The Pharma Data

JULY 28, 2021

Investigational TAK-994, which was discovered at Takeda’s laboratories in Shonan, Japan, part of the open innovation center at the Shonan Health Innovation Park, is the lead candidate in Takeda’s pioneering multi-asset orexin-focused franchise.

Clinical Development 52

Clinical Development Therapies Laboratories Treatment 52

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion and $86.01

Laboratories 52

Laboratories Clinical Development FDA Regulations 52

Sygnature Discovery

JANUARY 26, 2024

Leveraging years of experience, we efficiently advance your compounds through preclinical studies and reduce risks as you move into clinical development. Our talented team of scientists can assist you in crafting robust pre-clinical development strategies.

Process Chemistry 52

Process Chemistry Pharmacokinetics Clinical Development Laboratories 52

Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. “In Perlmutter, President, Merck Research Laboratories. “We

Therapies 52

Therapies Research Laboratories Engineering Laboratories 52

The Connected Lab

APRIL 8, 2020

Thermo Fisher Scientific is at the forefront for enabling centralized data management for laboratories. Thermo Fisher™ Platform for Science™ software enables centralized data management of laboratory data. A Tough Road: Cost To Develop One New Drug Is $2.6 References Duggan, Susan, and Norma Pence. “A 2019, Freedman, David H.

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development.

RNA 64

RNA Cell Biology Clinical Development DNA 64

The Pharma Data

JULY 12, 2021

The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. “It

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

FDA Approval 52

FDA Approval Therapies FDA Trials 52

The Pharma Data

JANUARY 21, 2021

The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

Immune Response 52

Immune Response Laboratories Trials Therapies 52

The Pharma Data

NOVEMBER 9, 2020

It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.”. “We

Research Laboratories 52

Research Laboratories Laboratories Treatment Therapies 52

The Pharma Data

JANUARY 21, 2021

Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. Abbott Laboratories and TAP Pharmaceuticals. a company previously known as miRagen Therapeutics.

Laboratories 52

Laboratories Pharmaceuticals Clinical Development Engineering 52

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

These body-on-a-chip (BOC) devices place each tissue type in its own pea-sized chamber and connect them via fluid-filled microchannels into living, integrated biological systems on a laboratory plate. 2] Clinical development success rates for investigational drugs. Sci Transl Med. 2019 Jun 19;11(497). [2] Nat Biotechnol.

Drugs 72

Drugs Science Treatment Clinical Trials 72

The Pharma Data

NOVEMBER 19, 2020

Evenstad served as chief executive officer of Upsher-Smith Laboratories. Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire. The company also announced the addition of Robin Patel to its clinical and scientific advisory board.

Laboratories 52

Laboratories Research Laboratories Science Organic Chemistry 52

Conversations in Drug Development Trends

JANUARY 24, 2024

Fortunately, today, various genetic testing laboratories have significant amounts of genetic and genomic data that can support life cycle management, clinical development plans, and country/site selection. Enrolling adequate populations will be required to advance these programs.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

The Premier Consulting Blog

JULY 9, 2023

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.

Small Molecule 52

Small Molecule DNA Drugs Clinical Development 52

The Pharma Data

AUGUST 31, 2021

“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

OCTOBER 1, 2021

thanks to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib. CESTidentified through 52 weeks of knowledge. At therapeutic doses, deucravacitinib doesn’t inhibit JAK1, JAK2 or JAK3.

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

Drug Target Review

OCTOBER 3, 2024

Moreover, ethical considerations regarding the use of laboratory animals further complicate the use of primate polyclonal serum, and successful immunisation is not always guaranteed. Generation by phage display and characterization of drug-target complex-specific antibodies for pharmacokinetic analysis of biotherapeutics.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Hunt, a graduate research fellow in Jewett’s laboratory, is the paper’s co-first author.

Treatment 52

Treatment Virus Laboratories Engineering 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

The Pharma Data

MARCH 8, 2021

“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

JULY 29, 2021

About Loxo Oncology at Lilly Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. For more information, please visit www.kumquatbiosciences.com. Source link: [link] nvestor.lilly.com/.

Small Molecule 52

Small Molecule Immune Response Research Laboratories Laboratories 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

Therapies 52

Therapies Clinical Trials Science Laboratories 52

NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

As an important step in this direction, NIH-funded researchers at the Morgridge Institute for Research and University of Wisconsin-Madison have produced neural tissue chips with many features of a developing human brain. References : [1] Clinical development success rates for investigational drugs. Nat Biotechnol.

RNA 52

RNA Science Laboratories Clinical Trials 52

The Pharma Data

JUNE 7, 2023

We are delighted that PREVYMIS is now approved to help prevent CMV disease in adult kidney transplant patients at high risk,” said Dr. Elizabeth Rhee, vice president, global clinical development, Merck Research Laboratories. “At Source link: [link]

FDA Approval 40

FDA Approval FDA Disease Research Laboratories 40

The Pharma Data

JANUARY 19, 2021

The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 52

The Pharma Data

DECEMBER 3, 2020

Previously, he served as president, general counsel and a board member at Unigene Laboratories. BioAge – Paul Rubin was named CMO of BioAge and will lead the company’s clinical development efforts. Mayes joins Antios following the acquisition of Engage Therapeutics where he served as CEO from 2017 until its acquisition.

Pharmaceuticals 52

Pharmaceuticals Clinical Development Medical Schools Pharmacy 52

The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.

Vaccine 40

Vaccine Research Laboratories Doctors 40

The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 Limited (Stock Code: 300759.SZ/3759.HK) million in cash.

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 40

PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Here’s how we do it.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. If appropriate, initiation of anti-HBV therapy may be warranted.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

MARCH 16, 2021

We are excited to embark on this partnership with Boehringer Ingelheim to identify potential therapeutic candidates and advance them to clinical development in order to help improve the lives of those affected by this serious mental health condition.”. The Lieber Institute for Brain Development. Weinberger, M.D.,

Licensing 52

Licensing Licensing Research Laboratories Treatment 52

Precision for Medicine

MAY 24, 2023

Precision applies novel biomarker approaches to clinical research that integrate clinical trial design and execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. This convergence of trials, labs, and data sciences is driving faster clinical development and approval.

Clinical Trials 40

Clinical Trials Clinical Research Science Trials 40

The Pharma Data

JUNE 2, 2023

Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “It is imperative that we create new ways to treat advanced cancers and help improve patient outcomes by building on the current standard of care.

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

The Pharma Data

AUGUST 7, 2020

Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. These manufactured antibodies have been developed and manufactured by Eli Lilly and Company ’s Lilly Research Laboratories in a partnership with AbCellera.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52