Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? provides a 10-year market exclusivity period. The sponsor must show at the time of marketing authorization application (MAA) that the orphan designation criteria are still met. Orphan designation in the E.U. countries examined between 2010 and 2017.

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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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The Pharma Data

JULY 8, 2021

Nasdaq:BIIB) today announced it will report second quarter 2021 financial results Thursday, July 22, 2021, before the financial markets open. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

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The Pharma Data

APRIL 9, 2021

today announced it will report first quarter 2021 financial results Thursday, April 22, 2021, before the financial markets open. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen.

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Drug Channels

JUNE 5, 2023

View the Agenda Snapshot Enhance Patient Service, Network Design, and Channel Strategies to Improve Patient Access and Support In its 8th year, the Specialty Network and Patient Support Services Summit is an important event for senior leaders in patient access, trade, channel, market access, brand and account strategy.

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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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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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Conversations in Drug Development Trends

JULY 9, 2024

The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.

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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. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology.

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PPD

FEBRUARY 22, 2023

The expected rebound of capital markets will drive a return-to-funding optimism. While volume and value from a deal perspective are down significantly, there is reason to remain optimistic that 2023 will see a rebound as the capital markets reopen, money comes off the sidelines, investors continue to be creative and M&As increase.

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The Pharma Data

DECEMBER 13, 2020

About Toripalimab Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain marketing approval in China. In addition, toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the US Food and Drug Administration in September 2020.

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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.

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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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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. In September 2014—nearly ten years ago!

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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.

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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.

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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.

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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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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. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

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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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FDA Law Blog: Biosimilars

MARCH 31, 2024

Several witnesses also noted the lack of grandfathering provisions for tests already on the market in the proposed rule, something that was included in the VALID Act. He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients. These are areas where “revenue is modest,” she said.

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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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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. Please see full Prescribing Information including Medication Guide. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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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.

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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. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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The Pharma Data

OCTOBER 29, 2020

Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. Received U.S. approval & positive CHMP opinion for ULTOMIRIS 100 mg/mL higher concentration formulation in paroxysmal nocturnal hemoglobinuria (PNH) & aHUS.

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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 Recorded a $4.7

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DrugBank

AUGUST 9, 2024

  The average cost of bringing a new drug to market is about $2.6 Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI. Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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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.

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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.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. Amanda Conti, AgencyIQ What kind of biologic products entered the market? As AgencyIQ has previously discussed , developing biosimilars is an expensive process. Read the AgencyIQ analysis here.

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The Pharma Data

NOVEMBER 17, 2021

Biogen moment blazoned that the European Commission (EC) has granted marketing authorization for VUMERITY ® (diroximel fumarate) to treat grown-ups with relapsing- remitting multiple sclerosis (MS).

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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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Agency IQ

FEBRUARY 15, 2024

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

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The Pharma Data

DECEMBER 13, 2020

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. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan.

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