Tue, Apr. 14, 9:32 AM
- The FDA accepts for review the New Drug Application (NDA) from Eagle Pharmaceuticals (NASDAQ:EGRX) for Orphan Drug-designated rapid infusion bendamustine HCl for the treatment of patients with chronic lymphocytic leukemia (CLL) or indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or with six months of treatment with rituximab (Rituxan) or a rituximab-containing regimen.
- Clinical studies showed that rapid infusion bendamustine HCl can be administered in 10 minutes in a low-volume 50 mL admixture compared to traditional infusion times of 30 minutes (CLL) to 60 minutes (NHL).
- Teva Pharmaceutical Industries (NYSE:TEVA) will commercialize the product in the U.S. The PDUFA date goal is December.
Wed, Apr. 8, 11:47 AM
- Mylan (MYL +10.4%) submits a non-binding proposal to Perrigo (PRGO +27.6%) to acquire it for $205 per share in a cash-and-stock deal. If consummated, the combined company would generate over $15B in annual sales.
- Generic drug-related tickers: (LCI +3%)(AKRX +4.4%)(MNK +2.8%)(IPXL +2.3%)(TARO +2.3%)(TEVA +3.2%)
Thu, Apr. 2, 10:09 AM
- The first patient has been enrolled in a Phase 2b clinical trial evaluating topically applied TV-45070 (4% and 8% w/w Ointment) for the treatment of postherpetic neuralgia (PHN). TV-45070 is a small molecule sodium channel inhibitor with broad application in nociceptive (sharp) pain.
- PNH is a painful complication of herpes zoster (shingles) in which pain persists for more than three months after the rash disappears. It affects ~20% of people living with herpes zoster, but increases with age. As many as 50% of PHN patients fail to respond to treatment.
- TV-45070 was initially developed by Xenon Pharmaceuticals (XENE -2.1%). Teva Pharmaceutical Industries (TEVA +1.3%) has exclusive global rights to the product candidate via a collaborative development and license agreement established in 2012. Teva is currently conducting a Phase 2b study of TV-45070 in osteoarthritis of the knee.
Wed, Apr. 1, 8:30 AM
- The FDA approves Teva Pharmaceutical Industries' (NYSE:TEVA) ProAir RespiClick (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients at least 12 years old with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients at least 12 years old. It will be commercially available this quarter.
- ProAir RespiClick is a breath-actuated, dry powder rescue inhaler for the treatment of acute asthma symptoms. It eliminates the need for hand-breath coordination during inhalation.
Tue, Mar. 31, 12:56 PM
- Oppenheimer upgrades Teva Pharmaceutical Industries (TEVA +1.1%) from Perform to Outperform and raises its price target to $77 (22% upside) citing more M&A deals to come.
- Piper Jaffray upgrades Horizon Pharma (HZNP +1%) from Neutral to Overweight with a price target of $31 (19% upside) due, no doubt, to its recent take out of Hyperion Therapeutics (HPTX -0.3%).
Tue, Mar. 31, 10:09 AM
Mon, Mar. 30, 7:18 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) acquires Auspex Pharmaceuticals (NASDAQ:ASPX) for $101 per share ($3.2B) in an all-cash transaction. The deal will enhance Teva's revenue and earnings growth profile as well as strengthen its central nervous system franchise.
- Auspex's lead product candidate is SD-809, a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), that is designed to regulate the levels of dopamine in the brain. It is being investigated for the treatment of various movement disorders.
- Shares are up 42% premarket on average volume.
- Previously: Auspex Pharma completes enrollment in tardive dyskinesia trial (Feb. 3)
- Previously: Auspex chorea treatment candidate successful in Phase 3, shares jump (Dec. 17, 2014)
- Previously: Auspex candidate for TS tagged an Orphan Drug (Jan. 14)
Fri, Mar. 27, 8:46 AM
- Bernstein analyst Ronny Gal lifts his price target 15% for Teva Pharmaceutical Industries (NYSE:TEVA) to $69 (from $60) citing the firm's continued shift to branded drugs, a deeper pipeline and a more global customer base. He also notes that management has a list of 25 preferred acquisition targets, including some in generics (for example, biosimilars) that would yield substantial synergies.
Tue, Mar. 24, 4:52 PM
- Teva Pharmaceutical Industries (NYSE:TEVA) subsidiary Teva Pharmaceutical Finance Netherlands II B.V. issues €2B in senior notes in two tranches: €1.3B 1.250% senior notes due March 2023 at €990.01/€1,000 principal amount and €700M 1.875% senior notes due 2027 at €995.01/€1,000 principal amount.
- Net proceeds will be used for general corporate purposes.
Mon, Mar. 23, 12:25 PM
- A Phase 2b clinical trial evaluating Teva Pharmaceutical Industries' (TEVA +1.3%) TEV-48125 for the prevention of high frequency episodic migraine (8 - 14 days of headache per month) met its primary and secondary endpoints achieving significant reductions in mean monthly migraine days and monthly headache days compared to baseline. Full results will be presented at a future scientific meeting.
- The 297 patients in the randomized, double-blind, placebo-controlled, parallel group study received an injection of either low or high dose TEV-48125 or placebo once per month for three months. They were allowed to continue their existing migraine prevention therapy.
- TEV-48125 is the first therapy to demonstrate efficacy in both chronic, based on earlier results in this setting, and episodic migraine, and at multiple doses. It is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine.
- Teva intends to advance TEV-48125 to Phase 3 development.
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Mar. 17, 4:37 PM
- Ignyta (NASDAQ:RXDX) acquires the worldwide rights and assets to four oncology development programs from Teva Pharmaceutical Industries (NYSE:TEVA) for 1.5M shares of Ignyta stock (6% stake).
- Concurrently, the companies entered into a stock purchase agreement whereby Teva will buy an additional 1.5M shares of RXDX at $10 per share. Other investors will buy an additional 2.7M RXDX shares also at $10, valuing the total offering at $41.6M.
- The four programs bought by Ignyta are: CEP-32496 (RXDX-105) - a Phase 1/2 small molecule inhibitor of BRAF, EGFR and RET; CEP-40783 (RXDX-106) - a preclinical pseudo-irreversible inhibitor of AXL and cMET; CEP-40125 (RXDX-107) - a preclinical nanoformulation of modified bendamustine and TEV-44229 (RXDX-108) - a preclinical selective inhibitor of the atypical kinase RKCiota plus next generation PKCiota inhibitors.
- Ignyta Chairman & CEO Jonathan Lim, M.D., says, "Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs."
- RXDX is up 31% after hours on light volume.
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Tue, Mar. 10, 7:29 AM
- Vivus (NASDAQ:VVUS) receives notice from Teva Pharmaceutical Industries (NYSE:TEVA) that it has filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Qsymia (phentermine and topiramate extended release). The company is currently reviewed the notice but a patent infringement lawsuit will surely be initiated considering its suit against Actavis (NYSE:ACT) for its ANDA submission. Once filed, there is an automatic 30-month stay of regulatory clearance to allow for the legal process to play out.
- Previously: Vivus sues Actavis over generic version of Qsymia (March 9)
Wed, Mar. 4, 8:23 AM
- Based on the findings of an independent advisory panel, the FDA issues a formal announcement that restricts testosterone drug makers from promoting their products for age-related low testosterone, an ever-increasing target of prescriptions. The number of men being prescribed testosterone jumped over 75% between 2009 and 2013.
- The agency asks (not really a request) manufacturers to change their labeling to clarify that their products are only approved for men with specific medical conditions and that taking the drugs could increase their risk of heart attacks and strokes.
- The agency also requests that manufacturers of approved products, including skin patches, solutions, intramuscular injections and topical gels, conduct studies to determine if their treatments increase cardiovascular risk.
- Last year, the FDA mandated that testosterone product makers update their labeling to include a warning about the risk of blood clots.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENDP) (NYSE:LLY) (NASDAQ:ATRS) (NASDAQ:RPRX) (NASDAQ:LPCN) (NYSE:TEVA) (NASDAQ:AUXL)
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