pharmaphorum

MARCH 16, 2022

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

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Druggist

SEPTEMBER 30, 2020

Both products contain the same drug – hyoscine butylbromide. The only difference comes in licensing of both products, which are reflected, for example by the broader availability of Buscopan IBS Relief and more stringent age restrictions for the product. Buscopan IBS Relief vs Buscopan Cramps: what is the difference? 73rd edn.

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The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

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Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Both the EU and the U.S. I agree with this 100%.

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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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XTalks

AUGUST 2, 2023

This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. Other drugs also contributed to Merck’s revenue growth. Toujeo generated Sanofi €1.12 Lagevrio made up a large proportion of Merck’s revenue increase with $5.68

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The Pharma Data

MAY 4, 2021

Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) — In February 2021, Pfizer announced that the FDA approved the supplemental Biologics License Application (sBLA) for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

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Druggist

OCTOBER 13, 2020

Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is also licensed as pre-exposure prophylaxis (PrEP) medication. One important message to take away is that Truvada and equivalent generic drugs are not 100% effective.

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Druggist

MARCH 25, 2021

This, however, does not come as a surprise since one of the requirements for licensing of generic medication is to provide the same products information leaflet as the branded drug’s leaflet. . New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS.

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The Pharma Data

MAY 6, 2021

In Belgium, too many clinical trial sponsors waffle about reporting required results ( STAT ). Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year ( STAT ). FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). OcuWho? .

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FDA Law Blog

MARCH 31, 2025

1095 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agencys review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here ).

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FDA Law Blog

APRIL 2, 2025

1095 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agencys review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here ).

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