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

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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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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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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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

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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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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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.” His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations.

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FDA Law Blog

NOVEMBER 20, 2023

Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). Those efforts add up to a clear message to industry that FDA is looking beyond CGMP when it evaluates drug makers. By John W.M. It’s also clear that culture counts.

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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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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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FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. By John W.M. Clinical Trials.

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

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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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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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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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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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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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The Pharma Data

JANUARY 4, 2021

Burr Boulevard, Teaneck, NJ 07666 (3) President: Yasushi Miyazawa (4) Scope of business: Clinical research and development (5) Paid in capital: US$100,000. Outline of the new company (1) Company name: Meiji Pharma USA Inc. (2) Location: 500 Frank W. Integrated Reports: [link].

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pharmaphorum

OCTOBER 3, 2022

The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. ALS affects over 30,000 people in the US. It can lead to progressive paralysis and death.

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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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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections.

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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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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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XTalks

JANUARY 31, 2023

The list of available medicines includes about 50 generic drugs. Amazon’s growing healthcare push has seen the company incorporate telehealth, drug delivery, fitness trackers and cancer research in its portfolio in recent years. The program also offers 24/7 assistance provided by pharmacists or support staff.

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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. billion, about 50% was dedicated to regulating medical products, including prescription drugs. The medications that we obtain in the U.S., and other high-income countries.

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Delveinsight

SEPTEMBER 15, 2021

Similarly, Delveinsight’s Oncology Based Reports related to Drug Insights cover the major manufacturers that produce pharmaceutical drugs. The drug reports are classified as branded drugs and generic drugs.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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pharmaphorum

JUNE 8, 2021

While all of the top ten best-selling oncology drugs in the US in 2019 were innovative therapies, four out of the top ten best-selling oncology drugs in China were for conventional chemotherapy. “In In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”. About the interviewee.

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Cloudbyz

MARCH 5, 2024

The choice between developing a biologic or a small molecule drug often depends on the nature of the disease target, the desired mechanism of action, and the feasibility of manufacturing and delivery. In both cases, clinical research must be meticulously designed to address these complexities.

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The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Source link: [link].

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Drug Discovery World

AUGUST 8, 2023

DDW’s Megan Thomas takes a deeper look into why India is ramping up drug discovery research, and explores the country’s innovation hubs of interest. Similarly, The Times of India says that branded generic medicines have “long fuelled India’s pharmaceutical exports” 4.

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Drug Discovery World

APRIL 10, 2023

Historically, this has been predominantly driven by generic drugs, with branded generics making up 70-80% of the retail market. However, the role of modern drug discovery technologies and novel treatment approaches is expected to grow over the next few years.

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Drug Channels

MARCH 15, 2022

Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics. If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive the email. WHAT’S GOING ON.

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The Pharma Data

DECEMBER 4, 2021

“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. Source link: [link].

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