Thu, Jul. 30, 7:15 AM
Wed, Jul. 29, 12:52 PM
Wed, Jul. 29, 10:28 AM
- The FDA approves Ignyta's (RXDX -2.3%) Investigational New Drug (IND) application for RXDX-107, a nanoformulation of modified bendamustine, a nitrogen mustard used to treat certain blood cancers. The company intends to start a Phase 1/1b clinical trial promptly.
- RXDX-107, acquired from Teva Pharmaceutical Industries (TEVA +0.3%) in March, is a new chemical entity comprising an alkyl ester of bendamustine encapsulated in human serum albumin to form nanoparticles. Its value proposition is a longer half-life and improved tissue biodistribution compared to traditional bendamustine.
- Previously: Ignyta up 31% after hours on Teva oncology deal (March 17)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Mon, Jul. 27, 12:48 PM
Mon, Jul. 27, 9:14 AM
Mon, Jul. 27, 8:00 AM
Mon, Jul. 27, 7:09 AM
- Mylan (NASDAQ:MYL) drops 12% premarket on increased volume in response to Teva's (NYSE:TEVA) $40.5B deal for Allergan's (NYSE:AGN) generics business, dashing investors' hopes that it would pursue its hostile bid for Mylan.
- In a statement, Mylan reaffirms its interest in Perrigo. A vote on the combination by Mylan shareholders is expected to happen in the next few weeks.
Mon, Jul. 27, 5:19 AM
- Teva Pharmaceuticals (NYSE:TEVA) has agreed to buy the generic-drug business of Allergan (NYSE:AGN) for about $40.5B in cash and stock, ending its effort to acquire rival Mylan (NASDAQ:MYL).
- Allergan will receive $33.75B in cash and shares in Teva valued at $6.75B, giving it a 10% stake in the enlarged company.
- The acquisition further extends a wave of mergers that has swept over the healthcare industry. Pharmaceutical deals so far this year have topped $180B, on pace to beat the $200B announced in 2014.
- TEVA +12.1% premarket
Mon, Jul. 27, 3:40 AM| Mon, Jul. 27, 3:40 AM | Comment!
Sun, Jul. 26, 6:37 AM
- Teva Pharmaceuticals (NYSE:TEVA) is in advanced talks to buy Allergan's (NYSE:AGN) generic drug business following an unsuccessful effort to acquire Mylan (NASDAQ:MYL), WSJ reports.
- A deal for the business, valued at about $45B, could be announced as early as Monday and would extend the recent wave of mergers that has swept over the healthcare industry.
- Previously: Bloomberg: Allergan thinking of selling/spinning off generics business (Jul. 24 2015)
Thu, Jul. 23, 1:06 PM
- An independent Dutch foundation, Stichting Preferred Shares Mylan, exercises its call option allowing it to purchase 50% of Mylan's (MYL -1.4%) shares, giving it temporary control of half the company. The call option (i.e., poison pill), a common feature in Netherlands-based foundations, is a mechanism by which these groups can block unwelcome bids like the one from Teva Pharmaceutical Industries (TEVA). According to Stichting, it is acting to "safeguard Mylan's stakeholder interests." Mylan rejected Teva's $40B offer in April.
- In a statement, Teva said it has the power to challenge to foundation's action in court and that it would "take the necessary actions at the appropriate time."
Mon, Jul. 13, 8:53 AM
- ANI Pharmaceuticals (NASDAQ:ANIP) acquires 22 previously marketed generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) for $25M in cash plus a percentage of future gross profits from product sales. According to IMS Health, the total market value of the portfolio is $650M. The deal is being financed with cash on hand.
Wed, Jul. 8, 2:22 PM
- Teva Pharmaceutical Industries (TEVA -1.3%) launches its generic version of Janssen's (JNJ -0.8%) Axert (almotriptan malate), 6.25 mg and 12.5 mg, in the U.S. for the acute treatment of migraine. According to IMS, Axert generated $31M in sales for the 12-month period ending in March.
- Teva markets over 375 generic medicines.
Tue, Jul. 7, 10:27 AM
- Biotie (BITI +0.6%) initiated with Buy rating and $26 (33% upside) price target by Roth Capital and a Buy rating with $30 (53% upside) price target by Stifel Nicolaus.
- Boston Scientific (BSX -0.1%) initiated with Overweight rating and $21 (20% upside) price target by Stephens & Co.
- Ophthotech (OPHT +1.9%) initiated with Outperform rating and $80 (49% upside) price target by Cowen & Co.
- Teva Pharmaceutical Industries (TEVA -0.5%) initiated with Buy rating and $77 (25% upside) price target by BTIG Research.
- Axovant Sciences (AXON -1.1%) initiated with Buy rating and $31 (64% upside) price target by Jefferies.
- PRA Heath Sciences (PRAH) initiated with Sector Weight rating and $36.06 (0% upside) price target by KeyBanc.
- Baxalta (BXLT -0.4%) initiated with Neutral rating and $36 (14% upside) price target by Goldman Sachs.
Tue, Jul. 7, 8:45 AM
- The U.S. Department of Justice reports that AstraZeneca (NYSE:AZN) has agreed to pay $46.5M to the U.S. and certain states to resolve allegations that it underpaid rebates owed under the Medicaid Drug Rebate Program.
- Under a separate settlement in the same case, Cephalon (NYSE:TEVA) agrees to pay $7.5M to resolve the same allegations.
- Drug makers are required to pay quarterly rebates to state Medicaid programs in exchange for Medicaid's coverage of their drugs. The rebates are based, in part, on the Average Manufacturer Prices (AMPs) that the companies report to the government for each of their covered medicines. The higher the reported AMP, the higher the rebate. The allegations in this case were that the two firms underreported AMPs by improperly reducing the reported AMPs for service fees they paid to wholesalers which resulted in the government being overcharged for the products.
- The settlements partially resolve a whistleblower suit brought by pharmacist Ronald Streck.
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