GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company. By Frank VinluanGSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced two vaccine candidates into clinical testing, and now GSK is taking over both, one of them in development for an infectious disease target that’s particularly hot right now. Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing, and a Covid-19 vaccine in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights ...
Just a week after Pfizer revealed a Phase III trial failure for its mini-dystrophin gene therapy for Duchenne muscular dystrophy (DMD), Sarepta has announced that it has scored a US label expansion for its DMD gene therapy Elevidys (delandistrogene moxeparvovec-rokl). As per the 20 June press release, the US Food and Drug Administration (FDA) has expanded Elevidys’ label to include DMD patients with a confirmed mutation in the DMD gene who are at least four years of age. Based on its functional benefits, Elevidys was granted traditional approval for ambulatory patients and accelerated approval for the non-ambulatory population. However, according to the announcement, which drove Sarepta’s shares up 36%, further progression on the approval track hinges on validated clinical benefits from a confirmatory study. When the therapy’s durability came into question, particularly in a non-ambulatory population, Sarepta CEO Douglas Ingram said in an investor call held on 21 June, that ...
Flagship Pioneering and ProFound Therapeutics have entered a partnership to develop new therapeutics for the treatment of obesity. The collaboration marks the first initiative executed under Flagship’s Pioneering Medicines deal with Pfizer announced in July 2023. Pioneering Medicines is the in-house drug discovery and development unit of Flagship and will spearhead the partnership’s efforts with Pfizer. ProFound’s ProFoundry Platform will be deployed with Pioneering Medicines’ capabilities in drug development to discover new proteins and assess their therapeutic potential to treat obesity. ProFound Therapeutics CEO and Flagship Pioneering CEO-partner John Lepore stated: “We are thrilled to be part of the Flagship and Pfizer partnership and to collaborate with Pioneering Medicines to discover and validate novel proteins that have the potential to lead to innovative, first-in-class medicines for patients with obesity. “Through our ProFoundry Platform, we have discovered and validated an extensive library of novel proteins that unlock a new universe of ...
Don Tracy, Associate Editor Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones. Nona Biosciences announced a major global license and option agreement with AstraZeneca, focusing on the development of monoclonal antibodies into targeted therapies for cancer treatment. Under terms of the deal, Nona Biosciences will receive an initial payment of $19 million. Additionally, the company will have the opportunity to receive up to $585 million pending the completion of milestones along with royalty payments on net sales.1 “We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies,” said Jingsong Wang, MD, PhD, chairman, Nona Biosciences, in a press release. “This agreement further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed ...
A new report from the Access to Medicine Foundation calls for urgent changes in research and development (R&D) to ensure new antibiotics and antifungals reach patients facing drug-resistant infections. The report examines five late-stage antimicrobial projects targeting severe drug-resistant pathogens, revealing that structured advance planning for access and stewardship is not yet standard among companies. Four out of five companies—GSK, Pfizer, Innoviva, and Venatorx—are conducting clinical trials involving children, aiming to improve access for paediatric patients. Despite these efforts, only five low- and middle-income countries (LMICs)—China, India, Mexico, South Africa, and Thailand—have concrete commitments for drug registration. Many of the remaining 108 LMICs with high burdens of targeted diseases lack such commitments. The report underscores the need for partnerships and licensing agreements to enhance access in LMICs. SMEs have pursued wider access through collaborations, like those with the Global Antibiotic Research and Development Partnership (GARDP). However, the report finds that ...
Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients. Yvonne Greenstreet, CEO, Alnylam It’s no surprise that Yvonne Greenstreet is winning awards. On Jan. 9, the Healthcare Businesswomen’s Association (HBA) announced the Alnylam CEO as its 2024 Woman of the Year. In the release, the HBA said that Greenstreet had earned the honor through her “notable and remarkable commitment and valuable contributions to women in the healthcare ecosystem.” It went on to describe Greenstreet as a trailblazer, advocate, and a true leader. Specifically, Greenstreet’s leadership at Alnylam, an RNA interference (RNAi) therapeutics company, was recognized. Since being appointed CEO in October 2021, she has helped steer Alnylam to being named one of Fortune’s Best Workplaces for Women. ...
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant.Novartis, whose presence in prostate cancer is mainly through the radiopharmaceutical Pluvicto, is expanding its prospects in the disease, striking a deal that brings a Phase 3-ready small molecule in the emerging therapeutic modality called targeted protein degradation. The drug, ARV-766, was developed by New Haven, Connecticut-based Arvinas. The deal announced Thursday calls for Novartis to pay $150 million up front. The Swiss pharmaceutical giant could shell out up to $1 billion more if the molecule achieves development, regulatory, and commercial milestones. Targeted protein degradation involves using a small molecule to target a disease-causing protein, marking it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degrader drugs, and the company’s pipeline ...
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