LAKE FOREST, Ill., July 16, 2015 /PRNewswire/ — Hospira, Inc. (NYSE: HSP), the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today announced it had obtained U.S. Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company’s Angiomax™. Branded […]
Artificial intelligence generated plenty of chatter amongst the pharma marketing intelligentsia in 2018. Will 2019 be the year when the industry fully embraces it as more than just a tactic?
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Leadership representing the 2018 Manny Award agency and network winners and finalists share their views on various healthcare industry trends and developments.
The top pharmaceutical companies are trying to proactively tackle, through shifts in R&D strategy and other tactics, the healthcare demands of the future.
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.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
India’s Supreme Court has asked the federal government to reexamine its pricing policy for essential medicines after a group of non-governmental organizations challenged the provisions, a lawyer involved in the case said. The Supreme Court labeled the formula by which prices of essential medicines are currently being fixed in India as “unreasonable and irrational”, the […]
UnitedHealth Group (UNH), buoyed by growth potential of its expanding pharmacy benefit business, raised its earnings outlook with the coming addition of a much larger drug management operation. The nation’s largest health insurer raised its net earnings outlook for 2015 to between $6.25 to $6.35 per share, up from $6.15 to $6.30, thanks to new […]
The Food and Drug Administration is talking to Google about how the search engine could help the agency identify previously unknown side effects of medications. Agency officials held a conference call on June 9 with a senior Google researcher who co-wrote a 2013 paper about using search query data to identify adverse drug reactions, according […]
Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Alprolix is a recombinant factor IX Fc fusion protein product candidate […]
July 14, 2015By Alex Keown, BioSpace.com Breaking News Staff SUMMIT, N.J. – Celgene Corporation (CELG) has struck again, acquiring Receptos, Inc. (RCPT) for $7.2 billion to enhance the company’s inflammation and immunology portfolio. The acquisition was announced Tuesday afternoon. The acquisition brings some key drugs into Celgene’s pipeline, including Ozanimod, an oral once-daily, selective sphingosine […]
The U.S. Food and Drug Administration approved AstraZeneca Plc’s drug, Iressa, as a first-line treatment for a common form of lung cancer. The FDA said on Tuesday the approval was based on results from a trial of 106 patients with previously untreated non-small cell lung cancer. (1.usa.gov/1Sjw5eo) The drug was previously approved for use only […]
Anacor Pharmaceuticals Inc’s experimental skin ointment succeeded in late-stage studies, taking the drugmaker a step closer to having a potential blockbuster in its portfolio and raising expectations that it could be taken over. The company’s shares, which have more than quadrupled in the past year up to Friday’s close, rose more than 50 percent on […]
Genentech’s Breakthrough Atezolizumab Joins Club of Successful Anti-PD-L1 Drugs, Shrinks Tumors in Bladder Cancer
July 13, 2015By Mark Terry, BioSpace.com Breaking News Staff South San Francisco, Calif.-based Genentech (RHHBY) announced positive results today for its urothelial bladder cancer (UBC) drug atezolizumab, or MPDL3280A. On Feb. 2, 2015, the U.S. Food and Drug Administration (FDA) granted the drug a second Breakthrough Designation. The drug, a monoclonal antibody that interferes with […]
TOKYO & VALBY, Denmark–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI® (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia. REXULTI was discovered by Otsuka and […]