Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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Drug Discovery World

JANUARY 25, 2024

This follows another BIA report in January 2024, which showed that the UK is a global leader in cell and gene therapy (CGT), with significant investment and the highest number of clinical trials in Europe. Major licensing and M&A deals demonstrate the ongoing quality and attractiveness of UK science.

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Drug Discovery World

JULY 12, 2024

Earlier this year, AskBio presented the 18-month Phase Ib clinical trial results for AB-1005 , which met its primary objective of evaluating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

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Drug Discovery World

FEBRUARY 1, 2024

GSK’s Omjjara (momelotinib) has been granted marketing authorisation in Great Britain for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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Drug Discovery World

JULY 28, 2023

The top stories: Partnership could enhance antibody discovery for cancer research Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. New eBook: Breakthroughs accelerating therapeutic antibodies The latest eBook by DDW is out now.

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Drug Discovery World

MARCH 7, 2024

The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX. The programme was licensed from Bayer Healthcare and is a fifth generation neutrophil elastase inhibitor (NEI) targeting the inflammatory aspects of AATD, a rare condition.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Drug Discovery World

DECEMBER 20, 2022

The CHMP has recommended conditional marketing authorisation of CSL’s (etranacogene dezaparvovec), a one-time gene therapy for the treatment of appropriate adults with the disease. . The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug.

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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.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. It is also increasing economic operator inspections.

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Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8%

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Drug Discovery World

AUGUST 23, 2022

The European Medicines Agency (EMA) has granted a Marketing Authorisation Application (MAA) for a combination treatment targeting adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy. .

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Drug Discovery World

JANUARY 17, 2023

Leqembi’s prospects in the Alzheimer’s disease market remain uncertain despite its advantages over Aduhelm, says analytics company GlobalData. . Although Leqembi is a clear improvement on Aduhelm in terms of efficacy, the 27% reduction in clinical decline in its Phase III Clarity AD trial is still modest.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

3582 went nowhere; and many additional unsuccessful attempts to get a similar bill passed followed over the years. 3) A covenant not to sue on any claim that the ANDA product or biosimilar biological product infringes a United States patent.

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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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Drug Discovery World

JULY 2, 2024

OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2. The centre currently has 58 pharma/biotech assets that are in pre-clinical development, alongside 29 that are being tested in clinical trials.

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Drug Discovery World

NOVEMBER 14, 2023

This is not only made clear by the fact that the global cancer mAbs market size was valued at $55.6 Earlier in 2023, a mAb to prevent Covid-19 in vulnerable patients, AZD3152, entered clinical trials less than 12 months after its discovery. The global arthritis monoclonal antibodies market grew from $49.44

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DrugBank

AUGUST 15, 2024

This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks. Additionally, industry partners bring a wealth of experience in drug development and commercialization strategies, essential for translating scientific discoveries into marketable products that can reach patients worldwide.

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Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. Even still, these approved drug products require a licensed healthcare provider’s prescription. Across the border in Canada, cannabis is legal for both recreational and medicinal purposes.

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Drug Discovery World

SEPTEMBER 7, 2022

From research to clinical trials, FDA assessment and monitoring beyond, the process is by no means quick; anything that helps expediate the route for getting a drug to market is desirable. According to MarketsandMarkets the global AI in drug discovery market is projected to reach $1,434 million by 2024 from $259 million in 2019.

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The Pharma Data

JANUARY 17, 2021

But that number doesn’t quite reflect the company’s likely market valuation , which is expected to be between $9 billion and $12 billion. Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments.

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). For further information, please see [link].

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Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

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Drug Discovery World

MAY 31, 2023

Eisai has submitted a marketing authorisation application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. The investigational therapy has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

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Drug Discovery World

FEBRUARY 9, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC). versus 11.5%).

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Drug Discovery World

JANUARY 9, 2024

Inspirna has initiated a Phase II double-blind randomised controlled trial in second-line RAS-mutant advanced or metastatic CRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab. Merck already has marketing rights outside the US and Canada for IgG1 monoclonal antibody Erbitux for mCRC.

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The Pharma Data

MARCH 30, 2021

There can be no guarantee that the FAP targeting agents, including FAPI-46 and FAPI-74, will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time.

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Drug Discovery World

JULY 22, 2024

Challenges going to market The sector faces a number of challenges when it comes to bringing CGTs to market, which Loiacono reflects are indicative of broader industry issues. Adequate funding and financial resources are crucial for advancing research, conducting clinical trials, and establishing production facilities.

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Drug Discovery World

FEBRUARY 12, 2024

There was great fanfare recently for a new Alzheimer’s drug, lecanemab (brand name Leqembi), which was shown in a trial to reduce the rate of cognitive decline in people with mild impairment. This was confirmed in human trials and the drug was subsequently approved by the FDA.

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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. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. TOKYO and CAMBRIDGE, England , Dec.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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Drug Discovery World

JULY 16, 2024

Here, regulatory affairs teams are able to pre-empt agency queries in their initial submissions and/or when trying to provide consistent replies to questions globally – thereby increasing their chances of new products or clinical trials, or changes thereto, being accepted quickly, and first time.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. About Burning Rock.

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