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
US Senators Cory Booker (Democrat, New Jersey), Bernie Sanders (Independent, Vermont) and Bob Casey (Dem, Pennsylvania) introduced legislation Tuesday to lower the skyrocketing cost of prescription drugs by allowing Americans to import safe, low-cost medicine from Canada. 1 March 2017
The European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. 1 March 2017
Shares in Lexicon Pharmaceuticals rose more than 5% in pre-market trading, following the announcement that the Texan biopharmaceutical company had received FDA approval for its carcinoid syndrome diarrhea treatment. 1 March 2017
Health plans partnering with Express Scripts are delivering high-quality, affordable pharmacy care to millions of individuals enrolled in government-sponsored programs, but this record is at risk without decisive action to advance additional pro-patient and pro-payer policy changes, according to new research. 1 March 2017
Having filed submissions in the USA, Canada and Europe, Danish diabetes giant Novo Nordisk has now set its sights on Japan as it seeks to gain approval for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes. 28 February 2017
The National Institute for Health and Care Excellence (NICE) today published draft guidance which does not recommend Keytruda (pembrolizumab) for untreated PD-L1-positive metastatic lung cancer. 28 February 2017
The US FDA has accepted for Priority Review the Biologics License Application (BLA) for avelumab, as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. 28 February 2017
The timing of the release of statistics showing that 2016 was a record year for the US Food and Drug Administration’s (FDA) generic drug program “couldn’t be better amid concerns about rising drug prices,” according to a senior figure at the agency. 28 February 2017
The US Food and Drug Administration has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. 28 February 2017
Bausch + Lomb and French biotech firm NicOx have re-submitted a New Drug Application to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%. 28 February 2017
In what is believed to be the first move of its kind ever, healthcare professionals in the UK have resorted to crowdfunding to provide cancer patients access to treatment. 28 February 2017
US healthcare giant Johnson & Johnson has released a 2016 US Transparency Report that includes information on pricing and other business practices, covering everything from discovery to the commercialization of pharmaceuticals. 27 February 2017
At a press conference held last week, the Hellenic Association of Pharmaceutical Companies (SFEE) issued an ultimate distress call and a strong warning against the irreparable detrimental consequences for Greek patients from the imminent Ministry of Health measures. 27 February 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval at its February meeting. 25 February 2017
As well as four new drug approvals, at its February meeting the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended broader use of three already marketed products. 25 February 2017
The mixed messages on drug pricing policy coming from new US President Donald Trump’s administration are starting to harm healthcare stocks, according to an analyst at the independent broker finnCap. 24 February 2017
US biotech firm Celgene has been approved to market Revlimid (lenalidomide) in the EU as a monotherapy for the maintenance treatment of certain adult patients with newly diagnosed multiple myeloma. 24 February 2017
The US Food and Drug Administration has accepted a supplementary New Drug Application for Zykadia (ceritinib) from Swiss giant Novartis. 24 February 2017
Pharmaceutical firm Zydus Cadila has received approval from Indian regulators to market its tetravalent inactivated influenza vaccine for seasonal flu, VaxiFlu 4. 24 February 2017
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
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024