Jul. 11, 2014, 7:44 AM| 3 Comments
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. 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, 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. 23, 2014, 9:46 AM
- Questcor Pharmaceuticals (QCOR +0.1%) acquires the commercial rights to Novartis' (NVS -0.7%) Synachthen (tetracosactrin) and Synacthen Depot in all countries worldwide except 13 European countries where NVS previously granted the rights to a third party.
- The products are approved ex-U.S. for multiple indications including certain autoimmune and inflammatory conditions. Questcor has begun pre-clinical development work in the U.S.
- Under the terms of the agreement, QCOR will have the right to develop, market, manufacture, distribute, sell and commercialize Synacthen in the assigned countries.
Jun. 5, 2014, 10:36 AM
- The European Medicines Agency (EMA) reinstates the GMP certificate for India's generic drug maker Ranbaxy Laboratories' Toansa manufacturing site after the company implements corrective measures. The EMA suspended the GMP certificate in January after an on-site FDA inspection discovered significant deficiencies. An EMA inspection team concluded that there was no evidence that any drugs in the EU market containing Toansa-made ingredients were of unacceptable quality or presented a risk to patients.
- Related generic drug tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
May. 28, 2014, 8:34 AM
- The FDA accepts Mallinckrodt's (MNK) NDA for MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen for the management of moderate to moderately severe pain where the use of opioids is appropriate.
- The product incorporates Depomed's (DEPO) Acuform drug delivery technology. The USPTO has issued a notice of allowance to MNK relating to composition claims pertaining to the design, formulation, pharmacokinetic and release characteristics of MNK-155.
- The FDA's acceptance of the filing triggers a $5M milestone payment to DEPO. Regulatory clearance will trigger another $10M milestone plus a 7.5% royalty on sales.
- Related tickers: (ZGNX) (TEVA) (ABBV) (ALKS)
May. 14, 2014, 9:43 AM
- Questcor Pharmaceuticals (QCOR -0.8%) enters a collaboration with an undisclosed privately held European firm to develop novel melanocortin peptides. The deal includes an option to acquire the technology during clinical development.
- The firm will focus on novel receptor-selective peptide compounds designed to target specific melanocortin cellular receptors in order to address specific autoimmune and inflammatory diseases with high unmet medical need. The agreement includes a technology platform that provides a library of these peptides.
- Under the terms of the agreement, QCOR will fund the development work while securing an exclusive global license to the peptides and technology including the aforementioned option to acquire the technology at a later date.
May. 12, 2014, 10:58 AM| 3 Comments
May. 8, 2014, 6:38 AM
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Apr. 28, 2014, 4:14 PM| 3 Comments
Apr. 28, 2014, 4:03 PM| 1 Comment
Apr. 27, 2014, 5:35 PM
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Mallinckrodt PLC develops, manufactures, markets & distributes generic specialty pharmaceutical products, active pharmaceutical ingredients and diagnostic imaging agents. It operates in two segments; Specialty Pharmaceuticals & Global Medical Imaging.
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