US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
In the USA, the Campaign for Sustainable Rx Pricing (CSRxP), a diverse coalition of seniors, health plans and private companies, has set out proposals to address the cost of prescription drugs, from speeding the approval of generics to publicly reporting notable price hikes. 26 April 2016
Swedish Orphan Biovitrium AB (Sobi) has gained approval from the US Food and Drug Administration for Orfadin (nitisinone) oral suspension to treat hereditary tyrosinaemia type-1 (HT-1), in combination with dietary restriction of tyrosine and phenylanine. 26 April 2016
Pharma giant Pfizer is remaining tight-lipped about the prospect of new data on its smoking cessation med Champix (varenicline) potentially leading to the removal of black triangle warnings on the drug’s side effects. 26 April 2016
Exelixis has received approval from the US Food and Drug Administration for Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 26 April 2016
A value-based pricing (VBP) system cannot work unless there is universal agreement on the definition of value, a panel of experts has said. 25 April 2016
US biotech Gilead Sciences has received marketing authorization for two doses of Descovy (emtricitabine and tenofovir alafenamide), a fixed-dose combination for the treatment of HIV-1 infection. 25 April 2016
Swiss firm Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for Veltassa (patiromer) for oral suspension. 25 April 2016
Aralez Pharmaceuticals reports Health Canada approval of Blexten (bilastine) for the treatment of the symptoms of seasonal allergic rhinitis (SAR) and chronic spontaneous urticaria (CSU) (such as itchiness and hives). 25 April 2016
Data from the Spanish Ministry of Health, Social Services and Equality shows that in January, public pharmaceutical expenditure at pharmacies experienced a growth of 1.67%, compared to the registered accumulated figure of January 2015. 25 April 2016
The Ukraine Association of Pharmaceutical Research and Development (APRaD), uniting the largest world leading pharmaceutical companies active in the research and development of new medicines with a presence in Ukraine, will disclose the information on transfers of value to healthcare professionals and organizations. 25 April 2016
Cannabis has had a long, difficult and often contradictory relationship with the pharmaceutical world but it is making something of a resurgence and the companies that specialize in it are full of confidence for the future. 24 April 2016
Gilead Sciences stock has risen sharply in the last 10 weeks, as a result of analysts upgrading the company. There was one up revision during the last seven days and five earnings per share up revisions during the last thirty days. 24 April 2016
Lundbeck said on Friday that the US Food and Drug Administration has accepted for review the resubmission of the New Drug Application (NDA) for intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. 23 April 2016
A new fast-track system to get the most innovative and transformative drugs to patients more quickly could be introduced in England and Wales, a conference has heard. 22 April 2016
Sarepta Therapeutics has suffered a further share-busting setback over its attempts to gain accelerated US Food and Drug Administration approval for eteplirsen as a treatment for certain patients with Duchenne muscular dystrophy (DMD). 22 April 2016
Cost-effectiveness watchdog for England and Wales the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending cabazitaxel, which is marketed as Jevtana by French pharma major Sanofi, for some prostate cancer patients. 22 April 2016
based Actelion reported net income for the first quarter of 2016 was 178 million Swiss francs ($184 million), up 12% from 159 million francs a year ago but below the poll average of 188 million francs. 22 April 2016
What is behind hepatitis C virus (HCV) drug Harvoni (ledipasvir/sofosbuvir) coming top of a list showing the medicines which accounted for the highest cumulative spending by US patients in 2015? 21 April 2016
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024