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. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

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Regulation Clinical Trials Clinical Trials Medicine 162

Camargo

OCTOBER 14, 2021

Continued development of the use of complex innovative trial designs. 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. Improved predictability in Human Factors and User-Related Risk reviews.

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Development Packaging Packaging Generic Drugs 189

World of DTC Marketing

JANUARY 31, 2021

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have been recruited by these companies who promise huge payouts when they are acquired if their drug shows promise in clinical trials. In pharma R&D returns have declined to 1.8

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In-Vivo Generic Drugs Drugs Gene Therapy 187

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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Marketing Manufacturing Generic Drugs Containment 100

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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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

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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Marketing Sales Manufacturing Drugs 173

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

FEBRUARY 2, 2022

Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. As it stands, the only other candidate for the disease listed in the clinicatrials.gov database is generic drug rapamycin.

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Trials Drugs Sales Generic Drugs 52

Pharmaceutical Technology

MAY 16, 2023

during Q1 2023 largely due to the advancement of a pair of Phase III trials, Oceanic-AF and Oceanic-Stroke, for their blood-thinning drug, Asundexian. Although Sanofi may face generic drug competition this year for its multiple sclerosis drug, Aubagio, the company is expected to maintain their sales of Dupixent, accounting for 43.3%

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Marketing Sales Generic Drugs Vaccine 130

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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Vaccine Vaccination Development Hormones 105

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.

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Medicine Drugs Production Development 97

pharmaphorum

OCTOBER 28, 2021

There were also numerically fewer deaths with the antidepressant – 17 out of 741 treated with fluvoxamine and 25 out of 756 allocated to placebo – in the TOGETHER trial, which has now been published in The Lancet. The results back up earlier, smaller studies that also found a benefit with the selective serotonin reuptake inhibitor (SSRI).

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Generic Drugs Sales Drugs Licensing 98

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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Marketing Sales Manufacturing Drugs 130

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

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

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

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

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.

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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. Clinical Trials.

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Compliance Clinical Trials Clinical Trials Regulation 59

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry.

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Drugs Generic Drugs FDA Approval Trials 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

Avéma, for example, specialises in small molecule, oral solid, and liquid dose drugs. generic drugs at both small development companies and multinational pharmaceutical companies. Avéma’s team of scientists and manufacturing experts have more than 40 years of Rx formulation development expertise and decades of producing.

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Manufacturing Drugs Production Development 147

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 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

pharmaphorum

MARCH 16, 2022

They said at the time that the trial court decision prevented a commercial launch, but added they were “committed to bringing a generic Symbicort to market as soon as possible.”

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FDA Approval Generic Drugs Marketing Drug Delivery 59

Druggist

SEPTEMBER 30, 2020

Ongoing treatment of irritable bowel syndrome Drug treatment can be considered on a trial basis alongside dietary and lifestyle adjustments , such as eating regular, healthy and well-balanced meals. Symptoms of diarrhoea and constipation can be managed with different drugs which are not reviewed in this post. 73rd edn.

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Pharmacy Containment Drugs Branding 98

FDA Law Blog

AUGUST 29, 2024

2117 (2024) was released, that landmark decision “ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment ‘right of trial by jury’ in all ‘suits at common law.’”

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Production Licensing Licensing Generic Drugs 59

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

pharmaphorum

AUGUST 28, 2020

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

FDA Law Blog

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S. inventors to compete.

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Production Branding Generic Drugs Drugs 76

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

XTalks

SEPTEMBER 20, 2023

Cost Plus Drugs Initiative by Mark Cuban The Mark Cuban Cost Plus Drug Company is a public-benefit corporation launched by billionaire entrepreneur Mark Cuban with a mission to improve public health by revolutionizing pharmaceutical industry operations.

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Pharmacy Drugs Manufacturing Generic Drugs 64

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. 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. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

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Clinical Trials Clinical Trials Trials Containment 40

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.

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Medicine Production Generic Drugs FDA Approval 52

The Pharma Data

MAY 7, 2021

Amid virtual trial craze, Science 37 earns unicorn status and a trip to Nasdaq on the back of SPAC deal ( Endpoints ). Another failed trial for Orphazyme’s ‘pipeline-in-a-product’ leaves shadow on drug’s future ( Endpoints ). Generic Drug Cos. .

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Vaccine Vaccination Drugs Regulation 52

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

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Drugs Research FDA Approval Manufacturing 52

FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

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Generic Drugs Production Drugs Marketing 52