Clinical Development, Licensing, Pharmaceutical Companies and Trials

Pfizer launches Phase III trial for Lyme disease vaccine

Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic.

Vaccine

Vaccine Disease Trials Pharmaceutical Companies

Europe: Where is the drug discovery innovation?

Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The CDD will sponsor and manage KWF-supported trials.

Drugs

Drugs Science Molecular Biology Clinical Trials

International Women’s Day: Female life science leaders

Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor.

International

International Science Pharmaceuticals DNA

Drug discovery hotspots: What is the secret to Switzerland’s success? (p1)

Drug Discovery World

JULY 2, 2024

In another example, university of Basel spin-off T3 Pharma reached Phase I development of a cancer therapy that harnesses the natural behaviours of live bacteria before being acquired by Boehringer Ingelheim for $509m at the end of 2023. Biopôle Lausanne has been created to provide a focus for life sciences activity in the region.

Science

Science Drugs Clinical Trials Licensing

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

Small Molecule

Small Molecule Licensing Licensing Clinical Trials

Ultimovacs Announces the Appointment of Ton Berkien as Chief Business Officer

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

Clinical Trials Small Molecule Pharmaceutical Companies Licensing

Advancing neurological therapies with Dr Bruce Leuchter

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

Therapies Drug Development Disease Clinical Development

Nomination Committee appointed for BioInvent International’s Annual General Meeting 2021

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

Clinical Trials International Licensing Licensing

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

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

Clinical Trials Licensing Licensing International

BioInvent to host Key Opinion Leader call on BI-1206 for relapsed or refractory Non-Hodgkin’s Lymphoma

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

Clinical Trials Licensing Licensing International

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

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

Trials Treatment Therapies Clinical Trials

EyePoint Pharmaceuticals Announces $15.7 Million Equity Investment by Asia Partner Ocumension Therapeutics

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

Pharmaceuticals Pharmaceutical Companies Licensing Licensing

CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin’s Lymphoma Patients

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

Pharmaceuticals Clinical Trials Licensing Licensing

Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs

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

Licensing Licensing Clinical Trials International

Where is the drug discovery expertise happening in the UK?

Drug Discovery World

OCTOBER 16, 2023

Dr Tralau-Stewart says: “Indeed, many academic institutions have established new ways of supporting the discovery pipeline, providing tech transfer offices to support licensing, and entrepreneurship and start-up support through fundraising, accelerators, and incubators. appeared first on Drug Discovery World (DDW).

Drugs

Drugs Science Therapies Targeted Protein Degradation

Amgen To Acquire Five Prime Therapeutics For $1.9 Billion in Cash

The Pharma Data

MARCH 5, 2021

The bemarituzumab Phase 2 FIGHT trial demonstrated clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) in the frontline treatment of patients with advanced gastric or GEJ cancer. About the FIGHT Trial. About Amgen Oncology.

Trials

Trials Therapies Clinical Development Pharmaceutical Companies

Resolutions at the Extraordinary General Meeting in BioInvent on November 27, 2020

The Pharma Data

NOVEMBER 26, 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

Clinical Trials Licensing Licensing International

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc.

FDA

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Biopharma Money on the Move: December 2 – 8

The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. Nuance Pharma . Sigilon Therapeutics .

RNA

RNA Protein Expression Therapies Disease

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Follow us at @JNJNews.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

The era of precision neuroscience

Drug Discovery World

MARCH 6, 2024

The fact that 100+ clinical trials in Alzheimer’s have failed to demonstrate clinical efficacy should warn us that this is too simplistic an approach in neurological diseases. This is wholly unsurprising. This has been the real failure of some areas of CNS drug discovery.

Clinical Trials

Clinical Trials Pharmaceutical Companies Disease Trials

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

FDA Approval

FDA Approval FDA Treatment Pharmaceutical Companies

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Cell and gene therapy – where is the innovation?

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . More so, the UK is now home to 29% of all European ATMP companies, making it a key location for global activity in the space. .

Therapies

Therapies Clinical Trials Production Trials

Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation

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

Regulations Pharmaceutical Companies International Pharmaceuticals

BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors

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

Virus Trials Clinical Trials Clinical Development

Everest Medicines Announces Amended Agreement with Spero Therapeutics

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. SHANGHAI , Jan.

Clinical Trials

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies

The rise of digital biomarkers in neuroscience drug development

Drug Discovery World

OCTOBER 10, 2022

As a result, many apparently attractive new drug candidates in neuroscience subsequently fail to meet their primary endpoints in clinical trials. In particular, the ever-increasing research and development costs required 1. Copyright of image: Cambridge Cognition with permission.

Drug Development

Drug Development Clinical Trials Drugs Trials

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

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

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology

Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

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

Drug Development Disease Engineering Therapies

BioDAOs are Community-Owned Research Translation Engines, Not Investment DAOs

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

Engineering Research Government Clinical Trials

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. Upon option exercise, Novartis would be responsible for all further development and commercialization activities.

Therapies

Therapies Virus Treatment Clinical Trials

Athersys Announces Three Appointments to Board of Directors

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms. Shah also serves on the boards of several civic organizations and initiatives.

Clinical Trials

Clinical Trials Trials Production International

BioLineRx Increases Previously Announced Bought Deal Offering to $30 Million

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

Clinical Trials Trials Clinical Development Pharmaceutical Companies

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

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. Protalix has licensed to Pfizer Inc. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials

Clinical Trials Disease Treatment Trials

BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC)

The Pharma Data

DECEMBER 15, 2020

These positive results are further supported by a long-lasting median durability of clinical benefit of 5.6 months that we observed in this trial. Therefore, even marginal improvements in survival endpoints in pivotal studies have been considered clinically meaningful and sufficient for regulatory approval. Kenilworth, N.J. ,

Clinical Trials

Clinical Trials Trials Treatment Therapies

Drug Discovery Digest

Pfizer launches Phase III trial for Lyme disease vaccine

Europe: Where is the drug discovery innovation?

Trending Sources

International Women’s Day: Female life science leaders

Drug discovery hotspots: What is the secret to Switzerland’s success? (p1)

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

Ultimovacs Announces the Appointment of Ton Berkien as Chief Business Officer

Advancing neurological therapies with Dr Bruce Leuchter

Nomination Committee appointed for BioInvent International’s Annual General Meeting 2021

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

BioInvent to host Key Opinion Leader call on BI-1206 for relapsed or refractory Non-Hodgkin’s Lymphoma

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

EyePoint Pharmaceuticals Announces $15.7 Million Equity Investment by Asia Partner Ocumension Therapeutics

CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin’s Lymphoma Patients

Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs

Where is the drug discovery expertise happening in the UK?

Amgen To Acquire Five Prime Therapeutics For $1.9 Billion in Cash

Resolutions at the Extraordinary General Meeting in BioInvent on November 27, 2020

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

Biopharma Money on the Move: December 2 – 8

Biopharma Leaders Unite To Stand With Science

Biopharma Leaders Unite To Stand With Science

The era of precision neuroscience

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Cell and gene therapy – where is the innovation?

Navigating the Challenges and Opportunities of the PICO Framework in the New EU HTA Regulation

BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors

Everest Medicines Announces Amended Agreement with Spero Therapeutics

The rise of digital biomarkers in neuroscience drug development

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

BioDAOs are Community-Owned Research Translation Engines, Not Investment DAOs

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

Athersys Announces Three Appointments to Board of Directors

BioLineRx Increases Previously Announced Bought Deal Offering to $30 Million

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC)

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