20:37 , Dec 10, 2018 |  BC Extra  |  Company News

U.K. government says Orkambi must go through proper NICE channels

Responding to a petition calling for NHS England to cover cystic fibrosis drug Orkambi lumacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), the U.K. government threw its support behind NICE and urged the biotech to re-engage with...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
01:21 , Dec 8, 2018 |  BioCentury  |  Strategy

Novo gets serious about AI-guided drug design

Novo Nordisk A/S is fashioning its R&D makeover to integrate artificial intelligence across its drug discovery and development process, after a pilot program delivered the cost and time savings the pharma was looking for. In...
22:43 , Dec 7, 2018 |  BC Extra  |  Politics & Policy

U.K. warns pharma industry to prepare for six-month import delay across straits

The U.K. government has revised its no-deal Brexit contingency plans and now expects import delays of up to six months on certain border crossings, according to a letter from Secretary of State for Health and...
20:08 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

Editas to enter clinic with in vivo CRISPR therapy

Editas Medicine Inc. (NASDAQ:EDIT) plans to begin a Phase I/II trial of its CRISPR therapeutic EDIT-101 to treat Leber congenital amaurosis type 10 (LCA10) after FDA cleared its IND. EDIT-101 would be the first in...
18:14 , Dec 7, 2018 |  BC Week In Review  |  Financial News

Aprea heading for Phase III with €50M series C round

Aprea Therapeutics AB (Solna, Sweden) raised €50 million ($56.9 million) in a series C round on Nov. 30, with which it intends to fund a Phase III study of lead candidate APR-246 to treat myelodysplastic...
18:08 , Dec 7, 2018 |  BC Week In Review  |  Company News

argenx gets $500M up front from Janssen for CD70 mAb

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) will receive $500 million up front from Janssen Pharmaceuticals Inc. in exchange for exclusive, worldwide rights to anti-CD70 mAb cusatuzumab (ARGX-110). The upfront payment comprises $300 million in cash from the...
18:04 , Dec 7, 2018 |  BC Week In Review  |  Company News

GSK gains Zejula, immuno-oncology portfolio in $5.1B Tesaro takeout

Although it's inheriting a portfolio of cancer compounds from Tesaro Inc. (NASDAQ:TSRO) that fall squarely into competitive areas, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expects to transform the candidates, including Zejula niraparib, into best-in-class therapies under Hal...
03:31 , Dec 7, 2018 |  BC Innovations  |  Tools & Techniques

Germline editing gets technical

As the smoke clears from Jiankui He’s bombshell germline editing announcement, the gap between where the gene editing field is now and where it would need to be to support responsible germline editing has become...
01:14 , Dec 7, 2018 |  BC Week In Review  |  Company News

Vertex, NICE, NHS miss Orkambi deadline

Although NHS England, NICE and Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) have complied with a Parliament committee's request and submitted documents regarding pricing negotiations over the biotech's cystic fibrosis drugs, there is still no reimbursement deal for...