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
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
Ahead of its Advisory Committee meeting to discuss the Biologics License Application for nonacog beta pegol, a long-acting factor IX for the treatment of hemophilia B, the US Food and Drug Administration has published briefing documents. 31 March 2017
There's no doubt about it - last week's failure to pass the American Health Care Act was a painful setback in the fight to repeal and replace Obamacare, wrote Sally Pipes in the Washington Examiner’s Beltway Confidential blog. 31 March 2017
The US Food and Drug Administration (FDA) has fully approved AstraZeneca’s non-small cell lung cancer (NSCLC) treatment Tagrisso (osimertinib), the company announced today. 31 March 2017
Canada-based Aeterna Zentaris’ announced that, following its meeting with the US Food and Drug Administration on March 29, 2017, the company intends to file a New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD). 30 March 2017
President Trump's choice to head up the US Food and Drug Administration, Scott Gottlieb, is severing ties with industry in an attempt to put clear blue water between his previous life as a pharmaceutical insider and his new incarnation as FDA Commissioner. 30 March 2017
UK-based Mundipharma has received the green light from Japanese regulators to market Mundesine (forodesine hydrochloride), the first regulatory approval for the novel therapy. 30 March 2017
International expansion and bringing affordable biosimilars to patients are two of the stated aims of privately-held Russian biotech company Biocad, and the company has taken a step forward on both fronts with news on one of its products. 30 March 2017
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers. 30 March 2017
The US Food and Drug Administration has accepted the Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). 30 March 2017
News that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for a generic version of a big-selling asthma medication caused a 3% drop in the share price of Mylan on Wednesday. 30 March 2017
Before Theresa May signed the decree absolute, Ireland began preparing its bid to become the new home of the European Medicines Agency (EMA). 29 March 2017
Steve Bates, the chief executive of UK trade group The BioIndustry Association (BIA), spoke of his opposition to the UK leaving the European Union (EU) prior to last year’s referendum, saying it would be damaging for the biopharma industry. 29 March 2017
US specialty pharma company Acorda Therapeutics has released positive results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s disease. 29 March 2017
The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 29 March 2017
US pharma giant Pfizer has received marketing authorization from the European Commission for its Xeljanz (tofacitinib citrate) 5mg twice daily oral tablets in combination with methotrexate (MTX) for moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. 29 March 2017
The US Food and Drug Administration has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). 29 March 2017
The US Food and Drug Administration has accepted the New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. 29 March 2017
NDA Group announced findings from its fourth annual comparison of drug approvals in the European Union and the USA, ahead of this year’s DIA EuroMeeting in Glasgow, Scotland. 29 March 2017