The European Medicines Agency’s main scientific committee, the CHMP, is recommending approval of the cellular immunotherapy for prostate cancer, Provenge (sipuleucel-T). Provenge was approved by the Food and Drug Administration in 2010.
The US Food and Drug Administration has approved the first recombinant coagulation Factor IX product for the prophylaxis of bleeding in people with haemophilia B. The manufacturer is Baxter Healthcare Corporation.
Prosensa Holding BV, a Dutch company that is developing antisense technology for therapies to treat rare diseases, has priced its previously-announced US initial public offering of shares at $13 per share. The offering comprises 6 million ordinary shares, giving a gross value of $78 million.
MorphoSys AG has secured its second antibody licencing agreement in less than a month – this time with Celgene Corp for the development of a new therapeutic for multiple myeloma. The deal is valued at up to $818 million before royalties.
Drisapersen, a candidate molecule for Duchenne muscular dystrophy (DMD), has received ‘breakthrough therapy’ status from the US Food and Drug Administration, according to GlaxoSmithKline Plc. Drisapersen is an antisense oligonucleotide.
A new company, Rodin Therapeutics, that will apply epigenetics to the search for new therapies for neurological disorders is being launched by Atlas Venture LP of Cambridge, Massachusetts, US and Proteros biostructures GmbH of Germany.
Heptares Therapeutics Ltd has announced the results of a Series B financing round in which it raised more than $21 million to advance a candidate product for Alzheimer’s dementia and disorders of cognitive impairment into the clinic.
AmpliPhi BioSciences Corp has placed $7 million of convertible preferred stock with a group of life science investors in order to finance the development of therapeutics for infectious diseases including bacterial infections.
Roche and AstraZeneca Plc have entered into a deal to share certain know-how in the area of medicinal chemistry in order to accelerate the discovery of new pharmaceutical compounds. Financial details were not disclosed.
The US Food and Drug Administration has approved updates to the US labels for Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin), treatments for Type 2 diabetes, in order to add pancreatitis to the warnings and precautions section of the labels, according to Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company.