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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STAT News

AUGUST 22, 2022

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S.

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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.

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Pharmaceutical Technology

AUGUST 12, 2022

Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction. Following the introduction of customs controls in January 2021, medicine imports from the EU fell to their lowest levels in years. Industry figures have spoken out against this prospect.

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Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4

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STAT News

AUGUST 3, 2022

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S.

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Pharma in Brief

APRIL 25, 2021

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,

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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 the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19.

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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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pharmaphorum

JUNE 6, 2022

The costs associated with the supply chain, rather than solely the cost of making the drug, raise the end price of medications, which are then passed onto consumers. MCCPDC’s site says it can lower prices by directly opening the pathway from manufacturers to consumers, decreasing medicine costs by cutting unnecessary expenses.

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pharmaphorum

JANUARY 25, 2022

.” The online pharmacy launch comes a few weeks after Cuban set up a pharmacy benefit manager (PBM) operation – the Mark Cuban Cost Plus Drug Company (MCCPDC) – promising to cut out the middleman in the medicines supply chain so it can eliminate markups on generic drugs and pass savings on to its customers.

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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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Pharmacy Checkers

DECEMBER 5, 2019

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! Decriminalizing Personal Drug Importation and Redefining “Counterfeit”.

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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].

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XTalks

MARCH 15, 2024

LillyDirect was launched at the beginning of this year to provide a digital end-to-end healthcare experience that includes access to the company’s drugs with home delivery and telehealth services. Launched last year, RxPass is a prescription drug subscription that offers medications for a monthly subscription of $5 for Amazon Prime members.

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Camargo

SEPTEMBER 8, 2021

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. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The FDA’s Role in Protecting Our Drug Supply.

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Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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Pharmaceutical Technology

DECEMBER 4, 2022

It is all about what you can get at the lowest cost,” says Dr. Raymond Cross, director of the inflammatory bowel disease program at University of Maryland’s School of Medicine, Baltimore. …[but] for biosimilars, it is all about the money. For example, Cross says that the Crohn’s disease space could be open to these biosimilars. Free Report.

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pharmaphorum

JULY 29, 2021

In a statement, Advanz said that it “utterly disagrees” with the CMA’s decision, saying it invested significantly to keep the product on the market to the specifications required by the Medicines and Healthcare products Regulatory Agency (MHRA). ” Advanz itself was directly fined £40.9 million and £51.9

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pharmaphorum

NOVEMBER 26, 2020

The majority of APIs and an increasing share of FDF is currently being manufactured in Asia,” explains Pawlu, adding that this was driven, particularly in generics, by price. “I Christian studied medicine in Germany, Canada and France and is a licenced physician. About the interviewee. About the author.

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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. Medicines for Europe said the supply issues were evidence of the damaging effects of European cost-containment measures.

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Pharmacy Checkers

DECEMBER 12, 2019

Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could. If the U.S.

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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. Let’s call him John.

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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.

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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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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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pharmaphorum

JUNE 3, 2021

The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its label that includes a claim of less weight gain with olanzapine on its own, a big problem with the widely-used generic drug that affects compliance with treatment. In its favour?

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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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Pharmacy Checkers

JANUARY 16, 2020

Blink Health advertising under the key phrase “drug prices in Canada” Launched in early 2016 , Blink Health offers consumers the ability to purchase prescription medicines from its app or website and pick them up from local pharmacies in their neighborhoods. pharmacies – ours is called the PharmacyChecker Discount Card.

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pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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FDA Law Blog

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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FDA Law Blog

MARCH 6, 2024

He’ll be speaking on “Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines.” Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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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. But there’s another side to this story.

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pharmaphorum

JANUARY 17, 2022

The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits.

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Pharmacy Checkers

DECEMBER 26, 2019

Still, the government’s most recent survey data, published in 2015, showed that about four million Americans import medicine each year because of cost. [vi]. Federal law provides extensive flexibility for Americans to personally import more affordable medicine as long as it doesn’t present an unreasonable risk to the patient.

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Drug Channels

FEBRUARY 23, 2021

Follow the Dollar Part II: Understanding the Cost of Brand Medicines Administered to Commercially Insured Patients in Hospital Outpatient Departments , PhRMA. It illustrates how a 340B hospital can earn three times what the manufacturer earns from a provider-administered product. See page 15 (reproduced below).

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