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MYL

Mylan

$39.05

0.47 (1.22%)

17:05
07/13/17
07/13
17:05
07/13/17
17:05

Mylan, Biocon say FDA's ODAC recommends approval of trastuzumab

Mylan and Biocon announced tha thte FDA's Oncologic Drugs Advisory Committee, or ODAC, recommended approval of the companies' proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings. Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar trastuzumab is highly similar to Herceptin, in line with the FDA assessment provided in the pre-meeting briefing documents. ODAC determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval.

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    Oct

MYL Mylan
$39.05

0.47 (1.22%)

06/21/17
WELS
06/21/17
NO CHANGE
WELS
Market Perform
Wells wouldn't be surprised to see greater scrutiny on Mylan coal tax credits
After a new report from Reuters questioned the way in which Mylan uses its ownership of coal processing plants to keep its taxes low, Wells Fargo analyst David Maris said this topic has interested him for some time but his questions to management on the issue were not answered. Maris, who said he would not be surprised to see greater public scrutiny on this issue after the report, keeps a Market Perform rating on Mylan shares.
06/16/17
CANT
06/16/17
INITIATION
Target $41
CANT
Neutral
Mylan initiated with a Neutral at Cantor
Cantor Fitzgerald analyst Louise Chen started Mylan with a Neutral rating and $41 price target.
06/12/17
SBSH
06/12/17
NO CHANGE
Target $38
SBSH
Buy
Citi says CRL for Coherus not worst case scenario
Citi analyst Mohit Bansal says Coherus Biosciences' (CHRS) complete response letter for its biosimilar version of Neulasta, while "clearly a negative outcome," is not the worst case scenario since the FDA did not ask for another study. The analyst sees a one year delay, which impacts his discounted free cash flow model by $5 per share. Coherus in premarket trading is down 30%, or $6.25, to $14.40. A one year delay would mean Coherus' CHS-1701 could still be on markets at the same time as competition from Mylan (MYL) and ahead of Sandoz's approval in 2019, Bansal tells investors in a research note. The analyst has a Buy rating on Coherus with a $38 price target.
05/31/17
WELS
05/31/17
NO CHANGE
WELS
Market Perform
Pension fund campaign a short-term negative for Mylan, says Wells Fargo
Wells Fargo analyst David Maris believes the campaign by four major pension funds to oppose the re-election of six directors is short-term negative for Mylan but has the potential to be a longer term positive. The campaign may pose a distraction to management, but if successful, it could address some governance concerns regarding compensation and performance at the company, Maris tells investors in a research note. The analyst has a Market Perform rating on Mylan shares.

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MBVX

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Reference Link

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