Biosimilars, FDA Approval, International and Licensing

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Biosimilars

Biosimilars Production Treatment FDA

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA has not approved an NDA for a drug containing botanical marijuana but notes that two drug products containing delta-9-tetrahydrocannabinol (“delta-9-THC”) (as dronabinol), the primary compound in marijuana have received FDA approval: Marinol and Syndros. to comply with its international treaty obligations.

FDA

FDA FDA Approval Treatment Drugs

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. Net Revenues of $4.305 Billion and International Profit Sharing of $1.009 Billion; Global Venclexta Net Revenues Were $1.337 Billion. Percent on a Reported Basis, or 13.4

Production

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

Also in 2010, the agency held a two-day public hearing on the subject; following the feedback and lessons from the Brookings Institute and the FDA’s own work, the agency then “narrowed down” the four PMI prototypes to two options, which were further studied by RTI International under a contract with FDA.

FDA

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Alexion Reports Third Quarter 2020 Results

The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. A global Phase 3 study of ULTOMIRIS in children and adolescents with aHUS is underway. Eastern Time.

Clinical Trials

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Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Rare Blood Disorder.

Vaccine

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Internal Medicine. and four additional selling days in international markets. REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *.

Vaccine

Vaccine Production FDA Biosimilars

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder. (Thirty-eight states authorize marijuana for specific qualifying medical conditions.) Basis at 63-64. to comply with its treaty obligations.

Regulations

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HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. to comply with its international treaty obligations. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. Denial of Petitions at 53,688-89, 53,767-68.

FDA

FDA Treatment FDA Approval Drugs

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products.

Regulations

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DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog: Biosimilars

MAY 5, 2024

OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.” The Administrator must control marijuana in the schedule she deems most appropriate to comply with U.S.

FDA

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Drug Discovery Digest

Amgen Reports Second Quarter 2021 Financial Results

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Alexion Reports Third Quarter 2020 Results

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

DEA Concurs: Marijuana Meets Schedule III Criteria

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