BioMimetic said GEM 21S received CE Mark approval in the EU to treat osseous defects resulting from tooth extraction and trauma and for use in compromised patients where poor healing may occur. The approval triggers...

Regulatory milestones Basilea Pharmaceutica AG (SIX:BSLN) gained CHF1.10 to CHF36.80 last week after announcing plans to submit an MAA to EMA next half for ceftobiprole to treat severe pneumonia in the hospital setting. BioMimetic Therapeutics...

BioMimetic Therapeutics Inc. (NASDAQ:BMTI) said it received a response letter from FDA for a PMA for the company's Augment Bone Graft requesting additional information from a pivotal trial. The agency also requested further information related...

The CHMP recommended that a contraindication be added to the label for Regranex bercaplermin stating that the dermal ulcers drug must not be used in patients with pre-existing cancer. CHMP is part of the European...

EMEA's CHMP issued a final negative opinion on BioMimetic's MAA for Gemesis bercaplermin (GEM 21S) to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums. The...

EMEA's CHMP issued a negative opinion on an MAA from BioMimetic for Gemesis bercaplermin (GEM 21S) to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums....

VaxGen and oncology company Raven caved under the weight of shareholder disapproval last week and terminated their merger plans. The deal had been scheduled for a shareholder vote on Friday, but was pulled due to...

BioMimetic (NASDAQ:BMTI) added $1.95 (30%) to $8.45 on Friday after the company said it did not receive any communication from FDA regarding its recombinant human platelet-derived growth factor (rhPDGF) products. On Thursday, BioMimetic fell $8.24...

BMTI will sell its remaining dental business to Sankyo's Luitpold Pharmaceuticals Inc. subsidiary for $40 million in cash. BMTI also will receive about $4 million in cash for existing inventory, plus royalty payments, on GEM...

BMTI raised $36.4 million through the sale of 2.1 million shares at $17.15 in a follow-on underwritten by Deutsche Bank; Pacific Growth; First Albany; and AG Edwards . Selling shareholders sold an additional 705,000 shares. BMTI's...