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 »

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 »

Eli Lilly and Company (NYSE: LLY) and Indiana University's Richard M. Fairbanks School of Public Health at IUPUI announced today the launch of a new neighborhood-based, data-driven pilot in Indianapolis to help address the high incidence of diabetes Read More »

“Employers, unions, and state health programs hire pharmacy benefit managers (PBMs) to reduce costs for patients by, among other things, negotiating discounts with drug companies and drugstores. Read More »

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read More »

Sanofi (NYSE: SNY; EURONEXT: SAN) and Regeneron Pharmaceuticals, Inc. today announced they will lower the net price of Praluent® (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Read More »

Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). Read More »

Teva Pharmaceutical Industries has announced that Teva and the Procter & Gamble Company [NYSE: PG] have agreed to terminate the PGT Healthcare partnership that the two companies established in 2011 to market OTC (Over The Counter) medicines. Read More »

wo new studies by pharmacy benefit manager Prime Therapeutics LLC (Prime), using real-world integrated medical and pharmacy data, show members with multiple sclerosis (MS) had 8.3 times higher annual total health care expense than members without MS. Read More »

"This approval marks an important milestone for the mental health community in Canada, where few approved treatment options are available to adolescents with bipolar depression" Read More »

titleABBVIE: AbbVie Submits Biologics License Application to U.S. Read More »

A study by pharmacy benefit manager Prime Therapeutics LLC (Prime) designed to forecast the potential use and cost of eculizumab (Soliris®), a drug billed through the medical benefit, to treat Myasthenia Gravis (MG) found the expanded use could lead to nearly a twofold increase in Soliris forecasted cost trend in 2018 and beyond. Read More »

AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study in Japanese Patients Read More »

Mylan Adds to Growing Women's Healthcare Portfolio with Launch of Generic for Oral Contraceptive Yaz® Read More »