Camargo

MAY 10, 2021

the Center’s chief of medical oncology, In it, they laid out their analysis of accelerated approvals for 35 oncology indications for anti-programmed death ligand 1 antibodies and reported that for 10 of the 35 indications, the confirmatory trials failed to show a benefit. Drug Product. Indication. Triple-negative breast cancer.

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Development Clinical Trials Clinical Trials Trials 185

ACRP blog

FEBRUARY 11, 2025

In the closing three months of 2024 alone, new guidance documents were drafted or finalized on a number of topics, including: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Postoperative Nausea and Vomiting: Developing (..)

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Compliance Clinical Research Research Regulation 59

Pharmaceutical Technology

MAY 31, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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Generic Drugs Hormones Manufacturing Development 100

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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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.

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Gene Expression Drugs FDA Approval Gene 111

pharmaphorum

DECEMBER 1, 2021

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

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Vaccination Vaccine Development Hormones 105

Pharmaceutical Technology

NOVEMBER 29, 2022

In the Phase I/II study, the drug’s effect on pain intensity at 15 minutes after treatment did not meet the required efficacy threshold for the trial’s success, but some efficacy was observed after 30 minutes. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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Drug Patent Watch

DECEMBER 9, 2024

From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. The Intersection of Pharmacognosy and Drug Patents Now, let’s explore how pharmacognosy and drug patents intersect, creating both opportunities and challenges.

Medicine 97

Medicine Drugs Production Development 97

Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

Marketing 130

Marketing Sales Manufacturing Drugs 130

FDA Law Blog

JULY 24, 2024

Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities.

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Generic Drugs Branding Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Bioequivalency Production Contamination Branding 130

FDA Law Blog

MAY 1, 2024

Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Sarah’s a tremendous attorney who always understood HPM’s culture and commitment to client service. I am very excited to have Sarah rejoin HPM.

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Development Drugs Compliance Clinical Trials 52

XTalks

JANUARY 20, 2025

Blockbuster products like Botox (botulinum toxin) and Restasis (cyclosporine) provided Actavis with high-margin, branded revenue streams that complemented its existing generic drug business. Key drivers of the acquisition included Allergans robust product portfolio, particularly in ophthalmology, neuroscience and aesthetics.

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Marketing Botox Life Science Pharma Companies 104

Pharmaceutical Technology

JULY 10, 2008

The industry sits at a pivotal point in its evolution and analysts say it can no longer rest on its laurels happy to produce generic drugs while expending vast sums on marketing at the expense of R&D.

Medicine 100

Medicine Clinical Trials Clinical Trials Development 100

FDA Law Blog

JANUARY 22, 2024

OC had a major hand in drafting some key guidances this year, including the recent draft guidance on Post-Warning Letter Meetings Under GDUFA , a potentially important enforcement guide for generic drug makers that we blogged on back in September. This is important information for every drug maker and its quality teams.

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Compliance Clinical Trials Clinical Trials Regulation 59

XTalks

JUNE 16, 2023

XTALKS WEBINAR: Fostering Patient-Centricity: Clinical Supply Chain Strategies and Sourcing Solutions Live and On-Demand: Thursday, July 20, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to review clinical trial trends and supply strategies that impact the patient experience.

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Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

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. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

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Generic Pharmaceutical Production Medicine Branding 69

The Pharma Data

DECEMBER 17, 2020

The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months.

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Clinical Trials Clinical Trials Trials Containment 40

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.”.

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Marketing Drugs Development Regulation 105

Druggist

SEPTEMBER 30, 2020

Mebeverine is the preferred drug of choice over antimuscarinic drugs such as hyoscine butylbromide (Buscopan), as it is less likely to cause side effects (BNF, 2017). When recommending treatment, NICE looks at existing evidence from clinical trials to support prescribing decision making. 73rd edn.

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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.”. It is not known if lenalidomide capsules are safe and effective in children.

Medicine 52

Medicine Production Generic Drugs FDA Approval 52

FDA Law Blog

AUGUST 16, 2021

While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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Production Drugs Generic Drugs Cosmetics 52

Cloudbyz

MARCH 5, 2024

Here are some of the complexities encountered in clinical research for each: Biologics : Immunogenicity: Biologics have a higher risk of inducing immune responses, which can affect efficacy, safety, and pharmacokinetics. Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics.

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Development Drugs Immune Response Manufacturing 97

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Both the EU and the U.S.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. Internationally, revenue reached $355.7

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FDA Approval Drugs Sales Development 101

The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com.

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Production Branding Development Regulation 40

XTalks

AUGUST 2, 2023

GSK’s Top 5 Best-Selling Drugs of 2022: 1) Shingrix (zoster vaccine recombinant, adjuvanted) Shingrix, with 2022 sales of £2.96 Clinical trials have shown that the vaccine is 90 percent effective in preventing shingles for individuals aged 50 and over. It is one of the largest generic drug manufacturers in the world.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

Vaccination 40

Vaccination Vaccine Production Sales 40

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. Internationally, revenue reached $355.7

FDA Approval 52

FDA Approval Drugs Sales Development 52

Druggist

OCTOBER 13, 2020

One important message to take away is that Truvada and equivalent generic drugs are not 100% effective. The effectiveness of Truvada for PrEP has been subject to different clinical trials. The ‘official’ NICE guidelines on the use of Truvada for PrEP looked at four clinical trials.

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Generic Drugs Pharmacy Branding Doctors 98

Druggist

MARCH 25, 2021

As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS. Do generic, and branded drugs produce exactly the same effect? .

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Branding Bioequivalency Pharmacy Generic Drugs 98

pharmaphorum

MARCH 3, 2022

” The average wholesale prices of the originator insulin are around $329 per vial and $510 for five pens, according to Civica, which says it will start clinical trials of the biosimilars this year with a view to filing for approval in 2023.

Insulin 52

Insulin Production Generic Drugs Medicine 52

The Pharma Data

MAY 6, 2021

In Belgium, too many clinical trial sponsors waffle about reporting required results ( STAT ). Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year ( STAT ). Generic-Drug Makers Knock States’ Objection To Sanctions ( Law360 ). OcuWho? .

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Sales Vaccine Vaccination Gene Therapy 52

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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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 25, 2025

Generic drugs have saved billions of dollars and benefited countless lives by making existing medicines more affordable. But a new study finds these drug copies may not all be created equal.

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Generic Drugs Drugs Research Branding 235

Drug Patent Watch

NOVEMBER 14, 2024

The pharmaceutical industry has undergone significant transformations in recent years, with the increasing complexity of clinical trials and the need for cost and time efficiency driving the growth of contract research organizations (CROs).

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