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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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 74% of responders (n=14) remain on treatment. About Regeneron Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

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LifeSciVC

APRIL 24, 2024

If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., adverse profile seen in homozygous null individuals but not in heterozygous carriers?) in liver, in CNS)? with antibodies), or correction (e.g.,

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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., License and research and development revenue. .

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Pharmaceuticals Clinical Trials Trials Small Molecule 52

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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Clinical Development Disease Treatment Licensing 40

Codon

APRIL 2, 2023

Read A one-time gene therapy injection for spinal muscular atrophy. Mice and human cells that were given the therapy had normal levels of the survival motor neuron protein, and no symptoms. Gene Therapy. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution.

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The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. 50 c/mL, meeting noninferiority criteria.

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FDA Approval Treatment RNA FDA 52

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

JANUARY 10, 2021

The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. ?. .

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The Pharma Data

NOVEMBER 22, 2020

Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Chief Medical Officer of Molecular Partners.

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Trials Clinical Trials Licensing Licensing 40

The Pharma Data

DECEMBER 29, 2020

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. nM and 13.81

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The Pharma Data

MARCH 5, 2021

The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued. Lilly Antibody Therapies Around the World. who require oxygen therapy due to COVID-19, OR. Some of these events required hospitalization.

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The Pharma Data

MARCH 11, 2021

This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258). There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001).

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