Pharmaceutical Technology

JULY 15, 2022

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

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pharmaphorum

JUNE 6, 2022

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . “Manufacturers get a bad rap as being the source of high pricing for patient meds.

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FDA Law Blog

JANUARY 22, 2024

OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year. Drug Supply Chain. Clinical Trials.

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Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Drug Discovery World

APRIL 10, 2023

Could India become an important centre of drug discovery innovation? India is traditionally known as ‘the pharmacy of the world’ due to its huge pharmaceuticals manufacturing capacity and high quantity of exports, particularly generic medicines and vaccines. Another new project was a process development facility for Yapan Bio.

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Both bills – S. Unfortunately, in the nearly eight years since FDA issued MaPP 5240.5,

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Both bills – S. Unfortunately, in the nearly eight years since FDA issued MaPP 5240.5,

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

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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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Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts.

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pharmaphorum

SEPTEMBER 9, 2022

With its heavy reliance on natural resources for product development and production, and complex supply chains with large carbon footprints, the pharmaceutical industry has been highlighted as one of the biggest contributors to global emissions,” said the authors of a whitepaper from climate intelligence specialists, Cervest.

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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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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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Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. Canada believes it is too small to facilitate U.S. The GAO plans to follow up on that to find out why.

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Druggist

MARCH 17, 2021

Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Antibacterial drugs such as lymecycline kill bacteria and stop acne development. . How does lymecycline work for acne?

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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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Pharmaceutical Technology

JULY 25, 2022

The only way forward for generics producers. Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. More specifically, Frank says drug-device combinations share some of these characteristics.

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Drug Discovery World

AUGUST 8, 2023

To many, the country is referred to as the ‘pharmacy of the world’. Generics According to a McKinsey report on the Indian pharmaceutical market, drug prices in India are among the lowest in the world, driven by intense generics competition 3. So, what is driving this success, and will it continue?

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XTalks

SEPTEMBER 14, 2020

And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The company is also in collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral treatment for COVID-19. helped protect COVID-19 patients against developing severe disease.

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Druggist

MARCH 8, 2021

In the UK, atomoxetine is available as a generic drug (atomoxetine hydrochloride) and branded as Strattera. Atomoxetine is a non-stimulant drug , which primarily affects one neurotransmitter in the brain called norepinephrine (noradrenaline). Drug Des Devel Ther. Atomoxetine availability in the UK. 2018;12:2665-2675.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.

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FDA Law Blog

SEPTEMBER 13, 2021

Tomorrow, our post will focus on the second piece: the drug pricing provisions of the House’s budget reconciliation bill (the Build Back Better Act), also released last Thursday and currently undergoing committee markup. White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities.

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