2018, Clinical Development, Licensing and Pharmaceuticals

2018

Clinical Development

Licensing

Pharmaceuticals

Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

A market research report published in late June 2018 by HTF market Intelligence Consulting suggested that the ADC market in China would grow exponentially by 2023 4. Under the terms of the licensing agreement, AstraZeneca will be granted an exclusive global license to research, develop, and commercialize LM-305.

Marketing

Marketing FDA Approval Licensing Licensing

Asieris and Photocure Expand Strategic Partnership to Bladder Cancer Diagnosis and Surgery in Mainland China and Taiwan

The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. ” About Photocure ASA.

Licensing

Licensing Licensing Clinical Development Pharmaceutical Companies

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Trending Sources

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

The Pharma Data

JUNE 28, 2021

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer.

Small Molecule

Small Molecule Licensing Licensing Therapies

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

He said: “This will discuss priorities in the clinical development of drugs for children, in particular in areas of unmet medical need, and coordinate studies relating to paediatric treatments.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai Lab is leading clinical development in its territory. “We Read on for this week’s.

FDA

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J.,

Pharmaceuticals

Pharmaceuticals Small Molecule Vaccine Protein Expression

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals’ SPN-812 for ADHD. Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Adamis Pharmaceuticals’ Zimhi for Opioid Overdose. Food and Drug Administration (FDA) in terms of PDUFA dates.

FDA

FDA Trials Pharmaceuticals Pharmacokinetics

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

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Sairiyo is currently focused on advancing the clinical development of Cepharanthine to treat rare cancer diseases.

FDA

FDA Drugs Clinical Development Pharmaceutical Companies

Dr. Henry Ji to Participate in a Fireside Chat at the B. Riley Securities Oncology Investor Conference on Jan 20, 2021

The Pharma Data

JANUARY 18, 2021

ZTlido ® was approved by the FDA on February 28, 2018. SEMDEXA is a trademark of Semnur Pharmaceuticals, Inc. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.

Small Molecule

Small Molecule Clinical Trials Trials Therapies

Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan

The Pharma Data

JANUARY 25, 2021

“ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. 75% of all bladder cancer cases occur in men.

Clinical Development

Clinical Development Licensing Licensing Production

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

Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China. References.

Trials

Trials Treatment Therapies Clinical Trials

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

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . The UK stands as one of the key markets for cell and gene therapies. Last year, Pfizer opened a $68.5

Therapies

Therapies Clinical Trials Production Trials

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

. Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. 15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. 2018) PLoS One. About Tonix Pharmaceuticals Holding Corp. CHATHAM, N.J.,

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

BioSpace Global Roundup: Ipsen Wins Fast Track Designation for Cancer Drug and More

The Pharma Data

DECEMBER 2, 2020

Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018. HZI – Germany’s Helmholtz Centre for Infection Research (HZI) secured two awards worth up to $15 million from CARB-X to develop non-traditional approaches against antibiotic-resistant pathogens. in Mainland China.

Licensing

Licensing Licensing DNA Vaccine

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

The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA ® and BioLineRx was the study sponsor and owns all rights to motixafortide. a company that supports oncology drug development. of new cancer cases.

Clinical Trials

Clinical Trials Trials Treatment Therapies

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Merck’s Commitment to HIV.

Trials

Trials Clinical Trials International Production

Drug Discovery Digest

Three trends in the antibody-drug conjugate (ADC) market

Asieris and Photocure Expand Strategic Partnership to Bladder Cancer Diagnosis and Surgery in Mainland China and Taiwan

Trending Sources

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

European Commission vs Big Pharma, or profit vs access?

FDA Action Alert: MacroGenics and Amgen

Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

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

Dr. Henry Ji to Participate in a Fireside Chat at the B. Riley Securities Oncology Investor Conference on Jan 20, 2021

Photocure Partners with Asieris MediTech to Commercialize Hexvix in Mainland China and Taiwan

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

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

Cell and gene therapy – where is the innovation?

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

BioSpace Global Roundup: Ipsen Wins Fast Track Designation for Cancer Drug and More

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

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

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