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

DrugBank

OCTOBER 4, 2024

Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value. billion, and the notoriously high failure rates in drug development have incentivized these companies to seek external innovation.

Pharmaceuticals 81

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 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 Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

JANUARY 17, 2021

. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. “R&D capabilities of Hanmi Pharmaceutical Co., Hanmi Pharmaceutical Co., U.S.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 108

Vaccine Trials Disease Treatment 108

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. www.molecularpartners.com ; Follow the Company on Twitter at @MolecularPrtnrs. Chief Medical Officer of Molecular Partners.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

DECEMBER 20, 2020

“This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. Philippe Archinard , PhD, Chairman and CEO of Transgene, said: “We are pleased that we have received a first approval to initiate the Phase l/lla trial of BT-001. The Company’s validated, proprietary F.I.R.S.T

Virus 52

Virus Trials Clinical Trials Clinical Development 52

The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 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. The Company’s validated, proprietary F.I.R.S.T

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Increases of ALT ?5x BA HCP ISI 09JUL2020.

Licensing 40

Licensing Licensing Therapies Laboratories 40

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

The Pharma Data

AUGUST 13, 2020

The vaccines are being developed by the Belgian pharmaceutical company Janssen and the US biotech company Novavax. With most vaccine trials ending in failure, the government is effectively hedging its bets, hoping that at least one of the vaccines it has purchased proves safe and effective.

Vaccine 52

Vaccine Virus Government Clinical Trials 52

The Pharma Data

OCTOBER 20, 2020

21, 2020 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage, specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, today announced the appointment of Thomas H. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Oct.

Licensing 40

Licensing Licensing Pharmaceutical Companies Clinical Trials 40

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. Wainberg, M.D.,

Trials 52

Trials Treatment Therapies Clinical 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. The Company’s validated, proprietary F.I.R.S.T

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

Codon

FEBRUARY 13, 2024

1 Yet even after more than two decades of research, media hype, and dozens of clinical trials and biotech start-ups that have come and gone, phage therapy has not scaled. No phage-based therapeutic has reached the latter stages of the clinical trial pipeline (where promising results lead to an expanded trial involving thousands of patients).

Therapies 115

Therapies Virus DNA Clinical Trials 115

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 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

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.

Research 52

Research Licensing Licensing Science 52

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development 52

Drug Development Disease Therapies Engineering 52

Drug Target Review

FEBRUARY 1, 2024

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. The lack of heterogeneity can introduce significant risk into mid- to late-stage studies.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

The Pharma Data

JANUARY 17, 2021

Spero has previously reported data from a Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for targeting MDR Gram-negative bacterial infections. SHANGHAI , Jan.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

The Pharma Data

JANUARY 4, 2021

5, 2021 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it is to regain the worldwide rights to its muscarinic agonist programs. The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. ” About the License Agreement.

Licensing 40

Licensing Licensing Clinical Trials Disease 40

DrugBank

MARCH 22, 2024

Due to open source data’s accessibility, it is an appealing resource for drug research as it often enables cost-effective sources for emerging pharmaceutical companies and academic research projects.  Paid Knowledge Bases Paying for access or licensing a knowledge base can be a difficult decision to make.

Licensing 74

Licensing Licensing Research Production 74

The Pharma Data

APRIL 22, 2023

Randomized controlled trials have demonstrated positive results with oral and injectable medications. Pharmaceutical companies have an ethical responsibility to make their new treatments for diabetes and obesity available for anyone in need, in any country.” The medication is not licensed for obesity alone.

Medical Schools 40

Medical Schools Licensing Licensing Treatment 40

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

MARCH 4, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials,” said Andy Plump, M.D., About Takeda Pharmaceutical Company Limited.

Treatment 52

Treatment Clinical Trials Pharmaceutical Companies Trials 52

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. George Yeh, President of TLC, commenced the conference and welcomed the company’s new Chief Business Officer, Mr. Tom Bliss. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

The Pharma Data

FEBRUARY 12, 2022

“As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. ” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. and Company?. About BLAZE-4. Clinical data confirm the neutralizing ability of bebtelovimab.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

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

MARCH 2, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

FDA 52

FDA Clinical Trials Trials Treatment 52

The Pharma Data

MARCH 2, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S.

Vaccine 52

Vaccine Clinical Trials FDA Licensing 52

The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

Packaging 52

Packaging FDA Trials Regulations 52