Industry News

U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.

Novartis announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints). Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

The U.S. Food and Drug Administration announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.

Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA’s safety committee (PRAC) has recommended that medicines containing 10 mg or more of cyproterone should only be used for hirsutism (excessive hair growth), androgenic alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed.

As part of its quest to provide access to life-saving medication and making a difference in the lives of patients, Cipla Medpro South Africa (Pty) Limited (“Cipla Medpro”), wholly-owned subsidiary of Cipla Limited, India (“Cipla”) and South Africa’s third largest pharmaceutical company in the private sector, has recently concluded an exclusive agreement (the “Agreement”) securing originator and authorised generic brands of an atypical anti-psychotic drug, Quetiapine (the “Medicine”).

U.S. Food and Drug Administration announced the launch of an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data.

US Pharmaceutical companies are sending antiviral drugs to China for helping them to fight against coronavirus outbreak, reported by Wall Street Journal.

Amazon pharmacy is expanding its working outside US and potentially in India, Canada, U.K. and Australia. Recently, Amazon has filed to trademark “Amazon Pharmacy” in Canada, the U.K. and Australia, signaling a potential move into selling prescription drugs outside of the U.S. reported by CNBC.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S.