$AMPH (Amphastar Pharmaceuticals, Inc.)

$AMPH {{ '2015-11-11T15:43:24+0000' | timeago}} • Announcement

Biotechnology company $MNTA said the U.S. Court of Appeals for the Federal Circuit (CAFC) vacated the Massachusetts district court's summary judgment in favor of $AMPH to the extent it was based on the scope of the safe harbor provision of 271(e)(1), a research exemption which allows generic manufacturers to prepare generic drugs in advance.

$MRK {{ '2017-07-21T15:21:07+0000' | timeago}} • Announcement

President Donald Trump announced that pharma giants $MRK and $PFE are collaborating with Gorilla Glass manufacturer Corning ($GLW) for manufacturing a new glass (Valor Glass), which is superior and reliable for the delivery of injectable drugs. Corning is planning to initially invest $500MM creating 1,000 jobs at 3 facilities in US.

$TBPH {{ '2017-07-20T12:32:48+0000' | timeago}} • Announcement

$TBPH and $MYL announced positive results from a 12-month Phase 3 safety study of revefenacin in patients with chronic obstructive pulmonary disease (COPD). The study of 1,055 patients with COPD demonstrated that revefenacin was generally well-tolerated, and no new safety issues were identified.

$AKRX {{ '2017-07-19T21:41:28+0000' | timeago}} • Announcement

Specialty generic pharmaceutical company $AKRX said that its shareholders have voted to approve the merger for the acquisition of Akorn by Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA. The companies expect the acquisition to close by early 2018.

$AGN {{ '2017-07-19T15:54:53+0000' | timeago}} • Announcement

$AGN appointed Joseph Boccuzi to its BoD, effective immediately. Boccuzi recently retired as a Partner in the Global Life Sciences, Board and Chief Executive Officer Practices at Spencer Stuart, following 24 years of service with the global executive search and leadership consulting firm.

$VRX {{ '2017-07-17T14:04:54+0000' | timeago}} • Announcement

$VRX has entered into an agreement to sell its Obagi Medical Products business for $190MM in cash to Haitong International Zhonghua Finance Acquisition Fund I, L.P. The transaction is expected to close in second half of 2017. $VRX intends to use the proceeds from the sale to permanently repay term loan debt under its Senior Secured Credit Facility.

$MYL {{ '2017-07-14T12:05:52+0000' | timeago}} • Announcement

Pharma firm $MYL said the FDA Oncologic Drugs Advisory Committee has recommended approval of the biosimilar trastuzumab developed by Mylan along with India-based Biocon Ltd. for  treatment of breast cancer. The committee determined no clinically meaningful differences exist between the biosimilar product and cancer drug Herceptin.

$AMGN {{ '2017-07-13T12:24:26+0000' | timeago}} • Announcement

$AMGN and $AGN announced they will discuss data supporting the ABP 215 Biologics License Application (BLA) with FDA's Oncologic Drugs Advisory Committee. ABP 215 is a biosimilar candidate to Avastin (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA.

$PFE {{ '2017-07-13T12:13:49+0000' | timeago}} • Announcement

The FDA has accepted $PFE's filing of supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis. The FDA has provided an anticipated Prescription Drug User Fee Act action date in March 2018 for the sNDA.

$PFE {{ '2017-07-12T11:41:14+0000' | timeago}} • Announcement

$PFE said the FDA's Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk benefit profile for Mylotarg on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML).

$PFE {{ '2017-07-11T20:58:23+0000' | timeago}} • Announcement

The US FDA's Oncologic Drug Advisory Committee (ODAC) voted in favor of $PFE's MYLOTARG (gemtuzumab ozogamicin), an antibody-drug conjugate used to treat acute myeloid leukemia. The role of the ODAC is to provide recommendations to the FDA. The FDA decision on whether or not to approve MYLOTARG is anticipated by Sept. 2017.

$AGN {{ '2017-07-10T16:14:16+0000' | timeago}} • Announcement

$AGN announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase 3 studies, which evaluated the efficacy and safety of Viberzi to treat the symptoms associated with irritable bowel syndrome with diarrhea, abdominal pain and diarrhea.

$VRX {{ '2017-07-10T13:27:06+0000' | timeago}} • Announcement

$VRX pays down $811MM of senior secured term loans using the net proceeds of the sale of Dendreon Pharmaceuticals LLC. The company has now reduced its debt by more than $4.3Bil since the end of 1Q16. $VRX still expects to pay down $5Bil in debt from divestiture proceeds and free cash flow within 18 months of August 2016.

$BMY {{ '2017-07-10T11:35:22+0000' | timeago}} • Announcement

$BMY said the FDA accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel.

$PFE {{ '2017-06-30T12:36:12+0000' | timeago}} • Announcement

$PFE received approval for its Besponsa as monotherapy from the European Commission. The Besponsa was approved for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). ALL is an aggressive type of leukemia that can be fatal within a matter of months if left untreated.

$PFE {{ '2017-06-27T13:34:31+0000' | timeago}} • Announcement

$PFE broke ground on its new R&D and process development facility in Chesterfield, Missouri. Construction is expected to be complete by mid-2019. The facility will house more than 450 employees who currently work at multiple locations, and an additional 80 employees that the company expects to hire over the coming years.

$AGN {{ '2017-06-27T13:15:55+0000' | timeago}} • Announcement

Pharma company $AGN launched Refresh Optive Mega-3, an over-the-counter artificial tear under the company’s Refresh portfolio. The formulation protects tears from evaporating while nourishing the damaged lipid layer and providing essential hydration to the tear film layers in patients suffering from ‘dry eye’.

$OSUR {{ '2017-06-27T12:34:45+0000' | timeago}} • Announcement

$OSUR has signed an agreement with Bill & Melinda Gates Foundation, under which the company will offer its OraQuick HIV Self-Test at an affordable price in 50 developing countries with funding from the foundation. The funding will comprise support payments tied to the volume of product sold by OraSure, and reimbursement of certain related costs.

$BMY {{ '2017-06-26T11:44:11+0000' | timeago}} • Announcement

$BMY said, in its Phase 3 study, Empliciti plus lenalidomide/dexamethasone continued to demonstrate efficacy in patients with plasma cell cancer, compared to patients treated with lenalidomide/dexamethasone alone. The combination therapy demonstrated a sustained reduction in risk of progression/death of 29%.

$PFE {{ '2017-06-22T20:52:12+0000' | timeago}} • Announcement

$PFE declared a $0.32 3Q17 dividend on the company’s common stock, payable September 1, 2017, to shareholders of record as on August 4, 2017.

$OSUR {{ '2017-06-22T12:43:35+0000' | timeago}} • Announcement

Point of care diagnostic tests and specimen collection devices manufacturer $OSUR appointed Mara Aspinall as a member of the company's BoD. Aspinall will also serve on the Audit and Compensation Committees of the Board.

Recent Transcripts

TEVA (Teva Pharmaceutical Industries Limited)
Thursday, May 11 2017 - 12:00pm
OMER (Omeros Corporation)
Wednesday, May 10 2017 - 8:30pm
MYL (Mylan N.V.)
Wednesday, May 10 2017 - 2:00pm
OREX (Orexigen Therapeutics, Inc.)
Tuesday, May 9 2017 - 9:00pm
AGN (Allergan plc)
Tuesday, May 9 2017 - 12:30pm
AEZS (Aeterna Zentaris Inc.)
Tuesday, May 9 2017 - 12:30pm
VRX (Valeant Pharmaceuticals International, Inc.)
Tuesday, May 9 2017 - 12:00pm
AMPH (Amphastar Pharmaceuticals, Inc.)
Monday, May 8 2017 - 9:00pm
OMED (OncoMed Pharmaceuticals, Inc.)
Monday, May 8 2017 - 12:30pm
ACET (Aceto Corp.)
Friday, May 5 2017 - 1:00pm
OFIX (Orthofix International N.V.)
Thursday, May 4 2017 - 8:30pm
PRXL (PAREXEL International Corporation)
Thursday, May 4 2017 - 2:00pm
CBM (Cambrex Corporation.)
Thursday, May 4 2017 - 12:30pm
PCRX (Pacira Pharmaceuticals, Inc.)
Thursday, May 4 2017 - 12:30pm
OSUR (OraSure Technologies, Inc.)
Wednesday, May 3 2017 - 9:00pm
PFE (Pfizer Inc.)
Tuesday, May 2 2017 - 2:00pm
BMY (Bristol-Myers Squibb Company)
Thursday, April 27 2017 - 2:30pm
MDCO (The Medicines Company)
Wednesday, April 26 2017 - 12:30pm
OREX (Orexigen Therapeutics, Inc.)
Tuesday, March 28 2017 - 9:00pm
OMER (Omeros Corporation)
Thursday, March 16 2017 - 8:30pm

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