Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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NY Times

SEPTEMBER 18, 2021

Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.

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FDA Law Blog

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Law Blog

NOVEMBER 16, 2021

That section of the bill – along with the other accompanying sections and parts of the bill – would amend Title XI of the Social Security Act to create a new part – Part E – requiring the HHS Secretary to establish a “Fair Price Negotiation Program” intended to lower prices for certain high-priced single-source drugs and biological products.

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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. However, that percentage of multiple first generics is not very high—approximately 10.6%

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Drug Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared. In other words, money over safety.

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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

MAY 22, 2020

One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. has proved itself to be too dependent on drug imports from China. How do we know?

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A,

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Pharmaceutical Technology

SEPTEMBER 7, 2022

The rising incidence of long-standing diseases such as hypertension, diabetes, cardiovascular diseases, and cancer requires prolonged medication and, thus, drives the growth and need for retail pharmacies in the market. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs.

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Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. Because the products would already have been tested within the exporting country, the testing would be duplicative and (to many people’s minds) unnecessary.

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Pharma in Brief

NOVEMBER 5, 2023

Background A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit ( ODB ) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.

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FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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pharmaphorum

NOVEMBER 2, 2020

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products. Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.

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Camargo

DECEMBER 9, 2020

Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.

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FDA Law Blog

JULY 13, 2022

As we explained last year, the Act proposes to amend Title XI of the Social Security Act to require that HHS establish a “Drug Price Negotiation Program” to “negotiate and, if applicable, renegotiate maximum fair prices” for certain single-source drugs and biological products. Each product is limited to two years of delay.

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Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

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FDA Law Blog

SEPTEMBER 13, 2021

A final rule to establish a Most Favored Nation model to base Medicare drug payment on international prices was enjoined by two federal courts, and HHS recently proposed to rescind the rule (see our post here ). The pieces of major drug pricing and payment reform are falling together. Court of Appeals (again, see our post ).

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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. So, what can we do to insulate against the risk of shortages in these crucial generic drugs? Tackling shortages.

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pharmaphorum

JULY 29, 2021

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. ” Advanz itself was directly fined £40.9

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FDA Law Blog

MAY 25, 2022

That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. And now there’s a report and analysis to back up that claim!

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Cloudbyz

MARCH 5, 2024

The difference between biologics vs small molecules in pharma drug development In pharmaceutical drug development, biologics and small molecules represent two distinct categories of medicinal products, each with their own unique characteristics, development processes, and mechanisms of action.

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FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Pharmacy Checkers

NOVEMBER 21, 2019

So, without further ado, a moment of praise amongst the criticism: Despite its inability to please everyone, the FDA protects, lengthens, and improves the quality of hundreds of millions of lives through its work regulating the development, creation and distribution of medical products. The FDA’s Role in Protecting Our Drug Supply.

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FDA Law Blog

MARCH 30, 2022

1463 ) and the “ Simplifying the Generic Drug Application Process Act ” ( S. We intended to quickly follow up that post with another post addressing a couple of bills that we thought fit the role of Lee Van Cleef as “the Bad,” and Eli Wallach as “the Ugly”: the “ Prompt Approval of Safe Generic Drugs Act ” ( H.R.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids.

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Creogenic Pharma

APRIL 15, 2023

1* Pharma Franchise Company Submit Lowest Price 250+ Products Best Service Best Quality Just a few decades ago Baddi was a town of dust. Baddi attracted a lot of manufacturing industries and the biggest one turned out to be pharmaceutical industry. Our rapid growth is a result of our adherence to ethical practices in the market.

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The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Development of oral biosensor and contract development & manufacturing. Psychedelic transdermal and sublingual drug formulation development. Four clinical studies in neurological indications in 2021.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Drug Discovery World

AUGUST 8, 2023

In the global pharmaceuticals market, India ranks third worldwide for production by volume and the domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 1. Similarly, The Times of India says that branded generic medicines have “long fuelled India’s pharmaceutical exports” 4.

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