The investigational hemophilia drug emicizumab cut the bleed rate by 87% in patients with resistance to standard therapy versus those receiving another treatment.
Seattle Genetics and Takeda Pharmaceutical Company announced positive results from the Phase III ECHELON-1 clinical trial in previously untreated advanced classical Hodgkin lymphoma.
European regulators recommended the approval of Aveo Pharmaceuticals Inc.’s drug to treat kidney cancer, marking a big victory for the U.S. biotech that has faced a number of setbacks in bringing the drug to the market.
European regulators recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine.
Merck KGaA won a key recommendation to become an entrant to the oral MS drug market in Europe, six years after its first attempt to launch the cladribine pill failed.
A European Medicines Agency (EMA) panel recommended approving Novartis’s Kisqali drug, bolstering the Swiss drugmaker’s bid to challenge rival Pfizer’s Ibrance against tough-to-treat breast cancer.
Shares of pain-relief company Cara Therapeutics were up more than 16 percent after the company grabbed the Breakthrough Therapy Designation for its chronic kidney disease treatment CR845.
bluebird bio’s interim data for its Phase III gene therapy LentiGlobin trial showed promising results in reducing a patient’s need for blood transfusions after one month after treatment, but the data also raised some concerns.
The U.S. FDA approved Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of adults with certain blood cancers.
Mylan NV shareholders voted against the generic drugmaker’s executive pay policy but re-elected the board at its 2017 annual meeting despite a shareholder campaign in the wake of a scandal over high prices for its EpiPen emergency allergy treatment.
A seven-year push by U.S. Republicans to dismantle Obamacare and kill the taxes it imposed on the wealthy reached a critical phase when Senate Republican leaders unveiled a draft bill they aim to put to a vote.
A Novartis anti-inflammatory drug cut cardiovascular risk for heart attack survivors in a pivotal trial, potentially changing ideas about treatment.
A well-known business book is called “The Art of the Deal” and dealmaking in the biotech sphere has certainly become an art form. Since the booming year of mergers and acquisitions in 2015, the rate of dealmaking in the pharma industry has declined.
OvaScience named a new chief executive officer and slashed its employee count by half.
The U.S. FDA placed a hold on Seattle Genetics’ Investigational New Drug Application for vadastuximab talirine.
Kamada Ltd. withdrew the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency with the EMA.
Missouri became the third U.S. state to accuse major drug manufacturers of fraudulently misrepresenting the risks of opioid painkillers.
Shingrix induced a strong immune response in older adults previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine.
The U.S. Food and Drug Administration moved to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.
Mylan N.V. is best known for producing EpiPen emergency allergy treatments and generic drugs. But a non-pharmaceutical offering – refined coal – has quietly generated hundreds of millions of dollars of tax credits for the company over the last six years that have boosted its bottom line, according to a Reuters review of company filings.