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Hutschison China MediTech get’s priority review status for its anti-cancer drug surufatinib

Hutchison China MediTech Limited said on Friday that it got approval from the China’s authority, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), a Priority Review status to the New Drug Application (NDA) for surufatinib, for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (NET).

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Symbiosis invests £1.5m in Stirling site

#Symbiosis Pharmaceutical Services has invested over £1.5m ($1.9m) during the last year, to expand its sterile biologics manufacturing facility in Scotland, UK by 25%.

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Roche buys Spark Therapeutics for $4.3 billion

Swiss-based Roche’s is buying Spark Therapeutics for of $114.50 per share in cash, total $4.3 billion through its fully owned subsidiary 022019 Merger Subsidiary.

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Inceptua names new CEO, adds to board of directors

Inceptua, a pharmaceutical company and service partner in comparator sourcing for clinical trials, through early access programs to licensing and commercialization of products, said Wednesday that Stefan Fraenkel, Executive Vice President, and Member of the Executive Leadership Team, is promoted to CEO effective 1 January, 2020.

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Synimmune’s anti-tumor Flysyn verywell tolerated in study

Synimmune GmbH, a biotechnology company focusing on the development of innovative and effective anti-tumor antibodies for orphan hematopoietic malignancies, presented results of its first-in-human clinical study of FLYSYN, a novel Fc-optimized antibody, for the treatment of acute myeloid leukemia (AML) were presented at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

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Merck buys ArQuele for $2.7 billion

Merck said Monday that it iwll, through a subsidiary, initiate a tender offer to acquire all outstanding shares of ArQule for nearly $2.7 billion, or for $20 per share in cash.

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FDA to fast track Equillium’s itolizumab for lupus nephritis

Equillium got U.S. FDA’s Fast Track designation for itolizumab for the treatment of lupus nephritis, after startign the phase 1 study of itolizumab in patients with lupus and lupus nephritis in September 2019.

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Inceptua, Onconova Therapeutics in pre-approval access collaboration

Inceptua Medicines Access, a business unit of the Inceptua Group, has announced the collaboration with Onconova Therapeutics to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world.

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Actinium’s phase 3 trial dosimetry results support low dose iomab-B for targeted lymphodepletion prior to adoptive cell therapy

Actinium Pharmaceuticals is advancing the development of low dose Iodine-131 apamistamab, a CD45 targeting antibody radiation-conjugate (ARC), as an alternative to today’s standard practice of chemotherapy-based lymphodepletion regimens like fludarabine/cyclophosphamide (Flu/Cy), which have been implicated in CAR-T toxicities including cytokine release syndrome (CRS) and neurotoxicity.

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Novartis’ clinical trial of inhaled dual combination QMF149 for patients with asthma, meets primary endpoint

Novartis Phase III Palladium clinical trial has met the primary endpoing, as it showed that QMF149, a once-daily fixed-dose combination of indacaterol acetate and mometasone furoate (IND/MF) in development, was superior to mometasone furoate (MF) at medium and high doses in improving lung function.

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