The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of domperidone-containing medicines and has recommended changes to their use throughout the European Union (EU).
Endo International has appointed Susan Hall, Ph.D. as executive vice president, chief scientific...
Dendreon Corporation today announced that it plans to make PROVENGE ® (autologous peripheral...
European Medicines Agency Recommends that Protelos/Osseor Remain Available But with Further RestrictionsFebruary 21, 2014 8:23 am | News | Comments
The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended...
Jean-Christophe Tellier, currently UCB’s Executive Vice President, Biopharma Brands and Solutions, will be appointed Chief Executive Officer-Elect and Chairman of the Executive Committee as of March 1, 2014. Jean-Christophe Tellier will also be proposed to be appointed as a member of the Board of Directors at the next Annual General Meeting of Shareholders on April 24, 2014.
There's one big reason why the United States has a dearth of execution drugs so acute that some states are considering solutions such as firing squads and gas chambers: Europe's fierce hostility to capital punishment. The phenomenon started nine years ago when the EU banned the export of products used for execution, citing its goal to be the "leading institutional actor and largest donor to the fight against the death penalty."
Leading cancer experts say Europe's antiquated drug regulatory system is stopping children from getting life-saving medicines and are calling for changes that would remove a loophole that allows companies to skip developing medicines for children already approved for adults.
Swiss food and drink giant Nestlé and French cosmetics company L'Oréal have approved a deal to transfer ownership of Swiss dermatology pharmaceuticals company Galderma.
UPS said Tuesday that it has completed its acquisition of Polar Speed, a company that helps deliver temperature-sensitive pharmaceutical supplies in the United Kingdom. Financial terms were not disclosed.
Jazz Pharmaceuticals today announced that it has commenced construction of a manufacturing and development facility to be located on a 17-acre site in Monksland, County Roscommon, approximately 75 miles east of the company's Dublin headquarters. This is the first manufacturing facility to be built by Jazz Pharmaceuticals.
AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU).
France's Health Ministry said that sales of Sativex, produced by Britain's GW Pharmaceuticals, will be allowed for the treatment of muscle spasms associated with multiple sclerosis.
A German pharmaceutical company says it is appealing a Spanish court ruling ordering it to pay compensation to 22 Spaniards who blame their disabilities on the drug thalidomide.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorization for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Jazz Pharmaceuticals PLC plans to buy drug maker Gentium SpA for roughly $1 billion in a cash deal aimed at expanding its rare disease drug portfolio. Shares of Jazz jumped nearly 6 percent to $121.50 in after-hours trading following the announcement.
Germany's Bayer AG is set to acquire cancer drug maker Algeta ASA after raising its offer for the Norwegian-based company to nearly $2.9 billion. The two firms said Thursday drug and chemical company Bayer will make a cash offer of 362 kroner ($59.24) per Algeta share.
Almirall, S.A. an international pharmaceutical company based in Spain, has announced a definitive agreement to acquire Aqua Pharmaceuticals, LLC, a privately held US-based prescription dermatology company.
Everett Laboratories, a privately held specialty pharmaceutical company and a subsidiary of Exeltis, headquartered in Madrid, Spain, today announced that it has acquired Quinnova Pharmaceuticals, Inc. from parent company Amneal Enterprises, LLC. The acquisition will result in the strategic expansion of Everett into the fast-growing U.S. dermatology market.
The new facility, which is estimated to cost nearly €40 million, will be used, among other things, to expand production to serve new markets such as China. In the two - story building, which will be constructed on the current Allergopharma premises, products for the diagnosis and treatment of type 1 allergies.
Roche and Prothena Corporation have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment of Parkinson's disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson's disease in 2014.
The European Commission has fined pharmaceuticals giants Johnson & Johnson and Novartis a combined $22 million for colluding to delay the entrance of a cheap generic form of a pain killer to the Dutch market.
The European Medicines Agency has started an in-depth review of the benefits and risks of the leukemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.
Genmab A/S announced today it had reached an in vivo pre-clinical milestone in the collaboration with H. Lundbeck A/S, triggering a [Eur]1.5 million payment (approximately DKK 11 million).
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorization to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age
Moberg Pharma AB has signed a deal to acquire three well established Over-The-Counter brands in the U.S. from Bayer HealthCare, LLC. Total annual sales for the brands are approximately 20 MSEK (ca 3 m$). The purchase price is 32 MSEK (4.8 m$) and is financed by available cash resources.
Alvotech today announced plans to invest $250 million in the development and manufacturing of a portfolio of biosimilar monoclonal antibodies. Alvotech’s current biosimilar assets include follow-on versions of leading monoclonal antibodies molecules, which will be brought to market by 2018.
Germany's Merck KGaA has announced plans to buy AZ Electronic Materials, which supplies high-tech materials for the electronics industry, for about 1.6 billion pounds ($2.6 billion). Pharmaceutical and high-tech materials company Merck said Thursday that it will offer 403.5 pence ($6.61) in cash.
Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that support them.
Who are the technical innovators in the US? The image we often have is that of the young Silicon Valley geek or the surfing California biopharma scientist -- sometimes brash and unafraid to challenge authority and champion new and better ideas.
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