India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative. 7 October 2024
US drugmaker Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Zeposia (ozanimod) for the treatment of moderately to severely active ulcerative colitis (UC). 29 December 2020
Adding more feathers to their cap in recent months, Indian drug majors have garnered 45% of all new Abbreviated New Drug Application (ANDA) approvals over the past nine months. 29 December 2020
Registration of Russia’s first gene therapy drug Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA), may be delayed by one and a half years as, in order to assess the quality of the drug, the Russian Ministry of Health has demanded from the Swiss pharma giant Novartis up to 40 vials with a total price of up to $88 million, reports The Pharma Letter’s local correspondent. 29 December 2020
The US Food and Drug Administration has accepted for Priority Review the supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). 29 December 2020
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers announced on Monday. 29 December 2020
Representatives of the Association of Cancer Patients, Zdravstvy, one of Russia’s leading public associations representing the interests of patients, has called on the national government to resume procurements of some high-priced original drugs, which are used to treat cancer and for which purchases are not planned for 2021. 29 December 2020
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
UK government officials confirmed on Sunday that the Medicines and Healthcare products Regulatory Agency (MHRA) would imminently approve the Oxford COVID-19 vaccine, adding that the announcement could come as soon as Tuesday, according to the Financial Times. 28 December 2020
This afternoon, Christmas Eve, we finally heard that the UK had reached a trade agreement with the European Commission on the terms of its departure from the European Union, that will come into effect on January 1, 2021. 24 December 2020
US biotech Moderna says that medicines regulator Health Canada has authorized its vaccine against COVID-19, mRNA-1273, for the immunization of people 18 years of age and older under an Interim Order. 24 December 2020
The US Food and Drug Administration has approved the New Drug Application (NDA) for once-daily Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults, from Urovant Sciences. 24 December 2020
US pharma giant Pfizer and German partner BioNTech have signed a second deal with the US government to supply an additional 100 million doses of BNT162b2, their COVID-19 vaccine, from production facilities in the USA. 23 December 2020
The European Commission has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer. 23 December 2020
The demand for foreign drugs designed for cancer treatment in Russia remains stable, despite the ever-growing number of generics in the local market, according to recent statements by some leading Russian pharma analysts and local media, reports The Pharma Letter’s local correspondent. 22 December 2020
Netherlands-based gene therapy company uniQure saw its shares down 15.7% at $38.75 around midday in New York trading today, after it announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the US Food and Drug Administration. 21 December 2020
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
HIV specialist company ViiV Healthcare, which is majority owned by GlaxoSmithKline, today announced the authorization of Vocabria (cabotegravir injection and tablets) in combination with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed. 21 December 2020
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
India's new Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) scheme is a significant step towards consolidating and advancing the country's biotechnology initiative. 7 October 2024
The Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, says it welcomes the allocation of 30 million euros ($32.9 million) for new medicines in Budget 2025. 7 October 2024
Important regulatory news last week included French pharma major Sanofi gaining approval from the US Food and Drug Administration (FDA) and the Chinese medicines authority for its blockbuster drug Dupixent as the first biologic for chronic obstructive pulmonary disease (COPD). Spanish epigenetics firm Oryzon Genomics announced that, with FDA feedback, it is preparing for a Phase III trial of its CNS drug candidate vafidemstat. Also, the FDA authorized Bristol Myers Squibb’s blockbuster drug Opdivo in a new lung cancer indication for patients with specific mutations such as EGFR or ALK. On the deal-making front, US biotech Arcus Biosciences has entered a collaboration with AstraZeneca to evaluate its casdatifan with the UK pharma major’s volrustomig in renal cell cancer. 6 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Spanish epigenetics firm Oryzon Genomics has announced the receipt of the official meeting minutes from a recent End-of-Phase II meeting for vafidemstat in borderline personality disorder (BPD) with the US Food and Drug Administration (FDA). 2 October 2024