing (..)

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Pharmaceutical Technology

APRIL 24, 2023

However, the reality is that traditional medicine has been the source of lead identification in modern drug discovery. Ethnopharmacology has been an important basis for modern medicine The estimated percentage of pharmaceutical drugs available today that are sourced from natural products varies.

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XTalks

SEPTEMBER 19, 2023

The US Food and Drug Administration (FDA) has issued warning letters to eight companies manufacturing or marketing unapproved eye products that violate federal law. The FDA said the warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.

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Pharmaceutical Technology

APRIL 5, 2023

Luye Pharma Group has signed a marketing and distribution agreement with Duopharma Biotech’s wholly-owned subsidiary, Duopharma Marketing, for a cholesterol management product in Malaysia. Both the companies are targeting a double-digit compound annual growth rate for the product in the local market over the next ten years.

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