Regeneron is eying potential regulatory approval of its treatment for a rare bone disease after Phase II clinical data showed an almost 90% reduction in the formation of new lesions in patients with fibrodysplasia ossificans progressiva (FOP). This morning, Regeneron…
Merck’s Keytruda Approved for High-Risk Bladder Cancer
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug. The company announced that the U.S. Food and Drug Administration (FDA) had approved the anti-PD-1 therapy as a monotherapy for patients with Bacillus Calmette-Guerin…
Biogen investment in Immuneel: Bringing CAR-T therapy to India
With nearly two million new cases and a million deaths each year in India, the war against cancer is amongst the most pressing crises in the country. Over the years, Eight Roads has had the privilege of partnering with companies…
FDA OKs alternative to open heart surgery for Abbott’s HeartMate 3 pump
Dive Brief: Abbott on Monday said FDA approved a less invasive surgical technique for its HeartMate 3 heart pump that will spare more patients from open heart surgery to have the device implanted. Called lateral thoracotomy, the alternative procedure enables…
Partnership aims to improve regulatory compliance management in life sciences
Natural Language Generation (NLG) company and document drafting technology supplier Litera have announced a partnership with Yseop to provide life science companies with more efficient and effective management of regulatory compliance processes. Bringing a new drug to market takes between 10…
PharmaLex merges with CompliMed
PharmaLex Group has completed its merger with CompliMed in the United Kingdom. CompliMed is the UK’s leading Healthcare Compliance Consultancy specialising in the ABPI Code of Practice. Their services include training, e-learning, outsourcing, audits, SOPs, medical review and final signatory…
New FDA cleared wearables for nausea on display at CES 2020
Wearables player Reliefband Technologies, has announced the unveiling of its new travel and sport therapeutic devices. The company specialises in technology that aims to prevent and treat nausea and vomiting symptoms, and has received have received U.S. Food and Drug…
Dural sealant patch receives CE mark
The device will be launched with immediate effect. Approval of the CE mark is based on data from Polyganics’ Encase I clinical trial, evaluating the safety and performance of Liqoseal in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. Three-month…
Transgene starts trials of ‘digital’ cancer vaccine with NEC
Undeterred by two clinical failures for its cancer immunotherapies in 2019, Transgene has kicked off the New Year by starting trials of a new vaccine for ovarian and head and neck cancers. The French biotech is partnering with artificial intelligence…
Merck & Co joins KRAS gold rush with Taiho and Astex collaboration
US-based Merck & Co has forged an R&D tie-up with Taiho and Astex Pharmaceuticals, focused on developing small molecule drugs targeting the KRAS gene that has become the subject of intense focus in pharma after a landmark trial from Amgen…
