FDA warns China facility over 'persistent' contamination
21 September 2016
Drugmakers looking to bring back hydrogen to deliver drugs over longer periods
21 September 2016
Drugmakers like Teva ($TEVA) are looking to bring back hydrogen as a possible delivery mechanism for drugs as the heavier element could slow the breakdown of compounds in the body and allow the patients to take medications on a less frequent basis.
Combination Products Challenge Regulators and Manufacturers
21 September 2016
Combination products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen, and emerging cellular and gene therapies. Manufacturers complain of delays in decisions by FDA’s Office of Combination Products (OCP) about which FDA center should take the lead in evaluating a new combo
Allergan Buys Liver Drug Maker Tobira for Up to $1.7 Billion
20 September 2016
Allergan Plc agreed to buy Tobira Therapeutics Inc. for as much as $1.7 billion to gain a late-stage experimental drug to treat liver diseases, one of the most anticipated categories in biotechnology.
Say what? Allergan just agreed to pay a 6X cash premium for Tobira and its troubled PhIII NASH drug
20 September 2016
A couple of months after a trial setback crushed Tobira’s share price, Allergan has swooped in to buy the company for $29.35 a share and up to $49.84 a share in contingent value rights if its late-stage NASH drug turns out to be a hit.
Allergan to buy Tobira in push for NASH treatments
20 September 2016
Allergan Plc (AGN.N) said it would buy Tobira Therapeutics Inc (TBRA.O) in a deal worth up to $1.7 billion, about 19 times the company's current value, to get a leg up in the race to develop therapies for NASH, an incurable fatty liver disease.
Acquisitive Allergan buys micro-cap NASH biotech Tobira months
20 September 2016
On the back of a number of deals in recent months, mainly in dermatology and after dodging its own $100 billion-plus consumption by Pfizer ($PFE) this year, Allergan ($AGN) has snapped up tiny Tobira ($TBRA) and its struggling fatty liver disease candidate, along with the rest of its pipeline, for potentially $1.7 billion.
The Next Frontier for Cancer Immunotherapy Trials
20 September 2016
With its measurable impact on patient survival, there’s no denying that immunotherapy is already causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.
20 September 2016
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, today announced that they have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to $1.695 billion . The Boards of Directors of both companies have unanimously approved the transaction.
EMA Recommends Breast Cancer Treatment
20 September 2016
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that it was recommending that Ibrance, a treatment for locally advanced or metastatic breast cancer, be granted marketing authorization in the European Union. According to EMA, the drug has been used to treat cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that it was recommending that Ibrance, a treatment for locally advanced or metastatic breast cancer, be granted marketing authorization in the European Union. According to EMA, the drug has been used to treat cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.
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