Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. However, that percentage of multiple first generics is not very high—approximately 10.6%

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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.

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Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. The only way forward for generics producers. They are sometimes referred to as hybrid medicines by the European Medicines Agency (EMA).

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions.

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Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction.

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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.

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Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc.

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XTalks

JANUARY 20, 2025

Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach. Actavis Acquisition of Allergan Deal value : $70.5

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Pharmaceutical Technology

OCTOBER 5, 2008

In addition, one very notable deal with India hints that Asia’s emerging market is also having a growing influence on what is happening in Japan. ’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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World of DTC Marketing

JUNE 22, 2022

Then there is the cost of generic drugs. Mark Cuban made a big splash in the world of gener­ic medications when he launched a new com­pa­ny ear­li­er this year, pledg­ing to on­ly charge a 15% mark-up for its gener­ic medicines, Wide­spread cost sav­ings from us­ing Cuban’s new com­pa­ny could be steep.

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Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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Pharmacy Checkers

DECEMBER 5, 2019

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! Decriminalizing Personal Drug Importation and Redefining “Counterfeit”.

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pharmaphorum

NOVEMBER 8, 2021

Switzerland’s Social Democratic Party has argued that the government should step in and acquire Novartis’ generics unit Sandoz if the company decides to sell it, according to local press reports. In its third-quarter results, Novartis reported that Sandoz’ sales fell 4% to $7.11

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pharmaphorum

AUGUST 20, 2020

“This case brought by the Department of Justice regarding these charitable contributions only seeks to further restrict patients’ access to important medicines and healthcare. The company will vigorously defend itself against these allegations.”

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pharmaphorum

JANUARY 25, 2022

.” The online pharmacy launch comes a few weeks after Cuban set up a pharmacy benefit manager (PBM) operation – the Mark Cuban Cost Plus Drug Company (MCCPDC) – promising to cut out the middleman in the medicines supply chain so it can eliminate markups on generic drugs and pass savings on to its customers.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The study of ketamine’s antidepressant effects has inspired research for different conditions, says Dr. Gerard Sanacora, director of the Depression Research Program at Yale School of Medicine, Connecticut. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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pharmaphorum

JULY 29, 2021

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. ” Advanz itself was directly fined £40.9

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Those 38 products generated just $10bn of the $316bn industry’s entire portfolio of medicines.

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pharmaphorum

MARCH 5, 2021

Teva’s Copaxone patent expired in Europe in 2015 and the Commission said it will investigate whether the company broke antitrust rules by defending the drug’s market position after the expiry. And in August last year, the US Department of Justice charged Teva with conspiring with other pharma companies to fix prices for generic drugs.

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pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”.

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pharmaphorum

JUNE 4, 2021

All told, the number of prescriptions rose to 78 million last year, peaking in March and April as the pandemic started to gather pace, and one single drug – sertraline – accounted for £113 million of the additional costs. Shortage-related price concessions data published last May indicated the price of sertraline was up 823% to £14.32

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Camargo

SEPTEMBER 8, 2021

The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. There are 19,000 approved prescription drugs for marketing in the U.S.

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pharmaphorum

NOVEMBER 26, 2020

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives. About the interviewee. About the author.

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XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. billion in 2021 to a high of $44.7 percent.

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pharmaphorum

MARCH 16, 2022

billion of that coming from the US market, where an authorised generic sold under license from AZ has been available since early 2020. Generics of Symbicort are already available in some non-US markets, including in Europe. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1

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pharmaphorum

JUNE 6, 2022

The costs associated with the supply chain, rather than solely the cost of making the drug, raise the end price of medications, which are then passed onto consumers. MCCPDC’s site says it can lower prices by directly opening the pathway from manufacturers to consumers, decreasing medicine costs by cutting unnecessary expenses.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids. In its favour?

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Pharmacy Checkers

MAY 22, 2020

Drug manufacturers are not forced to disclose where the APIs of their drugs are made. There are many thousands of drugs approved for the U.S. market, so maybe some do disclose this information, but most do not. But Metformin is an off patent, widely-manufactured generic drug. It’s sold in the U.S.

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Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Such support can reduce the time and cost associated with bringing a new biologic to market.

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The Pharma Data

DECEMBER 4, 2021

is a topical prescription medicine used to treat acne vulgaris. The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.

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Pharmacy Checkers

DECEMBER 12, 2019

Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could. If the U.S.

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Pharma in Brief

JUNE 21, 2020

On June 19, 2020, the Patented Medicine Prices Review Board ( PMPRB ) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. New patented medicines. Background.

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Pharmacy Checkers

JANUARY 16, 2020

Blink Health advertising under the key phrase “drug prices in Canada” Launched in early 2016 , Blink Health offers consumers the ability to purchase prescription medicines from its app or website and pick them up from local pharmacies in their neighborhoods. pharmacies – ours is called the PharmacyChecker Discount Card.

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FDA Law Blog

MARCH 6, 2024

He’ll be speaking on “Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines.” He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

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