The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The global phase 3 multi-center, randomized, double-blind, placebo-controlled study, also known as ELEVATE 12, enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy.

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Drug Discovery World

MARCH 29, 2023

All in all, this is a 10-year period, which the commission seeks to shorten. 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. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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The Pharma Data

MARCH 16, 2022

(Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease.

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The Pharma Data

MARCH 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial. Participants received etrasimod 2 mg or placebo once-daily. “For

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Drug Discovery World

MAY 1, 2023

The Commission states that, currently, there are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified.

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The Pharma Data

MARCH 16, 2022

The data also show that in both Phase 3 trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced. These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.”

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. However, such acquisitions also entail significant risks for biotech firms.

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Vial

APRIL 10, 2024

Positioned as a technology-centric CRO, Vial aims to revolutionize clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes. It draws upon 150 years of collective experience and expert scientific advisory board members to deeply understand clinical trial requirements.

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The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).

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The Pharma Data

MAY 26, 2023

Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

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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 geographical region, the global CRO services market in 2023 was dominated by North America.

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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 .

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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.

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Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. In all, around 130 clinical trials are ongoing for oligonucleotides.

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The Pharma Data

MARCH 13, 2022

Acquisition offers new, differentiated, and potentially best-in-class approach to address needs of a broader number of patients with immuno-inflammatory diseases. In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”.

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Agency IQ

AUGUST 2, 2024

Rare Pediatric Disease Priority Review Voucher Program Expiration Threat: The FDA’s popular voucher program for rare pediatric diseases is currently scheduled to expire as of September 30, 2024 unless it is renewed by Congress.

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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

APRIL 28, 2022

One of our immediate priorities following the NCD decision is to support patients on therapy who were uncertain whether they could receive their next infusion,” said Alisha Alaimo, President of Biogen’s U.S. About ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use ADUHELM is indicated for the treatment of Alzheimer’s disease.

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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The Pharma Data

MARCH 28, 2022

We are incredibly grateful for the selfless commitment of the individuals with ALS who participated in the study, and the community’s dedication to advancing research for this devastating disease,” said Toby Ferguson, M.D., Biogen Inc. Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc.

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The Pharma Data

JUNE 24, 2021

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries.

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The Pharma Data

MAY 2, 2022

AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex.

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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.

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FDA Law Blog: Biosimilars

APRIL 10, 2023

Booker opined that the Act would expedite rescheduling schedule I substances that receive breakthrough therapy designation to schedule II that “with DEA oversight-will enable patient access and reduce the burden on further clinical investigation.” Booker & Paul introduce the Breakthrough Therapies Act for Veterans and Patients, Mar.

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The Pharma Data

DECEMBER 13, 2020

The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 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. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms.

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Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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The Pharma Data

MAY 2, 2022

We believe the results from the LANDSCAPE and NEST programs, in which zuranolone demonstrated rapid and sustained effects and a well-tolerated safety profile in clinical trials, support zuranolone as a potential novel treatment option for MDD, if approved. Food & Drug Administration. For more information, please visit www.sagerx.com.

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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 10, 2020

(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Sridhar S. . .

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The Pharma Data

DECEMBER 9, 2020

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. 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.

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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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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Humira , AbbVie's monoclonal antibody for autoimmune diseases, generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023.  billion by 2030.

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The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

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Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

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Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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