Shares of Anacor Pharmaceuticals Inc. skyrocketed Monday on much-anticipated top-line data from two pivotal trials testing crisaborole topical ointment 2 percent (formerly AN2728) in atopic dermatitis, with impressive early onset of action and safety data pointing to a potential blockbuster. Read More
The vaccine product pipeline has never been fuller, with more than triple the number of candidates in development today than in 2005 and global sales on track to reach $40 billion in five years, according to the July/August Impact Report from the Tufts Center for the Study of Drug Development (CSDD). Read More
HONG KONG – Regulators in China will start making unannounced inspections at pharmaceutical and medical device companies. "This is the first set of regulations for unannounced inspections in China," said Chao Xu, managing director of Chinese medical device service group Osmunda's Germany branch. Read More
LONDON – The first comprehensive genome profiling of small-cell lung cancer (SCLC) has revealed that the disease occurs when both copies of two separate tumor suppressor genes are switched off. Read More
Ohr Pharmaceutical Inc. shares (NASDAQ:OHRP) snapped out of a months-long amble, jumping 62.6 percent to $3.69 Monday after a small midstage study showed that its lead candidate, OHR-102 (squalamine lactate ophthalmic solution 0.2 percent) eye drops, helped certain patients with macular edema receiving Lucentis (ranibizumab, Genentech Inc./Roche AG) achieve greater visual acuity gains than patients receiving Lucentis alone. Read More
NEW DELHI – The WHO has rapped yet another Indian clinical research organization (CRO) for "critical lapses and major deviations" during the conduct of clinical trials, bringing the spotlight back to the need for Indian pharma firms and CROs to pull up their socks over stringent adherence to trial protocols. Read More
strong>Astrazeneca plc, of London, said the FDA approved Iressa (gefitinib) tablets, 250 mg once daily, for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. Read More
TC Biopharm Ltd., of Edinburgh, Scotland, said it raised £1.18 million (US$1.82 million) in equity and grant funding to treat UK-based patients with melanoma, lung and kidney cancer. Scotland's only female angel group, Investing Women, led the £680,000 investment, with support from Scottish Investment Bank and WH Partnership. Read More
strong>Cleveland Biolabs Inc., of Buffalo, N.Y., reported that a phase I study of CBLB612, a drug in development for oncology indications, including the prevention of chemotherapy-induced myelosuppression, showed that single subcutaneous injections of the drug were generally well tolerated in 56 healthy volunteers. Read More
