Genmab A/S announced today it had reached an in vivo pre-clinical milestone in the collaboration...
AstraZeneca today announced that the European Commission (EC) has granted Marketing...
Moberg Pharma AB has signed a deal to acquire three well established Over-The-Counter brands in...
Eli Lilly and Company announced today that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment.
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.
The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson & Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals.
Pfizer has announced an update of its clinical trial data access policy that will simplify and broaden access to information gathered in Pfizer-sponsored clinical trials. The updated policy builds upon and expands the company’s established methods of clinical trial information sharing.
Roche and Molecular Partners AG today announced that they have entered into a research collaboration and licensing agreement to discover, develop and commercialize several proprietary therapeutics incorporating Molecular Partners’ DARPin ® biologics conjugated to toxic agents developed at Roche for the treatment of cancer.
Sanofi said Tuesday that its insulin U300 met its primary goals in a series of clinical trials, but some results were mixed. U300 is intended to be a longer-lasting version of Lantus that can be administered in lower doses. The company plans to file for marketing approval in the U.S. and European Union in the first half of 2014.
Forest Laboratories says it plans to cut about 500 jobs as part of a plan to trim $500 million in costs over the next two years. The company also plans to buy back at least $400 million in company stock and agreed to pay $240 million for the U.S. marketing rights to Saphris.
Under the terms of the agreement, Forest will make an upfront payment of $240 million and additional payments to Merck based on defined sales milestones. Merck will remain responsible for product supply. Forest will assume responsibility for continued commercialization, including completing certain post marketing studies of Saphris following a transition period.
Takeda Pharmaceutical has announced that Christophe Weber has been approved at the company's Board of Directors Meeting to become Chief Operating Officer (COO) and candidate as the next Chief Executive Officer (CEO). Mr. Weber will join Takeda to take the role of COO by April 2014.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.
New York officials say a $5.8 million grant and up to $6.2 million in tax credits have figured into Bausch & Lomb's decision to expand manufacturing and distribution in Rochester, N.Y. Gov. Andrew Cuomo says Valeant Pharmaceutical International will invest $106 million to expand capacity for its subsidiary's new line of contact lenses.
A government study offers a new theory on why the whooping cough vaccine doesn't seem to be working as well as expected. The research suggests that while the vaccine may keep people from getting sick, it doesn't prevent them from spreading whooping cough — also known as pertussis — to others.
Norway-based cancer drug maker Algeta ASA says it has received a preliminary takeover offer from Germany's Bayer AG that values the company at about $2.4 billion. Algeta said in a statement Tuesday that the offer is for 336 kroner ($55.11) per share; the company has nearly 44 million shares.
The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.
Mylan has announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer.
Eisai announced today that it has become a signatory to the Tuberculosis Drug Accelerator (TBDA) partnership, a ground-breaking initiative that aims to speed up the discovery of essential new treatments for tuberculosis (TB).
The FDA has expanded approval of a Bayer drug to treat patients with thyroid cancer. Bayer's pill Nexavar is already approved to treat kidney cancer and liver cancer that cannot be surgically removed. Now the FDA has approved the drug to treat cancerous growth of the thyroid gland, which is located in the neck.
The U.S. government has for the first time approved an adjuvanted vaccine to protect against H5N1 bird flu. The vaccine was made by Quebec City-based ID Biomedical, a subsidiary of pharmaceutical giant GlaxoSmithKline.
Swiss voters soundly rejected on Sunday a proposal to limit the pay of companies' highest-paid managers to 12 times that of their lowest-paid workers. Switzerland is home to global business players such as pharmaceutical companies Novartis and Roche; insurance groups Zurich and Swiss Re; and banks UBS and Credit Suisse.
Federal regulators on Friday approved a new drug from Johnson & Johnson for use in treating chronic hepatitis C infections. The U.S. Food and Drug Administration said it approved the drug, a protease inhibitor that blocks a protein needed by the virus to replicate.
Pfizer has announced that the FDA has granted XALKORI ® (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Forest Labs said regulators want more information on the drugmaker's potential schizophrenia treatment cariprazine before they decide whether to approve the drug. The potential drug aims to treat bipolar I disorder, which is also known as manic-depressive illness and characterized by unusual shifts in a person's mood, energy level or ability to carry out daily tasks.
Pfizer announced today that it has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.
Pfizer Inc. says it will close one of its three manufacturing plants in Puerto Rico by 2017. The world's largest drug maker says the manufacturing of products at its plant in the north coastal city of Barceloneta will be moved elsewhere.
Biopharm GmbH, Heidelberg, announced today that they have signed an agreement with Merck to cooperate with Merck Serono, the biopharmaceutical division of Merck in their research activities directed toward the molecular engineering of a biologic compound for the treatment of osteoarthritis.
- Page 1