WASHINGTON ‑ There’s a sorta funny, kinda snotty article in The Washington Post’s style section today – “Know your conventioneer” – that bills itself as “a handy field guide to help you identify which flock your summer conventioneer belongs to.” The article quotes the head of the Washington Convention Center Authority: “They travel in clusters. And their badges give them away.” A graphic that is supposed to help District of Columbians identify us, the 300,000 conventioneers who will come to their town this year, asks qualifying questions like, “Are the conventioneers multi-gendered? If the answer is no, the answer is...
WASHINGTON – For Western biotechs, getting regulatory approval to market a drug in the emerging Chinese market won't just involve the challenges of navigating a process that's different from the U.S. FDA's. There's also the challenge in dealing with drug review capacity at China's State Food and Drug Administration (SFDA) and its Center for Drug Evaluation (CDE) that's a fraction of the FDA's.
Pfizer Inc. partners Pain Therapeutics Inc. and Durect Corp. shared the pain of an FDA complete response letter (CRL) on Pfizer's resubmission of the new drug application (NDA) for Remoxy (oxycodone) extended-release capsules CII.
Achillion Pharmaceuticals Inc. stock soared nearly 21 percent by close Wednesday following the company's pricing of an underwritten public offering of 9.6 million shares at $5.90 a share, a 1.8 percent discount. The New Haven, Conn.-based company expects net proceeds of about $52.9 million, and could add about $7 million more through an underwriters' overallotment option for as many as 1.44 million shares.
In the largest Series B financing of the year – and what appears to be the largest biotech venture financing for any round in 2011 – privately held oncology start-up Tesaro Inc. raised $101 million to advance lead candidate rolapitant, a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting, and a small-molecule inhibitor of anaplastic lymphoma kinase.
A pivotal Phase II study of oral medicine vismodegib (RG3616/GDC-0449) showed positive results in people with inoperable, advanced basal cell carcinoma (BCC), a rare form of skin cancer, reported Genentech Inc., of South San Francisco, a member of the Roche Group.
I’m an American baby boomer. For me – and I suspect many others of my generation – China’s image has not been the best. In my mental collage, fascination with Chinese culture and invention is offset by wariness of China’s political system and potential power. Some parts of the collage: as a boy, listening to stories told by a Korean War vet uncle and neighbors about hand-to-hand fighting with young Chinese soldiers wearing tennis shoes on their frozen feet at Chosin Reservoir; as a teen, accounts of Mao Zedong’s chaotic Cultural Revolution, its purges and Red Guards; in middle age,...
Copenhagen, Denmark-based Zealand Pharma A/S licensed exclusive global development and commercialization rights to its lead glucagon/GLP-1 dual agonist drug candidate ZP2929, for the treatment of patients with Type II diabetes and patients with obesity, to Boehringer Ingelheim GmbH, of Ingelheim, Germany.
AVEO Pharmaceuticals Inc.'s golden touch remained intact as the Cambridge, Mass.-based company grossed $100 million plus in an underwritten public offering of 5.75 million shares of common stock at $17.50 a share, a discount of about 8 percent. An underwriters' option could add as much as $15 million more.
Vertex Pharmaceuticals Inc. positioned itself to expand the multi-billion dollar sales forecasts for recently approved hepatitis C virus (HCV) drug Incivek (telaprevir) with a potential $1.5 billion deal with privately held Alios BioPharma Inc., of South San Francisco, for worldwide rights to preclinical nucleotide analogues ALS-2200 and ALS-2158.
