DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. However, such acquisitions also entail significant risks for biotech firms.

Pharmaceuticals 81

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

Laboratories 62

Laboratories DNA Testimonials Biosimilars 62

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Licensing 52

Licensing Licensing Biosimilars Disease 52

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. Teva Pharmaceutical Industries Ltd.

Production 52

Production Pharmaceuticals Treatment Disease 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. for the years 2020 to 2022. Based on the E.U. FDA in October 2023.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan.

FDA 52

FDA Clinical Trials Trials Treatment 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. 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.

FDA 57

FDA Production FDA Approval Compliance 57

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.”. . The restriction will apply for two years. . EMA Report. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

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 52

Biosimilars Production Treatment FDA 52

The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

Disease 40

Disease Marketing Clinical Trials Treatment 40

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

The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease 40

Disease FDA Clinical Trials Licensing 40

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 (..)

FDA 40

FDA Science Regulations Production 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

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

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.,

Clinical Trials 52

Clinical Trials Production Trials Government 52

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.”

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

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. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Production 52

Production Clinical Trials Government Disease 52

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.,

Clinical Trials 52

Clinical Trials Production Trials Government 52

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

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. billion to $1.1

Production 52

Production Marketing Research DNA 52

The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. The EC is expected to deliver its final decision on Venclyxto combination therapy for use in AML in 2Q 2021. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties.

FDA 40

FDA Production Treatment International 40

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. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

Production 52

Production Clinical Trials International Small Molecule 52

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 ®. Neurology and Immunology. Net sales (€ million). Change at CER.

Vaccine 52

Vaccine Production FDA Disease 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

MAY 5, 2022

Nasdaq: BIIB) and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS). Biogen Inc.

Treatment 52

Treatment Biosimilars Disease Licensing 52

The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition.

Vaccine 52

Vaccine Production FDA Therapies 52

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. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S. RE47,739 for Ibrance by more than four years until March 2027.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

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.

Trials 40

Trials Production Clinical Trials Therapies 40

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.

Trials 52

Trials Production Clinical Trials Government 52

Agency IQ

DECEMBER 1, 2023

The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” In May 2023, the MHRA revealed which regulators will be included in the scheme: Australia, Canada, the E.U., or E.A.A.

International 40

International Regulations Production Marketing 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40