XTalks

MARCH 5, 2024

Forbes’ 2024 “ America’s Best Large Employers ” list shines a light on those companies that go above and beyond to create exceptional workplace environments, foster innovation and demonstrate a commitment to their employees’ growth and well-being. Related: Top 4 Most Sustainable Food Companies in 2024 1.

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Pharma in Brief

JUNE 20, 2023

The proposed changes would affect products classified as “New Medicines” with list prices that are below the median of prices in the basket of 11 comparator countries set out in the Patented Medicines Regulations (the PMPRB11 ). [1] The rights holders of these New Medicines will receive a Status Report letter once the assessment is completed.

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FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The initial notification may include a list of all affected covered finished products or API.

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XTalks

DECEMBER 20, 2023

Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device. Click here for the full list.

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Pharmaceutical Technology

JULY 29, 2022

5 compared with the currently authorised Moderna booster, regardless of prior infection status or age. The expansion will be operational in 2024. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

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XTalks

FEBRUARY 8, 2024

Due to the exorbitant demand, shortages of Ozempic , as well as Mounjaro, began in 2022 and are expected into 2024. Price of Humalog: The list price for a 5-pack of 3 mL Humalog U-100 KwikPens (totaling 15 mL or 1,500 units) is $159.12 , and the list price for a Humalog U-100 10 mL (1,000 units) vial is $66.40.

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FDA Law Blog

APRIL 14, 2022

Similarly, if the 70% goal is met in FY 2024 and adequate fee revenue is provided, the goal will be adjusted to 90% in FY 2027. During the pilot, over 85 testing laboratories have become ASCA accredited (see list here ).

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

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Delveinsight

AUGUST 27, 2021

Here is a list of major key players and competitors. We anticipate that the drug may enter the Japanese market by 2024. In 2017, Marathon Pharmaceuticals agreed to sell its newly approved steroidal treatment– Emflaza, to PTC, offloading the drug after backlash over initial plans to charge a list price of USD 89,000 per year.

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FDA Law Blog

APRIL 16, 2024

In 2020, CMS issued a final rule providing a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

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XTalks

FEBRUARY 5, 2024

Why it did so well: Keytruda was first approved in 2014 for advanced melanoma and a decade later, it has approvals in 39 indications across over 20 different cancer types in the US, with its most recent in late-stage cervical cancer granted by the FDA in January 2024. While Revlimid’s projected global sales in 2024 are expected to reach $11.93

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FDA Law Blog

FEBRUARY 5, 2024

In keeping with the goal of standardization, the Draft Guidance is issued by a long list of agency level offices (including the Offices of the Commissioner, Minority Health and Health Equity, and Women’s Health, among others) and all three human medical product centers (CDER, CBER and CDRH), as well as the Oncology Center of Excellence.

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XTalks

FEBRUARY 5, 2024

Why it did so well: Keytruda was first approved in 2014 for advanced melanoma and a decade later, it has approvals in 39 indications across over 20 different cancer types in the US, with its most recent in late-stage cervical cancer granted by the FDA in January 2024. While Revlimid’s projected global sales in 2024 are expected to reach $11.93

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Pharmaceutical Technology

JANUARY 25, 2023

Instead, reverse mergers, like privately-held Elicio Therapeutics’s plans to merge with the NASDAQ-listed company Angion Biomedica, might be a sign of things to come. While there will be some exceptions, fundraising and initial public offerings (IPOs) will be difficult for most. range in December 2022.

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FDA Law Blog

FEBRUARY 11, 2024

Houck — With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* January 29, 2024). By Larry K. Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

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