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22:45 EDT 26th March 2017 | BioPortfolio

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Momenta says Pfizer will fix plant but reiterates that Glatopa 40mg ANDA delay likely

Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.

Mylan wins court ruling for Copaxone 40mg/mL patents

Global generic and specialist pharmaceuticals company Mylan has won a US District Court Ruling with regards to its Copaxone 40mg/mL patents.

Teva MS drug under threat in US

A US court has hit Teva where it hurts, invalidating four US patents on its latest version of multiple sclerosis drug, Copaxone. Mylan wants to market a cheaper version of Teva’s three-times a week...

Copaxone 40mg Generic At-Risk Launch Anticipated As Soon As February

Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts...   

Momenta Delay Means Race For Copaxone Generic Is On

Just as Momenta Pharmaceuticals was about to reach its zenith, disaster struck. FDA approval of its generic form of the 40mg dose of Teva's multiple sclerosis drug Copaxone had been expected any d...

Spring Break: Novo's US Head Resigns After Rough Winter

Novo Nordisk's executive VP and head of North American operations, Jakob Riis, has resigned from the company – a move...   

Brazil/South Korea Move To ICH Driving Seat Raises Global Harmonization Expectations

Brazil and South Korea have been accepted as new regulatory members of the International Council for Harmonisation. This has raised...    

Teva Catches A Break On Copaxone 40mg, But For How Long?

An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear...   

Matching PubMed Articles

AFB1 hepatocarcinogenesis is via lipid peroxidation that inhibits DNA repair, sensitizes mutation susceptibility and induces aldehyde-DNA adducts at p53 mutational hotspot codon 249.

Aflatoxin B1 (AFB1) contamination in the food chain is a major cause of hepatocellular carcinoma (HCC). More than 60% of AFB1 related HCC carry p53 codon 249 mutations but the causal mechanism remains...

Rapid mixing with high-throughput in a semi-active semi-passive micromixer.

In this paper, we investigate a novel alternating current electrothermal (ACET) micromixer driven by a high efficiency ACET micropump. The micromixer consists of thin film asymmetric pairs of electrod...

Beyond feast and famine: Selecting a PHA accumulating photosynthetic mixed culture in a permanent feast regime.

Currently, the feast and famine (FF) regime is the most widely applied strategy to select for polyhydroxyalkanoate (PHA) accumulating organisms in PHA production systems with mixed microbial cultures....

Pharmacologic synergism of ocular ketorolac and systemic caffeine citrate in rat oxygen-induced retinopathy.

Caffeine or ketorolac decrease the risk of retinopathy of prematurity and may act synergistically to improve beneficial effect. Combination of caffeine (Caff) and ketorolac (Keto) to prevent oxygen-in...

Acute oral 18-methoxycoronaridine (18-MC) decreases both alcohol intake and IV nicotine self-administration in rats.

The ibogaine derivative 18-methoxycoronaridine (18-MC) has been found to decrease self-administration of morphine, nicotine and alcohol in rats after systemic injection. However oral dosing is the pre...

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