Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.

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Pharmaceutical Technology

MAY 16, 2023

Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK. NXP900 plus Osimertinibplus enzalutamide in vivo showed a possible ability to reverse acquired resistance in metastatic castration-resistant prostate cancer.

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The regulatory agency carried out the review of the Biologics License Application (BLA) for the therapy under the Priority Review approach. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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Pharmaceutical Technology

APRIL 28, 2023

Earlier in the year, the company had announced a move towards developing treatments for hemoglobinopathies like sickle cell disease and beta thalassemia and a focus on in vivo discovery. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. g/dL and 45.4%

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pharmaphorum

JULY 5, 2022

The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness. An estimated 1.57 Astellas is already working on other approaches to treating hearing loss.

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Drug Discovery World

FEBRUARY 23, 2024

In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space. News round-up for 19-23 February by DDW Digital Content Editor Diana Spencer.

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pharmaphorum

JANUARY 10, 2022

Bayer has bolstered its cell and gene therapy platform by securing access to a CRISPR-based gene-editing platform developed by US biotech Mammoth Biosciences. While the main thrust of the new alliance is finding in vivo therapies, Bayer said it is also working with Mammoth on ex vivo projects “on a nonexclusive basis.”

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Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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Pharmaceutical Technology

FEBRUARY 28, 2023

Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma and Shenzhen Chipscreen Biosciences’ holding subsidiary Chipscreen NewWay Biosciences have entered an exclusive licensing agreement for YH008, a bispecific antibody. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies.

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Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. BeiGene, Novartis partner to develop cancer drug Tislelizumab, an Anti-PD-1 Antibody.

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The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. . About ViGeneron.

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Drug Discovery World

AUGUST 4, 2022

Developability in the biopharmaceutical industry relates to the difficulty of making early candidate molecules with attractive biological activities into commercialised and marketable therapies. The ‘developability gap’ is the degree of uncertainty when the information needed to make such assessments is lacking at earlier stages of a process.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites. About Omidubicel.

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The Pharma Data

JUNE 7, 2023

a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas’ LNP technology will support Bayer’s in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver.

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Drug Discovery World

DECEMBER 12, 2023

KRRO-110 is an RNA editing oligonucleotide delivered to liver cells using clinically validated lipid nanoparticle (LNP) technology licensed from Genevant. Selecting a development candidate for our AATD program is an important milestone for Korro, but more importantly, for patients.

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pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process.

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Drug Discovery World

OCTOBER 2, 2023

We now appreciate that CAR-T therapy is an effective treatment for hematologic malignancies with great strides toward solid tumours and potentially autoimmune targets. With fully closed and automated devices, therapy manufacturing will hopefully be able to break the next barrier in patient access to generate safe products in record time.

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pharmaphorum

FEBRUARY 19, 2021

Snipping out this viral code with powerful CRISPR gene editing technology, which last year won Drs Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for chemistry, would in theory prevent the need for drugs to suppress the virus and the development of AIDS. The post Could CRISPR cure HIV?

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The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Those funds were used to advance its discovery and development programs. Of course, this is how biotech investments work.

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pharmaphorum

APRIL 12, 2021

Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). The rest of the money will come in the form of milestone payments if agreed development, regulatory and commercial targets are met.

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Drug Discovery World

SEPTEMBER 14, 2023

Also in July 2023, Alexion, AstraZeneca Rare Disease (Alexion) and Pfizer entered into an agreement for Alexion to purchase and license the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales. billion, a decrease of $15.0 Vaccines were up 9.1%

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Croasdale-Wood will then participate in a keynote chat, interviewed by Miho.

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The Pharma Data

MARCH 20, 2023

Children in LT-001 treated after SMA symptom onset maintained or achieved additional milestones up to 7.5 Children in LT-001 treated after SMA symptom onset maintained or achieved additional milestones up to 7.5 years post-dosing, children who were treated after presenting symptoms of SMA maintained all previously achieved motor milestones.

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The Pharma Data

OCTOBER 14, 2020

today announced a licensing agreement with MANA Therapeutics for use of its EDIFY platform for the development of an autologous multi-tumor antigen adoptive T cell therapy for the treatment of multiple myeloma and solid tumors, as an additional T cell focused immunotherapeutic for its product pipeline. “The 15, 2020 04:00 UTC.

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pharmaphorum

OCTOBER 8, 2020

Scribe – which counts new Nobel Prize for chemistry winner Jennifer Doudna among its founders – is getting $15 million upfront from Biogen for an alliance focusing on the development of a CRISPR-based therapy for neurodegenerative disease including amyotrophic lateral sclerosis (ALS). Benjamin Oakes.

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FDA Law Blog

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2).

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation.

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The Pharma Data

MARCH 8, 2021

This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. After initial maturation, projects are handed over for further development to Boehringer Ingelheim. population will have obesity.

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The Pharma Data

DECEMBER 9, 2020

Uniquely positioned in the rapidly evolving local biotech ecosystem in China in addition to an expansive global presence, Overland will strategically partner to jointly develop innovative, novel therapeutics. We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”.

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The Pharma Data

MARCH 25, 2022

” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. .”

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 6,7 This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in vivo) across all Omicron variants.6.

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The Pharma Data

APRIL 8, 2022

The mere motions of breathing are known to influence vital functions of the lungs, including their development in babies, the production of air-exchange-enhancing fluid on their inner surfaces, and maintenance of healthy tissue structure. a Wyss Technology Development Fellow at the Institute. During his Ph.D.

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness. mL to sustain the desired effect.

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Drug Discovery World

FEBRUARY 26, 2024

Perhaps the greatest example of this has come from CAR-T cell therapies, which have developed as treatments for aggressive lymphomas, particularly in childhood cancers. She and bit.bio are going beyond this cell type and looking at producing other cell types which may provide answers to a range of diseases beyond blood cancers.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g.

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