Lab Notes: Injections That Are ‘Soft as Silk’

(MedPage Today) — Tiny biodegradable needles made of silk protein may one day deliver ouchless injections, researchers suggested. Also in this week’s Lab Notes installment: stem cell wrapping to slow brain cancer.

Additional financing to fund Advaxis’ cervical cancer trials

Advaxis, Inc.,, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has entered into a definitive Convertible Notes Purchase Agreement (Agreement) with certain accredited investors, for the purchase of the aggregate principal value of approximately $1.2 million of Convertible Promissory Notes (Notes) for an aggregate purchase price of approximately $1.0 [...]

FDA To Review Potential New Use Of XGEVA® (Denosumab) At Oncologic Drugs Advisory Committee Meeting

Amgen (NASDAQ: AMGN) announced the U.S. Food and Drug Administration (FDA) has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing [...]

"Science" Names HIV Prevention Trial As Breakthrough Of The Year

Science named the HIV Prevention Trials Network (HPTN) 052 study “Breakthrough of the Year.” FHI 360 congratulates our HPTN 052 collaborating partners on this important achievement. This is the second year in a row that Science selected a trial for which FHI 360 provided scientific leadership and operational support…

Denali Concrete Management Inc. Announces The Commencement Of Patient Enrollment For The Phase 3 Dry Eye Syndrome Study

Denali Concrete Management Inc. (OTCBB: DCMG) announced that it has commenced patient enrollment for a phase 3 clinical study of the safety and efficacy of CF101, daily administered orally, in patients with moderate-to-severe Dry Eye Syndrome. This multi-center clinical trial is conducted in the United States, Europe and Israel…

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

HimalayaUSA recalls two batches of Organique by Himalaya Nourishing Night Cream

HimalayaUSA announced today it is conducting a voluntary recall of Organique by Himalaya Nourishing Night Cream with batch #S691001 and batch #S691002 effective immediately.

ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.

ARCA biopharma extends pharmacogenetic intellectual property protection around bucindolol

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype - homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor.

FDA approves Pfizer’s Prevnar 13 pneumococcal conjugate vaccine as a single dose for adults

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults.