Search Results for “EU” – Page 34 – media

Almirall and EpimAb Biotherapeutics enter $210m bispecific antibody partnership

Almirall and EpimAb Biotherapeutics have announced a bispecific antibody partnership worth up to $210m. The agreement will give dermatology-focused Almirall a licence to utilise EpimAb’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate, develop and commercialise bispecific antibodies. Almirall will have exclusive global rights for any resulting products and, in exchange, EpimAb is eligible to receive milestone payments totalling up to $210m plus royalties on net sales. Karl Ziegelbauer, executive vice president, research and development, and chief scientific officer of Almirall, said the agreement was “an important step” towards the company’s ambition to develop new biologics in the dermatology field. EpimAb’s FIT-Ig platform generates bispecific antibodies using only the basic structural parts of monoclonal antibodies without adding any complex changes. The company has so far focused the technology within the oncology space and currently has five clinical-stage assets being evaluated for indications including non-small cell lung cancer (NSCLC), gastrointestinal cancer and multiple ...
- Source: drugdu
- 134
- October 17, 2023
European Commission orders Illumina to divest Grail

Dive Brief The European Commission on Thursday ordered Illumina to unwind its 2021 acquisition of liquid biopsy-maker Grail, establishing deadlines for the company to follow as well as potential penalties for non-compliance. The commission in September 2022 prohibited Illumina from buying Grail, maker of a blood-based early cancer detection test, over concerns that the merger would stifle innovation in the emerging market. Illumina and Grail completed the $8 billion deal anyway, in an alleged breach of EU merger control rules. Illumina, which is appealing the EC’s decision, said in a statement Thursday that it was reviewing the order. Dive Insight Illumina has been expecting the EC’s divestment instructions while maintaining that the commission does not have jurisdiction over the merger. The gene-sequencing industry leader is appealing the jurisdictional issue with the European Court of Justice. The company has said it will pursue parallel paths, working to divest Grail according to ...
- Source: drugdu
- 188
- October 14, 2023
FDA Clears IND for Kyverna Therapeutics’ Scleroderma Treatment

KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
- Source: drugdu
- 111
- October 13, 2023
Q&A With David Klein, Co-Founder and CEO of Click Therapeutics

Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
- Source: drugdu
- 182
- October 12, 2023
In cutting sales guidance, EuroAPI cites CDMO industry struggles and customers’ inventory reductions

Flush with business during the COVID pandemic, the CDMO industry is struggling to adjust in the aftermath. Case in point is EuroAPI, which has slashed its projected revenue growth in 2023 from a range of 7% to 8% to a new window of 3% to 5%. The Sanofi drug ingredients spinoff also has dropped its estimated earnings growth from between 12.5% and 13.5% to range of 9% to 11%. During a conference call on Monday, CEO Karl Rotthier chalked the changes up to pricing pressures resulting from lower inflation, coupled with “inventory reduction programs implemented by some of our customers.” Rotthier also mentioned the “biotech funding crisis.” He said that more than 20 of the company’s projects have been delayed, reduced in scope or halted altogether. The board of EuroAPI has begun to conduct a strategic review of its operating model. The company’s midterm view of its prospects from 2023 ...
- Source: drugdu
- 111
- October 11, 2023
FDA Approves Novartis’ New Rheumatic Disease Treatment

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
- Source: drugdu
- 112
- October 11, 2023
Amgen Completes Purchase of Horizon Therapeutics

Acquisition includes company’s inflammatory disease medicines. Image Credit: Adobe Stock Images/SciePro Amgen revealed in a company press release that it has officially finished its purchase of Horizon Therapeutics for an approximate value of $27.8 billion. According to the company, the acquisition includes: • Alignment with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases. • Strengthening of Amgen’s leading inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), which treat rare inflammatory diseases. • Leveraging of Amgen’s world-class capabilities in biologics research and development, process development and manufacturing, as well as Amgen’s presence in more than 100 countries around the world. • Generating robust cash flow to support capital allocation priorities, including ongoing investment in innovation while sustaining a commitment to an investment grade credit rating. • Acceleration of revenue growth; expected to be ...
- Source: drugdu
- 192
- October 8, 2023
FDA expands total product life cycle program to cover neurological devices

Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
- Source: drugdu
- 197
- October 4, 2023
Ariceum doses first patient with satoreotide

by John Pinching The treatment targets extensive stage small cell lung cancer and aims to boost therapeutic impact Ariceum Therapeutics, a company developing products for the treatment of specific cancers, has announced that the first patient has been dosed with its satoreotide therapy. The treatment targets extensive stage small cell lung cancer (ES-SCLC), while the research is taking place at the Murdoch University Health Center in Australia. Ariceum’s broader open label phase 1b trial will analyse the tolerability and safety of the ‘theranostic pair’ of somatostatin receptor antagonists, ga-satoreotide trizoxetan and lu-satoreotide tetraxetan, among patients with ES-SCLC. The central aim of the research is to establish a recommended phase 2 dose and schedule in due course. ‘Theranostics’ is the system of incorporating two paired drugs: the first, a diagnostic agent to identify cells that exhibit a particular biomarker, and the second, a therapeutic drug which subsequently acts on those cells. ...
- Source: drugdu
- 206
- October 3, 2023
Azurity Pharmaceuticals Absorbs Slayback Pharma

The company expects to yield a significant number of new medicine launches from the acquisition. Azurity Pharmaceuticals, Inc. broke the news that it has officially acquired Slayback Pharma LLC from existing investors including KKR and Everstone Capital, making it a wholly owned subsidiary. According to Azurity, the acquisition is expected to realize its purpose of serving overlooked patients, hoping to yield a significant number of new medicine launches over the coming years. “I am delighted to announce this combination and the increased potential it brings to do more for overlooked patients,” said Richard Blackburn, CEO, Azurity. “The complementary expertise of the two companies in developing innovative dose forms will result in a strong pipeline of new medicines to meet the needs of patients. We will bring the commercial expertise of Azurity to Slayback’s pipeline and look forward to introducing an even wider range of dose-forms and formulations to meet a ...
- Source: drugdu
- 167
- September 29, 2023

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