Clinical Development, Events, Licensing and Regulations

How to get the biopharma deal you want

Drug Discovery World

MAY 29, 2024

For biotechs, partnerships with pharmas provide a source of income, useful technical knowledge, and a path to progress programs into the later stages of clinical development and commercialisation, the latter of which the biotech is unlikely to be able to do on its own.

International

International Licensing Licensing Regulations

Drug discovery quarterly review: Second quarter 2023

Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America.

Vaccine

Vaccine FDA Approval Drugs Licensing

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. CEO and Co-founder of BioNTech. “We

Licensing

Licensing Licensing Vaccine FDA Approval

4-1BB and the critical importance of local control

SugarCone Biotech

JUNE 10, 2024

[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. This is where things get interesting due to the complexity of the immune system and its regulation.

Immune Response

Immune Response Regulations Production Clinical Trials

Tauriga Sciences Inc. Funds the Entirety of the Master Services Agreement that it Recently Entered Into with CSTI

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

Science

Science Pharmaceuticals Clinical Development Production

MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. View source version on accesswire.com: [link].

Clinical Trials

Clinical Trials Clinical Development Clinical Supply Trials

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. Persons”, as such term is defined in Regulations under the U.S. PharmaDrug Inc.

FDA

FDA Drugs Clinical Development Pharmaceutical Companies

Kiromic Announces the Filing of Key European Patents for Its Chimeric PD-1 (chPD1) Target

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.

Molecular Biology

Molecular Biology Therapies Immune Response Science

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. LONDON and BOSTON, Jan.

Science

Science Virus FDA Approval Treatment

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

Regulations

Regulations International Disease Small Molecule

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

Vaccine

Vaccine Immune Response Disease Clinical Trials

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

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. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

Pharmaceuticals

Pharmaceuticals Small Molecule Vaccine Protein Expression

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. ” About Ascentage Pharma.

Clinical Development

Clinical Development Disease Treatment Licensing

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). One example of such a genetics exercise is represented in Fig.

Production

Production Small Molecule Regulations Trials

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

Vaccine

Vaccine Clinical Trials Trials Government

Moberg Pharma decides on fully guaranteed rights issue of approximately SEK 150 million

The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation. CET on November 6, 2020.

Marketing

Marketing Production Regulations Pharma Companies

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

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. Harmony Biosciences Media Contact: Nancy Leone. 215-891-6046. nleone@harmonybiosciences.com. 484-539-9736.

FDA Approval

FDA Approval FDA Treatment Pharmaceutical Companies

The era of precision neuroscience

Drug Discovery World

MARCH 6, 2024

Mutations in the dark genome affect gene regulation rather than coding, exerting a positive or negative impact on the expression of genes that may be related to disease processes. An example of this is our clinical development partnerships with clinical-stage pharmaceutical companies like Nanopharmaceutics.

Clinical Trials

Clinical Trials Pharmaceutical Companies Disease Trials

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

Clinical Trials

Clinical Trials Trials Pharmaceuticals FDA

Amgen To Showcase Data From Oncology Pipeline During ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar.

Clinical Trials

Clinical Trials Production Trials Government

Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine

The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Amgen, along with members of?Amgen’s

Production

Production Clinical Trials Trials Government

GeneTx and Ultragenyx Announce Positive Interim Phase 1/2 Data on Investigational GTX-102 Demonstrating Improvement in Patients with Angelman Syndrome

The Pharma Data

OCTOBER 28, 2020

Preliminary results from the first five patients treated indicate substantial improvements in all patients in at least two disease domains including communication, behavior, sleep, gross motor function, and fine motor function as measured by the Clinical Global Impression of Improvement Scale for Angelman Syndrome (CGI-I-AS) at day 128.

Protein Expression

Protein Expression Production Therapies Treatment

BioLineRx Increases Previously Announced Bought Deal Offering to $30 Million

The Pharma Data

JANUARY 19, 2021

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

Clinical Trials

Clinical Trials Trials Clinical Development Pharmaceutical Companies

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

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. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

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

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. Protalix has licensed to Pfizer Inc. mL/min/ 1.73m 2 in males, and 86.14 nM and 13.81 About Fabry Disease.

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

The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone; adverse event (AE) and severe adverse event (SAE) profiles were as expected with chemotherapy-based treatment regimens.

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

How to get the biopharma deal you want

Drug discovery quarterly review: Second quarter 2023

Trending Sources

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

4-1BB and the critical importance of local control

Tauriga Sciences Inc. Funds the Entirety of the Master Services Agreement that it Recently Entered Into with CSTI

MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

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

Kiromic Announces the Filing of Key European Patents for Its Chimeric PD-1 (chPD1) Target

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

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

Biopharma Leaders Unite To Stand With Science

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

Biopharma Leaders Unite To Stand With Science

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Moberg Pharma decides on fully guaranteed rights issue of approximately SEK 150 million

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

The era of precision neuroscience

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Amgen To Showcase Data From Oncology Pipeline During ESMO Virtual Congress 2020

Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine

GeneTx and Ultragenyx Announce Positive Interim Phase 1/2 Data on Investigational GTX-102 Demonstrating Improvement in Patients with Angelman Syndrome

BioLineRx Increases Previously Announced Bought Deal Offering to $30 Million

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

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)

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

Stay Connected