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Innocoll Holdings - FDA indicated xaracoll should be characterized as drug/device combination, which would require co submit additional information.
Innocoll - company will request a type a meeting with FDA to seek clarification of what additional information, if any, will be required.
Innocoll holdings - FDA determined that application, which…
Medivir AB announces that the acquisitions of the two clinical stage oncology programs from TetraLogic Pharmaceuticals Corporation (Nasdaq: TLOG) have been completed.
In connection with the closing, Medivir has paid the upfront payment of US$12M to TetraLogic.
Medivir will be holding an investor call on January 9, 2017 to present…
Beijing Beilu Pharmaceutical Co., Ltd. Says it received goods manufacture practice (GMP) certificate from State Food and Drug Administration of Beijing.
Says certificate issued to granules and Chinese drug's extraction and the valid period is until Dec. 18, 2021.
German pharmaceutical company Boehringer Ingelheim agreed to divest five types of animal health products to settle charges that a proposed asset swap with Sanofi would harm competition, the U.S. Federal Trade Commission said on Wednesday.
The proposed asset swap involved Boehringer Ingelheim's acquisition of Sanofi's $13.5 billion animal care subsidiary…
Anthera Pharmaceuticals Inc said on Tuesday that its drug to treat certain cystic fibrosis patients failed a late-stage study, sending the company's shares tumbling nearly 70 percent in after-hours trading.
The latest setback for Anthera comes just over a month after the company said an experimental drug to treat lupus…
France's Sanofi has filed a lawsuit in the United States accusing Novo Nordisk of falsely claiming that Sanofi insulin drugs would no longer be available for many U.S. patients so it could promote its competing drug.
The complaint, filed by Sanofi US in U.S. District Court for the District of…
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Tretinoin Capsules, 10 mg, the generic version of Vesanoid Capsules, 10 mg, of Hoffmann La Roche, Inc. (which is no longer being marketed in the United States).
According to IMS…
Tasly Pharmaceutical Group Says the Topline Analysis Report of its compound Danshen dripping pills proves that its compound Danshen dripping pills have positive treatment effect for angina pectoris.
Says the clinic trial is for the New Drug Application of U.S FDA.
Sun Pharma today said its subsidiary has invested $13 million (about Rs 88 crore) in the US-based scPharmaceuticals Inc.
"One of the wholly-owned subsidiaries of the company has acquired 13,000,000 Series B preferred stock of scPharmaceuticals Inc (equivalent to 14.58 per cent fully diluted equity stake on conversion) by way…
The U.S. Food and Drug Administration on Friday said it has approved Biogen Inc's drug to treat spinal muscular atrophy, the leading genetic cause of death in infants.
It is the first FDA-approved medicine for spinal muscular atrophy, a devastating disease that affects about one in 10,000 live births.