Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., of total revenue).

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. .

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R. Moreover, Eisai should explain how PTE application for a withdrawn “revoked” of active ingredient BELVIQ® (lorcaserin hydrochloride) is in compliance with requirements of 37 C.F.R.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week. The pharma reform package remains in E.U.

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. The file will head to the Parliament for a vote next. Device news is unsettled.

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Agency IQ

MARCH 29, 2024

medical device regulators are expected to pass some notable legislative amendments, which would extend the compliance deadlines of the IVD Regulation by risk class, allow a phased roll-out of EUDAMED, and also require manufacturers to notify stakeholders of any interruptions in device supply.

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The Pharma Data

SEPTEMBER 16, 2020

Additionally, data from Amgen ‘s bispecific T cell engager (BiTE ® ) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 20 and AMG 160, Monday Sept. Reese , M.D.,

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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., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

SEPTEMBER 20, 2020

and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1 , 2020). Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. Reese , M.D.,

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Agency IQ

JULY 8, 2024

Coming up is publication of the amendments to the IVDR and MDR, that would postpone the final IVDR compliance date for diagnostics that qualify for the extension, allow for a phased rollout of EUDAMED and would require manufacturers of certain devices to notify regulators and clients of upcoming shortages.

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The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions.

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Agency IQ

OCTOBER 27, 2023

Webinar/ Seminar ( OPEN ) Coordinating Research and Evidence for Medical Devices (CORE-MD) 11/6/2023 11/7/2023 ENVI Committee Meetings in 2023 Committee Meeting ( OPEN ) European Parliament committee on the environment, public health and food safety (ENVI) 11/6/2023 11/8/2023 6th European Training Course on Quality Management for Blood Establishments (..)

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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The Pharma Data

APRIL 27, 2021

At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. reflecting lower treatment compliance during the COVID-19 pandemic.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Revenue outside the U.S. decreased 28 percent to $95.6

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Agency IQ

OCTOBER 27, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

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The Pharma Data

OCTOBER 29, 2020

. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs.

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Agency IQ

SEPTEMBER 1, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. The procedure is available for E.U. Major objections may revert the application to the Recognition B procedure.

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Agency IQ

DECEMBER 1, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

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