Celltrion Healthcare Inc. planted the oncology flag in biosimilars with the European Commission's approval of Truxima, a biosimilar to Rituxan (rituximab, Roche Holding AG/Biogen Inc.), and the compound will provide estimated health care savings across the 28 countries of the EU of about €570 million (US$602 million) over a three-year period.
The endpoint miss in phase II with a topical version for moderate to severe acute vulvovaginal candidiasis (VVC, often known as yeast infection) did not dim Cidara Therapeutics Inc.'s optimism for an intravenous (I.V.) form of the echinocandin antifungal CD101 in candidemia, though Wall Street apparently felt otherwise.
With a pair of drugs devoted to what Ionis Pharmaceuticals Inc. CEO Stanley Crooke called "systematically knocking off the remaining lipid risk factors" for patients facing cardiovascular (CV) trouble, the company and its subsidiary, Akcea Therapeutics, closed their potential $1.6 billion deal with Novartis AG.
Key opinion leaders (KOLs) were "giddy" about Ardelyx Inc.'s phase III data with tenapanor for hyperphosphatemia in patients with end-stage renal disease who are on dialysis, said CEO Mike Raab, and the company is putting together plans for another experiment that could lead to approval.
Adding to its portfolio in an increasingly attractive therapeutic area and hoping to bring back patients after a landmark Women's Health Initiative (WHI) study on estrogen treatments, Amag Pharmaceuticals Inc. signed a deal with Endoceutics Inc. that brings U.S. commercial rights to Intrarosa (prasterone), an FDA-cleared, daily non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA) due to menopause.
In order to go it alone with antibody drug conjugate (ADC) IMMU-132, Immunomedics Inc. would need to immediately raise $150 million to cover the phase III trial in triple-negative breast cancer (TNBC) and another $125 million to build a sales force, which is one reason why the company signed a potential $2 billion deal with Seattle Genetics Inc. focused on the drug more specifically known as sacituzumab govitecan, said Jason Aryeh, vice chairman of the board and chairman of the transaction committee.
"You get what you get," Acorda Therapeutics Inc.'s chief technology officer, Richard Batycky, told BioWorld Today on the subject of the placebo effect in the successful phase III trial with inhaled levodopa CVT-301 for improving motor function in Parkinson's disease (PD) patients.
The era when a clinical failure in Alzheimer's disease (AD) meant major headlines, stock sell-offs and conference calls attempting damage control seems to be over, as two pharma giants – this year and last year – practically murmured their mid and late-stage blowups with AD candidates in the 5HT6 receptor antagonist class.
“I don’t think we had any real safety issue” with giving two doses in an earlier trial, Kiadis Pharma NV CEO Manfred Rüdiger told BioWorld Today, but Canadian phase III testing of ATIR101 (Allodepleted T-cell ImmunotheRapeutics) will deploy a single dose of the treatment, designed to provide safe donor lymphocyte infusion from a partially matched family member without the risk of causing graft-vs.-host-disease (GVHD) in hematopoietic stem cell transplant (HSCT) patients with leukemia.
