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Intec Pharma announced its Parkinson's disease hopeful missed its primary endpoint in a phase 3 trial.
Celgene announced that the U.S. FDA has approved Otezla for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
It was great while it lasted. But Pfizer’s blockbuster drug, Lyrica, is now officially facing generics competition.
Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.
Novartis CEO Vas Narasimhan announced that $700 million has been set aside in the hope of settling a decade-old lawsuit alleging that the Swiss drugmaker bribed U.S. doctors.
With the FDA getting ready to knock on their door, officials at Strides Pharma Science Ltd. appear to have attempted to destroy quality-control documents.
The FDA has given the go-ahead to an antibiotic developed by Merck to treat urinary tract and abdominal infections.
The company's Kite Pharma subsidiary will now produce its own Yescarta viral vector material, which it had previosly been purchasing from contractors.
The company's crizanlizumab will receive a priority review, shortening the standard FDA process from ten months to six months.
Eton Pharmaceuticals announced that the U.S FDA provided Eton’s partner with a Complete Response Letter relating to the application for investigational eye drops.
Gilead Sciences has struck a major expansion deal with a European biotech firm to target the high-growth anti-inflammatories market.
Boehringer Ingelheim announced its acquisition of AMAL Therapeutics, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform, KISIMA.
The Department of Justice is reportedly investigating claims that Johnson and Johnson officials lied about cancer risks tied to its popular baby powder.
How the pharma industry's big ideas are impacting sterile manufacturing
Illinois-based Nexus Pharmaceuticals is planning a $250-million project in Wisconsin in order to build and equip a 100,000-square-foot, three-story sterile drug manufacturing facility.
Reckitt Benckiser Group will pay up to $1.4 billion to settle U.S. investigations into whether its former pharma unit organized a multibillion-dollar fraud to drive up sales of its opioid-addiction treatment, Suboxone.
GlaxoSmithKline reported this week that its combo HIV treatment met its main goal in a study comparing it to a mix of three drugs.
The challenges are mounting for Canadian generics drugmaker Apotex.
The company's Sandoz unit is making its generic available to local pharmacies across the country, helping to alleviate an EpiPen shortage caused by manufacturing issues.
YaoPharma, Fosun's Chongqing unit, will spend up to $36 million to buy GlaxoSmithKline's Suzhou pharmaceutical factory.
GlaxoSmithKline has opened two “state-of-the-art” facilities in Singapore with continuous manufacturing capabilities.
A new treatment being investigated for bipolar depression has failed to meet its main goal in a recent study.
Roche and Spark Therapeutics agreed to extend the deadline for Roche's $4.3 billion takeover bid for the U.S. gene therapy specialist.