Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Read More »

Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, today announced the U.S. Food and Drug Administration (FDA) clearance of the Spectrum IQ Infusion System with Dose IQ Safety Software. Read More »

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. Read More »

Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period Read More »

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced the expansion of its blood typing solutions portfolio in the U.S. Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. Read More »

In President Trump’s remarks today at the White House, he made clear the essential role that generic and biosimilar medicines play in containing prescription drug costs for patients. Read More »

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. Read More »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the publication of data from the Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly (every three months) and monthly subcutaneous dosing regimens of fremanezumab for the prevention of episodic migraine (EM). Read More »

Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, announced today the publication last week of a manuscript titled “Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: a Retrospective Analysis” in Advances in Therapy, an international, peer-reviewed journal. Read More »

BIO President and CEO Jim Greenwood issued the following statement after President Trump announced his administration’s plan to lower prescription drug costs: Read More »

The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Read More »

Boomer Esiason’s commitment to enhancing the quality of life for cystic fibrosis sufferers has become the stuff of legend. Add Teaser here Read More »

Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients2. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Read More »

The fundamental issues with prescription drug affordability are the high prices set by and marketing practices of pharmaceutical manufacturers, so we welcome the Administration’s focus on reducing drug costs. Read More »

Alkermes plc (Nasdaq: ALKS) today announced a new competitive awards program, the ALKERMES Pathways Research AwardsSM Program, which is designed to support the next generation of researchers who are working on the front lines to advance understanding and awareness of central nervous system (CNS) disorders. Read More »

The U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available. Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. Read More »

“The American Diabetes Association’s new white paper on insulin prices confirms that drugmakers set, and continue to raise, prices. Read More »