Pharmacy Checkers

DECEMBER 5, 2019

While the DAL doesn’t legalize personal medicine imports of drugs approved in a foreign market, China will exempt or be lenient for imports of small quantities of such drugs. It will be interesting to see how this change in law impacts the international online pharmacy market. Last year, the Financial Times reported.

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Camargo

MAY 10, 2021

The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. So, we are perhaps a step closer to remote inspections, but not there yet.

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Pharmacy Checkers

JANUARY 10, 2020

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations.

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FDA Approval Branding Pharmacy Manufacturing 62

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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Clinical Trials Clinical Trials Production Medicine 52

FDA Law Blog

APRIL 26, 2021

Koblitz — So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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FDA Law Blog

APRIL 26, 2021

So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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FDA Law Blog

NOVEMBER 16, 2021

139001 lays out a process by which the Secretary would: Identify “negotiation-eligible drugs” from among qualifying single-source drugs that are among the top 50 with the highest Part D spending, the top 50 with the highest Part B spending, and insulins. It means less – or no – generic/biosimilar competition.

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World of DTC Marketing

JANUARY 28, 2022

” Essentially, if certain circumstances are met, the government can act (“march-in”) and use its authority under the Bayh-Dole Act to grant a license to generic drug manufacturers to produce a drug in the United States—in this case,,, a generic version of Xtandi.

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Drugs Manufacturing Generic Drugs Licensing 284

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. Even following the Brexit vote, the EU remains the UK’s largest trading partner, and a high proportion of UK drugs originate from European countries.

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Druggist

MARCH 8, 2021

In the UK, modafinil has narrow licensed use. The second licensed use of modafinil covers individuals who experience excessive sleepiness , defined as difficulty keeping wakefulness and an increased likelihood of falling asleep in inappropriate situations (eMC, 2020). Is modafinil a smart drug? Modafinil alternatives drugs.

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Drugs Licensing Licensing Doctors 90

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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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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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.” We can no longer afford to accept Pharma’s Alice in Wonderland arguments against drug importation. I agree with this 100%.

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The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. More details regarding the collaboration will be disclosed following the execution of a formal agreement.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

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Vaccination Vaccine Production Sales 40

The Pharma Data

MAY 6, 2021

FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs ( Press ). million to resolve claims it paid drug kickbacks through charity ( STAT ).

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Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Its indirect relation to personal drug importation is noted at the end of this post. Some of this is guesswork.

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FDA Approval Drugs Manufacturing Pharmacy 55

Pharmaceutical Technology

JANUARY 6, 2023

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

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