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. One of the first things Avéma does with a new project is to evaluate the drug molecule to make sure it's a fit for available facilities.

Manufacturing 147

Manufacturing Drugs Production Development 147

Drug Patent Watch

NOVEMBER 9, 2023

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2018 to 2023. Companies that successfully challenge patents on branded drugs are granted six… The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

Generic Pharmaceutical 59

Generic Pharmaceutical Drugs Branding 59

Drug Patent Watch

JULY 25, 2024

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2019 to 2024. Companies that successfully challenge patents on branded drugs are granted…

Generic Pharmaceutical 52

Generic Pharmaceutical Drugs Branding 52

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

FDA Approval 130

FDA Approval Generic Pharmaceutical Drugs Production 130

Drug Patent Watch

JULY 26, 2023

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2018 to 2023. Companies that successfully challenge patents on branded drugs are granted six… The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

Generic Pharmaceutical 52

Generic Pharmaceutical Drugs Branding 52

Drug Patent Watch

NOVEMBER 9, 2022

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2017 to 2022. Companies that successfully challenge patents on branded drugs are granted six…. The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

Generic Pharmaceutical 52

Generic Pharmaceutical Drugs Branding 52

Pharmaceutical Technology

JULY 28, 2022

The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs). There are no disease-modifying drugs currently approved for OA.

Marketing 130

Marketing Generic Pharmaceutical Sales Production 130

Pharmaceutical Technology

FEBRUARY 28, 2023

According to GlobalData, Phase I drugs for Malignant Mesothelioma have a 77% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 28, 2023

According to GlobalData, Phase III drugs for Paroxysmal Nocturnal Hemoglobinuria have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Drugs Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 28, 2023

According to GlobalData, Phase III drugs for Glomerulonephritis have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Iptacopan hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Drugs Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 22, 2022

The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs).

Marketing 147

Marketing Generic Pharmaceutical Clinical Trials Clinical Trials 147

Drug Patent Watch

NOVEMBER 8, 2020

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2015 to 2020. Companies that successfully challenge patents on branded drugs are granted six…. The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

Generic Pharmaceutical 40

Generic Pharmaceutical Drugs Branding 40

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

Packaging 52

Packaging Packaging Drugs Generic Pharmaceutical 52

Drug Channels

SEPTEMBER 10, 2020

George examines the economic impact of generic pharmaceuticals on the U.S. He argues that the generics industry provides safe, effective, and affordable medicines for many Americans. d/b/a Drug Channels Institute. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

Medicine 52

Medicine Generic Pharmaceutical Drugs 52

Pharmaceutical Technology

FEBRUARY 18, 2023

The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Generic Pharmaceutical 100

Generic Pharmaceutical Dermatology Antibody Development 100

BioTech 365

MAY 18, 2021

OTC PINK:SHMN), a generic pharmaceutical, nutraceutical, and cosmeceutical company that manufactures and markets generic drugs covering … Continue reading → Chino Hills, 05/18/2021 / 15:31, CET/CEST – EQS Newswire – Sohm, Inc. CHINO HILLS, CA / ACCESSWIRE / May 18, 2021 / SOHM, Inc.

Generic Pharmaceutical 40

Generic Pharmaceutical Generic Drugs Manufacturing Marketing 40

BioTech 365

JUNE 3, 2021

the “Company”) (OTC PINK:SHMN), generic Pharmaceutical, Nutraceutical, and Cosmeceutical company that manufactures and markets generic drugs … Continue reading → Chino Hills, 06/03/2021 / 18:51, CET/CEST – EQS Newswire – Sohm, Inc.

Generic Pharmaceutical 40

Generic Pharmaceutical Generic Drugs Manufacturing Marketing 40

Pharmaceutical Technology

DECEMBER 22, 2022

The main focus is the antibody-drug conjugate (ADC ), Enhertu (trastuzumab deruxtecan), which had already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Insulin 130

Insulin Production Development Genetics 130

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.

Generic Pharmaceutical 69

Generic Pharmaceutical Production Medicine Branding 69

The Pharma Data

JANUARY 4, 2021

Meiji Seika Pharma, since it launched penicillin in Japan in 1946, has been providing high-quality pharmaceutical products such as antibiotics, antidepressants and antipsychotics in Japan and overseas. Integrated Reports: [link].

Generic Pharmaceutical 40

Generic Pharmaceutical Generic Drugs Clinical Development Clinical Research 40

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.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 4, 2023

Recently, US Food and Drug Administration (FDA) also approved the citrate-free HCF of Hyrimoz ® (adalimumab-adaz) injection. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company.

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Frequent amendments (1998–2016). Frozen” register.

Regulation 52

Regulation Compliance Medicine Manufacturing 52

Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. 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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Production Manufacturing Drugs Generic Drugs 263

FDA Law Blog

JANUARY 24, 2024

We identify R&D opportunities to promote the development of innovative biomanufacturing pathways that could address supply chain bottlenecks for critical drugs, chemicals, and other materials. Louis, Missouri, APIIC convened a working group of 15 experts in an event titled “Pathway to Build Supply Chain Resilience for Critical Drugs.”

Manufacturing 69

Manufacturing Drugs Generic Pharmaceutical Production 69

FDA Law Blog

OCTOBER 29, 2023

The report recommend that Departments consider issuing further guidance to (1) clarify requirements regarding “appropriate medical management” for coverage of contraceptives, which could include providing guidance that “all FDA-approved contraceptive products that do not have a therapeutic equivalent should be covered without cost-sharing as part of (..)

FDA Approval 45

FDA Approval Production Generic Pharmaceutical Pharmacy 45