The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In June 2021, Lilly announced the U.S. vice president of pain and neurodegeneration, Lilly.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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Agency IQ

JULY 26, 2024

When finalized, this will supersede recommendations from a 2021 Q&A guidance. Last finalized in 2021, the guidance “ Questions and Answers on Biosimilar Development,” includes one question and answer on postapproval manufacturing changes – question Q.I.20. in the annual report instead of via a post-approval supplement).

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

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The Pharma Data

DECEMBER 29, 2020

“We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021.” Protalix has licensed to Pfizer Inc.

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. ?.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. MARSEILLE, France, Jan. Cell 2019 ).

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The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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The Pharma Data

OCTOBER 27, 2020

INCREASE sNDA under FDA review with April 2021 action date; Remunity launch preparations continue. License-related fees (5). License-related fees (5). In August 2020 , the FDA accepted the sNDA for review, which we expect will be complete in April 2021.

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The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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The Pharma Data

MARCH 2, 2021

and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March.

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New Drug Approvals

SEPTEMBER 29, 2024

The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In February 2021, the FDA placed a partial clinical hold on GAIN because of liver abnormalities in some participants ( press release ). gingivalis DNA, according to data presented at CTAD 2021 in November. 2017 ; Ilievski et al.,

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Regulatory reviews continue in Australia and Switzerland , and several additional submissions are planned throughout 2021. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies.

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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.

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Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. from 2021 to 2022, up to $625 million. Ricciardi M.J. Will Bedingfield.

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The Pharma Data

APRIL 14, 2021

This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

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The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Bristol Myers Squibb’s Lisocabtagene Maraleucel (CAR-T) for R/R Large B-Cell Lymphoma.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. The Company currently plans to perform an interim analysis with 20 patients and 12 months of ABR in 2021. approval in 2021.

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The Pharma Data

APRIL 16, 2021

Going forward, Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

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The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. Posted: January 2021. INDIANAPOLIS, Jan.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

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The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2021 [link]. 2021; doi: 10.1016/j.cell.2021.02.037.

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The Pharma Data

MARCH 26, 2021

Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalisation or death due to COVID-19.

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New Drug Approvals

APRIL 5, 2025

Retrieved 25 January 2025. ^ “Health product highlights 2021: Annexes of products approved in 2021” Health Canada. Retrieved 25 January 2025. ^ “AusPAR: Trecondi” Therapeutic Goods Administration (TGA). 4 July 2023. 3 August 2022. Romaski M, Wachowiak J, Gwka FK (October 2018). 57 (10): 12551265. PMC 6132445.

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Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Human trials have shown that cabotegravir prevents HIV more reliably than daily PrEP pills and the FDA approved an injectable version in 2021; the only side effect is minor injection-site discomfort. This has happened before with other drugs.

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