|
News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days Check below for free stories on MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA the last two weeks. |
|
|
| May 23, 2013 |
| 07:37 EDT |  | CELG | Celgene says FDA grants priority review for ABRAXANE sNDA
 Subscribe for More Information |
|
| 07:08 EDT | | ALKS | Alkermes changes fiscal year end, sees 9-months EPS 61c-75c
Alkermes has changed its fiscal year-end from March 31 to Dec. 31 and outlined financial expectations for the nine-month period ending Dec. 31, 2013. Alkermes expects total revenues to range from $395M-$425M, and non-GAAP net income to range from $85M-$105M or 61c-75c per share, for the nine months ending Dec. 31, 2013. Following the change in the company’s financial year-end, the company expects total pro forma revenues for the calendar year ending Dec. 31, 2013, to range from $558M-$588M and expects pro forma non-GAAP net income for the calendar year ending Dec. 31, 2013, to range from $141M-$161M. |
|
| 07:03 EDT |  | ALKS | Alkermes reports Q4 EPS 40c, may not compare to consensus 17c
Reports Q4 revenue $163.4M, consensus $128.01M. Revenues for the quarter included $30.0M of intellectual property license revenue unrelated to key development programs. |
|
| May 22, 2013 |
| 16:23 EDT | | TEVA | Alexza Pharmaceuticals chief commercial officer to leave company
Subscribe for More Information |
|
| 09:01 EDT | | AZN | Par Pharmaceutical begins shipment of generic Atacand
Subscribe for More Information |
|
| 08:59 EDT | | PFE | On The Fly: Pre-market Movers
Subscribe for More Information |
|
| 08:06 EDT | | PFE | Zoetis comments on Pfizer’s split-off plans for remaining interest
Subscribe for More Information |
|
| 08:04 EDT | | PFE | Pfizer announces plan to split-off remainder of Zoetis
Subscribe for More Information |
|
| 08:02 EDT | | PFE | Pfizer announces plan to split-off remainder of Zoetis
Subscribe for More Information |
|
| May 21, 2013 |
| 17:59 EDT |  | NPSP | NPS Pharmaceuticals 6M share Secondary priced at $14.53
Subscribe for More Information |
| |
| 10:00 EDT |  | PRXL | On The Fly: Analyst Initiation Summary
Subscribe for More Information |
|
| 09:29 EDT | | AZN | AstraZeneca says Phase III studies of Naloxegol met primary, secondary endpoints
AstraZeneca (AZN) presented the results of two pivotal Phase III studies of naloxegol showing the 25 mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Data was presented at the Digestive Disease Week meeting in Orlando, Florida. The primary endpoint in both trials was percentage of OIC responders, versus placebo, over 12 weeks of treatment. The secondary endpoints included the 12-week response rate in a laxative inadequate response population, the median time to first spontaneous bowel movement and the number of days per-week with at least one bowel movement. Plans for naloxegol will be finalized over the coming months, incorporating the outcome of ongoing discussions with health authorities in the US, EU and Canada, the company said. Naloxegol, a peripherally-acting mu-opioid receptor antagonist, has been specifically designed for the treatment of opioid-induced constipation and is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics (NKTR). |
|
| 07:40 EDT | | PRXL | PAREXEL initiated with a Neutral at ISI Group
Subscribe for More Information |
|
| 07:34 EDT |  | NPSP | UBS to host a conference
Subscribe for More Information |
|
| 07:16 EDT | | PFE | Pfizer management to meet with Leerink
Subscribe for More Information |
|
| May 20, 2013 |
| 17:04 EDT | | PFE | Pfizer discontinues phase 3 study of inotuzumab ozogamicin
Subscribe for More Information |
|
| 16:22 EDT | | NPSP | NPS Pharmaceuticals files to sell 6M shares of common stock
J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for the proposed offering. |
|
| 11:27 EDT | | TEVA | Appeals court reverses, remands patent ruling in Sanofi suit against Mylan, Teva
Subscribe for More Information |
|
| 09:51 EDT | | CELG | Celgene management to meet with JPMorgan
Meetings to be held in Boston on May 22-23 hosted by JPMorgan. |
|
| 07:12 EDT | | ACOR | Acorda Therapeutics says issued additional U.S. patent for AMPYRA
Subscribe for More Information |
| |
| May 17, 2013 |
| 10:36 EDT | | AZN | Leerink's major/specialty pharma analyst holds analyst/Industry conference call
Subscribe for More Information |
|
| 08:41 EDT | | AZN | Impax commenced shipment of authorized generic Zomig
Impax (IPXL) announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig tablets, as part of an agreement with AstraZeneca (AZN). Zomig is indicated for the treatment of migraine headaches in adults. According to IMS Health data, U.S. sales of Zomig tablets and orally disintegrating tablets were approximately $196M in the 12 months ended April 2013. |
|
| 05:51 EDT |  | CELG | Stocks with implied volatility movement; CBST CELG
Subscribe for More Information |
|
| May 16, 2013 |
| 11:50 EDT | | CELG | Celgene, Gilead lower after new data published at ASCO
Subscribe for More Information |
|
| 08:55 EDT | | PFE | BofA/Merrill's pharmaceuticals analysts hold analyst/industry conference call
Subscribe for More Information |
|
| May 14, 2013 |
| 07:24 EDT | | AZN | EBD Group to host a conference
BioTrinity 2013 is being held in Newbury, England on May 14-16. |
|
| May 13, 2013 |
| 16:53 EDT |  | AZN | Optimer gets bids from AstraZeneca, Cubist, Astellas, Bloomberg says
Optimer (OPTR) has received first round bids from AstraZeneca (AZN), Cubist (CBST), and Astellas, reports Bloomberg, citing people familiar with the matter. Shares of Optimer spiked higher following the report, closing up $1.85, or 14.44%, to $14.66. The report notes the company disclosed almost three months ago it was exploring its strategic options. Reference Link |
|
| 15:55 EDT | | AZN | Optimer gets first round bids from AstraZeneca, Cubist, Bloomberg says
Subscribe for More Information |
|
| 09:44 EDT | | TEVA | Several companies reportedly interested in buying Adcock Ingram, Globes says
Subscribe for More Information |
|
| 07:49 EDT |  | TEVA | FDA decision on Opana a modest positive for Impax, says Leerink
Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires. |
| |
| May 10, 2013 |
| 16:29 EDT |  | PFE | On The Fly: Closing Wrap
Subscribe for More Information |
|
| 12:31 EDT | | PFE | On The Fly: Midday Wrap
Subscribe for More Information |
|
| 11:48 EDT | | PFE, AZN | Drugmakers to face pressure on U.S. prices, Reuters says
Subscribe for More Information |
|
| 10:00 EDT | | TEVA | On The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 3D Systems (DDD) initiated with a Buy at Janney Capital... Actavis (ACT) initiated with an Outperform at BMO Capital... Allergan (AGN) initiated with an Outperform at BMO Capital... Emeritus (ESC) initiated with an Outperform at Wells Fargo... Ensign Group (ENSG) initiated with a Market Perform at Wells Fargo... Forest Labs (FRX) initiated with an Underperform at BMO Capital... J2 Global (JCOM) initiated with an Outperform at Wedbush... Mylan (MYL) initiated with an Underperform at BMO Capital... Splunk (SPLK) initiated with a Market Perform at FBR Capital... Teva (TEVA) initiated with an Outperform at BMO Capital... Workday (WDAY) initiated with an Outperform at Oppenheimer... Nuance (NUAN) initiated with an Outperform at Wedbush... Demandware (DWRE) initiated with an Outperform at Wedbush... Synchronoss (SNCR) initiated with an Outperform at Wedbush... Trius Therapeutics (TSRX) initiated with a Buy at Guggenheim... Proto Labs (PRLB) initiated with a Buy at Janney Capital... Stratasys (SSYS) initiated with a Buy at Janney Capital. |
|
| 09:21 EDT | | PFE | On The Fly: Pre-market Movers
Subscribe for More Information |
|
| 08:08 EDT | | PFE | Pain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence. |
|
| 07:46 EDT | | PFE | DURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39. |
|
| May 9, 2013 |
| 16:35 EDT | | TEVA | Teva initiated with an Outperform at BMO Capital
Subscribe for More Information |
|
| 11:13 EDT | | PRXL | Pharmaceutical services provider Quintiles surges on first day of trading
Subscribe for More Information |
|
| 10:17 EDT | | AZN, PFE | Shire trades higher in London amid takeover chatter, Guardian says
Subscribe for More Information |
| |
| 10:11 EDT | | ACOR | Acorda Therapeutics has a conference call hosted by JPMorgan
Subscribe for More Information |
|
| 08:16 EDT | | NPSP | NPS Pharmaceuticals reports Q1 EPS (9c), consensus (13c)
Subscribe for More Information |
|
| 07:05 EDT | | ACOR | Acorda says data support initiation of current dalfampridine development program
Subscribe for More Information |
|
|
|
|
|
