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 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended a total of nine new medicines for approval at its April meeting. 22 April 2017
A special state fund, the reserves of which will be used for the purchase of the most expensive and rare drugs, will soon be established in Russia, according to a recent initiative put forward by the members of the Russian Council of Federation, the upper house of the Russian Parliament, reports The Pharma Letter’s local correspondent. 21 April 2017
A major trust which invests in the global biotechnology industry says that the US political environment has stabilized, and uncertainty over drug pricing has lessened. 21 April 2017
The US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application for CCP-07, a long-acting cough-cold formulation for UK-based Vernalis. 21 April 2017
Netherlands-based gene therapy company uniQure today announced that it will not pursue the renewal of the Glybera (alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017. 20 April 2017
The Australian Therapeutic Goods Administration (TGA) has approved Afstyla (lonoctocog alfa) a recombinant single chain coagulation factor VIII (rFVIIISingleChain) in patients with hemophilia A (congenital factor VIII deficiency). 20 April 2017
Genentech, part of Swiss pharma giant Roche, has received accelerated approval from the US Food and Drug Administration (FDA) for its cancer immunotherapy Tecentriq (atezolizumab) to treat people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. 19 April 2017
The UK affiliate of French pharma group Ipsen is remaining optimistic despite receiving a second blow to its hopes of having its Cabometyx (cabozantinib tablets) made available for advanced kidney cancer on the National Health Service (NHS) in England and Wales. 19 April 2017
Consumers and health professionals in Australia are advised that the Therapeutic Goods Administration (TGA) has completed a review of idelalisib and the medicine should no longer be used in combination with rituximab in specific situations outlined in further detail below. 19 April 2017
Indian generic drugmaker Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration for anti-depressive medication vilazodone hydrochloride. 19 April 2017
Japan Vaccine Co, a joint venture of UK pharma major GlaxoSmithKline and Japanese company Daiichi Sankyo, have submitted a New Drug Application in Japan seeking approval for the candidate shingles vaccine, Shingrix, for the prevention of herpes zoster (shingles) in people aged 50 years or over. 18 April 2017
Swiss pharma giant Novartis’ Cosentyx is to be made available on the National Health Service (NHS) in England and Wales for another condition affecting a a major patient group. 18 April 2017
China has recently done much work to encourage novel drug development in the country. Among the efforts is a testing program of market authorization holder scheme (MAH), an optimized approval process for novel drugs and the requirement of clinical data validation, reports The Pharma Letter’s local correspondent Wang Fangquing. 18 April 2017
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. 18 April 2017
Californian biotech firm Rigel Pharmaceuticals is renewing its bid to secure regulatory approval in the USA for fostamatinib, this time for a rare autoimmune disorder. 18 April 2017
The US Food and Drug Administration has approved Lucentis (ranibizumab injection) for the monthly treatment of all forms of diabetic retinopathy, reported Genentech, a subsidiary of Swiss pharma giant Roche, which markets the drug in the USA. 18 April 2017
In a holiday-shortened week, there were still a bunch of important announcements, among which was the US approval of Neurocrine Sciences’ movement disorder drug Ingrezza, two lots of bad news for OncoMed and Bristol-Myers Squibb offloaded two product candidates as well as entering a research collaboration with Apexigen. 17 April 2017
The US Food and Drug Administration has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis (RA). 17 April 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