Drug Patent Watch

APRIL 8, 2025

Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation. Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs.

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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. Changes to batch testing requirements.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Pharmaceutical Technology

JULY 25, 2022

Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman.

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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. Misconceptions about the efficacy and safety of biosimilars can lead to hesitancy in prescribing or using these products.

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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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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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Pharmaceutical Technology

OCTOBER 5, 2008

’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi. ” The move, which came in June, also gives Japanese drugs maker Daiichi Sankyo a foothold in the Indian market through Ranbaxy’s location. .”

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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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XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. Key drivers of the acquisition included Allergans robust product portfolio, particularly in ophthalmology, neuroscience and aesthetics.

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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. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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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. Product variation creates patient uncertainty. However, there tend to be some differences between the products.

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pharmaphorum

NOVEMBER 8, 2021

Switzerland’s Social Democratic Party has argued that the government should step in and acquire Novartis’ generics unit Sandoz if the company decides to sell it, according to local press reports.

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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. It is estimated that more than 8 million Americans rely on insulin products to manage their diabetes.

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Those 38 products generated just $10bn of the $316bn industry’s entire portfolio of medicines.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan's pharmaceutical industry has warned that the supply of some medicines may be interrupted if the NHI drug prices remain low and claimed that the current price policy has discouraged drug manufacturers from launching new products in Japan.

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pharmaphorum

NOVEMBER 26, 2020

COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. First, we saw a doubling or tripling of usual demand for a lot of our products. But never in recent history have we had to pull out strategies for so many of our products and subsidiaries at the same time and put them into place.”.

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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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Pharmacy Checkers

MAY 22, 2020

has proved itself to be too dependent on drug imports from China. Although I for one can’t stand China-bashing or any unnecessary nationalistic rhetoric, that doesn’t mean we should be as reliant as we are on China for critical products such as life-saving pharmaceuticals. They will make actual “American drugs.” How do we know?

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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 medications that we obtain in the U.S., Far from it.

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pharmaphorum

MARCH 5, 2021

The Commission will also examine whether Teva may have launched a communication campaign to create a “false perception” about the health risks of prescribing generic competitors, aimed at healthcare professionals and hospitals.

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FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

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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. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan's pharmaceutical industry has warned that the supply of some medicines may be interrupted if the NHI drug prices remain low and claimed that the current price policy has discouraged drug manufacturers from launching new products in Japan.

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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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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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Druggist

SEPTEMBER 30, 2020

Over the counter, Buscopan is sold as Buscopan Cramps and Buscopan IBS Relief (same drug, different names and availability). Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). Both products contain the same drug – hyoscine butylbromide.

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The Pharma Data

DECEMBER 4, 2021

is a topical prescription medicine used to treat acne vulgaris. The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. IMPORTANT SAFETY INFORMATION.

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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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XTalks

JUNE 16, 2023

There are currently no shortages of cancer drugs in Europe or other countries; however, last year, Germany was experiencing a critical shortage of the breast cancer drug tamoxifen. Medicines for Europe said the supply issues were evidence of the damaging effects of European cost-containment measures.

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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

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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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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Pharmacy Checkers

JANUARY 10, 2020

The FDA can prevent the importation of such drugs – but the agency is actually encouraged by law not to do so if the import is for personal use only. It’s also a story about consumers and their providers navigating conflicting public information about buying less expensive medicines online from foreign countries. Let’s call him John.

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pharmaphorum

MARCH 16, 2022

“This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective, and affordable medicines for patients and consumers,” she added. . The post Update: FDA clears first generic of AZ’s blockbuster Symbicort appeared first on.

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. For innovative medicines, this share was 77%. Sanofi and Astra Zeneca have also announced plans for new API production plants in Europe.”

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The Pharma Data

JANUARY 27, 2021

CSE:XPHY)(OTCQB:XPHYF)(FSE:4XT ) (“ XPhyto ” or the “ Company “) is pleased to announce its drug formulation and delivery business strategy and milestones for 2021. Pending positive results, the Company plans to advance the products toward a final pivotal study and application for regulatory approval.

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