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
The National Institute for Health and Care excellence (NICE) has today published draft guidance for US pharma major Eli Lilly’s (ixekizumab) for psoriasis. 1 November 2016
GlaxoSmithKline today announced that it has received approval from the German regulatory authority, Paul-Ehrlich-Institut, acting as the reference authority in Europe, for the update of the Boostrix and Boostrix Polio vaccine labels with additional safety data in pregnant women. 1 November 2016
Innovation-driven development is a core strategy of China’s 13th Five-Year (2016-2020) Plan and biomedicine is a key driver of that innovation. Pharmaceutical innovation is not only an engine for long-term economic development but also contributes to people’s welfare. 1 November 2016
The National Institute for Health and Care Excellence (NICE), in draft guidance released this morning, said that head and neck cancer drug Erbitux (cetuximab) does not represent value for money. 1 November 2016
“With just under 10 years left to meet the target of reducing premature deaths from non-communicable (NCDs) diseases by 25%, governments and policy-makers must act now to ensure equitable access to services to allow people to live with and survive cancer.” 1 November 2016
Norgine today presented new UK real-world data, IMPRESS, that show Xifaxan 550mg (rifaximin-α) for the treatment of hepatic encephalopathy could reduce costs related to non-elective hospital admissions, critical care bed occupancy, emergency room visits and 30-day emergency re-admissions. 31 October 2016
Health Canada has approved Alecensa (alectinib), a drug developed by Japanese drugmaker Chugai Pharmaceuticals, a member of Swiss pharma giant Roche's group of companies, to treat an aggressive and rare form of lung cancer. 31 October 2016
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC). 31 October 2016
Businesses in Australia can now apply for a licen
se to cultivate cannabis for medicinal purposes, to manufacture medicinal cannabis products or to conduct medicinal cannabis related research under the Medicinal Cannabis Scheme. 31 October 2016
TheStreet's Jim Cramer highlighted two healthcare companies whose stocks were going in different directions Tuesday, the day Merck & Co and Eli Lilly presented their third-quarter 2016 results. 30 October 2016
Trade group Pharma Industry Finland (PIF) is warmly in favor of Member of Parliament Annika Saarikko’s proposal to move the European Medicines Agency (EMA) to Finland. 30 October 2016
The US Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 29 October 2016
AstraZeneca confirms that the US Food and Drug Administration has placed a partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. 28 October 2016
On September 25, 2016, New Zealand’s Pharmaceutical Management Agency PHARMAC consulted on a proposal to list Novartis’ Lucentis (ranibizumab) and Bayer’s Eylea (aflibercept) in Section H of the Pharmaceutical Schedule from November 1, 2016 for the treatment of wet age-related macular degeneration (wet AMD). 28 October 2016
Health Canada has issued a warning saying that an increased risk of hemolysis or low hemoglobin has been observed when patients already being treated with Solaris (eculizumab) were vaccinated against serogroup B meningococcal infection with Bexsero. 26 October 2016
Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration and a Type II Variation application to the European Medicines Agency. 26 October 2016
The US Food and Drug Administration has granted earlier-than-expected approval for Merck & Co’s Keytruda (pembrolizumab) for use in previously untreated lung cancer patients, making it the only such drug so far cleared for first-line treatment. 25 October 2016
Beximco Pharmaceuticals has received US Food and Drug Administration approval for sotalol hydrochloride, a generic version of the cardiovascular drug Betapace. 25 October 2016
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo (nivolumab) to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC). 25 October 2016