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
Merck & Co says that its Keytruda (pembrolizumab) has received conditional approval for the treatment of Canadians living with metastatic non-small cell lung cancer (NSCLC). 21 April 2016
Some 88.6% of doctors know what biosimilar medicines are and 59% have already prescribed biosimilar medicines as a high quality treatment for their patients, according to EuropaBio paper on physician preference regarding biosimilar labels (SmPC). 21 April 2016
20 civil society associations are urging European Union member states to support the Dutch EU Presidency’s vision on access to affordable medicines. The call for backing comes as Health Ministers meet in Amsterdam this week, according to posting on the website of the European Public Health Alliance. 20 April 2016
Physicians in Europe would like to have more information in the biosimilar label than is currently available for these biological copy drugs. 20 April 2016
US biopharma company Chiasma suffered a share price collapse, after it revealed the news that the US Food and Drug Administration would require further clinical evidence in order to approve its Mycapssa (octreotide). 20 April 2016
After its assessment in 2013, the German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed the added benefit of Xalkori (crizotinib) in comparison with the appropriate comparator therapy, concluded that an added benefit of crizotinib for the first-line treatment of advanced bronchial carcinoma is not proven. 19 April 2016
Israeli biotech firm RedHill Biopharma has announced that its RHB-105 combination for the treatment of H. pylori infection has taken steps closer to approval in the USA. 19 April 2016
Despite the setbacks in the global markets since the beginning of 2016, the valuations of biotechnology companies remain attractive in comparison to the S&P and are based on strong fundamentals, says Carl Harald Janson, investment manager at SV Life Sciences Managers. 19 April 2016
Concerned at being sidelined from the USA-led Trans-Pacific Partnership (TPP) trade deal, India is preparing to reach a deal this year amidst preparations to deal with the adverse impact. 18 April 2016
Australian regulator the Therapeutic Goods Administration (TGA) has approved a variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment with tadalafil for patients with pulmonary arterial hypertension (PAH) in Australia. 18 April 2016
Activist fund Starboard Value targeted Depomed, a small drug maker with an approximate $1 billion market capitalization late last week, wrote Bret Jensen, a regular contributor to the Seeking Alpha blog. 17 April 2016
Boehringer Ingelheim said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its lung cancer therapy Gilotrif (afatinib). 16 April 2016
The National Institute for Health and Care Excellence (NICE) on Friday recommended Translarna (ataluren), from US pharma company PTC Therapeutics for treating children aged five and over with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. 16 April 2016
In April, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review and extended the scope of an ongoing review procedure. 15 April 2016
The Strategic Advisory Group of Experts on Immunization (SAGE) has issued its recommendations to the World Health Organization on the use of Dengvaxia dengue vaccine, from Sanofi Pasteur. 15 April 2016
New European Union rules to help companies win legal redress against theft or misuse of their trade secrets were voted by Parliament today (April 14). 14 April 2016
The USA’s Physicians Payment Sunshine Act, proposed in 2010 and started in 2013, was created to make the financial relationship between health care providers and the pharmaceutical industry more transparent. 14 April 2016
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) from pharma major Bristol-Myers Squibb, which seeks to expand the use of Opdivo (nivolumab) to patients with classical Hodgkin lymphoma (cHL) after prior therapies. 14 April 2016
US drug giant Merck & Co is a step closer to making Keytruda (pembrolizumab), its already marketed cancer drug, as a treatment for head and neck cancer, available to patients. 14 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