Spain has imported a U.S.-made experimental Ebola drug to treat a Spanish missionary priest evacuated from Liberia last week after testing positive for the killer virus. The Health Ministry announced Monday that the ZMapp drug, made by Mapp Biopharmaceutical Inc. of San Diego, was obtained in Geneva this weekend and brought to Madrid to treat Miguel Pajares.
Walgreens today said it has exercised its option to complete the second step of its strategic...
The inspection confirmed the site to be compliant with the principles and guidelines of Good...
Packaging Coordinators has reached a definitive agreement to acquire Penn Pharmaceutical Services Limited. Penn Pharma is headquartered in Tredegar, Wales in the United Kingdom and operates regional offices in New Hope, Pennsylvania and Tokyo, Japan.
European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary EmbolismJuly 29, 2014 8:38 am | News | Comments
Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.
PaxVax, Inc., a specialty vaccine company focused on travel and biodefense, today announced that it has acquired the oral typhoid vaccine Vivotif® from Crucell Switzerland AG, as well as its manufacturing facility in Thörishaus, near Bern, Switzerland.
Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded "economic patriotism" from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers.
Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.
The experimental shot is the most advanced candidate vaccine for malaria but results from previous trials have been disappointing. Research published in 2012 showed the shot only reduced malaria cases by about 30 percent in babies aged six to 12 weeks, the target age for immunization.
The European Medicines Agency says a commonly used morning-after pill is suitable for use by heavier women after reviewing the evidence, sparked by a French pharmaceutical company's declaration last year that the drugs didn't work in women weighing more than 176 pounds.
Salix Pharmaceuticals, Ltd. and Cosmo Pharmaceuticals S.p.A. announced a definitive merger agreement under which Salix will combine with Cosmo Technologies Limited (“Cosmo Tech”), a subsidiary of Cosmo. Under the terms of the agreement, Salix will become a wholly-owned subsidiary of Irish domiciled Cosmo Tech.
The European Union's antitrust body is imposing a fine of 428 million euros ($580 million) on France's pharmaceutical company Servier and five producers of generic medicines for distorting competition.
EYLEA Injection Recommended for Approval for the Treatment of Visual Impairment due to Diabetic Macular Edema in the EUJune 27, 2014 8:33 am | News | Comments
Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME).
Vertex Pharmaceutical today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of KALYDECO™ (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European UnionJune 27, 2014 8:20 am | News | Comments
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes.
A French doctor was acquitted Wednesday of poisoning charges after giving lethal injections to seven terminally ill patients, and Britain's Supreme Court said an assisted-suicide ban is incompatible with human rights, fueling the arguments of those who say the duty of doctors is to end the suffering of those beyond treatment.
The Dublin-based drugmaker Shire said Friday it has rejected an unsolicited 27 billion-pound ($46.2 billion) offer from AbbVie Inc., arguing that it fundamentally undervalues the company and its prospects. The company said in a statement Friday that U.S.-based AbbVie's proposal was for 20.44 pounds ($34.78) and 0.7988 shares per Shire share.
ViiV Healthcare has entered into an agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialization of a single-tablet combining dolutegravir (Tivicay) and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine (Edurant).
Lonza Invests in Single-Use Technology and Facility Upgrades for Clinical Antibody Drug Conjugate (ADC) ManufacturingJune 11, 2014 8:34 am | News | Comments
The planned upgrades include the introduction of single-use technology for flexible ADC manufacturing, along with a recently optimized plant layout and revamping of the Heating, Ventilation, Air Conditioning (HVAC) systems, which has resulted in a larger ADC production area.
Xcelience announced today the opening of a 3,000 square foot facility in Birmingham, UK, making it the first small to mid-sized American CDMO to launch international operations. The new plant will become a gateway for the Florida-based company’s clinical packaging and distribution services in the UK, Europe and abroad.
In line with his own wishes, the contract of Dr. Marijn Dekkers will be extended by just two years on expiration of the initial five-year period. Dekkers cited family reasons for extending his contract only until the end of 2016.
Glenmark Pharmaceuticals S.A (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), announced the opening of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland.
Italy's health ministry is seeking 1.2 billion euros ($1.63 billion) in damages from Swiss pharmaceutical giants Novartis and Roche after an anti-trust court ruled the two companies colluded to prevent the distribution of an eye medication.
Researchers found more than 2 billion people worldwide are now overweight or obese. The highest rates were in the Middle East and North Africa, where nearly 60 percent of men and 65 percent of women are heavy. The U.S. has about 13 percent of the world's fat population, a greater percentage than any other country.
Usually, doctors adapt standard dialysis machines for babies, but that can be risky since the devices can't always be accurately tweaked. About 1 to 2 percent of hospitalized infants have kidney problems that may require dialysis, which cleans toxins from the blood when the kidneys aren't working.
The European Commission granted marketing authorization for Jardiance (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced.
The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers.
Jazz Pharmaceuticals has announced the appointment of Russell J. Cox to the newly created position of chief operating officer (COO). Mr. Cox, who joined Jazz Pharmaceuticals in July 2010, most recently served as executive vice president and chief commercial officer at the company.
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