Sep. 18, 2014, 7:40 AM
- In a joint meeting between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members vote 20-1 in favor of drug developers' need to further assess the cardiovascular risks of testosterone products. Sixteen voted that it should be studied only in certain situations.
- Members also voted 20-1 in favor of a revision of who should be prescribed the drugs. The panel says there is little evidence that testosterone replacement therapies (TRT) are effective for treating low levels of hormone caused by aging.
- Prescriptions for TRT products almost doubled from 2010 to 2013. About 20% of TRT patients do not have laboratory evidence that they need the therapy.
- Eli Lilly (NYSE:LLY) says that current evidence does not support a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients.
- The committees meet today to discuss Clarus Therapeutics' NDA for an oral testosterone.
- Related tickers: (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Sep. 16, 2014, 12:33 PM
- On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
- Briefing docs
- Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- Related tickers: (ABBV +0.7%) (LLY +0.9%) (AUXL -1.6%) (TEVA +1.8%)
Sep. 15, 2014, 4:08 PM
- The Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet on Wednesday, September 17 to discuss the appropriate population for testosterone replacement therapy (TRT) and the potential for adverse cardiovascular outcomes associated with TRT.
- Briefing docs
- Related tickers: (ABBV +0.1%) (LLY -0.1%) (AUXL -2.9%) (TEVA -1.4%)
Sep. 11, 2014, 11:49 AM
- In a Phase 3b clinical study evaluating the incidence of injection-related adverse events, (TEVA +0.1%) finds that three-times-per-week injections of Copaxone 40 mg resulted in a 50% reduction in such events compared to daily injections of Copaxone 20 mg.
- The number of injections was reduced 57% (3 days vs. 7 days) and the number of injection-related adverse events was reduced 50%. The results certainly appear predictable.
Sep. 9, 2014, 2:55 AM
- The Federal Trade Commission has sued AbbVie (NYSE:ABBV) and other drug companies over delaying entry of generic competition for the company's blockbuster testosterone-replacement drug AndroGel.
- "We believe the defendants' anticompetitive conduct has forced consumers to overpay hundreds of millions of dollars for this medication," says FTC Chairwoman Edith Ramirez.
- The commission also sued Teva Pharmaceutical Industries (NYSE:TEVA) over allegations that AbbVie paid Teva to withdraw legal claims which could have led to a generic version of AndroGel.
Sep. 8, 2014, 10:34 AM
- In a Phase 3 clinical trial, Teva Pharmaceutical Industries' (TEVA -0.2%) product candidate for patients with uncontrolled moderate-to-severe asthma, the anti-IL-5 monoclonal antibody reslizumab, demonstrated significant improvements in lung function compared to placebo in patients with elevated eosinophils.
- Results from a second study in an asthma population not selected for elevated eosinophils, reslizumab demonstrated minimal improvements in asthma control.
- The data support the eosinophil threshold of 400/uL established for the reslizumab program.
Sep. 4, 2014, 10:36 AM
- Teva Pharmaceutical Industries (TEVA -0.2%) launches its generic equivalent to Bristol-Myers Squibb's (BMY +0.2%) Baraclude (entecavir) Tablets, 0.5 mg and 1 mg, in the U.S. Teva was first to file its ANDA so it has 180 days of marketing exclusivity before other generic makers' offerings are cleared for sale.
- According to IMS Health, Baraclude generated ~$330M in sales in the 12-month period ended June 2014.
Sep. 3, 2014, 9:16 AM
- The U.K. High Court rules in favor of Teva Pharmaceutical Industries (NYSE:TEVA) in its case challenging the validity of AstraZeneca's (NYSE:AZN) patent (EP 1,085,877) covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AZN's fixed dose formoterol/budesonide combination product, Symbicort.
- The Court agreed with Teva's position that AZN's SMART patent is obvious and rejected AZN's proposed amendments on the basis that they added matter.
- The ruling facilitates Teva's European launch of DuoResp Spiromax, its version of a formoterol/budesonide fixed dose combination product.
Sep. 2, 2014, 10:29 AM
- Teva Pharmaceutical Industries' (TEVA +0.3%) investigational anti-IL-5 inhibitor, reslizumab, achieves its primary endpoint of a reduction in the frequency of clinical asthma exacerbations (CAE) compared to placebo in two Phase 3 trials. Treatment with reslizumab reduced the frequency of CAE 50% and 60% in the studies (p value < 0.0001 for both). The results were highly statistically significant.
- Reslizumab is an investigational humanized monoclonal antibody against interleukin-5 (IL-5). IL-5 has been shown to play an important role in the maturation, growth and chemotaxis of inflammatory white blood cells called eosinophils that are implicated in a number of allergic diseases.
- The company expects to submit its regulatory applications in 1H 2015.
Aug. 30, 2014, 12:05 PM
- In the largest study of its kind ever done, Novartis' (NYSE:NVS) investigational heart failure drug candidate, LCZ696, demonstrated superiority over the ACE-inhibitor enalapril on several key endpoints.
- LCZ696 reduced the risk of death from cardiovascular disease by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%. All the results were highly statistically significant.
- The twice-daily tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system. Current therapies act only to block the harmful effects.
- Novartis intends to submit its NDA to the FDA by the end of 2014 and its MAA to the EC in early 2015.
- Related tickers: (NYSE:VRX) (NYSE:TEVA) (NASDAQ:MYL) (NYSE:TARO) (NYSE:RDY)
Aug. 28, 2014, 11:53 AM
- The FDA accepts Mylan's (MYL -0.2%) ANDA for a 3x/week Glatiramer Acetate Injection 40 mg/mL which is a generic version of Teva's (TEVA -0.3%) Copaxone 40 mg/mL indicated for the treatment of patients with relapsing multiple sclerosis. Mylan believes it is one of the first companies to make the filing so it expects to be eligible for 180 days' market exclusivity (although this is based on the "first to file").
- According to IMS Health, Copaxone generated ~$412M in U.S. sales over the 12-month period ending June 30, 2014.
Aug. 25, 2014, 10:18 AM
- The FDA approves Iroko Pharmaceuticals' Zorvolex (diclofenac) for the management of osteoarthritis pain. The agency cleared the NSAID for the treatment of mild-to-moderate pain in adults in October 2013.
- Related tickers: (PFE +0.1%) (MRK +0.9%) (OTCPK:BAYZF) (OTCPK:BAYRY +1.2%) (OTCQX:RHHBY +0.6%) (TEVA -0.5%) (MYL +0.8%) (PRGO -0.1%) (GSK +0.8%)
Aug. 22, 2014, 5:00 AM
- The DEA has reclassified hydrocodone combination drugs to stem a rise in their abuse, and will now label them in a category reserved for medical substances with the highest potential for harm.
- The move has been resisted by many drug makers and wholesalers, but others like Mallinckrodt (NYSE:MNK) support it and say it will have no significant impact on their business.
- Major makers of hydrocodone combination drugs include Actavis (NYSE:ACT), Teva (NYSE:TEVA), AbbVie (NYSE:ABBV), Zogenix (NASDAQ:ZGNX), Lannett (NYSE:LCI), and Alkermes (NASDAQ:ALKS).
Aug. 4, 2014, 10:26 AM
Jul. 31, 2014, 7:49 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) Q2 results: Total Revenues: $5,045M (+2.5%), Generic Medicine: $2,515M (+4.3%), Specialty Medicine: $2,027M (-1.2%); Operating Income: $1,094M (+14.8%); Net Income: $745M (-26.8%); EPS: $0.87 (-27.5%); CF Ops: $1,053M (+20.3%).
- Product sales: Copaxone: $939M (-12.2%), Treanda: $190M (+7.3%), ProAir: $133M (+15.7%), Women's Health: $128M (+19.6%).
- 2014 Guidance: no update provided.
Jul. 31, 2014, 7:05 AM| Comment!
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