The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

Biosimilars 52

Biosimilars FDA Approval Treatment Therapies 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 58. Complaint ¶ 59.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

The Pharma Data

JANUARY 12, 2021

In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million , as well as pay royalties on sales of resulting therapies. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen.

Licensing 52

Licensing Licensing Biosimilars Clinical Development 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.

Treatment 52

Treatment Clinical Pharmacology Drugs Clinical Development 52

The Pharma Data

JUNE 25, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation.

Biosimilars 52

Biosimilars Therapies Disease Treatment 52

The Pharma Data

MARCH 22, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

Biosimilars 52

Biosimilars Therapies Disease Treatment 52

The Pharma Data

SEPTEMBER 1, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

The Pharma Data

JULY 8, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

The Pharma Data

APRIL 9, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website. About Biogen.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

Therapies 52

Therapies Production Government Disease 52

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

The Pharma Data

JUNE 7, 2022

AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc.

Licensing 40

Licensing Licensing Small Molecule Disease 40

The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.

Treatment 40

Treatment Clinical Trials Biosimilars Pharmaceutical Companies 40

The Pharma Data

MAY 31, 2022

The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson’s disease.

Disease 52

Disease Small Molecule Engineering Biosimilars 52

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. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen. About Aducanumab.

Licensing 52

Licensing Licensing Biosimilars Disease 52

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § Last month bipartisan legislation, S.

Research 59

Research Therapies Clinical Trials Treatment 59

The Pharma Data

APRIL 28, 2022

currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. For those already on ADUHELM, this meant a potential halt in their treatment plans. Organization.

Clinical Trials 52

Clinical Trials Treatment Biosimilars Disease 52

The Pharma Data

MARCH 28, 2022

While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies. We remain focused on pioneering new treatments that will positively impact people living with this debilitating disease.”. Biogen Inc.

RNA 52

RNA Therapies Disease Biosimilars 52

The Pharma Data

MAY 2, 2022

Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). percentage points (-3.6

Biosimilars 52

Biosimilars Clinical Trials Treatment Marketing 52

The Pharma Data

MARCH 23, 2022

(NYSE: PFE) today announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2mg once daily.

Trials 52

Trials Small Molecule Biosimilars Therapies 52

The Pharma Data

MARCH 16, 2022

Food and Drug Administration (FDA) granted accelerated approval for ADUHELM as the first Alzheimer’s disease treatment to address a defining pathology of the disease. ADUHELM is indicated for the treatment of Alzheimer’s disease. SVP, Head of Neurodegeneration Development at Biogen. “We

Disease 52

Disease Clinical Trials Trials Treatment 52

The Pharma Data

JUNE 1, 2022

In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. About Zuranolone Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Biosimilars 52

Biosimilars Treatment Therapies Disease 52

The Pharma Data

MARCH 16, 2022

These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques. These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.” Biogen Inc. About Biogen.

Disease 52

Disease Clinical Trials Treatment Trials 52

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Trials Disease 52

The Pharma Data

MARCH 5, 2021

Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. We are making 15 drugs that treat key symptoms of COVID-19 available to low-and lower-middle income countries at zero profit until a vaccine or curative treatment is available.

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

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. and a disease control rate (DCR) of 86.2%

FDA 40

FDA Clinical Trials Trials Treatment 40

Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

AUGUST 2, 2024

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

JULY 8, 2021

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. ADUHELM is indicated for the treatment of Alzheimer’s disease.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

Therapies 40

Therapies Clinical Trials Production Treatment 40

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. 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

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

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). No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). ” Amgen Webcast Investor Call Amgen?will

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. Detailed results from the SOURCE trial will be presented at a future medical meeting.

Trials 40

Trials Production Clinical Trials Therapies 40

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

FDA Approval 59

FDA Approval FDA Production Therapies 59