Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review
Drug Patent Watch
AUGUST 15, 2023
A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.
The CHMP recommends 14 new medicines for approval
Drug Discovery World
JULY 24, 2023
The following novel medicines and biosimilars each received a positive opinion: Abrysvo (bivalent, recombinant) , a vaccine to protect small infants and older people against lower respiratory tract disease caused by respiratory syncytial virus (RSV). Inaqovi (decitabine/cedazuridine) for the treatment of acute myeloid leukaemia.
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Biologics for bowel disease face threat from cheaper small molecules
Drug Discovery World
DECEMBER 21, 2023
The increase in IBD biologic treatments has been a major driving force in the growth of this market in recent years. In another example, Insilico Medicine recently launched Phase I studies into its poly hydroxylase domain (PHD) 1/2 inhibitor for the treatment of IBD. billion in the US in 2023, according to analysts.
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AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB)
The Pharma Data
APRIL 18, 2022
. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. “We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options.” Reese, M.D., million people in the United States.
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Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease
The Pharma Data
APRIL 7, 2022
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. ADUHELM is indicated for the treatment of Alzheimer’s disease.
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Lilly, Novo Nordisk and Vertex lead on market capitalisation growth
Drug Discovery World
FEBRUARY 22, 2024
Lilly’s growth was further fuelled by Mounjaro’s FDA approval for the treatment of obesity received in Q3, with Mounjaro forecasted to reach global forecast sales of $4.7 in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. billion for 2023.
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Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation
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.
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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
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Syneos vs Vial | Pros and Cons
Vial
APRIL 24, 2024
In addition to the areas above (aside from DTx), Syneos Health offers biosimilars , cell and gene therapy , endocrine and metabolic, immunology and inflammation, infectious diseases, pediatrics, respiratory, and women’s health services. Dermatology Phase I Units are critical to advancing care and validating treatments.
European Commission vs Big Pharma, or profit vs access?
Drug Discovery World
MARCH 29, 2023
UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation?
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EVOQ Therapeutics Announces a License And Collaboration Agreement with Amgen
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.
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Proposals for changes to EU pharma legislation raise concerns for SMEs
Drug Discovery World
MAY 1, 2023
High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems. The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified.
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FDA Action Alert: MacroGenics and Amgen
The Pharma Data
DECEMBER 13, 2020
“We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer.
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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
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.
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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis
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.
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The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis
The Pharma Data
NOVEMBER 17, 2021
The blessing of VUMERITY provides a new oral treatment option with low gastrointestinal termination rates that may help cases to start and cleave to treatment,” said Simon Faissner,M.D., In EVOLVE-MS-2, the rate of overall treatment termination was lower in actors treated with VUMERITY compared to those treated with TECFIDERA (1.6
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Biogen to Participate in SVB Leerink’s 3rd Annual CNS Forum
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.
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Biogen to Participate in the Morgan Stanley 19th Annual Global.
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.
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Biogen to Report Second Quarter 2021 Financial Results July 22, 2021
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.
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BIOGEN TO PARTICIPATE IN THE STIFEL 3RD ANNUAL CNS DAY
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.
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BIOGEN TO REPORT FIRST QUARTER 2021 FINANCIAL RESULTS APRIL 22, 2021
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.
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A review of Japan’s drug discovery and development landscape
Drug Discovery World
OCTOBER 20, 2022
Similarly, biosimilars are expected to grow. This is unsurprising – our drug discovery industry does, after all, centre itself around creating initiatives that leave no one behind, from cancer therapies to malaria vaccines. . Overview . Investment and collaboration . Real-world evidence .
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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC
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.
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Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume
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. on November 17, 2023 for treatment of adults with chronic hypoparathyroidism.
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Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
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.
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Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies
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.
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Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)
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.
A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research
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.
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Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis
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.
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BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021
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.
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Pfizer Completes Acquisition of Arena Pharmaceuticals
The Pharma Data
MARCH 13, 2022
NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. Pfizer Inc.:
Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute
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.
Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients
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.
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Novartis delivers solid Q3 results, with strong growth in Innovative Medicines. Announces strategic review of Sandoz
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
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Article EMA Thank You What we expect European regulators to do in March 2024
Agency IQ
MARCH 1, 2024
The EMA has a number of scientific guidelines and reflection papers that are currently open for public consultation, including the development of products for the treatment of depression, Hepatitis B, and hemophilia A and B.
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ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease
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
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Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints
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).
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First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
The Pharma Data
JUNE 24, 2021
The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,
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ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years
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.
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Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential
The Pharma Data
MARCH 29, 2022
(NYSE: PFE) today announced positive top-line results from a second 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 2 mg or placebo once-daily.
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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024
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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Amgen Reports Second Quarter 2021 Financial Results
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.
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Article EMA Thank You What we expect European regulators to do in April 2024
Agency IQ
MARCH 29, 2024
Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1
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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma
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%
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