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News Breaks
February 22, 2013
07:25 EDTACT, NVSEMA gives positive recommendation for Actavis' generic imatinib
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imatinib Actavis, 50 mg and 100 mg hard capsule and 100 mg 400 mg Film-coated tablet intended for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia for whom bone marrow transplantation is not considered as the first line of treatment, pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis, or adult patients with Ph+ CML in blast crisis. The applicant for this medicinal product is Actavis Group (ACT). Imatinib Actavis is a generic of Novartis' (NVS) Glivec.
News For ACT;NVS From The Last 14 Days
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April 22, 2014
05:20 EDTNVSNovartis to acquire GSK oncology products for $14.5B
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April 21, 2014
08:58 EDTACTImpax appoints G. Frederick Wilkinson as CEOActavis
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08:18 EDTNVSMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
07:21 EDTNVSFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 17, 2014
16:18 EDTACTActavis to purchase four marketed products from Akorn and Hi-Tech Pharmacal
Actavis (ACT) announced that it has entered into agreements with Akorn (Akrx) and Hi-Tech Pharmacal (HITK) to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn's acquisition of Hi-Tech. Financial terms of the agreements were not disclosed. The agreements include three products marketed under Abbreviated New Drug Applications and one product marketed under a New Drug Application: Lidocaine/Prilocaine Topical Cream. The agreements also include one product under development.
16:08 EDTACTActavis, Forest Labs receive second request under Hart-Scott-Rodino from FTC
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April 16, 2014
13:51 EDTNVSAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
11:19 EDTNVSNovartis launches new eye care products facility in Singapore, Nikkei says
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10:00 EDTACTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
08:34 EDTACTPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:59 EDTACTActavis initiated with a Buy at Sterne Agee
Target $230.
April 15, 2014
10:21 EDTACTMylan announces settlement agreement for first-to-file Generess
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08:07 EDTACTActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess® FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
07:35 EDTNVSAlnylam outlook not affected by Novartis decision, says JMP Securities
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07:22 EDTNVSNovartis to Shire said to mull offers for ThromboGenics, Bloomberg says
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06:36 EDTNVSRanbaxy inspection failures add $900M to heart drug costs, Bloomberg says
A gap in U.S. patent law has kept cheap copies of Novartis' (NVS) heart drug Diovan off the market for 18 months, which has cost U.S. consumers and insurers as much as $900M in possible savings, reported Bloomberg. Ranbaxy (RBXLY) is the only company permitted to sell a generic version of Diovan, and hasn’t been able to manufacture and market them after four factories it runs in India failed U.S. inspections. Reference Link
06:32 EDTNVSPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
14:42 EDTNVSAlnylam slips after Novartis reportedly cuts back RNAi development
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11:48 EDTNVSNovartis significantly reducing RNAi development efforts, FierceBiotech says
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April 11, 2014
10:30 EDTACTActavis and Mylan shares recommended at Bernstein
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