$AMRI (Albany Molecular Research Inc.)

$AMRI {{ '2016-02-05T10:42:54+0000' | timeago}} • Announcement

A global contract research and manufacturing organization $AMRI said that Anthony Maddaluna, EVP of $PFE and President of Pfizer Global Supply, has been elected to the $AMRI BoD, effective as of Feb. 4, 2016. Additionally, the company announced that Mr. Gabe Leung, Director and member of the audit committee has retired from the $AMRI BoD.

$PRXL {{ '2017-09-18T13:38:17+0000' | timeago}} • Announcement

$PRXL shareholders have approved the proposed acquisition of the company by certain investment funds affiliated with Pamplona Capital Management. Under the terms of the acquisition, Pamplona will acquire all outstanding shares of PAREXEL for $88.10 per share in cash. The closing of the transaction is anticipated on or about Sept 29, 2017.

$MDT {{ '2017-09-18T13:29:52+0000' | timeago}} • Announcement

$MDT announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve workflow.

$AMGN {{ '2017-09-14T19:26:48+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi for the treatment of five types of cancer. Amgen and Allergan's bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a Marketing Authorization Application submitted in December 2016.

$AMGN {{ '2017-09-14T19:26:21+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi (bevacizumab-awwb) for the treatment of five types of cancer. The approval was based on totality of evidence from global development program showing Mvasi is highly similar to Avastin. Mvasi is the first anti-cancer biosimilar, as well as first bevacizumab biosimilar, approved by the FDA.

$LLY {{ '2017-09-14T15:00:58+0000' | timeago}} • Announcement

$LLY and $INCY announced that new data from Phase 2 study of atopic dermatitis drug Baricitinib showed better outcomes. Atopic dermatitis is a type of inflammation of the skin, which results in itchy and red skin. Lilly and Incyte plans to start Phase 3 clinical program for atopic dermatitis later this year.

$MDT {{ '2017-09-11T12:01:51+0000' | timeago}} • Announcement

$MDT voluntarily recalls specific lots of infusion sets used with all models of Medtronic insulin pumps due to a certain discontinued component. The recall comes after reports from patients that a component, the vent membrane, may be susceptible to being blocked by fluid during priming and fill-tubing, which can lead to over-delivery of insulin.

$AGN {{ '2017-09-08T19:54:30+0000' | timeago}} • Announcement

$AGN transferred all patents for its dry eye treatment drug Restasis to the St. Regis Mohawk tribe to protect the drug patents. The tribe has granted Allergan back an exclusive license for the drug. As per the agreement, the tribe will get $13.75MM as one-time payment, and potentially $15MM annually in royalties.

$INCY {{ '2017-09-08T12:59:10+0000' | timeago}} • Announcement

$INCY priced its underwritten public offering of 4.945MM shares of its common stock. The company has granted the underwriter an option to purchase up to an additional 741,750 shares of common stock. The offering is expected to close on Sept. 12, 2017.

$MDT {{ '2017-09-08T11:44:21+0000' | timeago}} • Announcement

$MDT's IN.PACT Admiral Drug-Coated Balloon received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease in the upper leg. Before $MDT can begin commercialization, it must partner with Japanese MHLW to gain reimbursement to ensure broader access to this therapy.

$AMGN {{ '2017-09-07T12:11:23+0000' | timeago}} • Announcement

$AMGN announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a novel anti-thymic stromal lymphopoietin monoclonal antibody being developed by $AZN in collaboration with $AMGN.

$MDT {{ '2017-09-05T15:49:22+0000' | timeago}} • Announcement

$MDT launched a long-term clinical study of its INFUSE Bone Graft for use during Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study. The 10-year program is looking to enroll 550-700 individuals between the pilot and pivotal studies of both procedures.

$INCY {{ '2017-08-31T12:36:56+0000' | timeago}} • Announcement

$INCY said a study conducted by the European Society for Medical Oncology revealed that epacadostat, the company’s selective IDO1 enzyme inhibitor, demonstrated strong and durable responses in patients with advanced melanoma, when administrated in combination with KEYTRUDA. The society is expected to release the detailed results next month.

$LLY {{ '2017-08-30T13:53:36+0000' | timeago}} • Announcement

$LLY to resubmit the New Drug Application for rheumatoid arthritis medication Baricitinib, to the U.S. FDA, before the end of January 2018. Last month, Lilly and its development and marketing partner $INCY announced that resubmission of Baricitinib will take at least 18 months.

$CBM {{ '2017-08-30T13:52:07+0000' | timeago}} • Announcement

$CBM said it is expanding its High Point, NC facility with the addition of a new $3.2MM, 11,000 sq. ft. analytical laboratory. The investment comes in response to growing customer demand for analytical development and validation services in support of cGMP products at the clinical stage.

$MDCO {{ '2017-08-30T13:09:58+0000' | timeago}} • Announcement

$MDCO said the FDA has approved Vabomere (meropenem and vaborbactam) for injection for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

$MDT {{ '2017-08-29T14:48:11+0000' | timeago}} • Webcast

On the IT disruption, $MDT said it is very difficult to separate and quantify the impact related to the outage. The company did say that the outage is not material to 1Q18 revenue or EPS, but stated that it is "very difficult to quantify beyond that."

$MDT {{ '2017-08-29T14:41:58+0000' | timeago}} • Webcast

$MDT said it is not really focused on transformative M&A, but will continue to have a disciplined approach to pursuing tuck-in acquisitions. Notably, the company is still in the last year of integration of Covidien.

$MDT {{ '2017-08-29T14:29:13+0000' | timeago}} • Webcast

$MDT's overall sensor unit demand has more than doubled in the past 10 quarters since launching the MiniMed 640G. The company now expects to see increasing revenue momentum from several new product launches over the balance of the fiscal year 2018.

$AGN {{ '2017-08-29T10:53:21+0000' | timeago}} • Announcement

$AGN and its subsidiaries reached a settlement regarding its litigation with Famy Care Ltd. relating to the company's patent covering Restasis (Cyclosporine Ophthalmic Emulsion). All Famy Care litigation regarding Restasis patents will be dismissed and Famy Care will terminate its pending petitions for Inter Parties Review.

$PRXL {{ '2017-08-28T22:48:19+0000' | timeago}} • Announcement

For 4Q17, $PRXL’s service revenue increased 3.8% to $557.2MM compared with 4Q16. On a segment basis, service revenue was $432.3MM in Clinical Research Services, $50MM in PAREXEL Consulting and $74.9MM in PAREXEL Informatics.

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