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
A US drugmaker has joined the list of companies that have refused to supply the drugs that are used in the USA to implement capital punishment. Lethal injection has long been the most common form of execution in the USA. 14 May 2016
Eisai has received approval from the US Food and Drug Administration for Lenvima (lenvatinib mesylate), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. 14 May 2016
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its May meeting, adopted a summary report following the review of a meta-analysis of data from three observational studies, aiming to assess the risk of developing inhibitors (antibodies) against individual recombinant factor VIII products in previously untreated patients with severe hemophilia A. 13 May 2016
The European Commission has now approved Idelvion (coagulation Factor IX [recombinant], albumin fusion protein), from Australia’s CSL Limited, for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). 13 May 2016
Nordic company Swedish Orphan Biovitrum and US biotech major Biogen have received European approval for their Alprolix (rFIXFc) extended half-life therapy for hemophilia B. 13 May 2016
The US companies represented by trade group Pharmaceutical Research and Manufacturers of America (PhRMA) invested an estimated $58.8 billion into research and development (R&D), according to the latest survey of its members. 13 May 2016
The first and only immuno-oncology combination therapy for the treatment of advanced melanoma has been approved by the European Commission. 12 May 2016
The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. 12 May 2016
The European Commission has approved multiple myeloma drug Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone in adult patients who have received at least one prior therapy, it has been announced. 12 May 2016
Around 88% of the bodies set up to deliver health care across England are not implementing national guidelines aimed at minimising the risk of antibiotic resistance. 12 May 2016
Anglo-Swedish pharma major AstraZeneca has received orphan drug designation from the US Food and Drug Administration (FDA) for the MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). 12 May 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC announced this morning the approval of an agreement with the local subsidiary of Janssen-Cilag for the listing of bedaquiline (Sirturo) and siltuximab (Sylvant). 12 May 2016
The European Medicines Agency has published a report summarizing the experience with its small and medium-sized enterprise (SME) initiative over the last 10 years. 12 May 2016
Bristol-Myers Squibb today confirmed a decision from the UK cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) that could deny National Health Service patients with the most common form of lung cancer access to Opdivo (nivolumab). 12 May 2016
The US Food and Drug Administration is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body, the agency announced late Tuesday. 11 May 2016
The Russian government has decided to postpone the introduction of a controversial scheme for the compulsory licensing of drugs imported into Russia, as proposed by some local drugmakers, reports The Pharma Letter’s local correspondent. 10 May 2016
The Ukraine government plans to ease access to imported drugs to the domestic market, through the reduction of the time for registration of the newly-launched drugs from the current 30 to 10 days. 10 May 2016
In our weekly expert view piece Dr Nick Meyers, programme director at Boyd Consultants examines the implications what the regulatory and legislative landscape in the biopharmaceutical industry could look like post-Brexit. 10 May 2016
The US Generic Pharmaceutical Association (GPhA) and its Biosimilars Council have expressed fears over a proposed demonstration from the Centers for Medicare and Medicaid Services (CMS) to revamp how the Medicare Part B program pays for prescription drugs. 10 May 2016
Transparency is the buzzword in pharma with a new code of conduct and a forthcoming “Sunshine” law demanding better clarity and disclosure across the industry in the UK but will it ever be applied to drug pricing? 9 May 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