$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.

$AMGN {{ '2018-01-19T13:28:13+0000' | timeago}} • Announcement

The European Commission (EC) has granted marketing authorization for MVASI from $AMGN and $AGN. MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers.

$AGN {{ '2018-01-17T13:14:16+0000' | timeago}} • Announcement

$AGN and $IRWD reached an agreement with Indian pharma company Sun Pharma to resolve a patent litigation for the generic version of constipation drug Linzess in the U.S. As per the agreement, Sun Pharma will be able to market the generic version of Linzess in the U.S. from Feb. 1, 2031. All the litigations related to Linzess were dismissed.

$AGN {{ '2018-01-09T15:46:35+0000' | timeago}} • Announcement

$AGN, which announced its plan to give pink slips to 1,000 of its employees and cut down 400 open positions earlier this year, provided FY18 financial outlook. In 2018, Allergan plans to sell its remaining position of 10% stake in $TEVA through Forward Sale Agreements and/or open market sales.

$CELG {{ '2018-01-08T19:25:23+0000' | timeago}} • Announcement

$CELG announced preliminary results for 4Q17 and FY17. Celgene also provided the outlook for FY18 and reaffirmed FY20 guidance. The company is expected to finalize these results when it announces the earnings results on Jan. 25, 2018.

$MLNT {{ '2018-01-08T17:08:01+0000' | timeago}} • Announcement

$MLNT completed the acquisition of $MDCO’s infectious disease business. $MLNT also announced that $MDCO’s Mike McGuire has joined the new organization as SVP, Commercial, replacing Chief Commercial Officer, John Temperato, who left $MLNT to pursue other opportunities.

$CELG {{ '2018-01-08T14:00:46+0000' | timeago}} • Announcement

$CELG agreed to acquire start-up firm Impact Biomedicines for an upfront payment of $1.1Bil. Under the deal terms, Celgene will further pay up to $1.25Bil on Impact's cancer drug Fedratinib getting FDA's approvals. If the global annual net sales of the drug exceed $5Bil, Celgene will pay a maximum of $4.5Bil. The deal is expected to close in 1Q18.

$MDCO {{ '2018-01-08T13:17:52+0000' | timeago}} • Announcement

Pharma firm $MDCO closed the sale of its infectious disease business to $MLNT for $215MM of guaranteed cash and 3.3 MM common shares of Melinta. The sale consideration also includes royalty payments of 5-25% on certain drug sales and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.

$PFE {{ '2018-01-04T13:11:11+0000' | timeago}} • Announcement

Arvinas LLC collaborates with $PFE for the discovery and development of drug candidates using Arvinas' PROTAC Platform, a novel technology used to create small molecule therapeutics aimed at degrading disease-causing cellular proteins. Arvinas may receive up to $830MM in upfront and potential development and commercialization milestone payments.

$ACET {{ '2018-01-02T20:11:33+0000' | timeago}} • Announcement

$ACET's finished dosage form generics subsidiary Rising Pharmaceuticals launched the first generic for Efavirenz Capsules. This is an FDA-approved generic version of the reference listed drug, Sustiva from $BMY, which in combination with other drugs is indicated for the treatment of HIV-1 infection in adults and pediatric patients.

$MYL {{ '2017-12-29T16:32:47+0000' | timeago}} • Announcement

$MYL announced the U.S.launch of Estradiol Vaginal Cream, the first generic version of Allergan's Estrace Cream. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of vulvar and vaginal atrophy.

$MYL {{ '2017-12-29T10:49:56+0000' | timeago}} • Announcement

$MYL said the biosimilar Trastuzumab, co-developed by the company and Biocon Ltd. has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica. Trastuzumab is indicated for the treatment of breast cancer and gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora.

$PFE {{ '2017-12-26T12:25:28+0000' | timeago}} • Announcement

$PFE and $MRK announced that the US FDA has approved STEGLATRO (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN (ertugliflozin and sitagliptin) tablets for adults with type 2 diabetes.

$AGN {{ '2017-12-26T12:22:55+0000' | timeago}} • Announcement

$AGN said that the Federal Circuit confirmed that a proposed generic version of Combigan eye drug from Sandoz, a unit of $NVS, did not infringe Allergan's two patents. The Federal Circuit also reversed the district court's decision that Sandoz's proposed generic product infringes Allergan's 3rd patent. Allergan plans to file for rehearing within 30 days.

$MRK {{ '2017-12-22T16:34:34+0000' | timeago}} • Announcement

$MRK and $PFE announced that the FDA approved STEGLATROTM (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN (ertugliflozin and sitagliptin) tablets.

$CELG {{ '2017-12-22T14:11:59+0000' | timeago}} • Announcement

$CELG's cancer drug Revlimid fails to meet the endpoint in the first Phase 3 trial. Celgene said that additional analyses are ongoing and it would present the complete analyzed data in a future medical conference. Revlimid contributed 63% of Celgene's revenue in their recently ended third quarter.

$PFE {{ '2017-12-21T21:14:41+0000' | timeago}} • Announcement

$PFE announced that the US FDA has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA for treatment-naive patients with advanced renal cell carcinoma (RCC). This is the second Breakthrough Therapy Designation granted to avelumab.

$AGN {{ '2017-12-21T14:38:43+0000' | timeago}} • Announcement

$AGN and its partner $PRTK announced that FDA accepted to review Seysara, an investigational drug for treating acne. Allergan, which has the U.S. rights of developing and marketing Seysara, expects FDA to take action on this in 2H18. Paratek retains the non-U.S. rights. In March 2017, Allergan announced positive results from Seysara Phase 3 trials.

$ABBV {{ '2017-12-21T13:23:43+0000' | timeago}} • Announcement

$ABBV announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

$PFE {{ '2017-12-20T12:23:04+0000' | timeago}} • Announcement

The US FDA has approved $PFE's supplemental New Drug Application to expand the indication for BOSULIF  to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph CML).

$AGN {{ '2017-12-18T22:26:29+0000' | timeago}} • Announcement

Robert Stewart, COO of $AGN will resign from his role. He has been named as the CEO of the newly formed Amneal Pharmaceuticals, effective Jan. 25, 2018. Following Rob's departure, Wayne Swanton, SVP, Global Operations has been promoted as EVP, Global Operations of Allergan.

Recent Transcripts

CNCE (Concert Pharmaceuticals, Inc.)
Thursday, November 9 2017 - 1:30pm
AMPH (Amphastar Pharmaceuticals, Inc.)
Wednesday, November 8 2017 - 10:00pm
CCXI (ChemoCentryx, Inc.)
Tuesday, November 7 2017 - 10:00pm
CBM (Cambrex Corporation.)
Tuesday, November 7 2017 - 1:30pm
VRX (Valeant Pharmaceuticals International, Inc.)
Tuesday, November 7 2017 - 1:00pm
PTLA (Portola Pharmaceuticals, Inc.)
Monday, November 6 2017 - 9:30pm
MYL (Mylan N.V.)
Monday, November 6 2017 - 3:30pm
TXMD (TherapeuticsMD, Inc.)
Monday, November 6 2017 - 1:00pm
ACET (Aceto Corp.)
Friday, November 3 2017 - 1:00pm
TEVA (Teva Pharmaceutical Industries Limited)
Thursday, November 2 2017 - 12:00pm
AGN (Allergan plc)
Wednesday, November 1 2017 - 12:30pm
PFE (Pfizer Inc.)
Tuesday, October 31 2017 - 2:00pm
ABBV (AbbVie Inc.)
Friday, October 27 2017 - 1:00pm
BMY (Bristol-Myers Squibb Company)
Thursday, October 26 2017 - 2:30pm
CELG (Celgene Corporation)
Thursday, October 26 2017 - 1:00pm
MDCO (The Medicines Company)
Wednesday, October 25 2017 - 12:30pm
ABT (Abbott Laboratories)
Wednesday, October 18 2017 - 1:00pm
ACET (Aceto Corp.)
Friday, August 25 2017 - 1:00pm
AMPH (Amphastar Pharmaceuticals, Inc.)
Wednesday, August 9 2017 - 9:00pm
PTLA (Portola Pharmaceuticals, Inc.)
Wednesday, August 9 2017 - 8:30pm

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