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
Samsung Bioepis says that its Brenzys – also known as SB4, a biosimilar to Enbrel (etanercept), has received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. 13 September 2016
On September 8, 2016, Taro Pharmaceuticals USA Inc, as well as two senior officers in its commercial team, received grand jury subpoenas from the US Department of Justice, Antitrust Division, the Israel-headquartered company revealed in a Securities and Exchange Commission filing. 12 September 2016
GlaxoSmithKline today announced the regulatory submission of a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 12 September 2016
Scotland-based MGB Biopharma announced today that the US Food and Drug Administration has granted MGB-BP-3, the firm’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated diarrhea (CDAD). 12 September 2016
Janet Woodcock, director of the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference. 12 September 2016
Shares of Dynavax Technologies were jumping 24.29% to $13.56 on heavy trading volume mid-Tuesday morning as investment bank William Blair said the US Food and Drug Administration’s cancellation of a November 16 Vaccines and Related Biological Products Advisory Committee meeting for the company's hepatitis B vaccine Heplisav is a net positive. 11 September 2016
America’s largest pharmacy benefits management company has launched an initiative aimed at controlling costs and improving care for people with inflammatory conditions like rheumatoid arthritis, psoriasis and Crohn's Disease. 9 September 2016
The USA’s Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will shape an upcoming report on abuse-deterrent opioids. 9 September 2016
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that Netherlands-incorporated drugmaker Mylan’s $7.2 billion acquisition of Swedish drugmaker Meda would likely be anticompetitive. 9 September 2016
In draft guidance issued today, the National Institute for Health and Care Excellence (NICE) is recommending Zepatier (elbasvir-grazoprevir) as an option to treat certain types of hepatitis C. 9 September 2016
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
US biotech Q BioMed has bought the rights to the US Food and Drug Administration-approved drug strontium chloride (SR89) with the promise to keep prices down. 8 September 2016
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health, noted the European Medicines agency on a website posting. 8 September 2016
Japanese drugmaker Ono Pharmaceutical has taken two steps forward in strengthening its oncology presence in Japan by gaining a new approval for Opdivo (nivolumab) and launching Kyprolis (carfilzomib). 8 September 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list a new treatment for HIV, dolutegravir (Tivicay) and to amend the listing of a currently-funded HIV treatment, abacavir sulphate with lamivudine (Kivexa). 8 September 2016
The chief executive of Ireland-headquartered Allergan has vowed to limit price increases of its medicines and said it will not engage in ‘price gouging actions’ or ‘predatory pricing’. 7 September 2016
The US Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) from pharma giant Merck & Co for Keytruda (pembrolizumab). 7 September 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation to SAGE-547 for the treatment of postpartum depression (PPD) from US clinical-stage biotech Sage Therapeutics. 7 September 2016
In India, the mandatory marketing code for pharma companies would be having strong penal provisions in order to prevent bribing of doctors for prescribing drugs by drug companies. 7 September 2016
In the wake of steep price increases and Congressional investigations, New York Attorney General Eric Schneiderman announced that his office has commenced an investigation into the US unit of Netherlands-incorporated Mylan the maker of EpiPens. 7 September 2016