XTalks

AUGUST 16, 2023

In this episode, Ayesha talked about the FDA approval of Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). However, the FDA rejected it in MDD and only handed the approval in PPD. The company said it will appeal the decision as it continues to offer talc claimants a $8.9

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Outsourcing Pharma

OCTOBER 17, 2022

The company, through its subsidiary, PPD, announced that it had created a network that would provide learning materials to those investigators and research sites looking to use decentralized clinical trials (DCTs) for drug development.

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Outsourcing Pharma

AUGUST 4, 2020

This month's spotlight on new hires, promotions and company acquisitions involves Elligo Health Research, PPD, Pfizer, Covance and other industry firms.

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Drug Discovery World

MARCH 3, 2023

The open-label, Phase IIa, proof-of-concept trial will evaluate LYT-300 in a small number of patients with moderate to severe PPD. To overcome this, oral chemically modified analogs of allopregnanolone have been developed, though these may not capture the full therapeutic potential of natural allopregnanolone.

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The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD). Sage Therapeutics, Inc.

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The Pharma Data

JUNE 1, 2022

Nasdaq: SAGE) today announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Zuranolone is an investigational two-week, once-daily oral drug being developed for major depressive disorder (MDD) and PPD.

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BioTech 365

SEPTEMBER 14, 2020

–(BUSINESS WIRE)–PPD, Inc. Nasdaq:PPD) (the “Company”), a leading global contract research organization, today announced that certain stockholders of the Company, including stockholders affiliated with Hellman & Friedman LLC and The Carlyle Group Inc., WILMINGTON, N.C.–(BUSINESS

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Pharmaceutical Technology

MAY 26, 2023

Pharma company merger and acquisition (M&A) activity in the first half of 2023 has remained relatively low, consistent with the second half of last year, but investors predict deals will increase later in 2023. Somerset, NJ, US) and Recipharm AB (Stockholm, Sweden) were particularly active in acquiring companies during this period.

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BioTech 365

OCTOBER 22, 2020

Moderna to make statement at today’s FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting Moderna thanks PPD, its CRO partner, for the successful execution of COVE Study enrollment CAMBRIDGE, Mass.–(BUSINESS Nasdaq: MRNA) a biotechnology company pioneering … Continue reading →

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pharmaphorum

OCTOBER 20, 2021

The renaissance of Biogen and Sage Therapeutics antidepressant zuranolone continues, with the companies indicating they now plan to start a rolling submission for the drug early next year.

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pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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XTalks

FEBRUARY 23, 2024

According to a press release , Linden and Ontario Teachers will invest in “exceptional companies deploying cutting-edge technology to foster seamless connections and collaborations among patients, research sites, pharmaceutical companies and the broader clinical research community.”

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pharmaphorum

JULY 5, 2021

The handover comes four years after Pamplona Capital Management bought the company for around $5 billion, and just a few weeks after lab tech company Thermo Fisher Scientific agreed to acquire another CRO – PPD – in a deal valued at $17.4 billion to claim ownership of the contract research organisation.

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Drug Discovery World

JUNE 29, 2023

Read more: Discovery represents the ‘first step’ to better anti-anxiety drugs Neurosteroids for anxiety and postpartum depression PureTech Health has launched a clinical trial of its therapeutic candidate LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).

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BioTech 365

SEPTEMBER 16, 2020

–(BUSINESS WIRE)–PPD, Inc. WILMINGTON, N.C.–(BUSINESS

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pharmaphorum

NOVEMBER 30, 2020

The deal comes as both companies are facing a challenging period. Biogen has invested heavily in its Alzheimer’s candidate aducanumab, but an FDA advisory committee was unimpressed with the company’s rehashed data for the anti-amyloid drug and voted that it didn’t support efficacy.

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ECRG Media's Clinical Research Podcast

APRIL 25, 2018

Whether it is to start as an intern at a company like Syneos health, IQVIA formerly Quintiles, PPD or Parexels, or some other way to get in the industry. Whether it is to start as an intern at a company like Syneos health, IQVIA formerly Quintiles, PPD or Parexels, or some other way to get in the industry.

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ECRG Media's Clinical Research Podcast

APRIL 25, 2018

Whether it is to start as an intern at a company like Syneos health, IQVIA formerly Quintiles, PPD or Parexels, or some other way to get in the industry. Whether it is to start as an intern at a company like Syneos health, IQVIA formerly Quintiles, PPD or Parexels, or some other way to get in the industry.

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pharmaphorum

JULY 22, 2021

All the company’s digital therapeutics are based around its Woebot conversational agent – sometimes referred to as a digital therapist – which according to a recent study was able to establish an empathetic bond with users – something previously thought to be impossible. . — Woebot (@HiWoebot) July 15, 2021.

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XTalks

NOVEMBER 16, 2020

The early results from both Moderna and Pfizer place the companies in a strong position to submit applications for emergency use authorizations to the FDA in the coming weeks. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization, has also been integral to assisting on the COVE study.

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VirTrial

JANUARY 10, 2020

The competition highlights companies that demonstrated innovative solutions, technologies, and services that have the potential to make the greatest impact for biotech and pharma companies. The company was selected for its industry leading Virtual Care Management (VCM) program. About VirTrial. About Questex .

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Drug Discovery World

DECEMBER 20, 2022

Ariel Katz, CEO & co-founder of healthcare data company H1 , predicts that we will see more drugs rejected by regulatory bodies because the company is not able to demonstrate accountability regarding diversity in its clinical trial recruitment. Novel therapeutic platforms will drive innovation . M&A activity will accelerate.

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VirTrial

SEPTEMBER 21, 2020

The annual peer-reviewed awards program from the publisher of Fierce Biotech and Fierce Pharma highlights companies that have demonstrated innovative solutions, technologies, and services and have the potential to make the greatest impact for biotech and pharma companies.?. 2020 Accolades.

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The Pharma Data

DECEMBER 3, 2021

Zuranolone ( Savant-217/ BIIB125) is a formerly-daily, two-week, investigational medicine in development for the treatment of major depressive complaint (MDD) and postpartum depression (PPD). The NEST program includes two placebo- controlled studies of zuranolone in cases with PPD (ROBIN and SKYLARK Studies). About Sage Rectifiers.

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XTalks

MAY 1, 2023

New and Promising Treatments for ALS Amylyx Pharmaceuticals, a biopharmaceutical company based in Cambridge, Massachusetts, obtained FDA approval in 2022 for its oral medication Relyvrio (sodium phenylbutyrate and taurursodiol) for the treatment of ALS.

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pharmaphorum

FEBRUARY 10, 2022

CVS Health has said it will beef up its clinical trials operations, improving its ability to recruit patients from a broad demographic spectrum, via an agreement with digital health company Medable.

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Delveinsight

DECEMBER 27, 2020

Key pharmaceutical companies such as Celon Pharma, Otsuka Pharmaceutical, NeuroRx, among others worldwide are profoundly working in fuelling the Bipolar depression market size growth. Company: IntraCellular Therapies. Company : NeuroRx. Company: Celon Pharma. Company : Sage Therapeutics. Company : Sunovion.

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The Pharma Data

NOVEMBER 16, 2020

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.

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XTalks

DECEMBER 5, 2023

PPD Laboratory Services’ Lab Data Solution: Preclarus Managing the lifecycle of laboratory data, from collection to archiving or disposal, while ensuring it remains useful and accessible, is a complex task. There is a long list of things the company wants to do with it based on user/site requests for specific additional functionalities.

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XTalks

OCTOBER 26, 2023

In this Spotlight feature, Xtalks spoke with Lisa Kierstead, PhD, Executive Director, Vaccine Sciences Lab, PPD, part of Thermo Fisher Scientific, to learn more about navigating the respiratory virus season this year with the flu and COVID-19.

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XTalks

MARCH 22, 2023

The deal was surrounded by controversy as Swiss pharma Novartis was pushed out of the running by the French government, which reportedly sought to keep the companies’ combined economic power within the country’s borders. However, Alcon has since separated from Novartis in 2019 and is now operating as a standalone eye care company.

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The Pharma Data

NOVEMBER 30, 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 that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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The Pharma Data

MAY 15, 2023

3 Under the agreement, Thermo Fisher will identify local labs that will be using the company’s NGS technology and ensure they have the necessary infrastructure, trained staff, and quality control measures to meet industry standards for NGS testing services for breast and lung cancer. million deaths worldwide. million cancer deaths.

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