The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

JANUARY 13, 2021

Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

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The Pharma Data

NOVEMBER 22, 2021

The streamlined findings from the companies’ vital Phase 3 trial show that a two- cure series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per cure) was 100 effective against COVID-19, measured seven days through over four months after the alternate cure. We look forward to participating these data with the FDA and other controllers.”.

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The Pharma Data

SEPTEMBER 4, 2020

Saloui was interviewed by Mary Louis Kelly on NPR , and said: “There is a very, very low chance that the trials that are running as we speak could read before the end of October, and therefore there could be – if all other conditions required for an emergency use authorization are met and approved.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

MAY 4, 2021

Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ). 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice ( Health Canada ).

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The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Eur J Neurol. 2020;27(S1).

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. “In the long term, evaluations of tests should be added to the existing pre-registers for clinical trials. Across government, action is being taken to enforce these tough regulations. ” Image copyright. .

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. government by the end of December 2020. government has agreed to purchase supply of the Moderna COVID-19 Vaccine under U.S. Under Operation Warp Speed, the U.S. W911QY-20-C-0100.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(1).

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. However, such acquisitions also entail significant risks for biotech firms.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

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The Pharma Data

OCTOBER 15, 2020

In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. The median duration of response with long-term follow-up was 27 weeks. “We About Y-mAbs.

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The Pharma Data

NOVEMBER 17, 2021

2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 3,4,5,6,7). .” 3,4,5,6,7).

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

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Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ Licensing fees and revenue generated flow back to the smart contract (eg.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. government will manage allocation and distribution of the vaccine in the U.S. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. The terms of the EUA allow use of the vaccine while more data are gathered.

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. In some cases, governments may have regulatory pathways similar to an EUA. Manufacturing and Delivery Capabilities. About the Study.

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The Pharma Data

NOVEMBER 27, 2020

Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. On behalf of Y-mAbs, I want to thank all the patients and physicians who took part in our clinical trials and our scientific partner, Memorial Sloan Kettering, for helping us achieve this goal.”. “We

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The Pharma Data

APRIL 4, 2022

Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic. today announced that the U.S. 7 Implementing an international differentiated pricing strategy specifically designed to address needs during this pandemic and improve affordability.7

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc., million to 7.5

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The Pharma Data

JANUARY 12, 2021

The Swiss Federal Government has secured 7.5 Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. million doses of the COVID-19 Vaccine Moderna.

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Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. Funding typically comes from a mix of government agencies, venture capitalists (VCs), and pharmaceutical companies.

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The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc. .

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The Pharma Data

JUNE 24, 2021

“We appreciate the agency’s thorough and efficient review of the data from our clinical trial, and look forward to seeing more people across Europe immunized as a result of today’s decision.”. The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years.

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The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. It should also include a well-defined risk assessment of the following parameters: The manufacturing history of the process from inception through the pivotal clinical trial supply.

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