$ANIP (ANI Pharmaceuticals, Inc.)

$ANIP {{ '2016-02-25T18:15:56+0000' | timeago}} • Announcement

Specialty pharmaceutical company $ANIP said that its partner Dexcel Pharma Technologies Ltd. received approval from the FDA of the Abbreviated New Drug Application (ANDA) for Donepezil HCl 23mg Tablets for the treatment of dementia of the Alzheimer's type. For calendar year 2015, this product's sales were $44MM according to IMS Health.

$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.

$MRK {{ '2018-01-09T20:27:32+0000' | timeago}} • Announcement

Pharma company $MRK said the FDA has granted 'Breakthrough Therapy Designation' for Lenvima, a multiple receptor tyrosine kinase inhibitor developed by Eisai in combination with Merck's anti-PD-1 therapy Keytruda for the treatment of renal cell carcinoma. The FDA action was based on the results of a multi-center study conducted in US and Europe.

$MRK {{ '2018-01-09T18:45:44+0000' | timeago}} • Announcement

Merck today announced that it has received Breakthrough Therapy Designation from FDA for LENVIMA and KEYTRUDA. The combination therapy (LENVIMA & KEYTRUDA) is being jointly developed by Eisai and $MRK for treating patients with advanced and/or metastatic renal cell carcinoma. In 2017, approx. 63,990 new cases were estimated to have occurred in US.

$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.

$MRK {{ '2018-01-02T20:34:14+0000' | timeago}} • Announcement

Merck announced today that Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its cancer drug KEYTRUDA for treating patients with Urothelial Carcinoma, a type of bladder cancer. This approval helps $MRK to market KEYTRUDA for 4 types of cancer in Japan. The company plans to market KEYTRUDA in partnership with Taiho Pharmaceuticals.

$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.

$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.

$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.

$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.

$IPXL {{ '2017-12-18T13:05:53+0000' | timeago}} • Announcement

Amneal Pharmaceuticals LLC and $IPXL said Robert Stewart will join Amneal as President, effective Jan. 25, 2018. Stewart most recently served as COO of $AGN. After completion of combination of Amneal and $IPXL, Stewart will become President and CEO of the combined company, to be named Amneal Pharmaceuticals Inc., and will become a BoD member.

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IPXL (Impax Laboratories Inc.)
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MYL (Mylan N.V.)
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ACET (Aceto Corp.)
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AGN (Allergan plc)
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