Jul. 23, 2014, 5:33 PM
- The FDA approves Purdue Pharmaceuticals' Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) for the treatment of severe pain requiring around-the-clock long-term opioids where alternative treatment options are inadequate.
- Targiniq incorporates abuse deterrent technology. When a pill is crushed and/or dissolved (for snorting or injecting) the naloxone blocks the euphoric effects of oxycodone making it less desirable for abusers than oxycodone alone.
- The agency requires a postmarket study to assess the risks of long-term use beyond 12 weeks and the effects of the abuse deterrent features.
- Related tickers: (NASDAQ:ZGNX) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS) (NYSE:MNK) (NYSE:PFE)
Jul. 19, 2014, 8:25 AM
- The derivatives research team at UBS lists six companies on which investors should not use an option strategy, as it expects near-term catalysts to drive the stocks higher.
- Abercrombie & Fitch (NYSE:ANF): UBS cites continuing share repurchases, leaner inventory and improving fashion offerings as possible catalysts.
- Air Products (NYSE:APD): Don't overwrite or hedge the stock for 60 days, UBS says, as it sees activist investors becoming more aggressive in the name over the next two months.
- PetSmart (NASDAQ:PETM): Activist pressure to unlock value has stepped up, and the company is talking with Wall Street banks for possible strategies.
- Tesla (NASDAQ:TSLA): The UBS team says the possibility of a Gigafactory announcement could boost the stock, which has long been volatile.
- Teva Pharma (NYSE:TEVA): It is well positioned to take advantage of the high number of branded drugs going off-patent in coming years, and there's no way UBS is hedging the stock with M&A rampant in the sector.
- Weyerhaeuser (NYSE:WY): UBS expects volatility after it completes a corporate structural change, and an expected capital allocation announcement could prove to be a catalyst.
Jul. 14, 2014, 11:29 AM
- Israeli industrialist Benny Landa leads a group of investors intending to shoot down two board resolutions at Teva's (TEVA +0.7%) annual shareholders' meeting later this month. Landa and Teva founding family member Ruth Cheshin lead a proxy fight opposing the reappointment of board member Ory Slonim and the purchase of liability insurance for directors and officers.
- Landa says that Teva's board is too big and it is lacking in global pharma experience. In response to the criticism, outgoing Chairman Philip Frost reduced the number of board seats to 13 from 15 and appointed a senior pharma executive to the board.
Jul. 14, 2014, 10:55 AM
- The U.S. FDA has accepted for standard review Teva Pharmaceutical Industries' (TEVA +0.9%) NDA for its albuterol multi-dose dry powder inhaler (MDPI) as a treatment for reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients at least 12 years old.
- Teva expects a response from the regulator by late Q1 2015.
Jul. 11, 2014, 7:48 PM
- Reuters reports that generic drug firm Mylan (MYL -1%) is in advanced negotiations with Abbott Laboratories (ABT +0.1%) to purchase a multibillion dollar portfolio of its established off-patent Europe-based drugs. The transaction is a tax inversion deal that will enable Mylan to redomicile in Switzerland.
- Mylan has been in the hunt for foreign assets since its failed attempt to buy Swedish drugmaker Meda AB earlier this year. Its two main competitors, (TEVA +0.9%) and Actavis (ACT +0.5%) are domiciled in lower tax countries.
- Abbott will use the proceeds of the sale, rumored to be as high as $5B, to invest in higher growth opportunities.
Jul. 11, 2014, 7:23 AM
- Sun Pharmaceutical Industries voluntarily recalls 41,127 bottles of antidepressant venlafaxine hydrochoride in the U.S. because the pills do not meet dissolution specifications. The recall is classified as Class II which means that the use of the drug may cause temporary or medically reversible adverse health consequences.
- Pfizer (PFE) recalled 104,000 bottles of the same drug several months ago after a pharmacist noticed that one of the bottles contained a heart medication. It sells in the U.S. under the brand name Effexor XR.
- Sun is also recalling 200 vials of the chemo drug gemcitabine in the U.S. due to a lack of assurance of sterility.
- Related tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
Jul. 8, 2014, 7:16 AM
- The FDA grants Priority Review to Purdue for its tamper-resistant pain medication that competes with Zogenix's (ZGNX) Zohydro. The agency's review of the company's hydrocodone tablet should take ~six months.
- Purdue's chronic pain offering is hard for abusers to crush so it makes it more difficult to snort or inject. The FDA has stated that Zohydro could be pulled from the market if another manufacturer gets an abuse-deterrent version approved. Zogenix plans to submit an sNDA for an abuse-deterrent formulation of Zohydro in October. Two other competitors are in Phase 3 trials with their product candidates.
- Related tickers: (TEVA) (ABBV) (ALKS) (MNK) (PFE)
Jul. 4, 2014, 9:30 PM
- The EMA's Committee for Medicinal Products for Human Use issues a positive opinion regarding the marketing authorization of Teva's (TEVA) extended-regimen oral contraceptive Seasonique (levonorgestrel/ethinyl estradiol). The committee's positive vote clears the way to a product launch in selected European countries by the end of this year.
- Seasonique is a regimen that contains 84 active pills comprised of levonorgestrel/ethinyl estradiol followed by seven days of ethinyl estradiol tablets. These are used in the seven day regimen instead of placebo to allow women to have four scheduled periods per year while lessening the withdrawal symptoms caused by a sudden drop in hormones.
Jul. 3, 2014, 8:28 AM
- In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
- Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
- One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
- Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
Jul. 2, 2014, 1:19 PM
- The FDA grants tentative approval to Eagle Pharmaceuticals' (EGRX -0.5%) NDA for a ready-to-dilute concentrate version of bendamustine hydrochloride for the treatment of Indolent B-cell non-Hodgkin lymphoma. The product is currently marketed as a lyophilized powder requiring reconstitution and dilution.
- The approval is termed "tentative" because of the company's ongoing patent litigation with (TEVA +2.1%) and the resolution or expiry of certain Orphan Drug exclusivities held by Teva.
Jul. 2, 2014, 7:54 AM
- Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.
- The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration. Zogenix plans to submit an NDA in H1 2016.
- Related tickers: (TEVA) (ABBV) (ALKS) (MNK)
Jun. 24, 2014, 3:45 PM
- (TEVA -0.9%) unit Cephalon wins its suit involving certain drug wholesalers who sued the company over its "pay for delay" agreements with generic competitors. Philadelphia District Court judge Mitchell Goldberg tossed the claims that Cephalon conspired with generics makers to delay cheaper versions of the sleep disorder drug Provigil saying that an overall conspiracy to improperly put off generic competition "cannot be established."
Jun. 20, 2014, 9:41 AM
- Teva Pharmaceutical Industries (TEVA +0.4%) settles its litigation against Perrigo Pharmaceutical Co. and Catalent Pharma Solutions LLC regarding four patents for Teva's ProAir HFA (albuterol sulfate) Inhalation Aerosol product. Under the terms of the settlement, Teva will provide a license to both firms to sell limited quantities of Perrigo's generic version beginning December 19, 2016 and ending June 2018. Afterward, no limits will apply.
Jun. 18, 2014, 9:20 AM| Comment!
Jun. 17, 2014, 9:33 AM
- Teva Pharmaceutical Industries (TEVA) settles its patent infringement suit regarding patent no. 7,132,570 for Nuvigil (armodafinil) tablets. It grants licenses to sell generic versions to Sandoz, Actavis (ACT), Lupin, and Apotex 180 days after first filer Mylan (MYL).
- Actavis will be able to launch generic 100 mg and 200 mg dosages in June 2016. The others may launch the same dosages 180 days later. Mylan may launch generic versions of 50 mg, 150 mg and 250 mg dosages beginning in June 2016.
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