The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharma breathed a sigh of relief when, after months of strident rhetoric damning the industry, President Trump picked industry insider Scott Gottlieb as the new FDA Commissioner. 11 August 2017
Jeevan Virk, commercial director for the UK and Ireland at French molecular nuclear medicine specialist Advanced Accelerator Applications, admitted that it was not a shock when the National Institute for Health and Care Excellence (NICE) published draft guidance not recommending Lutathera (Lutetium Lu 177 dotatate) for treating neuroendocrine tumors of gastrointestinal and pancreatic origin. 11 August 2017
Lipocine has resubmitted a New Drug Application (NDA) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (TRT). 11 August 2017
Californian biotech firm Gilead Sciences has received priority review status from the US FDA for an investigational combination of HIV candidate bictegravir plus emtricitabine/tenofovir alafenamide. 11 August 2017
TherapeuticsMD saw its shares dip 1.23% to $5.60 in after-hours trading on Thursday after it announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR. 11 August 2017
A two-tier manufacturing market and forecast increased acquisitions by Indian companies, along with a notable improvement in the international reputation of Indian made pharmaceuticals have been identified in a new report for CPhI titled: 2017 India Pharma Market Report. 10 August 2017
The China Food and Drug Administration (CFDA) has been accepted as a member of the ICH, a global federation of regulators that seeks to harmonize health technology regulations. 10 August 2017
The UK’s National Institute for Health and Care Excellence (NICE) has today released a Final Appraisal Document (FAD) recommending Nexavar (sorafenib) for use on NHS England. 10 August 2017
The Russian government is considering legalizing the parallel importation of drugs into the country in an attempt to force foreign producers to reduce the prices for their range in Russia. 9 August 2017
Ahead of the Prescription Drug User Fee Act (PDUFA) date of August 24, 2017, for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, the US Food and Drug Administration announced another setback for Valeant Pharmaceuticals International. 8 August 2017
Netherlands-based drugmaker Mylan has received marketing authorization from the Drug Controller General of India for its antiretroviral (ARV) drug Avonza (TLE400). 8 August 2017
In March 2016, Barack Obama became the first US President to visit Cuba since 1928, marking one of the final stages in a progressive thaw in relations that, it was hoped, would usher in a new era of trade and cooperation between the two countries. 7 August 2017
German pharma major Bayer got a boost to its shares this morning after it revealed an important additional indication approval for its cancer drug Stivarga (regorafenib) in the European Union. 7 August 2017
American generics drugmaker Mylan has received tentative approval to distribute its HIV/AIDS treatment TLD in developing countries under the US President's Emergency Plan for AIDS Relief (PEPFAR). 7 August 2017
The US Food and Drug Administration (FDA) has approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy. 7 August 2017
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-08, a prescription cough cold treatment. 7 August 2017
The Indian biosimilar drugs industry is poised for exponential growth owing to the increasing acceptance, entry of new players, and successful launch of biosimilar products. 7 August 2017
In a meeting late July with the Minister of Health, Ricardo Barros, the president of the Brazilian Society of Rheumatology (SBR), Georges Christopoulos, presented an agenda for reviving the benefit of patients with rheumatic diseases, positioning the entity also against the eventual reduction of the medications for rheumatoid arthritis (RA), as has been broadcast in recent weeks. 7 August 2017