Investors relished third quarter earnings Wednesday, pumping up shares of Alkermes plc and Dyax Corp., while cooling their outlooks on Gilead Sciences Inc. and Vertex Pharmaceuticals Inc., worried over lower-than-anticipated sales of their top drugs. Read More
BOGOTA, Colombia – In a move that could lead to sharp increases in the operational timing and costs of introducing generic and subsequent entry of biologic drugs into the Brazilian market, Brazil's National Health Surveillance Agency (Anvisa) updated its guidelines for the issuance of certificates of good practice of bioavailability and bioequivalence studies for both domestic and international labs. Read More
Aileron Therapeutics Inc.'s wider series E round of $48 million came as a result of upped attention from investors, thanks to "work that's gone on during the last 10 months," said Joseph Yanchik, CEO of the Cambridge, Mass.-based firm, which is developing stapled-peptide technology. Read More
Cara Therapeutics Inc.'s opioid candidate CR845 passed with flying colors a critical test, demonstrating significantly lower abuse potential compared to a comparator schedule IV narcotic, results that could give it an edge in the multibillion-dollar analgesic market as the first opioid with a schedule V – perhaps even nonscheduled – labeling. Read More
Although it's still in an embryonic stage, an international neonatal consortium was birthed Wednesday to accelerate the development of much-needed drugs and devices for neonates. Read More
LONDON – The discovery of more than 30 genes containing new mutations that are highly likely to play a role in the development of autism spectrum disorder (ASD) will provide new insights into the causes of these conditions. Read More
Imevax GmbH, a newly formed spinout from the Technical University of Munich (Technische Universität München; TUM), raised €7.5 million (US$9.6 million) in a series A round to fund clinical trials of a vaccine against Helicobacter pylori. Read More
Ultragenyx Pharmaceutical Inc. gained FDA orphan status for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome, also known as De Vivo disease. The Novato, Calif.-based company is conducting a phase II study of triheptanoin, which is a synthetic triglyceride. Read More
Synergy Pharmaceuticals Inc., of New York, said it priced a private offering of $175 million aggregate principal amount of 7.50 percent convertible senior notes due in 2019. The company also granted the initial purchasers of the notes an option to purchase up to an additional $25 million of the notes. Read More
Pfizer Inc., of New York, said a study published in the Journal of Clinical Psychiatry showed comparable sexual function in adult patients diagnosed with major depressive disorder (MDD) who were treated daily with Pristiq (desvenlafaxine) extended release tablets at 50 mg and 100 mg doses compared to placebo. Read More
Intas Pharmaceuticals Ltd., of Ahmedabad, India, received an ex parte injunction from the Delhi High Court against the sale of the anti-epilepsy drug, Valrope, by Arinna Lifesciences Pvt. Ltd., also of Ahmedabad. Intas accused Arinna of a trademark violation against its brand, Valprol. Read More
