BioPharma Drive: Drug Pricing

JULY 30, 2025

Published July 30, 2025 Ned Pagliarulo Lead Editor post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC Therapeutics and Arrowhead Pharmaceuticals that you may have missed.

Drugs

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

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.

Therapies

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

BioPharma Drive: Drug Pricing

JULY 28, 2025

To learn how industry-leading manufacturers are leveraging data-driven approaches to improve commercial outcomes, watch this on-demand webinar. Forging the path for commercial excellence The stakes for specialty-lite brands have never been higher.

Specialty Pharmacies

BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.

FDA

BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 • Updated 2 hours ago Delilah Alvarado Staff Reporter post share post print email license A sign bearing Sanofi's logo sits outside the company's U.S. Last year, the French pharma partnered with Novavax , gaining rights to co-market its protein-based COVID shot. headquarters in Bridgewater, New Jersey.

Vaccine

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products. The balance is complex, as obesity carries its own serious health risks.

Treatment

Perficient: Drug Development

OCTOBER 27, 2023

The webinar covered three pivotal aspects: Seamless Migration, Future-Ready Strategies, and the PWA Revolution. Seamless Migration: Composable Storefronts and Accelerators The webinar initiated with a comprehensive exploration of seamless migration strategies. The added assurance of SAP’s managed support promises stability.

Compliance

Fierce BioTech

MARCH 31, 2025

Beyond the Science: Accelerating Biotech Success dwunderlin Mon, 03/31/2025 - 16:17 Wed, 05/14/2025 - 11:00 Resource Type Webinar Vik Chawla Paul Holmes Biotech success isnt just about great scienceits about building a compelling commercial narrative from day one. Listing Image SyneosHealth_ListingLogo_250x190.png

Science

Drug Channels

MARCH 18, 2025

Pharmacies and PBMs, Examining $683 Billion Market Review pricing/license options and download the full 2025 report Order before March 31, 2025 to receive special discounted pricing! Want to bundle the report with DCIs video webinars ? Note: All license versions include exhibits within the text.) Didnt get it?

Pharmacy

The Pharma Data

JANUARY 19, 2021

CSE: BHSC) (the “Company” or “BioHarvest”) invites its shareholders and the general public to join a Live Video Conference (“Webinar”) on Thursday, January 21st, 2021 at 2:00 PM Eastern Standard Time (11:00 AM Pacific Standard Time). . – January 20, 2021) – BioHarvest Sciences Inc.

Science

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

FDA

The Pharma Data

JANUARY 27, 2021

This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.

Clinical Trials

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

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

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

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

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

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

BioPharma Drive: Drug Pricing

JULY 23, 2025

Published July 23, 2025 By Kristin Jensen post share post print email license Stadtratte via Getty Images Dive Brief: Abivax’s shares soared more than 500% on Wednesday after the company released positive Phase 3 results for its experimental ulcerative colitis medicine. Smith wrote in a note to clients. euros Tuesday.

Trials

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

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

BioPharma Drive: Drug Pricing

JULY 21, 2025

And the team must have the capability to offer regulatory support for each target market. The past few years have seen multiple high-profile FDA approvals for AAV-based therapeutics, with a series of regulatory decisions in the pipeline for 2025. “It By Jacob Bell • May 6, 2025 Keep up with the story.

Therapies

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

BioPharma Drive: Drug Pricing

JULY 21, 2025

While Stelara is used in fewer indications than Humira, it commands a large market share in its therapeutic areas, most notably in plaque psoriasis, Crohns disease and ulcerative colitis. This move opened the floodgates for other distribution partnerships and Humira began losing significant market share. billion in 2024.

Biosimilars

BioPharma Drive: Drug Pricing

JULY 28, 2025

Published July 28, 2025 Jonathan Gardner Senior Reporter post share post print email license An illustration of a T cell attacking a cancer cell. Suvannavejh added that, even with the revenue from the deal and associated cost cuts, “it is still unclear to us [the company’s] liquidity concerns have been adequately addressed.”

Therapies

BioPharma Drive: Drug Pricing

JULY 28, 2025

to Oust Advisory Panel on Cancer Screenings, HIV Prevention Drugs BioSpace Drug Pricing Just One Point of Confusion Over New FDA Vouchers SFGate Layoffs, shutdowns and billions up in smoke.

FDA

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

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

BioPharma Drive: Drug Pricing

JULY 23, 2025

Published July 23, 2025 Delilah Alvarado Staff Reporter post share post print email license HHS Secretary Robert F. The move will affect several multi-dose vaccines that are currently marketed in the U.S., By Ben Fidler and Gwendolyn Wu • Updated June 19, 2025 Latest in Marketing RFK Jr. Kennedy Jr. involve these preparations.

Vaccine

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

BioPharma Drive: Drug Pricing

JULY 21, 2025

Published July 21, 2025 Ben Fidler Senior Editor Ned Pagliarulo Lead Editor post share post print email license Courtesy of Sarepta One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. The resulting standoff between Sarepta and the FDA has few precedents.

Therapies

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

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

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

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