Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

JANUARY 5, 2023

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. The post Capsida Biotherapeutics and Prevail to develop CNS gene therapies appeared first on Pharmaceutical Technology.

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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. for patients with NTRK fusion cancer across all solid tumors.

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Pharmaceutical Technology

APRIL 13, 2023

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Under the terms, Biogen will handle all the development and commercial activities of ATV: Aβ, along with the related expenses.

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Pharmaceutical Technology

JULY 28, 2022

Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults. It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.

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Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

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Pharmaceutical Technology

OCTOBER 4, 2022

Developed under joint research between Shionogi and Hokkaido University, the antiviral averts SARS-CoV-2 replication by hindering 3CL protease. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.

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Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. 3BP receives an initial payment of $40m, and $425m as development, regulatory and commercial milestone payments.

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XTalks

FEBRUARY 4, 2025

It then studies how these variants affect disease progression and uses this information to develop treatments that either mimic protective variants or block harmful ones. The Phase I trial showed promising safety and pharmacokinetics. Maze plans to begin a Phase II trial in 2025 and expects proof-of-concept data by early 2026.

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Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

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XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

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Trials Clinical Trials Clinical Trials Insulin 59

XTalks

APRIL 3, 2025

Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.

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Trials Clinical Trials Clinical Trials Genetics 59

Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year.

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Vaccination Vaccine Clinical Trials Clinical Trials 246

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

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Pharmaceutical Technology

FEBRUARY 6, 2023

South Korean biotechnology company Qurient has entered a licence agreement with TB Alliance for the development and commercialisation of telacebec (Q203). Under the deal, TB Alliance will have the exclusive global license to develop and market telacebec except in Russia, South Korea, and the Commonwealth of Independent States (CIS) countries.

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Development Drugs Licensing Licensing 147

Pharmaceutical Technology

DECEMBER 2, 2022

The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC), supported Bharat Biotech in developing the new intranasal vaccine for Covid-19. Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine.

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Vaccination Vaccine Clinical Trials Clinical Trials 217

XTalks

MARCH 19, 2025

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. Participants were randomized in a 2:1 ratio to receive eneboparatide or a placebo.

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Trials Hormones Engineer Licensing 59

Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

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Pharmaceutical Technology

AUGUST 8, 2022

The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.

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Hormones Clinical Trials Clinical Trials Licensing 246

Pharmaceutical Technology

APRIL 12, 2023

Panbela Therapeutics has regained the global rights for the development and commercialisation of Flynpovi (a combination of CPP-1X [eflornithine] and sulindac) to treat familial adenomatous polyposis (FAP) patients. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

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Pharmaceutical Technology

MAY 30, 2023

As part of an exclusive licensing agreement, Amplo Biotechnology secured access to AAV-ColQ data developed by Professor Kinji Ohno’s laboratory at Nagoya University, which forms the basis of the therapy. It is expected to enter clinical trials in 2024.

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Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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Pharmaceutical Technology

MAY 18, 2023

Director of Corporate Development, in an interview with Pharmaceutical Technology. The trial, a six-week study, will assess the change in the Hamilton Depression Rating Scale score, says Houghtaling. The trial will take place at US clinical sites, adds Houghtaling. Rob Houghtaling, Sr.

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pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. This is particularly important in developing countries, where access to cold-chain is limited,” said Channon. There are other theoretical advantages as well.

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XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. In the first trial, 122 adults received Crenessity twice daily and 60 received placebo twice daily for 24 weeks. Crenessity marks the third approved drug for Neurocrine. billion in revenue by 2024.

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XTalks

APRIL 1, 2025

The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD. While the trial data showed that itolizumab did not improve complete or overall response rates at Day 29, statistically significant and clinically meaningful benefit in longer-term outcomes were achieved.

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Pharmaceutical Technology

MARCH 2, 2023

resulted primarily from the development of the US dollar and the Chinese renminbi. Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022. organic rise.

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pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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Worldwide Clinical Trials

OCTOBER 19, 2022

Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials. Aside from the obvious complexities of managing a drug that alters the mind, the regulatory and ethical nuances can hold ill-prepared developers back.

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Pharmaceutical Technology

JUNE 13, 2023

The funding, with participation from Oxford Science Enterprises (OSE), includes AGTC’s acquisition and capital to help accelerate Beacon Therapeutics’ candidate development. The asset, now transferred to Beacon Therapeutics, is currently in Phase II clinical trials. The total financing was £96m ($120m).

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XTalks

DECEMBER 4, 2024

Proceeds from the IPO will propel key initiatives, including the Phase II clinical trial of Jotrol in Parkinson’s disease. These efforts aim to fast-track commercialization and out-licensing agreements in one of the world’s most promising pharmaceutical markets.

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