Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
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Biotechnology
Japanese drugmaker Chugai, which is majority owned by Roche, On Friday revealed that Zenyaku Kogyo has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan (rituximab) intravenous injection 100mg and 500mg, which is co-marketed by both companies, for chronic idiopathic thrombocytopenic purpura (ITP) in children. 23 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
Draft EU regulatory proposals have been described by the leading European trade body as “sabotage” of the industry. We consider the fallout with Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin. 31 March 2023
Biotechnology
Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit. 31 March 2023
Biotechnology
Chinese biopharma Hutchmed today revealed that it completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer (CRC). 31 March 2023
Generics
The expiration of the patent for palbociclib, a leading anti-breast cancer drug, in India has opened up new opportunities for generic versions of the drug. The Indian government highlighted this development in Parliament and intensely discussed the endless possibilities that could arise from the availability of generic palbociclib and other similar generic oncology drugs, reports The Pharma Letter’s India correspondent. 30 March 2023
Biotechnology
The US Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase I/II VELA trial of BLU-222, said the drugs developer, Blueprint Medicines, sending the US biotech’s shares up 4% to $42.57. 30 March 2023
Biotechnology
Ireland-headquartered biotech Horizon Therapeutics today announced that the Italian medicines regulator, the AIFA, has approved the reimbursement of inebilizumab for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD). 30 March 2023
Biotechnology
A short delay to bluebird bio’s US regulatory submission for lovo-cel (lovotibeglogene autotemcel) appears to have spooked investors, with shares in the company falling by a quarter. 30 March 2023
Biotechnology
New Jersey, USA-based cancer giant Merck has converted a conditional nod for its checkpoint blocker, Keytruda (pembrolizumab), into regular approval. 30 March 2023
Biotechnology
The European Commission (EC) has approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression, US biotech firm Regeneron revealed today. 29 March 2023
Generics
Russia will allow domestic drugmakers to develop generics of original foreign drugs under patent protection only in case of exodus of their producers from the Russian market. 29 March 2023
Biotechnology
Bristol Myers Squibb’s Sotyktu (deucravacitinib) is continuing to vindicate the company’s decision to favor the drug’s development over Otezla (apremilast). 28 March 2023
Biotechnology
Having won approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in September last year, Astra-Zeneca’s biologic Tezspire (tezepelumab) has now received backing from the health technology assessor. 28 March 2023
Biotechnology
Health Canada has scored a regulatory first, granting approval to Roche’s new blood cancer med, Columvi (glofitamab). 28 March 2023
Biotechnology
Shares of USA/Israel-based biotech BrainStorm Cell Therapeutics rose as much as 13% yesterday on more positive news from the US regulator, which in February issued a refusal-to-file (RTF) letter regarding the submission for its cell therapy NurOwn (autologous MSC-NTF cells). 28 March 2023
Biotechnology
Netherlands-based iOnctura today announced that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, a potential treatment for metastatic uveal melanoma by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA). 28 March 2023
Biosimilars
Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, welcomes the announcement by the government of Newfoundland and Labrador that it is implementing a “switching” or transitioning policy to expand the use of biosimilar biologic medicines for its public drug program. 28 March 2023
Biotechnology
US rare diseases focused biotech Amicus Therapeutics today announced that the European Commission (EC) has granted approval for Pombiliti (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD). 27 March 2023
Biotechnology
Having gained US approval with much fanfare in December 2022 and in Europe in February this year, Hemgenix (etranacogene dezaparvovec), from Australian biotech CSL Limited, has now received regulatory clearance in the UK 27 March 2023
Biotechnology
Germany’s Merck KGaA has regained exclusive worldwide rights to develop, manufacture, and commercialize its checkpoint blocker Bavencio (avelumab). 27 March 2023
Pharmaceutical
Shares of Incyte fell 2.8% to $70.23 on Friday, after the US Food and Drug Administration (FDA) unexpectedly rejected an extended-release version of its blockbuster drug, Jakafi (ruxolitinib). 27 March 2023
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