European Pharmaceutical Review

NOVEMBER 25, 2024

The pharmaceutical analytical testing market is seeing significant growth following a greater incidence in the complexity of medicine development and higher demand for biologics and biosimilars, according to a report by Straits Research Pvt. The market is furthermore expected to see a compound annual growth rate (CAGR) of 7.3

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pharmaphorum

AUGUST 25, 2022

The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business. billion by 2024.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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European Pharmaceutical Review

APRIL 11, 2023

Therefore, the projected compound annual growth rate (CAGR) is 5.7 The key drivers of this industry include advancements in bioprocessing, development of novel microbial strains for production of high-value compounds and the rising demand for biopharmaceutical products such as antibiotics, vaccines and enzymes. percent by 2033.

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Express Pharma

JANUARY 11, 2024

The sales growth of gout therapies across the seven major markets (7MM: the US, 5EU, and Japan) is set to increase at a compound annual growth rate (CAGR) of 8.8 Canakinumb, set for a 2030 launch, is a biosimilar to the established Ilaris therapy. per cent from $4.6 billion in 2022 to $10.8

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Express Pharma

JUNE 28, 2024

The osteoporosis market, the prevailing metabolic bone disorder globally, which is characterised by reduced bone mineral density and increased fracture risk, is set to experience a compound annual growth rate (CAGR) of 5.4 per cent across the seven major markets (7MM*) from $10.5 billion in 2023 to $17.9 billion in 2033, forecasts GlobalData.

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Pharma Pathway

SEPTEMBER 14, 2022

Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Walk-In Interviews for Sterile (Manufacturing/ Compounding/ Aseptic Filling Production) / Engineering Operators/ Process Engineering Maintenance @ Dr. Reddy’s Laboratories Ltd.

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Pharmaceutical Technology

FEBRUARY 3, 2023

However, after almost seven years of staving off competitors through patents and litigation, Humira’s market-leading position in the US will be affected as Amgen’s adalimumab biosimilar, Amjevita, started to roll out on January 31, 2023. According to GlobalData estimates, in 2022, the adalimumab biosimilars market was valued at $184.2

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Now, all nonresident pharmacies will need to be licensed in order to dispense prescription drugs to patients in Massachusetts.

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FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. 353b(a)(8). 353b(a)(8). the wholesale distributor, repackager, relabeler).

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Express Pharma

JUNE 5, 2023

billion in 2031 across the 8MM, registering a compound annual growth rate (CAGR) of 1.9 GlobalData’s latest report, ‘Myelofibrosis: Eight-Market Drug Forecast and Market Analysis,’ reveals that the MF market will grow from $2.39 billion in 2021 to $2.89 per cent, driven by the approvals of nine pipeline agents.

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European Pharmaceutical Review

APRIL 3, 2024

As such, the sector is expected to grow at a compounded annual growth rate (CAGR) of 6.5 A shift towards advanced therapeutic approaches, such as biopharmaceuticals and biosimilars, “has led pharmaceutical companies to explore outsourcing options for manufacturing”, the research stated. percent between 2022-2030.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Upcoming biosimilar competition for Humira means AbbVie’s focus may turn to Rinvoq, approved in the US for atopic dermatitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, and Skyrizi, approved in the US for psoriatic arthritis and plaque psoriasis. AbbVie reported a 22.7%

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Some takeaways on those efforts that we gleaned from the report: Compounding. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain. Communication in this area included on-line videos, webinars, summits, conferences, and international outreach.

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pharmaphorum

FEBRUARY 3, 2022

As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds. The injectable drug delivery market is expected to rise at a compound annual growth rate of 12.9%

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5 micrograms per day “for any unstudied chemical that poses a negligible risk of carcinogenicity or other toxic effects.”

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Pharmaceutical Technology

SEPTEMBER 13, 2022

“We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless and rapid fashion.”. In August, the company announced plans to spin off Sandoz, its generics and biosimilars division , to create a new standalone company.

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European Pharmaceutical Review

JANUARY 18, 2024

Insomnia market Dual orexin receptor antagonists (DORAs) [dual orexin receptor antagonists (DORAs)]… offer a new mechanism of action [in treating insomnia]” Across the seven major markets, the insomnia market is anticipated to grow at a compound annual growth rate (CAGR) of 2.6 percent from $3.2 billion in 2022 to $4.1

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Pharmaceutical Technology

DECEMBER 9, 2022

Research and development highlights from the research period include the company’s work with Mirati Therapeutics in developing methods to determine torsion rotational energy barriers of the clinical compound, MRTX1719, which is being developed for use as an inhibiter to MTAP-deleted cancers. HQ ADDRESS: Römerpark 2. 4303 Kaiseraugst.

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Eye on FDA

FEBRUARY 10, 2021

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. It was also noted that the “ Bad Ad ” program turned 10 years old this year.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

Perhaps most importantly, the guidance concludes with examples of how manufacturers would apply this framework to Nitroso compounds. All drug manufacturers and API manufacturers would be well served to examine the guidance, and perform analysis suitable for their products, to determine whether further assessment is necessary.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

A “specified drug” means, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by a specified manufacturer. A “specified small manufacturer drug” means, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by a specified small manufacturer.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

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FDA Law Blog: Biosimilars

AUGUST 14, 2023

OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.

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pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. 6 The stakes were extremely high, with annual costs of insulin reaching $736 per patient in 2013, up threefold since 2002.

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Pharmaceutical Technology

JULY 23, 2008

” Looming biosimilar legislation and the disregard for patents in the developing world is also threatening the intellectual property, and therefore profit margins, of companies looking to develop cancer drugs. “Intellectual property is becoming more of an issue,” says Ando.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). By Larry K. Houck — Last week the U.S.

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FDA Law Blog: Biosimilars

AUGUST 10, 2023

This section grants FDA the authority to request records regarding drug products remotely, without an on-site inspection: Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of (..)

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Express Pharma

JULY 10, 2024

Sasmitha Sahu, Managing Consultant, GlobalData states, “While India has demonstrated success in generic drug production, the same is not true for novel and biosimilar biopharma products.” These trends serve as crucial catalysts, necessitating a shift in priorities and a much-needed transformation of the manufacturing sector.”

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STAT

APRIL 24, 2024

The problem: Even if officials can get drugmakers to cut prices, the companies can yank a drug off the market, without guaranteeing that other manufacturers will continue to make the compound. Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and are set to cost the U.S.

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European Pharmaceutical Review

FEBRUARY 23, 2023

On the contrary, keeping stronger patents, eg, compound patents, in and opting less robust, second‑medical‑use patents out may help favourably shape the jurisprudence. Arrow declarations are useful for generics or biosimilars as they give commercial certainty that a product may be launched without the risk of a later infringement action.

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pharmaphorum

DECEMBER 2, 2020

It was at this time they set their site at Sandwich in the UK, initially just to finish processing compounds imported from America, but due to tariffs on imported products the company rapidly expanded the plant to accommodate producing medicines from scratch. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.

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Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

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Express Pharma

NOVEMBER 2, 2023

Though the entry of biosimilars will contract the market, significant growth is expected over the next 8-10 years, driven by the launch of new assets. Against this backdrop, the CD drug sales across the eight-major markets (8MM*) are set to increase at a compound annual growth rate (CAGR) of 4.7 per cent from $9.5

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Express Pharma

OCTOBER 16, 2024

The CRO sector in India, growing at a compound annual growth rate (CAGR) of 10.75 Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. per cent, is projected to reach $2.5 billion by 2030 (2). per cent, hitting $44.63

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Pharma in Brief

NOVEMBER 18, 2020

The action related to Pfizer’s filgrastim biosimilar drug. In Amgen Inc v Pfizer Canada ULC , 2020 FCA 188 , the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 ( 537 Patent ) invalid for obviousness. Appeal decision.

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FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. Koblitz — We need to talk about nitrosamines. What are nitrosamines?

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