DrugBank

MARCH 15, 2023

The moment you decide which DrugBank license or products best suit your needs isn’t the final step in our relationship, it is just the beginning. Depending on your unique needs, license*, and project goals, you might interact with all of them firsthand, or you might be off and running with just a little help from one team.

Licensing 52

Licensing Licensing International Bioinformatics 52

The Pharma Data

DECEMBER 15, 2020

Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. KOL Webinar Information BioLineRx will host a KOL webinar today, December 16, 2020 at 8:00 a.m. Interested parties can register for the webinar here. Kenilworth, N.J. ,

Clinical Trials 40

Clinical Trials Trials Treatment Therapies 40

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. both pre- and post-market. New roadmap sets out U.K.

Regulations 40

Regulations Government Compliance Marketing 40

Agency IQ

JULY 22, 2024

As AgencyIQ has previously discussed, the rule focuses primarily on LDTs that are being offered by clinical laboratories as alternatives to legally marketed IVDs. For example, during its July 16 webinar on the classification of IVDs, the FDA focused on the basics of medical device classification for IVDs.

FDA 40

FDA Laboratories Regulations Clinical Trials 40

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market.

Therapies 181

Therapies FDA Treatment Licensing 181

The Pharma Data

DECEMBER 12, 2020

The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany , as well as the strong pipeline of additional indications for Ultomiris. Webinar and conference call.

Regulations 75

Regulations International Disease Small Molecule 75

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. and European drugmakers.

Disease 112

Disease Licensing Licensing Therapies 112

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. market more quickly. The procedure is available for E.U.

International 40

International Regulations Production Marketing 40

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. and sold [Karuna],” wrote RBC Capital Markets analyst Brian Abrahams, in a note to clients. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.

Licensing 122

Licensing Licensing Therapies Vaccine 122

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

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 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. MHRA also offered an online webinar to learn more about the pathway and public involvement.

Regulations 40

Regulations Science Production Vaccine 40

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. In a note to clients, RBC Capital Markets analyst Brian Abrahams called the magnitude of the protection CD388 displayed as “exceeding” the firm’s “best case scenario.” Influenza A virus" [Micrograph].

Drugs 264

Drugs Virus Therapies FDA 264

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Prohaska, Kavita C. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40

BioPharma Drive: Drug Pricing

JUNE 30, 2025

Published June 30, 2025 Jonathan Gardner Senior Reporter post share post print email license Moderna announced results from an influenza vaccine clinical trial on June 30, 2025. as early as the 2026-2027 flu season. However, its mRNA platform continues to generate effective vaccines. You can unsubscribe at anytime.

Vaccine 100

Vaccine Marketing Trials Clinical Trials 100

BioPharma Drive: Drug Pricing

JULY 2, 2025

Published July 2, 2025 By Kristin Jensen post share post print email license Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen. Organon acquired the drug in its purchase of Forendo Pharma in 2021. But many development hurdles still stand in the way of new medicines for the brain.

Clinical Trials 245

Clinical Trials Drugs Licensing Licensing 245

BioPharma Drive: Drug Pricing

JUNE 9, 2025

GLP-1 therapies are among the most expensive drugs on the market, with monthly prescriptions exceeding $1,000 USD in some cases. If GLP-1s can address obesity at scale, we may be looking at a public health revolution with economic ripple effects. While some insurers are expanding coverage, it remains inconsistent.

Clinical Trials 146

Clinical Trials Drugs Therapies Clinical Supply 146

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million.

FDA 280

FDA Drugs Therapies Science 280

BioPharma Drive: Drug Pricing

JUNE 30, 2025

Published June 30, 2025 Gwendolyn Wu Senior reporter post share post print email license The vast majority of Sage Therapeutics' workforce will be laid off by August 2025, the biotechnology company in a late June regulatory filing. At its peak, Sage commanded a share price of nearly $200 apiece. You can unsubscribe at anytime.

Clinical Trials 100

Clinical Trials Licensing Licensing Therapies 100

BioPharma Drive: Drug Pricing

JUNE 12, 2025

Published June 12, 2025 Amy Baxter Staff Reporter post share post print email license Win McNamee via Getty Images First published on The budget bill currently under consideration in Congress is big — and it’s complicated. Will Trump and the GOP make the leap? By Jacob Bell • May 6, 2025 Keep up with the story.

Small Molecule 130

Small Molecule Packaging Therapies Pharmacy 130