FDA approves new indication for Lynparza
The US Food and Drug Administration has approved a new indication for Lynparza (olaparib) for the maintenance treatment of adults with suspected germline BRCA-mutated advanced ovarian cancer.
The US Food and Drug Administration has approved a new indication for Lynparza (olaparib) for the maintenance treatment of adults with suspected germline BRCA-mutated advanced ovarian cancer.
Less than a year after buying out Novartis’ interest in a joint consumer products venture, GlaxoSmithKline Plc has reached an agreement with Pfizer Inc to set up a new consumer products venture with expected sales of £9.8 billion.
Within three years of the closing of the transaction, GSK plans to separate the joint venture via a demerger of its equity interest and list the venture on the UK equity market. This would leave two GSK listed companies: one focused on consumer healthcare and the other on pharmaceutical and vaccine R&D.
Novo Holdings A/S is providing $15 million in Series A financing for the launch of a new San Diego, US-based company with plans to build a portfolio of drugs targeting serious inflammatory diseases. Aristea Therapeutics Inc will use the funds to start a Phase 2 trial of a small molecule anti-inflammatory drug in-licensed from AstraZeneca Plc called RIST4721.
In connection with the financing, Tiba Aynechi and Ken Harrison from Novo Ventures (US) Inc, which is owned by Novo Holdings, will join Aristea’s Board of Directors.
Summit Therapeutics Plc plans to raise $25 million in a private share placement that will finance a Phase 3 clinical programme of the investigational antibiotic ridinilazole for the treatment of Clostridium difficile.
The funds will also support a product to treat gonorrhoea which is poised to enter Phase 1 and a group of discovery assets targeting pathogens (ESKAPE pathogens) that are responsible for the majority of nosocomial infections in the world.
Santhera Pharmaceuticals Holding AG has raised CHF 23.5 million (€20.82 million) in a share placement to complete the acquisition of rights to vamorolone, a synthetic glucocorticoid corticosteroid which is being developed for Duchenne muscular dystrophy (DMD).
The European Medicines Agency’s main scientific committee has recommended approval of a new hybrid medicine for managing chronic pulmonary infection due to the bacteria Pseudomonas aeruginosa in patients with cystic fibrosis.
An RNA oligonucleotide drug that is being tested as a combination therapy in patients with pancreatic and colorectal cancers has produced positive data in a Phase 1 clinical study. Top-line results from the combination of NOX-A12 (olaptesed pegol) and Keytruda produced responses from patients whose cancers had progressed rapidly on prior therapy.
e-Therapeutics Plc is to collaborate with Novo Nordisk A/S to discover potentially novel therapeutic approaches for treating a specific area of Type 2 diabetes. The two companies will use e-Therapeutics’ discovery platform to identify new biological pathways and compounds.
The agreement lasts 12 months. Financial terms were not disclosed.
Argenx NV has secured a licensing agreement for its early-stage antibody drug cusatuzumab with Janssen Pharmaceutical Companies to develop the drug for acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS). Announced on 3 December, the deal features an upfront cash payment of $300 million and potential milestones of $1.3 billion.
In addition to the current and future cash payments, Janssen will purchase $200 million of newly issued Argenx shares representing 4.68% of the Belgian company’s outstanding shares at a price of €100.02 per share.
GlaxoSmithKline Plc has taken a major step to rebuild its oncology portfolio with the agreed acquisition of Tesaro, Inc for $5.1 billion which has a poly ADP ribose polymerase (PARP) inhibitor on the market for the treatment of patients with ovarian cancer. This drug is Zejula (niraparib).