Mon, Nov. 28, 5:49 PM
- Akorn (NASDAQ:AKRX) perks up 2% after hours on light volume in response to its announcement that the U.S. Patent Office's Patent Trial and Appeals Board (PTAB) ruled in its favor in its inter partes review of U.S. Patent No. 6,114,319 covering Alcon's (NYSE:NVS) Durezol (difluprednate ophthalmic emulsion).
- The ruling paves the way for full FDA approval of Akorn's Abbreviated New Drug Application (ANDA) for a generic version of the drug. It was the first to file an ANDA so it will have a 180-day period of market exclusivity after approval before other generics can enter the market.
- According to IMS Heath, Durezol sales in the U.S. are ~$190M.
Wed, Nov. 23, 3:43 PM
- The potential haircut to future revenue that PDL BioPharma (PDLI -15.2%) faces from Eli Lilly's (LLY -10.5%) solanezumab flop was already priced into the stock says RBC's Adnan Butt. PDL was eligible to receive royalties on solanezumab sales.
- He calls the sell-off an "overreaction" and adds that the most significant near-term catalyst is Novartis' (NVS +1%) hypertension drug Tekturna (aliskiren), which the company owns a piece of through its initial $75M equity investment in Noden Pharma DAC (Noden acquired global rights from Novartis). PDL expects to invest an additional $64M by next year.
Mon, Nov. 21, 8:58 AM
- BioLineRx (NASDAQ:BLRX) in-licenses a novel anti-inflammatory treatment for dry eye syndrome (DES) from Hebrew University of Jerusalem. The product candidate, BL-1230, is the third project in the company's strategic collaboration with Novartis Pharma AG (NYSE:NVS).
- BL-1230 is a selective cannabinoid receptor type 2 (CB2R) agonist. BioLineRx plans to explore its use in treating systemic inflammatory conditions as well.
- The financial terms of the license are not disclosed.
Mon, Nov. 21, 4:44 AM
- Expanding its pipeline of medicines to combat blood diseases, Novartis (NYSE:NVS) is buying Selexys Pharmaceuticals, a research lab in blood and inflammatory disorders, for $665M.
- The deal has been in the works since 2012, when Novartis obtained the option to buy Selexys and its sickle cell disease drug SelG1, depending on how its trials fared.
Fri, Nov. 18, 8:28 AM
- Seventh Sense Biosystems receives a $10M funding round from a group of investors that includes Novartis (NYSE:NVS) and LabCorp (NYSE:LH). The Medford-MA-based firm is developing a disposable blood collection device called Touch Activated Phlebotomy which used microscopic needles to collect a fingerstick-sized blood sample.
- Controversial diagnostic start-up Theranos tried to develop a similar product before crashing amid investigations and failed operations.
Thu, Nov. 17, 6:59 AM
- Britain's advisor to its National Health Service (NHS), the National Institute for Health and Care Excellence (NICE) continues its success with corralling prices from drug makers. Roche (OTCQX:RHHBY) and Bristol-Myers Squibb (NYSE:BMY) are the latest to extend discounts for access to the NHS.
- Roche cut the price to breast cancer drug Perjeta earlier this year as did BMY with leukemia med Sprycel.
- Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) have also offered increased discounts of late. The specific amounts are confidential, however.
Wed, Nov. 16, 6:41 PM
- A Phase 3 clinical trial, STRIVE, assessing Amgen's (NASDAQ:AMGN) erenumab (AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid change from baseline in mean monthly migraine days at week 24 compared to placebo.
- STRIVE randomized participants to receive either 70 mg or 140 mg of erenumab or placebo administered subcutaneously once per month for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. At week 24, the average reductions in migraine days per month for the 70 mg, 140 mg and placebo arms were 3.2, 3.7 and 1.8, respectively.
- Erenumab's safety profile was comparable to placebo and was consistent with previous studies. The most common adverse events were nasopharyngitis, upper respiratory infection and sinusitis.
- The analysis of the data is ongoing. Detailed results will be submitted for publication and for presentation at a future medical conference.
- It was also successful in another Phase 3 study called ARISE. Regulatory submissions are on tap for 2017.
- Erenumab, a fully human monoclonal antibody, inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. It is being co-developed with Novartis (NYSE:NVS). Amgen retains commercial rights in the U.S., Canada and Japan and Novartis has commercial rights elsewhere.
- Shares are up 1% after hours on average volume.
- Previously: Amgen's erenumab (AMG 334) successful in late-stage study in migraine prevention (Sept. 28)
Mon, Nov. 14, 10:02 AM
- The FDA accepts under Priority Review Novartis' (NVS -2.2%) New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged PKC412 (midostaurin) for the treatment of acute myeloid leukemia (AML) in newly diagnosed adults with a genetic mutation called FMS-like tyrosine kinase-3 (FLT3) and for the treatment of advanced systemic mastocytosis (SM).
- The late-stage data supporting the filing was generated in the RATIFY study which showed treatment with PKC412 plus standard chemo in FLT3-positive AML patients significantly extended overall survival compared to placebo plus chemo with 23% less risk of death (hazard ratio = 0.77; p=0.0074).
- Data from a Phase 2 study in SM showed a 60% response rate in the PKC412 cohort with a median duration of response of 24.1 months.
- The company's marketing application in Europe for these two indications is currently under review.
- Priority Review status shortens the review clock to six months from the standard 10 months.
- PKC412 (midostaurin) is an oral, multi-targeted kinase inhibitor. Kinases help regulate many essential cell processes so interfering with their activity interrupts the ability of cancer cells to grow and multiply.
Mon, Nov. 14, 6:31 AM
- Novartis (NYSE:NVS) is in talks to acquire U.S. generic-drugs maker Amneal Pharmaceuticals as it seeks to bolster its Sandoz business amid consolidation in the industry.
- A sale of could value closely held Amneal at as much as $8B depending on the structure of the deal, sources told Bloomberg.
- NVS -1.3% premarket
Sun, Nov. 13, 8:00 AM
- Novartis (NYSE:NVS) is considering selling its struggling eye care division, Chairman Joerg Reinhardt told SonntagsZeitung, but all options - including a turnaround - are still on the table.
- The drugmaker has blamed a failure to innovate and inconsistent customer service for the problems at Alcon, a business that Novartis gradually bought from Nestle in deals totaling $51B.
Fri, Nov. 11, 12:27 PM
Fri, Nov. 11, 9:30 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the use of Novartis' (NYSE:NVS) Arzerra (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL).
- The original European indication specifies the use of Arzerra, in combination with the chemo agents chlorambucil or bendamustine, in treatment-naive CLL patients who cannot be treated with fludarabine and in CLL patients who do not respond to fludarabine and alemtuzumab [Sanofi's (NYSE:SNY) LEMTRADA].
- A final decision from the European Commission usually takes ~60 days.
- Novartis is developing ofatumumab under a collaboration with Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
Fri, Nov. 11, 6:47 AM
- Novartis (NYSE:NVS) upgraded to Buy from Hold with an $85 (15% upside) price target by Argus Research.
- Humana (NYSE:HUM) upgraded to Overweight from Neutral with a $202 (5% upside) price target by JPMorgan.
- McKesson (NYSE:MCK) upgraded to Buy from Neutral with a $147 (0% upside) price target by Mizuho Securities.
- AmerisourceBergen (NYSE:ABC) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $89 (12% upside) from $84.
- Healthways (NASDAQ:HWAY) upgraded to Buy from Sell by UBS Global Research. Price target raised to $24 (9% upside) from $22.50.
- ACADIA Pharmaceuticals (NASDAQ:ACAD) upgraded to Buy from Neutral by Bank of America. Price target lowered to $35 (22% upside) from $39.
- Biogen (NASDAQ:BIIB) upgraded to Overweight from Neutral with a $335 (3% upside) price target by Piper Jaffray.
- Juno Therapeutics (NASDAQ:JUNO) upgraded to Neutral from Sell by BTIG Research.
- Express Scripts (NASDAQ:ESRX) upgraded to Hold from Sell by Deutsche Bank. Price target increased to $70 (7% downside risk) from $69.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
Tue, Nov. 1, 9:55 AM
- The FDA will review Novartis' (NVS) New Drug Application (NDA) seeking approval of ribociclib (LEE011) for the first-line treatment, in combination with letrozole (Femara), of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced/metastatic breast cancer under its Priority Review process. The status shortens the review clock to six months from the standard 10 months. The PDUFA date is not provided but should be in early April.
- Breakthrough Therapy-tagged LEE011 inhibits a class of enzymes called cyclin dependent kinases (CDKs). It slows the progression of cancer by binding to two specific kinases: CDK4 and CDK6. When over-activated, they enable cancer cells to grow and proliferate too quickly. Novartis is developing the candidate under a research collaboration with Astex Pharmaceuticals.