$NKTR (Nektar Therapeutics)

$NKTR {{ '2016-06-02T22:28:45+0000' | timeago}} • Announcement

Medical technology company $NKTR said that John Nicholson has been named SVP & COO and Gil M. Labrucherie has been named SVP & CFO of the company. Mr. Nicholson will be responsible for leading global business and corporate development, marketing, quality assurance, while Mr. Labrucherie will be leading $NKTR's finance and accounting teams.

$AGN {{ '2017-09-22T21:53:16+0000' | timeago}} • Announcement

$AGN received a Refusal to File letter from the US FDA on its Supplemental New Drug Application (sNDA) for Vraylar for treatment of negative symptoms associated with schizophrenia in adult patients. VRAYLAR is an oral antipsychotic approved in the US to treat schizophrenia. The FDA said the sNDA was not sufficient to permit a substantive review.

$A {{ '2017-09-22T21:43:23+0000' | timeago}} • Announcement

$A said its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the US FDA to aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by $MRK. These approvals mean these patients have the possibility of receiving a targeted anti-PD-L1 immunotherapy.

$JNJ {{ '2017-09-22T21:34:55+0000' | timeago}} • Announcement

$JNJ said Janssen Biotech, Inc. received a complete response letter from the US FDA for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. The letter states that additional clinical data are needed to further evaluate the safety of sirukumab.

$AGN {{ '2017-09-22T14:30:34+0000' | timeago}} • Announcement

$AGN announced top-line results from new data for the Centaur Phase 2b study which supports the anti-fibrotic efficacy and safety of Cenicriviroc (CVC) for the treatment of liver fibrosis in adults with NASH. $AGN is currently enrolling patients in a 2,000 patient phase 3 clinical trial of CVC called the Aurora trial.

$NKTR {{ '2017-09-21T21:21:13+0000' | timeago}} • Announcement

$NKTR appointed Jeff Ajer, EVP and Chief Commercial Officer of BioMarin, as an independent director to Nektar's BoD. Ajer has more than 25 years of biotechnology industry experience within rare disease and specialty medicine.

$PFE {{ '2017-09-20T18:14:48+0000' | timeago}} • Announcement

$PFE filed a lawsuit against $JNJ over anticompetitive practices. The lawsuit alleges J&J violated federal antitrust laws by signing exclusionary contracts with health insurers, hospitals and doctor groups to ensure its medicine Remicade was given preferential treatment over Pfizer's new biosimilar Inflectra.

$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.

$NKTR {{ '2017-09-12T13:42:15+0000' | timeago}} • Announcement

$NKTR began dosing in Propel study to gauge the efficacy of NKTR-214, its immuno-oncology therapy in tandem with approved checkpoint inhibitors, TECENTRIQ (atezolizumab) and KEYTRUDA (pembrolizumab). NKTR-214 can expand specific cancer-fighting T cells and natural killer cells in the tumor microenvironment and up expression of PD-1 on these cells.

$COO {{ '2017-09-11T20:51:49+0000' | timeago}} • Announcement

Medical devices company $COO has signed an agreement with pharma firm $TEVA to acquire the global rights and business of Teva’s Paragard Intrauterine Device for $1.1Bil in cash. The transaction, which is likely to close prior to the end of the calendar year, is expected to be accretive to Cooper's earnings by $0.7-0.75 per share in the first year.

$TEVA {{ '2017-09-11T20:47:29+0000' | timeago}} • Announcement

Israeli drugmaker $TEVA appointed Kare Schultz as its CEO replacing the current acting CEO Yitzhak Peterburg, who will continue as acting CEO until Schultz joins. Schultz, who will move to Israel and be based at Teva's headquarters, recently served as CEO of Denmark-based H. Lundbeck A/S. Prior to this job, he held the post of COO in Novo Nordisk.

$MRK {{ '2017-09-11T17:08:33+0000' | timeago}} • Announcement

$MRK announced that Keytruda is the only programmed death (PD-1) drug with data to show it can improve overall survival rate in the second-line bladder cancer. Phase 3 results show that patients whose disease had progressed following platinum chemo treatment, Keytruda demonstrated an OS advantage vs. chemo with median follow-up of 22.5 months.

$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.

$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.

$JNJ {{ '2017-09-06T18:27:40+0000' | timeago}} • Announcement

Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of $JNJ, received FDA approval for a new 32 mg tablet for oral suspension for TRACLEER for use in pediatric patients aged three years and older, suffering from high blood pressure in the arteries of the lungs. The medication will be available from 4Q17.

$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.

$MRK {{ '2017-08-29T14:59:23+0000' | timeago}} • Announcement

$MRK and Oxford University's Clinical Trial Service Unit announced the REVEAL study results of anacetrapib, the company's investigational cholesteryl ester transfer protein (CETP) inhibitor. Anacetrapib reduced the risk of major coronary events by 9% relative to placebo. $MRK is reviewing the results with external experts for filing NDA with FDA.

$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."

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NVO (Novo Nordisk A/S)
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