Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
While many of us from blue states and urban bubbles fret over some of the actions of President Donald Trump, it’s good to take a clear-eyed view of whether or not Trump and this administration has been good for the medical marketing industries. Moreover, it’s useful to consider how a “blue wave” in the midterm elections might change the dynamic.
Shares of Israeli drugmaker Teva Pharmaceutical Industries rose more than 5 percent after the U.S. Food and Drug Administration approved the company’s new migraine treatment.
The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis
Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.
Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.
GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
Johnson & Johnson said the company would work with the Indian government to compensate patients who had suffered from hip implants that were recalled by the U.S. healthcare firm eight years ago after data showed high failure rates.
Akcea Therapeutics Inc. planned to cut its workforce by about 10 percent after the U.S. health regulator declined to approve the company’s Waylivra drug for treating a genetic disease that causes fat accumulation in blood.
Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.
Hutchison China MediTech won Chinese approval for a closely watched new cancer drug in a significant boost for “made in China” medicine.
Thirty more people were reported sick after eating Kellogg Co.’s Honey Smacks cereal contaminated with Salmonella, the Centers for Disease Control and Prevention (CDC) said, bringing the total to 130 cases in 36 states.
The French drugmaker Sanofi secured approval in Europe for a rare blood-clotting disorder treatment using nanobodies.
The U.S. FDA approved two of Merck & Co. Inc.’s HIV oral drugs nearly two months ahead of schedule.
The U.S. FDA approved Bayer AG’s long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily.
The U.S. FDA said a serious genital infection was reported in patients taking a certain class of diabetes drugs, with one death and 11 others hospitalized.
The U.S. Food and Drug Administration warned four online networks that operate 21 websites selling opioids online.
The U.S. FDA declined to approve a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a genetic disease that causes fat accumulation in the blood.