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 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
The Royal Decree Law 1090/2015 regulating clinical trials has allowed, since its coming into force last January 13, that the time needed to kick off a new clinical trial in Spain is reduced by more than a month (19%) in Spain, reported the trade group Farmaindustria. 25 October 2016
Inovio Pharmaceuticals saw its shares tank, after it announced that the US Food and Drug Administration has placed a clinical hold on its proposed Phase III clinical program for VGX-3100. 24 October 2016
Melinta Therapeutics has submitted New Drug Applications (NDAs) to the US Food and Drug Administration for approval of IV and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). 24 October 2016
GlaxoSmithKline has filed a Biologics License Application (BLA) to the US Food and Drug Administration for its shingles vaccine Shingrix. 24 October 2016
The new pricing Agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the State which was finalized in July, is on course to save the State over 140 million euros ($154 million) in its first year. 24 October 2016
An official from the Department of Drug and Cosmetics Registration of the China Food and Drug Administration (CFDA) was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications,” reported by media. 24 October 2016
Medicinal product authorization holders are obliged to notify Switzerland’s regulatory authority, Swissmedic, of the companies involved in manufacturing and to have them approved. 24 October 2016
A new report published by the UK government today, puts forward a number of recommendations aimed at speeding up the process by which the NHS implements newly developed drugs and medical procedures. 24 October 2016
By Barbara Obstoj-Cardwell. Editor
PTC Therapeutics is having a tough time convincing regulators on both sides of the Atlantic Ocean to reconsider the marketing application for its Duchenne muscular dystrophy drug Translarna, wrote Adam Feuerstein on The Street. 23 October 2016
The US Food and Drug Administration on Friday approved pharma giant Merck & Co’s Biologics Licensing Application for Zinplava (bezlotoxumab) Injection 25mg/mL. 22 October 2016
The US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. 22 October 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