Astrazeneca plc moved AZD9291 (osimertinib) across the finish line in rapid fashion, gaining accelerated approval from the FDA a little more than 30 months after advancing the drug into the clinic in March 2013. Read More
HONG KONG – The CFDA released new regulations to accelerate drug approvals and enhance the integrity of clinical data. At the same time, the regulator is soliciting opinions on a fast-lane approval process for novel drugs. Read More
HONG KONG – The China Securities Regulatory Commission (CSRC) said Friday it plans to lift the four-month ban on IPOs that started during a bout of extreme volatility in the financial markets in Mainland China throughout June and July. Read More
LONDON – It has taken many years of painstaking research, largely conducted in academic labs, but there is now a palpable sense that cell and gene therapies have reached a tipping point. A growing volume of early stage data indicates those products do – as promised – deliver unprecedented clinical benefit. Read More
SHANGHAI – For the second time this year, Eli Lilly and Co. entered a strategic collaboration agreement with a local Chinese company to co-develop a novel candidate for the China market, this time with Shanghai-based Wuxi Pharmatech (Cayman) Inc., the well-respected, multifunctional contract research organization (CRO) and contract manufacturer. Read More
Cerecor Inc., of Baltimore, said the units issued in its recent IPO will separate. Each unit consists of one share of common stock of the company, one class A warrant to purchase one additional share of common stock and one class B warrant to purchase one-half additional share of common stock. The class A and class B warrants will trade separately on Nasdaq under the symbols CERCW and CERCZ, respectively, with the common stock trading under the symbol CERC. Read More
Gilead Sciences Inc., of Foster City, Calif., said the FDA approved additional indications for hepatitis C virus (HCV) drug Harvoni (ledipasvir/sofosbuvir) for use in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV. Read More
Genspera Inc., of San Antonio, provided an update on trials with mipsagargin (G-202), a prostate-specific membrane antigen (PSMA)-activated prodrug targeting the tumor endothelium, in adult patients with recurrent or progressive glioblastoma. Read More
Researchers from Harvard Medical School and the Brazilian Universidade de Sao Paulo have discovered a gene variant that could counteract the effects of mutant dystrophin. Read More
