$ANIP (ANI Pharmaceuticals, Inc.)

$ANIP {{ '2016-05-23T12:54:08+0000' | timeago}} • Announcement

$ANIP said it appointed Mark Ginski as VP Corticotropin Product Development, effective May 23, 2016. Mark is an accomplished scientist with over 20 years of experience in API and drug product development, formulation, analytical development and API and drug product manufacturing.

$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.

$GILD {{ '2018-01-18T17:34:32+0000' | timeago}} • Announcement

Kite, a $GILD company, has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the combination of Yescarta and Pfizer's utomilumab, in patients with refractory large B-cell lymphoma. A multi-center Phase 1/2 study sponsored by Kite is expected to begin in 2018.

$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.

$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.

$AMGN {{ '2018-01-05T14:22:45+0000' | timeago}} • Announcement

$AMGN gets US FDA's approval for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

$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.

$ANIP {{ '2017-12-29T17:23:26+0000' | timeago}} • Announcement

$ANIP acquired the NDAs and US rights to market ATACAND, ATACAND HCT, ARIMIDEX, and CASODEX from AstraZeneca for $46.5MM in cash, royalties, and sales-based milestones. AstraZeneca will continue to market and supply these four products outside the US. The acquisitions were funded through a combination of cash and debt.

$ANIP {{ '2017-12-29T17:17:28+0000' | timeago}} • Announcement

$ANIP has entered a new five-year Senior Secured Credit Facility for up to $125MM with Citizens Bank. The facility is comprised of a $75MM five-year term loan that was closed in support of $ANIP’s acquisition of four NDAs acquired from AstraZeneca for $46.5MM in cash. This facility also includes a $50MM Senior Secured Revolving Credit Facility.

$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.

$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.

$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.

$LCI {{ '2017-12-21T16:48:17+0000' | timeago}} • Announcement

$LCI BoD named Timothy C. Crew as the company's chief executive officer, effective January 2, 2018. He has over 25 years of experience in the generic and branded pharmaceutical industries. Crew will succeed Arthur Bedrosian, the current CEO.

$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.

$IPXL {{ '2017-12-19T14:14:39+0000' | timeago}} • Announcement

$IPXL agreed to sell its manufacturing facility in Taiwan to Bora Pharmaceuticals. Bora will buy all issued share capital in Impax Taiwan and certain loans outstanding between Impax and Impax Taiwan for $18.5MM. $IPXL expects to record pre-tax impairment charge of about $70-80MM in 4Q17. The deal will close in 1Q18.

$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.

$AGN {{ '2017-12-18T22:14:14+0000' | timeago}} • Announcement

$AGN and its development partner Gedeon Richter Plc reported positive results from phase 3 study of cariprazine, which is used to treat the bipolar depression. Allergan plans to file the New Drug Application to the FDA in 2H18.

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GILD (Gilead Sciences Inc.)
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CELG (Celgene Corporation)
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