DUBLIN – Takeda Pharmaceutical Co. Ltd. has convinced the board of Shire plc of the merits of its £46 billion (US$62.1 billion) cash-and-shares takeover offer. Now it must do likewise with Shire's investors – as well as its own. Read More
Wishes do come true. The U.S. Patent and Trademark Office (USPTO) is proposing a rule that would align the standard the Patent Trial and Appeal Board (PTAB) uses in interpreting claims in inter partes review (IPR), post-grant review and covered-business method proceedings with that of the courts. Read More
LONDON – Faron Pharmaceuticals Ltd.'s share price crashed by 86 percent to £1.04 (US$1.41) after it announced the phase III failure of Traumakine in the treatment of acute respiratory distress syndrome (ARDS). Read More
Volanesorsen (Waylivra), the antisense oligonucleotide (ASO) targeting apolipoprotein C-III mRNA, gets a hearing before the FDA Thursday when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meets to review the new drug application submitted by sponsor Akcea Therapeutics Inc. The therapy has been advanced as an adjunct to diet to treat individuals with familial chylomicronemia syndrome (FCS), a rare genetic disease characterized by the build-up of chylomicrons, the largest lipoprotein particle, responsible for transporting dietary fat and cholesterol. FCS is characterized by extremely high triglycerides (TGs), putting patients at risk for multiple complications, including recurrent, potentially fatal bouts of pancreatitis. Read More
HONG KONG – China's Luye Pharma Group Ltd. acquired the rights of Astrazeneca plc's antipsychotics Seroquel (quetiapine fumarate) and Seroquel XR. The transaction, which will allow Luye to manufacture the drugs and market them in 51 countries and regions, is a win-win, helping Luye tap into the global market while Astrazeneca seeks to spin off products that are no longer part of its core business. Read More
Fresh off presenting positive new mechanistic data on its lead candidate, seladelpar, at the 2018 International Liver Congress in Paris, Cymabay Therapeutics Inc. said patient screening for a phase IIb proof-of-concept study of the drug in nonalcoholic steatohepatitis (NASH) is now underway. Enrollment is estimated to take about 12 months, with a top-line readout expected in the second half of 2019, Cymabay's CEO and president, Sujal Shah, told BioWorld. Read More
Intercept Pharmaceuticals Inc., of New York, reported worldwide sales of primary biliary cholangitis drug Ocaliva (obeticholic acid) totaling $35.2 million for the first quarter, with $28.5 million coming from the U.S. Read More
Scancell Holdings plc, of Nottingham, U.K., a cancer-focused company, said it has raised in aggregate about £7.5 million (US$10.2 million) in a placement of about 57.3 million shares and subscription of about 5 million shares at 12 pence per share. Read More
Genprex Inc., of Austin, Texas, selected Accenture to provide clinical data management services to help accelerate the clinical development of its lead drug candidate, Oncoprex (TUSC2 nanoparticles), for the treatment of non-small-cell lung cancer. Read More
