Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

Disease 52

Disease Clinical Trials Trials Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. –( BUSINESS WIRE )– Marinus Pharmaceuticals, Inc. About the RAISE Trial. About Marinus Pharmaceuticals. Marinus Pharmaceuticals, Inc. Marinus and Ceribell, Inc. RADNOR, Pa.–(

Clinical Trials 52

Clinical Trials Trials Hospitals Pharmaceutical Companies 52

PPD

MAY 7, 2024

Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies. Particularly for small and mid-size pharmaceutical companies, meeting these timelines could be a significant hurdle.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Pharma Data

DECEMBER 27, 2020

In these unprecedented times, we are especially grateful for the dedication of our research site staff and trial participants, whose commitment to EXCELLENCE facilitated the advancement of our lead program,” said George Yeh, President of TLC. “We SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Trials 40

Trials Clinical Trials Pharmaceutical Companies Pharmaceuticals 40

The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

Drug Target Review

JANUARY 8, 2024

With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK. We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation.

Science 145

Science Disease FDA Approval Clinical Trials 145

Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

Drug Target Review

FEBRUARY 1, 2024

Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinical trials. We were able to license a molecule from a multi-national pharmaceutical company.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

The Pharma Data

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development. LUND, Sweden and STRASBOURG, France , Dec.

Virus 52

Virus Trials Clinical Trials Clinical Development 52

Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

Marketing 59

Marketing Pharmaceutical Companies Regulations Pharmaceuticals 59

The Pharma Data

OCTOBER 19, 2020

van de Laar has over 20 years of experience in biotechnology scale up and manufacturing and will be responsible for leading the Company’s preparations for commercial readiness, CMC activities and global supply chain management. Dr. Kraan joins AM-Pharma from Pierre Fabre S.A., Find out more about us online at: www.am-pharma.com. pharma.com.

Trials 40

Trials Small Molecule Cell Biology Clinical Trials 40

PPD

DECEMBER 14, 2023

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel.

Clinical Development 52

Clinical Development Clinical Trials International Trials 52

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

JUNE 19, 2023

The findings bolster the idea, which is currently under investigation in at least three clinical trials, that when it comes to treating resistant breast cancer, two drugs may be better than one. A promising new frontier in cancer treatment The study, a collaboration with pharmaceutical company Pfizer Inc.,

Drugs 40

Drugs Clinical Trials Pharmaceutical Companies Clinical Development 40

The Pharma Data

OCTOBER 19, 2020

19, 2020 — A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports. She is executive medical director of immunology clinical development for the pharmaceutical company AbbVie in North Chicago, Ill.

Clinical Trials 52

Clinical Trials Drugs Trials Treatment 52

Cytel

DECEMBER 2, 2022

For 35 years , Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value, and make evidence-based decisions with confidence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Clinical Trials Clinical Development 52

The Pharma Data

JANUARY 6, 2021

With the IND approval, UNION is granted permission to advance oral orismilast into Phase 2b trials in humans with moderate to severe plaque psoriasis to evaluate the safety and efficacy of orismilast. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

MARCH 29, 2022

“We believe in advancing health through partnerships and are excited to embark on this journey, strengthening our ability to create a positive impact on patient lives,” shared Uli Brödl, senior vice president, global clinical development and operations at Boehringer Ingelheim.

Therapies 52

Therapies Clinical Development Pharmaceutical Companies Research 52

The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that its subsidiary, InspirMed Inc., SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Jan.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials Disease 52

The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. He also previously served as Global CMO at Taiho Pharmaceutical Company, Ltd. Benedetti most recently served as chief medical officer for Apollomics, Inc.,

Engineering 52

Engineering Pharmaceuticals Clinical Development Virus 52

The Pharma Data

DECEMBER 8, 2020

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. The FDA plans to launch Operation Warp Speed for Rare Diseases in 2023 with a focus on increased communication between the agency and drug and biotech companies. Keep in mind, there is no cost to register an IBC with the NIH.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

JANUARY 19, 2021

The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials. NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology.

Clinical Trials 52

Clinical Trials Trials Clinical Development Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. CARMIEL, Israel and BOSTON , Dec. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JANUARY 19, 2021

BioInvent’s management team will also give an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and BioInvent’s partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

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.

Engineering 52

Engineering Research Clinical Trials Government 52

The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, The Company’s validated, proprietary F.I.R.S.T

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

JANUARY 3, 2021

03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK),

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Licensing Licensing 52

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. Yeh then proceeded to provide a company and pipeline update, details of which are as follows: Patient enrollment of EXCELLENCE, the Phase III pivotal study of TLC599 for symptomatic knee osteoarthritis , is at 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

Clinical Trials 40

Clinical Trials Pharmaceutical Companies Clinical Development Pharmaceuticals 40