World Health Organization member states began voting for the next director-general, with an Ethiopian candidate vying to be the first African to head the United Nations agency.
“As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.” – Scott Gottlieb, M.D., Commissioner of Food and Drugs.
Britain’s competition watchdog has accused Merck & Co. of operating an unfair discount scheme for its medicine Remicade that it said was designed to restrict competition from so-called biosimilar copies.
Bioverativ is buying True North Therapeutics for an upfront payment of $400 million and up to $425 million in milestones.
AstraZeneca’s experimental injection for severe asthma cut substantially the need for patients to take problematic oral steroid drugs in a late-stage study.
FDA Approves Kevzara for Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients
The U.S. FDA approved Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
The U.S. FDA expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.
Shares of Puma Biotechnology Inc. surged about 80 percent after the U.S. Food and Drug Administration staffers concluded after a preliminary review that the company’s experimental breast cancer drug was effective.
Celgene Corp. said its oral drug to treat relapsing multiple sclerosis met the main goal in a second late-stage study.
Shares of Amgen fell after the company announced it does not anticipate its experimental osteoporosis drug Evenity will be approved by the U.S. Food and Drug Administration during 2017.
British pharmaceutical firm BTG said its EKOS combination therapy device for pulmonary embolism (PE) was effective using smaller drug dosages and shorter treatment periods than the current standard.
AstraZeneca PLC sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati S.p.A. for $300 million.
Trimbow is the first triple combination in a single inhaler for the treatment of COPD to receive positive opinion from the CHMP in Europe
Chiesi Group announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for the extrafine triple combination ICS/LABA/LAMA, under the brand name Trimbow, for the first time in a single inhaler for the treatment of Chronic Obstructive Pulmonary Disease.
Novartis’ push to win approval for Zykadia as an initial treatment for a type of lung cancer got a lift with a positive recommendation from the EMA’s CHMP.
A look at five biotech companies in the cancer market and their upcoming releases at the 2017 American Society of Clinical Oncology (ASCO).
All eyes will be on the White House Is President Donald Trump is expected to release his full budget proposal–which reportedly still contains deep cuts to the National Institutes of Health (NIH).
Apple continues to delve into the medtech world. Chief Executive Officer Tim Cook was seen wearing a new device that monitors his blood sugar levels and tracks how those levels respond to things such as diet and exercise.
Novartis AG is shaking up its operations by terminating approximately 500 production and development positions in Switzerland, but adding an additional 350 jobs to its growing biotech business, Matthias Leuenberger said in a posting on the company’s Swiss site.
Merck’s Keytruda (pembrolizumab) received FDA approval for two new indications for certain patients with locally advanced or metastatic urothelial carcinoma, including first-line treatment in patients ineligible for cisplatin-containing chemotherapy.
Greater Than One Inc. (GTO) announced the appointment of Kieran Walsh as President of its US operations. Walsh is responsible for leading the GTO staff and offices in New York and San Francisco, and for providing oversight on all US-based accounts.