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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 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
Ireland-incorporated Shire has received US Food and Drug Administration approval for Xiidra (lifitegrast ophthalmic solution) 5% as a treatment for dry eye disease. 12 July 2016
The UK government has brought in pharma industry chiefs to co-chair a ministerial group aimed at ensuring Brexit does not damage the country’s life sciences sector. 11 July 2016
At its July meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. 11 July 2016
A biosimilar version of the world’s best-selling drug is ‘highly similar’ to the reference product, according to a US Food and Drug Administration staff briefing documents published ahead of tomorrow’s committee meeting. 11 July 2016
Recent changes as a result of the introduction of medical price reforms in China are expected to eliminate public hospital mark-ups on drug prices and cut prices for medical examinations and supplies by the end of 2020, according to a guideline issued by the National Development and Reform Commission (NDRC) last week. 11 July 2016
The Indian government is looking to widen the scope of price controls on pharmaceuticals. In a move that could create another potential hurdle for multinational drug companies doing business in India, the Department of Pharmaceuticals is examining a proposal to look into the pricing of patented drugs in the country, reports The Pharma Letter’s India correspondent. 11 July 2016
All Periodic Safety Update Reports (PSURS) for centrally and nationally authorized medicinal products in Europe must be submitted via the PSUR Repository as of June 13, 2016. 11 July 2016
More than $1 billion was wiped from the market value of biotech groups racing to develop a revolutionary cancer treatment, after one of the companies, Juno Therapeutics, revealed that three young patients had died after receiving its experimental therapy on a clinical trial. 10 July 2016
Bosses at Japanese pharma major Eisai are angry at the exclusion of its oncology drug Lenvima (lenvatinib) from the Cancer Drugs Fund (CDF) in England. 8 July 2016
The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ Epclusa (sofosbuvir 400/velpatasvir), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 8 July 2016
Knowing when to prescribe biosimilars is a massive issue internationally, and action is being taken on the issue in the UK to make sure they are used appropriately and in consultation with patients. 8 July 2016
The deaths of two patients has led the US Food and Drug Administration to put a clinical hold on the Phase II trial of JCAR015, a leukemia drug being developed by USA-based biopharma company Juno Therapeutics. 8 July 2016
The US Food and Drug Administration has approved Xolair (omalizumab), from Roche subsidiary Genentech, to treat moderate to severe persistent asthma in children six to 11 years of age. 8 July 2016
The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review. 8 July 2016
The US Food and Drug Administration has issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. 8 July 2016
As European Union member states vie to get re-location of the European Medicines Agency to their country following the UK referendum vote to leave the EU, Spain being the latest to pitch its case, the EMA acknowledges the outcome and says it is now up to the UK government to decide how to act. 7 July 2016
Ireland-headquartered Shire has had its marketing authorization extended for its short bowel syndrome (SBS) treatment Revestive (teduglutide) by the European Commission to allow for use by pediatric patients. 7 July 2016
Following a Request for Proposals (RFP) for the supply of gonadotropin-releasing hormone analogues (GnRH analogues), issued in March 2016, New Zealand’s Pharmaceutical Management Agency, PHARMAC, has entered into a provisional agreement with AstraZeneca over a cancer drug. 7 July 2016
The National Institute for Health and Care Excellence (NICE) has today recommended National Health Service use of US pharma giant Pfizer’s Bosulif (bosutinib) for treating some people with chronic myeloid leukemia. 7 July 2016
The Spanish government has confirmed its interest in Spain hosting the European Medicines Agency (EMA) if it moves from its current UK base following the vote for Brexit in last month’s referendum. 6 July 2016