US regulators have approved a label update to Bristol-Myers Squibb’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/bms_opdivo_cleared_for_monthly_use_1226100AstraZeneca has bumped up its stake in US biotech Moderna, which is pioneering the development of a new class of drugs made of messenger RNA, to nine percent. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/az_ups_stake_in_moderna_1095937Mylan has announced that US regulators are going to reject its generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/fda_to_reject_mylans_advair_diskus_generic_1239903Shire has now confirmed that it has thus far rejected three merger proposals from Takeda, the last one being valued at around $44 billion. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/shire_turns_down_takedas_advances_1232652It is currently looking unlikely that Chiesi’s Lamzede will become routinely available on the NHS for patients with alpha-mannosidosis, after cost-regulators issued a preliminary rejection of the drug. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/nice_rejects_chiesis_lamzede_1236762Janssen’s Symtuza has been approved US regulators as the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV in adults. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/us_approves_janssens_hiv_pill_symtuza_1244683NHS England has announced two more regions chosen to become Local Health and Care Record Exemplars (LHCRE), tasked with establishing an integrated health and care record across a large population. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/nhs_england_names_two_more_1242336US regulators have finally issued a green light for AstraZeneca’s Lokelma as a treatment for hyperkalaemia - elevated potassium levels in the blood - in adult patients. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/us_green_light_for_az_lokelma_1236110The European Medicines Agency has issued a marketing authorisation for Orexo and MundiPharma’s Zubsolv (buprenorphine and naloxone) for opioid dependence. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/eu_nod_for_opioid_dependence_therapy_1212098Shire’s Board has notified Takeda that it would be “willing to recommend" the latter’s latest merger proposal to shareholders, which is now valued at £46 billion pounds. - News - PharmaTimes
by Selina McKee
www.pharmatimes.com/news/shire,_takeda_move_closer_to_merger_deal_1233173
