PharmaShots

FEBRUARY 1, 2023

The US FDA’s review is expected to be completed in H2’23 Under the Aug 2020 agreement, Alvotech and Teva collaborated for the exclusive commercialization in the US of five biosimilar product candidates incl. and Coherus common stock & is also eligible to receive other regulatory and launch milestones and share profits.

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover Ozempic? affected by a shortage).

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

NOVEMBER 22, 2022

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. Guangdong is based in the south and has a comparatively strong number of manufacturing relationships producing innovative FDA and EMA drugs.

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PharmaShots

JUNE 7, 2023

Amgen also claims that the US FDA approval decision on the biosimilar candidate could come before its relevant patents expire. The US FDA approved Fylnetra, a leukocyte growth factor based on data demonstrating a high degree of similarity over reference products with no clinical differences 11.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.”

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STAT

SEPTEMBER 23, 2022

… The White House is pitching an added benefit to the recent drug-pricing reform package: lower cancer death rates , STAT explains. A  A new analysis by the Council of Economic Advisers focused on a provision that caps Medicare out-of-pocket costs for pharmacy drugs at $2,000 a year, starting in 2025.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The EMA started a rolling review for this Omicron-adapted vaccine on 27 June and the FDA plans to review the vaccine for EUA. 1 sub-lineage on 19 July.

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The FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.

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The FDA Law Blog

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States ( link , link ). By Charles D.

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The FDA Law Blog

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. The description or name of the food (i.e.,

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Pharma Marketing Network

APRIL 3, 2025

This article dives deep into how patient marketing has changed, whats driving this transformation, and what strategies are leading the way for 2025 and beyond. Additionally, integrating offline and online experiencessuch as QR codes on packaging leading to mobile resourcesenhances the continuity of care.

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European Pharmaceutical Review

APRIL 2, 2025

11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. FDA Discussion Paper And Request For Feedback.

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European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Food and Drug Administration (FDA), 2004. Figure 2 outlines four main topics where PAT can play an important role: (1) Industry 4.0

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