Biopharma News
Study Finds Prescription Drug Spending Rose 13% in 2014
Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.
Hydra Biosciences Enters into Collaboration Agreement with Boehringer Ingelheim
Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.
Pfizer Announces PCSK9 Competitive Grants Program
The grants will be offered to investigators conducting research in the field of PCSK9 biology.
Baxter Recalls IV Solutions
Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.
Mylan Offers $29 Billion for Perrigo
Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.
Novartis and Juno Settle Over CAR-T Therapy Technology
Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.
ISPE Names 2015 Facility of the Year Category Winners
Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.
GSK Announces US Vaccine R&D Center
GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.
CMS Provides Guidance on Reimbursement and Formulary Policies for Biosimilars
Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.
Merck Joins CAR T-cell Market with $941 Million Intrexon Alliance
Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.
FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance
Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.
Novartis Inks $250 Million Alliance with Aduro
Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.
FDA Expands Usage of Regeneron’s Eylea
FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.
Genentech Expands Oregon Fill/Finish Site
Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.
Emergent Dives Further into the Anthrax Treatment and Vaccine Market
Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.
Novartis' Cosentyx Shows Promise in the Treatment of Psoriasis
Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.
Biogen Idec Drops the Idec
The company’s new corporate name will be simply Biogen.
Biogen Idec Presents Results from Promising Alzheimer's Disease Drug Trials
Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.
US Judge Dismisses Amgen's Request to Block the Launch of Zarxio
As a result of the decision, Sandoz will be able to immediately launch Zarxio, the first biosimilar in the United States.
Early Studies Suggest PCSK9 Inhibitors Cut Heart Attack Risk in Half
Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.
23andMe Adds Therapeutics Unit
The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.
McNeil Fined $25 Million for Adulterated Medications
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
AbbVie to Acquire Pharmacyclics for $21 Billion
AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.
Canon Announces New Biomedical Company
Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.
Sagent Pharmaceuticals Recalls Atracurium Besylate Injection
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Baxter's New Biopharma Baxalta to Have Headquarters in Illinois
Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.
Kite Pharma Expands Clinical Manufacturing for T-Cell Therapies
Leased facilities in California will expand Kite Pharma's capacity for T-cell therapies.
FDA Issues Warning Letter to India Facility
The agency cites Apotex’s Bangalore facility with quality system failures.
Sanofi Picks Bayer's Brandicourt as New CEO
Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.
Johnson & Johnson’s Remicade Patent Invalidated
The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.