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
The US Food and Drug Administration has published draft guidance relating to the 180-day exclusivity for generic drug product provisions as the agency seeks to establish its current approach to this topic. 16 January 2017
A new report published by the Organization for Economic Cooperation and Development has warned of pressures in public health spending, blaming pricing policies in the pharmaceutical and medical device industries. 16 January 2017
An independent report has underlined just how important the contribution is of some of the pharmaceutical industry’s biggest companies to Europe’s economy. 16 January 2017
US Biotechnology Innovation Organization (BIO) president and chief executive Jim Greenwood participated in economic development meetings with top Indian government officials, including Prime Minister Narendra Modi, while attending the Vibrant Gujarat Global Summit 2017 last week. 16 January 2017
As the pace picks up after the festive break and the realities of our respective New Year’s resolutions settle on us, Australian trade group AusBiotech says it is starting the year with a renewed focus on leadership in policy and a resolution to continue committed advocacy for innovation in life sciences. 16 January 2017
US pharmaceutical companies Eli Lilly and Incyte have announced that the US Food and Drug Administration has extended by three months the action date for its review of their rheumatoid arthritis candidate baricitinib. 16 January 2017
On January 17, Health Ministers from Organization for Economic Cooperation and Development (OECD) countries will gather in Paris to discuss how healthcare systems can reform to better deal with the challenges and to realize the opportunities of tomorrow. 16 January 2017
Biogen courted controversy after announcing a price for its newest approved rare disease drug that would make it one of the most expensive in history, but trial data released by the Cambridge biotech on Friday indicates that the treatment is effective. 15 January 2017
In December, the UK pharmaceutical industry gave evidence to the Exiting the EU Committee where, though its trade body the Association of the British Pharmaceutical Industry (ABPI), it stated that in the opinion of the UK's £60 billion (~$74 billion) Life Sciences sector, a primary objective for government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation. 14 January 2017
VivaGel (astodrimer sodium) has been designated a Qualified Infectious Disease Product and given Fast Track status by the US Food and Drug Administration. 13 January 2017
In an early benefit assessment the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether crizotinib offers advantages for patients over the appropriate comparator therapies. 13 January 2017
There were two new developments in the backlash against Mylan’s US pricing policy for its EpiPen Auto-Injector (epinephrine injection, USP) this week. 13 January 2017
Heron Therapeutics has submitted a New Drug Application (NDA) for Cinvanti (HTX-019), for the prevention of chemotherapy-induced nausea and vomiting (CINV), to the US Food and Drug Administration. 13 January 2017
Even before the new US President has been inaugurated, the health care provision introduced to ensure affordable health care for millions of poorer Americans – and heavily criticized by Donald Trump during his election campaign – appears to be on its way out. 12 January 2017
Shares of US cancer drug developer Tesaro dipped 2.48% to $142.028 by mid-morning trading today, after the company revealed that the US regulator had rejected approval of its intravenous presentation of rolapitant. 12 January 2017
Japanese drugmaker Shionogi has announced positive top-line trial results for cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, 12 January 2017
Afinitor (everolimus) has been recommended for use on the National Health Service (NHS) in England and Wales after Novartis agreed to reductions to its £32,076 ($39,165) annual treatment cost per patient. 12 January 2017
Ever since his surprise election win in November, what Donald Trump’s Presidency might mean for pharma has been the subject of plenty of guesswork. 11 January 2017
The European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents. 11 January 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