Mylan Soars after $465mn EpiPen Classification Settlement-Mylan $MYL shares gained sharply in aftermarket hours on Friday after reaching an agreement with government agencies in a $465mn settlement linked to Medicaid rebate classifications for its EpiPen. The settlement -- concerning the question of whether EpiPen Auto-Injectors were correctly classified as a non-innovator drug with Medicaid -- means Mylan admits to no offence.Mylan will take a pretax charge of about $465M for that reason, and has downwardly revised the guidance: It now sees full-year (adjusted) EPS at $4.70-$4.90, compared to earlier forecast of $4.85-$5.15, mainly due to changes in EpiPen access programs and the upcoming generic version. The company maintains that it will book a EPS of $6 in 2018. Q3 results are due on Nov 9.
Bristol-Myers drug Flunks to meet immunotherapy Expectations-A new lung treatment from Bristol-Myers Squibb $BMY that aimed to make the body into a defence against cancer flunked. The treatment failed to beat chemotherapy in a large head-to-head clinical trial. The outcome is a big setback for the new field of immunotherapy. Those participants taking Opdivo typically survived for just more than four months before the disease aggravated, while those who received chemotherapy survived for six months before the cancer worsened, a clinical trial of 541 patients showed.
Incyte’s epacadostat and Merck’s Keytruda Shows Encouraging Results in Melanoma Patients-Incyte $INCY announced its updated results from the Phase 1 part of a Phase ½ clinical study, ECHO-202, evaluating the combination of epacadostat and Merck’s $MRK Keytruda (pembrolizumab) in treatment-naive advanced/metastatic melanoma patients. The outcome of the clinical trial is being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen. The enrollment for the Phase 2 is underway.
Roche’s Triple Combination Therapy Shows Encouraging Results in Advanced Melanoma Patients-Result from a Phase 1b clinical study evaluating the safety and clinical activity of the triple combination of Roche's a $RHHBY COTELLIC (cobimetinib), ZELBORAF (vemurafenib) and TECENTRIQ (atezolizumab) in treatment-naive patients with BRAF V600-positive advanced melanoma showed a positive treatment benefit although with side effects. The data will be made public on Monday, October 10 at the European Society of Medical Oncology 2016 Congress in Copenhagen.
Clovis’ rucaparib shows 54% Response Rate in Mid-Stage Study in Treatment-resistant Ovarian Cancer but adverse events persistent-Clovis Oncology $CLVS slumped 20% premarket amid heavy volume trading in response to its announcement of discouraging mid-stage trial data on PARP inhibitor rucaparib in certain patients with treatment-resistant advanced ovarian cancer, an indication that is currently under FDA review (action date is February 23, 2017). The results are being shown at the European Society for Medical Oncology 2016 Congress in Copenhagen.
Alcobra Receives Written Notice From FDA on MDX Clinical Hold-Alcobra $ADHD reported that it has received the written full clinical hold notice from the FDA in relation to its Metadoxine Extended Release (MDX) in adult patients with attention deficit/hyperactivity disorder [ADHD]. Shares had plunged about 60% on September 29, when the company first verbally announced the FDA’s decision.
BeiGene’s Lead-Product Candidate Shows Encouraging Result in non-Hodgkin lymphoma-Updated data from an ongoing Phase 1 Clinical Trial evaluating BeiGene’s $BGNE lead product candidate BGB-3111 in patients with Waldenstrom’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma, demonstrated an encouraging treatment effect. The results were presented today during the 9th International Workshop on Waldenstrom's Macroglobulinemia and Symposium on Advances in Multiple Myeloma in Amsterdam, The Netherlands.
Novartis’ LEE011 Shows Good Results in Late-Stage Breast Cancer Study but with more side effect-Interim results from a Phase 3 study, MONALEESA-2, assessing Novartis’ $NVS LEE011 (ribociclib) for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced/metastatic breast cancer showed pre-eminence over standard-of-care treatment. The data were presented on Saturday at the European Society for Medical Oncology 2016 Congress in Copenhagen and published simultaneously online in The New England Journal of Medicine.