The Pharma Data

MARCH 29, 2022

Boehringer Ingelheim and Veeva Systems (NYSE: VEEV) today announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies.

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The Pharma Data

SEPTEMBER 29, 2021

Patients are going to be randomized to receive either finerenone 10mg or 20mg or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy like an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

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DrugBank

SEPTEMBER 26, 2024

Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts. Still, significant differences exist between these two major markets.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim is pioneering a range of versatile therapeutic platforms in order to develop innovative medicines that target the tumor directly (tumor cell-directed therapies) or that enable the immune system to target the tumor (immune cell-targeted therapies). About Boehringer Ingelheim.

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Licensing Licensing Therapies Science 52

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. billion in 2023 to 1.2 billion in 2035.

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Drug Development Clinical Trials Drugs Small Molecule 52

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. The first guidelines published in 1996 and known as ICH GCP E6 provided guidance on the design, conduct, and reporting of clinical trials.

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Clinical Trials Trials Clinical Research International 52

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Tissue Sensitivity : The sensitivity of target tissues and nearby organs to radiation therapy can vary considerably.

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Clinical Trials Therapies Regulations Clinical Development 52

Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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Drug Development Treatment FDA Approval Drugs 52

Vial

APRIL 24, 2024

In addition to the areas above (aside from DTx), Syneos Health offers biosimilars , cell and gene therapy , endocrine and metabolic, immunology and inflammation, infectious diseases, pediatrics, respiratory, and women’s health services. Digital therapeutics is not explicitly listed as a therapeutic area of expertise for Syneos Health.

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Clinical Trials Trials Biosimilars Disease 52

PPD

JUNE 17, 2024

For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.

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Clinical Trials Clinical Development Trials International 52

PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

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Clinical Trials Clinical Development Clinical Research Trials 52

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

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Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

NOVEMBER 1, 2020

Telix has appointed China Grand Pharma as its exclusive partner for the Greater China market (‘Territory’) 1 and grants China Grand Pharma exclusive development and commercialisation rights to Telix’s portfolio of prostate, renal and brain (glioblastoma) cancer imaging and therapeutic MTR products in the Territory. .

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The Pharma Data

MAY 30, 2023

The development of this unique digital asset underscores Syneos Health’s continued focus on Medical Affairs, an increasingly critical component of successful clinical development. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Clinical Development 52

Clinical Development Therapies Marketing 52

The Pharma Data

APRIL 7, 2022

“At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Sisunatovir has been granted Fast Track designation by the U.S.

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Virus Vaccine Clinical Development Hospitals 52

The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. About Eisai Co.,

Disease 40

Disease Treatment Therapies FDA 40

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Figure 2 shows pipelines across modalities for some of the competitive targets today.

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The Pharma Data

DECEMBER 2, 2020

Based on the Phase 2 study findings to date, marstacimab may have the potential to offer improved bleed control via subcutaneous injection and potentially eliminate the need for prophylactic factor replacement, providing an enhanced treatment option compared to factor replacement therapy.”. About Pfizer Rare Disease. Pfizer Inc.:

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Therapies Treatment Disease Clinical Trials 52

Drug Target Review

JULY 18, 2024

How is leveraging liquid biopsy leading to innovative trial designs in oncology and ultimately our ability to develop new drugs in the adjuvant setting? This helped us to identify as many patients as possible who already had microscopic tumour spread. Dr Haqq holds multiple patents and publications.

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Drug Development Clinical Trials Drugs Vaccine 59

Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

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Clinical Trials Trials Pharmacokinetics FDA 83

The Pharma Data

DECEMBER 9, 2020

This acquisition will significantly strengthen Boehringer Ingelheim’s focus on targeted cancer cell therapies, gaining the company access to NBE’s innovative immune-stimulatory iADC platform. . It has shown remarkably high safety and tolerability measure during non-clinical development. . billion US. .

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FDA Approval Clinical Development Therapies Vaccine 52

The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

Treatment 52

Treatment Clinical Development Therapies Clinical Trials 52

Drug Target Review

APRIL 3, 2024

I had to learn to actively make noise, advertise my work, engage in discussions, network with peers, and become active in self-marketing. I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications.

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Science Clinical Development Treatment DNA 105

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.

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Drug Target Review

JUNE 3, 2024

Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments? It was published by Pfizer and Sarepta that the T cell component is responsible for toxicity in humans within gene therapy trials.

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Disease Therapies Pharmaceuticals Clinical Trials 49

Vial

MARCH 1, 2024

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

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Clinical Trials Clinical Research Trials Laboratories 52

The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the novel combination of the cancer treatments copanlisib and rituximab. Senior Vice President and Head of Oncology Development at Bayer. “We Fields, M.D.,

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Treatment Therapies Trials Clinical Development 52

Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

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Clinical Trials Trials FDA Therapies 52

Precision for Medicine

JUNE 26, 2023

Baseline Control’s expertise will become part of Project Farma, Precision for Medicine’s existing biomanufacturing strategy and execution group, expanding the scope of its manufacturing solutions for life science companies and driving greater speed and efficiency in bringing new drugs to market. For more information, visit projectfarma.com.

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Science Small Molecule Clinical Research Engineering 40

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

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Engineering Pharmaceuticals Clinical Development Virus 52

The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

JUNE 7, 2023

In this exploratory analysis, Trodelvy demonstrated a clinically meaningful improvement in median OS benefit compared to TPC (median OS: 14.5 At this stage of disease, sequential chemotherapy is common, and benefits may become smaller with subsequent lines of therapy. months vs. 11.2 months; hazard ratio (HR): 0.79; [95% CI: 0.65-0.95];

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Medical Schools Therapies Treatment Clinical Development 40

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. About Targeted Alpha Therapies (TAT) at Bayer Targeted Alpha Therapies (TAT) are an emerging class of radionuclide therapy for various difficult to treat tumors.

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Small Molecule Licensing Licensing Therapies 52

The Pharma Data

SEPTEMBER 29, 2020

The FDA approval is based on data from a clinical development programme that included positive results from a pivotal phase 3 study. HES is a rare and under-diagnosed disorder which is characterised by persistent and market overproduction of eosinophils, a type of white blood cell. Source link.

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FDA Approval FDA Treatment Clinical Development 52

The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. For additional background on the acquisition, please read the announcement press release here.

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Pharmaceuticals Small Molecule Biosimilars Disease 52

PPD

MAY 7, 2024

This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies. Further, uncertainties arise regarding the applicability of centralized advice at the national level and the potential for longer timeframes to access certain markets.

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