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 granted approval for Ireland-headquartered Shire’s Cuvitru (immune globulin subcutaneous [human], 20% solution) in adult and pediatric patients two years of age and older. 14 September 2016
The UK’s Department of Health has announced a record £816 million ($1.08 billion) investment into biomedical research in a move welcomed by the Association of the British Pharmaceutical Industry (ABPI). 14 September 2016
In our weekly expert view piece, pharmacovigilance team leader at Berlin-based CRO, KCR, examines the increasing benefits of post-authorization studies and the collection of real-world data. 14 September 2016
French drugmaker Ipsen revealed today that the European Commission has approved Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. 14 September 2016
Australia’s Turnbull government has today introduced important legislation to ensure security and law and order is maintained, as the Coalition leads the way in allowing for the cultivation of a safe, legal and reliable local supply of cannabis for medicinal products. 14 September 2016
Santhera Pharmaceuticals was trading more than 3% higher on Tuesday afternoon after new Phase III data was published on Raxone (idebenone) on inspiratory function in patients with Duchenne muscular dystrophy (DMD), just days after the granting of orphan drug designation for the same treatment in Australia. 13 September 2016
Documents on the smoking cessation product Chantix (varenicline) which will be considered by a US Food and Drug Administration (FDA) advisory committee on Wednesday have questioned the validity of data provided by Pfizer. 13 September 2016
Samsung Bioepis says that its Brenzys – also known as SB4, a biosimilar to Enbrel (etanercept), has received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. 13 September 2016
On September 8, 2016, Taro Pharmaceuticals USA Inc, as well as two senior officers in its commercial team, received grand jury subpoenas from the US Department of Justice, Antitrust Division, the Israel-headquartered company revealed in a Securities and Exchange Commission filing. 12 September 2016
GlaxoSmithKline today announced the regulatory submission of a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 12 September 2016
Scotland-based MGB Biopharma announced today that the US Food and Drug Administration has granted MGB-BP-3, the firm’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated diarrhea (CDAD). 12 September 2016
Janet Woodcock, director of the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference. 12 September 2016
Shares of Dynavax Technologies were jumping 24.29% to $13.56 on heavy trading volume mid-Tuesday morning as investment bank William Blair said the US Food and Drug Administration’s cancellation of a November 16 Vaccines and Related Biological Products Advisory Committee meeting for the company's hepatitis B vaccine Heplisav is a net positive. 11 September 2016
America’s largest pharmacy benefits management company has launched an initiative aimed at controlling costs and improving care for people with inflammatory conditions like rheumatoid arthritis, psoriasis and Crohn's Disease. 9 September 2016
The USA’s Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will shape an upcoming report on abuse-deterrent opioids. 9 September 2016
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that Netherlands-incorporated drugmaker Mylan’s $7.2 billion acquisition of Swedish drugmaker Meda would likely be anticompetitive. 9 September 2016
In draft guidance issued today, the National Institute for Health and Care Excellence (NICE) is recommending Zepatier (elbasvir-grazoprevir) as an option to treat certain types of hepatitis C. 9 September 2016
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
US biotech Q BioMed has bought the rights to the US Food and Drug Administration-approved drug strontium chloride (SR89) with the promise to keep prices down. 8 September 2016
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health, noted the European Medicines agency on a website posting. 8 September 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