Pharma News

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.

The U.S. Food and Drug Administration  approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.

The U.S. Food and Drug Administration  approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

The U.S. Food and Drug Administration  approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

The U.S. Food and Drug Administration 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. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

Aerie Pharmaceuticals, Inc an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye, announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. RoclatanTM is a once-daily eye drop designed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa®, which is currently available in the United States, and the widely-prescribed PGA (prostaglandin analog) latanoprost. RoclatanTM successfully achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1, the results of which are included in the NDA submission.

The Indian Ocean Rim Association - Regional Centre for Science and Technology Transfer (IORA-RCSTT) Coordination Centre was inaugurated on 7 May 2018 at the Central Institute of Medicinal and Aromatic Plants (CIMAP) campus of the Council of Scientific and Industrial Research (CSIR) in Lucknow.

[adsense:336x280:8701650588]

Strides announced that it has agreed with Apotex, in principle, to merge their respective Australian business operations. The transaction is subject to entering into definitive agreements between the parties, satisfactory due diligence, customary closing conditions and statutory approvals, including approval of Australian Competition and Consumer Commission (ACCC).

Cochrane Library shows that human papilloma virus (HPV) vaccines protect against cervical lesions in young women, particularly in those who are vaccinated between the ages of 15 and 26. It also summarizes findings on harms that have been assessed in randomized controlled trials.