Gilead Sciences Inc. did not disappoint in its third-quarter performance, reporting 14 percent higher revenues, at $2.43 billion, compared to $2.12 billion the same period a year earlier.
On the eve of reporting third-quarter earnings, Eli Lilly and Co. confronted a storm warning from Fitch Ratings, which affirmed the big pharma's ratings – including the issuer default rating (IDR) – at "A" but lowered its outlook on the company from "stable" to "negative."
GlaxoSmithKline plc (GSK) took extraordinary steps toward data transparency last week, disclosing plans to accelerate its "open innovation" approach to R&D by allowing researchers access to detailed patient-level data underlying clinical trials both in approved medicines and failed investigational compounds.
In recent months, Gilead Sciences Inc. appeared to be in the driver's seat in the race for an all-oral, interferon-free hepatitis C virus (HCV) regimen. However, Abbott's posting of the first Phase III trial of its combination HCV regimen on ClinicalTrials.gov puts Gilead on notice that it won't cross the finish line unchallenged.
GlaxoSmithKline plc (GSK) took extraordinary steps toward data transparency Thursday, disclosing plans to accelerate its "open innovation" approach to R&D by allowing researchers access to detailed patient-level data underlying clinical trials both in approved medicines and failed investigational compounds.
In a report issued early Thursday morning, the independent Presidential Commission for the Study of Bioethical Issues warned that whole genome sequencing – likely available in the near future for as little as $1,000 – could raise enormous ethical dilemmas not only in patient care but also in the conduct of clinical trials.
The FDA's decision last week that an approved generic bupropion wasn't comparable to GlaxoSmithKline plc's antidepressant Wellbutrin XL 300 mg (bupropion) raises questions about the hurdles biosimilar developers may face along the new regulatory path.
On Friday, monoclonal antibody (mAb) developer KaloBios Pharmaceuticals Inc. filed a registration statement with the SEC for a proposed initial public offering (IPO), indicating a proposed maximum offering price of $60 million.
In a potential sign the initial public offering (IPO) waters may become more treacherous for biotechs during this year's presidential election season, Regulus Therapeutics Inc. slashed the price of its IPO to $4 per share – less than half of the proposed price range of $10 to $12 – while more than doubling the number of shares, from a proposed 4.5 million to 11.3 million.
Flush with $27 million from a Series A in August, Aerpio Therapeutics Inc. is moving full speed ahead into its clinical development program for AKB-9778, a first-in-class human protein tyrosine phosphatase-beta (HPTP-beta) inhibitor, with dosing of the first patients in a Phase Ib/IIa study in diabetic macular edema (DME).
