Drug Patent Watch

NOVEMBER 20, 2024

Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.

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Drug Patent Watch

JULY 31, 2024

The journey of a generic drug developer is a complex and multifaceted one, involving rigorous research, meticulous development, and stringent […] Source

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Drug Patent Watch

OCTOBER 23, 2024

The pharmaceutical industry has faced significant challenges in recent years, including the loss of patents, increased regulatory scrutiny, and rising research and development costs.

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Drug Patent Watch

AUGUST 14, 2024

The role of academic research in generic drug development is multifaceted and crucial. Academic research plays a vital role in driving pharmaceutical innovation by fueling scientific discoveries…

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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. Still, the FDA does prioritize the review of submissions for first generics.

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Scienmag

JUNE 20, 2022

billion by purchasing generic drugs at Mark Cuban prices Abstract: [link] URL goes live when the embargo lifts A brief research report found that Medicare could have saved up to $3.6 billion by purchasing generic drugs at the same prices as the Mark Cuban Cost Plus Drug […].

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ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

increase in revenue from 2020 to 2021 from sales of Revlimid, its multiple myeloma therapy, with a global analyst consensus sales forecast of $12.8bn for 2021, according to GlobalData’s Drugs Database. However, other challenges facing biopharmaceutical companies include growing generic drug competition, which places pressure on drug prices.

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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.

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The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. Lei Zhang, the deputy director for the office of research and standards in OGD, said that in FY 2020, FDA issued a record high number of new and revised PSGs totaling 258.

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Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don’t lead to greater affordability or even access here in the U.S.

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World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Generic drugs may also be cheaper with a coupon than your drug insurance. Imagine if Medicare, like most employer insurance plans, offered a single drug plan. The result:? Not our system.

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Pharmaceutical Technology

OCTOBER 5, 2008

’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi. ” The move, which came in June, also gives Japanese drugs maker Daiichi Sankyo a foothold in the Indian market through Ranbaxy’s location. .”

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. This may include implementing gain-sharing models, where savings from biosimilar use are reinvested in patient care or research.

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Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. Depression research spurs efforts for other conditions. That research led to a substantial amount of evidence suggesting that ketamine can have rapid effects on a host of measures associated with neuroplasticity,” he says.

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Drug Patent Watch

DECEMBER 9, 2024

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. What is a Drug Patent?

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Pharmaceutical Technology

JULY 15, 2022

CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm.

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pharmaphorum

OCTOBER 12, 2021

A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients with Alzheimer’s disease. The results are strong enough to back a proof-of-concept study in people with genetic risk of Alzheimer’s according to the researchers.

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Pharmaceutical Technology

AUGUST 12, 2022

It is part of the good manufacturing practice (GMP) quality assurance system, and is undertaken by laboratories, usually at contract research organisations (CROs). Even following the Brexit vote, the EU remains the UK’s largest trading partner, and a high proportion of UK drugs originate from European countries.

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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Camargo

OCTOBER 14, 2021

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. If you are developing a generic drug, Camargo has extensive experience with ANDA strategies and FDA interactions and can assist you with your development program.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

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FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. By Douglas B. After his remarks, Mr.

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Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Pharmaceutical Technology

MAY 31, 2023

Les Laboratoires Servier overview Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company also provides generic drugs and contract development and manufacturing services across its global network.

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Pharmacy Checkers

FEBRUARY 5, 2021

For those of you looking for a methodologically strong analysis of international drug prices and a history of related studies, this is the report for you. In looking at all drugs, brand and generic, the percentage goes down to 256%. That’s because, as the report shows, generic drugs in the U.S.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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pharmaphorum

JUNE 4, 2021

Researchers in the UK have found that there was a four million rise in prescriptions for antidepressants in England during 2020, adding £139 million to NHS costs. Shortage-related price concessions data published last May indicated the price of sertraline was up 823% to £14.32

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pharmaphorum

SEPTEMBER 9, 2022

Novo Nordisk can be credited with re-invigorating the market for obesity drug therapies with its GLP-1 agonist therapies – Saxenda (liraglutide) and Wegovy (semaglutide) – which collectively saw sales increase 84% to $950 million, despite some supply constraints for Wegovy. Novo Nordisk recently predicted its obesity sales could reach $3.7

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. But what does this all say about where our drugs really come from?

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FDA Law Blog

AUGUST 16, 2022

That impression was corroborated this week at the GMP by the Sea conference when Douglas Throckmorton, Deputy Director for Regulatory Programs at FDA’s Center for Drug Evaluation and Research, stated that domestic FDA inspections of facilities have been performed at “standard operational levels” since October 2021.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organisation for branded drugs, said the proposals ‘would irretrievably sabotage’ the EU pharma industry and ‘would send Europe to the back of the queue for healthcare treatments, clinical research, jobs, and global investment’ The draft’s (..)

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pharmaphorum

OCTOBER 28, 2021

A generic pill has been shown to reduce hospitalisation rates in high-risk patients with early COVID-19, potentially offering a low-cost alternative to oral antivirals from Merck & Co and others, according to researchers in Brazil.

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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. ” “The pharmaceutical industry requires better incentives to research and develop medicines that prevent or cure diseases.”

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Pharmaceutical Technology

DECEMBER 4, 2022

Broadly speaking, price is the determining factor on the US healthcare market, says Jakub Hlávka, PhD, research assistant professor of health policy and management at the University of South California, Los Angeles. Raymond Cross, director of the inflammatory bowel disease program at University of Maryland’s School of Medicine, Baltimore.

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