Quality Matters

JUNE 26, 2023

Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. FDA 1 Even the requirements for TE for different types of products within individual NBCP categories may not be the same. FDA publishes Product Specific Guidances (PSGs).The

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Quality Matters

JUNE 12, 2023

Complex generics: The need and challenges Generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions filled in the United States , generic medicines are essential to increasing patient access to important drug therapies. What are complex generics?

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Express Pharma

AUGUST 30, 2023

Prof (Dr) J A Jayalal, Secretary General, Commonwealth Medical Association & Former National President, IMA , asserted, “An act perceived as draconian has galvanized the medical fraternity and ignited a nationwide fervour. The dichotomy between generic and branded drugs, accentuated by limited quality control measures, beckons scrutiny.

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Pharmaceutical Technology

JUNE 12, 2023

It sources a wide range of branded or generic equivalent drugs from across the globe to meet the needs of the local market. The collaboration will launch a portfolio of products in the therapeutic categories of ophthalmology, cardio-metabolic and oncology, commencing in the fourth quarter of 2023.

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pharmaphorum

AUGUST 11, 2022

Rebecca speaks about generics and biosimilars: what they are, why they’re important for medication access and healthcare cost sustainability, and what Sandoz has learned about succeeding in the off-patent world. She also touches on the patient stories behind the headlines and the effect of COVID-19 on the generics market.

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Biosimilars 52

pharmaphorum

JULY 4, 2022

At Teva , he replaces Hafrun Fridriksdottir, a 25-year Teva veteran who was named R&D chief almost immediately after Kare Schultz took over the reins of Teva in 2017 with the task of turning around the fortunes of the ailing generics giant. He will be based out of Teva’s US headquarters in Parsippany, New Jersey.

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Generic Medicine Biosimilars 52

European Pharmaceutical Review

NOVEMBER 15, 2023

Sandoz] has the only major remaining vertically-integrated production network for penicillins in Europe” Penicillins are the leading category of antibiotics worldwide, Sandoz highlighted. Launch of these new facilities help to ensure sustainable access to quality antibiotics and spearhead development of biosimilars, Sandoz noted.

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Biosimilars 65

pharmaphorum

FEBRUARY 28, 2022

” Viatris’ departure from the biosimilars business comes shortly after another player in the category, Biogen, also announced its plans to exit the category by selling its stake in the joint venture Samsung Bioepis for $2.3 The post Biocon buys Viatris biosimilars for $3.3bn, eyes IPO appeared first on.

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Pharma in Brief

JUNE 21, 2020

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ).

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Biosimilars Generic Medicine Dosage Documentation 40

pharmaphorum

NOVEMBER 15, 2022

UK-based pharma Indivior has agreed a takeover deal with Opiant Pharma that consolidates its position in the addiction treatment category with a new intranasal therapy, due to be filed with the FDA before the end of the year. Opiant developed Narcan (naloxone nasal spray) as well.

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pharmaphorum

FEBRUARY 12, 2021

Novartis exited novel antibiotics R&D three years ago, but is clearly still interested in the category – its Sandoz unit has just spent $350 million buying GlaxoSmithKline’s cephalosporin franchise. .

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Pharmaceutical Technology

DECEMBER 22, 2022

Business Expansion is one of our largest categories and looks at the core functions of business operations within the sector. The Environmental category aims to highlight companies that are undertaking projects that reduce their impact on the natural environment or contribute to its general health. Business Expansion.

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Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 6, 2022

Servier is already in the process of transforming itself into a much bigger player in cancer, and has just tripled its sales objectives for the category. ” Its updated plan predicts group sales of €6 billion in 2025 and operating profits of around €1.3 billion, rising to €8 billion and approximately €2.4

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FDA Law Blog: Biosimilars

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

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Pharmaceutical Technology

OCTOBER 31, 2022

Two categories of novel therapies stand out: cell therapies and therapies with novel MOAs, with new products in each category being forecast to launch between 2023 and 2025. These are forecast to contribute significantly towards sales in the OA market in 2031, accounting for 10% and 14.2% of the 7MM sales, respectively.

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European Pharmaceutical Review

NOVEMBER 8, 2022

4) prohibiting ‘product hopping’ and interference with generic and biosimilar substitutions. 562), titled Ensuring Timely Access to Generics Act of 2021, imposes requirements related to third-party petitions concerning applications for FDA approval to market a generic or biosimilar drug. 5) monitoring access to biosimilars.

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Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52

pharmaphorum

APRIL 7, 2022

Novartis’ generics unit Sandoz has moved on to the next stage of a collaboration with Ares Genetics, which is focusing on the use of artificial intelligence to track antimicrobial resistance (AMR), improve diagnoses and guide the most effective use of antibiotics.

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Compounding 52

Express Pharma

AUGUST 7, 2023

This is an unending discussion and the problem is further fuelled by generic and branded generics propaganda. It will be desirable to have a look at the prices and the cost of the drugs in the Ayurvedic category too, most of the drugs are taken in multiple units every day for months together.

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pharmaphorum

SEPTEMBER 11, 2020

The focus of the special purpose acquisition company, or SPAC, is firmly in Saunders ’ familiar territory of medical aesthetics, eyecare, longevity and wellness categories, although the IPO prospectus indicates Vesper “may pursue targets in any industry”.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

By Riëtte van Laack — On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed amendments to the FDC Act would provide CVM with the needed authority.

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Labelling 45

Pharma in Brief

FEBRUARY 2, 2022

In making these decisions, the Panel considered, among other information: a product’s listing status on existing federal, provincial, and territorial formularies; utilization data; availability of a generic or biosimilar; and information about safe use in pregnant and lactating women. Drug cost was not a consideration.

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Insurance Coverage and Processing Biosimilars Diabetes 59

pharmaphorum

SEPTEMBER 9, 2022

It also marks the first move by Kry beyond the primary care category, where it provides virtual GP consultation services to millions of patients across various European countries, into tools for the treatment and prevention of chronic diseases. Novo Nordisk recently predicted its obesity sales could reach $3.7 billion in 2025.

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RX Note

MARCH 10, 2023

At work, we often have to refer MOHMF for prescriber category, approved indications and purchase method. To improve the comprehensiveness of the database, Brand name search has been emphasized to include both original brand and local generic brands. Many customers at community pharmacy only recognize their drugs by brand names.

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pharmaphorum

FEBRUARY 10, 2022

The decision gives Bayer a shot at narrowing the gap with its main rivals in the category – Bristol-Myers Squibb and Johnson & Johnson – which are thought to be out in front the in race to bring an oral FXIa inhibitor to market with their milvexian candidate. The anticoagulant is Bayer’s biggest product, adding almost €3.5

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Drug Channels

MARCH 6, 2023

Attorney's Office for the Districts of MA and NJ , and Viatris You'll take a deep dive into the hottest topics keeping you up at night, including Drug Pricing Transparency Pressures DOJ Drug Pricing Transparency Priorities Legal Updates on Authorized Generics and the U.S. Cannot be combined with special category rates or other offers.

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Drug Pricing 84

pharmaphorum

OCTOBER 26, 2022

The Langenfeld-headquartered company is a specialist in pharmacological therapies for central nervous system diseases, including branded products and generics, as well as consumer health products, with operations across the EU, UK, and Eastern Europe.

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Communication 64

European Pharmaceutical Review

MARCH 14, 2023

The Court assessed whether rebranding of a generic product with the original’s brand by parallel importer is permissible. In both cases, parallel importers (Impexeco and Pi Pharma) imported repackaged and rebranded generic Sandoz BV medicinal products from the Netherlands into Belgium with the trademarks of Novartis’ reference products.

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Packaging Generic Medicine Labelling Pharmaceutical Companies 80

Express Pharma

SEPTEMBER 26, 2023

About PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) At present a major component of Indian exports are low value generic drugs while a large proportion of the demand for patented drugs is met through imports. The medical device sector is also an essential and integral constituent of the healthcare sector.

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Biosimilars 100

RX Note

APRIL 10, 2023

There are few key important points that I would like to highlight: The top row should be the title of the information , for example: Generic name, Brand Name, Prescriber Category, and others. generic name and brand name) so that you can use different search terms to reach the same drug.

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Express Pharma

MAY 4, 2023

It has a good product mix of consumer and Rx brands with most leading or in the top five brands in their categories. Finally, tailwinds from global sourcing diversification, and the opportunity for generics where India has the largest share in global supply by volume, make the sector a long-term bet, as per the Bain-IVCA report.

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Pharma in Brief

OCTOBER 25, 2020

Vaccines to be subject to the same complaints-based investigation criteria as patented biosimilars and generics”. Allowing for increases in the Maximum Rebated Price for Category I new medicines to the Maximum List Price level”.

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Biosimilars Documentation Vaccines 52

European Pharmaceutical Review

NOVEMBER 3, 2022

The survey, which offers a collateralised metric of all major categories, acquired data from 400 global pharma companies. Inflation and energy prices, particularly for generic and API manufactures in parts of Europe will test their resilience. Industry challenges for the year ahead.

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Drug Channels

OCTOBER 17, 2022

Cannot be combined with special category rates or other offers. Don’t miss the chance to unite with colleagues and master the complexities of pharmacy and distribution models to accelerate patient access! Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to November 11, 2022.*.

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Biosimilars 58

pharmaphorum

OCTOBER 10, 2022

The pharma group said earlier this year it is hoping for eight new cardiovascular therapy approvals between now and 2030, for diseases like atherosclerosis, heart failure, and thrombosis as well as PAH, that will swell its sales from in the category to $10 billion around the end of the decade.

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Diabetes 52

pharmaphorum

MAY 6, 2022

The deal is something of a milestone for the digital therapeutics category, with the sums involved in the same ballpark as when biopharma companies license rights to promising drug-based treatments. million in development and commercial milestones plus royalties on any eventual sales.

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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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pharmaphorum

DECEMBER 19, 2022

Earlier this year, the market analysis company predicted MDD sales of around $740 million in the US, the five largest European markets (France, Germany, Italy, Spain, and the UK), plus Japan and Canada, although it noted competition is growing in the category.

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Labelling 52