Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Manufacturing Controls.

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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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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions.

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Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

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Pharmaceutical Technology

AUGUST 12, 2022

This trade has been able to continue for the most part, as the UK’s regulator (the MHRA) remains aligned in many areas with the EU’s regulator (the EMA). Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA) remarked that these duplicative processes would add time and cost. “We

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. Continue to STAT+ to read the full story…

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Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications.

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. Similarly, the European Medicines Agency (EMA) has been at the forefront of biosimilar regulation, with a well-established approval process in place since 2006.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Pharma in Brief

APRIL 29, 2021

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme. [1]. 1, particularly section 80.2,

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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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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?

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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Outsourcing Pharma

OCTOBER 5, 2021

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.

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pharmaphorum

JULY 29, 2021

The drugmaker specialises in selling generic drugs that are hard to manufacture, which places a barrier to widespread generic competition. The regulator said that in addition to the fines, the NHS may choose to pursue the companies for damages in the courts. ” Advanz itself was directly fined £40.9

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Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. Requirements for obtaining a listing are set out in O.

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XTalks

JUNE 16, 2023

This means patients are being given alternate drugs that could have more severe side effects, or instead of a combination, they may be only given one drug that is available. These drugs are often generics and hence have a low unit price, making them less appealing to manufacturers.

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Pharmacy Checkers

SEPTEMBER 10, 2020

Food and Drug Administration to make sure those drugs will work as directed by their prescribers. While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Because they don’t do adequate testing to prove safety and effectiveness of drugs.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John wanted to know if these prices were for the “same” drug. and arguably just as safe. requirements.

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FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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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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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § FDA regulations, at 21 C.F.R. 355(j)(2)(A)(v). patients in harm’s way.”

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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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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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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. But it is not always clear which types of patents are eligible for listing in the Orange Book. The FDA Commissioner is quoted as saying that “[t]he FDA stands ready to assist the FTC.

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The Pharma Data

MAY 17, 2021

As examples, the authors cited remdesivir – formerly an unsuccessful Ebola drug – and dexamethasone – a generic drug widely available for decades – being repurposed as COVID-19 treatments. After 5 years, the median number of manufacturers of 8 UDI-approved self-administered drugs decreased from 5.5

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FDA Law Blog

AUGUST 7, 2024

On July 30, brand name drug sponsor Novartis asked the District Court for a Temporary Restraining Order ( here and here ) enjoining FDA’s approval of a generic version of its ENTRESTO (sacubitril and valsartan) with certain dosing and indication information carved-out or modified.

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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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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion the drug generated in 2021. every eight weeks for the 90 mg dose, according to the manufacturer. First FDA-approved in March 2017, the list price of Ocrevus was about $75,102 annually, as reported by the manufacturer.

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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