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 »

Novartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from home Read More »

Shire announces revised proposal and extension of PUSU deadline to 8 May 2018 The Board of Shire (the “Board”) announced earlier today that it had received a further revised proposal from Takeda Pharmaceutical Company Limited (“Takeda”) regarding a possible offer for the Company. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments. Read More »

Shire notes the announcement made by Takeda. The Board of Shire (the “Board”) confirms that it has received three conditional proposals from Takeda regarding a possible offer for the Company, on 29 March 2018 (the “First Proposal”), 11 April 2018 (the “Second Proposal”) and 13 April 2018 (the “Third Proposal”). Read More »

Merck known as MSD outside the United States and Canada, announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for the company’s Type II Variation, which seeks approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). Read More »

Astellas Pharma Inc. announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). Read More »

Merck known as MSD outside the United States and Canada, announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treatment-emergent nephrotoxicity (kidney toxicity), a secondary endpoint, compared to a Colistin (colistimethate sodium) plus imipenem regimen. Read More »

Pfizer Inc. announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. Read More »

Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced that it has dosed the first patient in the Company’s Phase 1/2 clinical trial evaluating the safety and efficacy of an investigational AAV-based gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP). Read More »

Merck known as MSD outside the United States and Canada, and Invenergy, North America’s largest privately held renewable energy company, announced a Virtual Power Purchase Agreement (VPPA) that adds 60 megawatts (MW) of renewable energy to the electrical grid and supports Merck’s environmental sustainability goals. Read More »