A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
The US Food and Drug Administration (FDA) has placed a partial clinical hold on all trials of Gossamer Bio’s GB5121, in response to serious adverse events that have been observed in the Phase Ib/II STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. 5 April 2023
The US Food and Drug Administration (FDA) has granted accelerated approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab), with the decision coming ahead of anticipated date of April 21. 4 April 2023
Dermatology company Botanix Pharmaceuticals has safely navigated the US Food and Drug Administration (FDA) mid-cycle review with sofpironium bromide. 4 April 2023
The COVID-19 pandemic brought into the spotlight, at European level and particularly in Greece, the gaps in the national health systems, which are mainly due to underfunding and long-standing distortions, commented the Hellenic Association of Pharmaceutical Companies (SFEE). 3 April 2023
At its March 2023 meeting, the European Medicines Agency’s human medicines committee (CHMP) came up with positive recommendations for six novel medicines. 31 March 2023
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
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
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
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
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
New Jersey, USA-based cancer giant Merck has converted a conditional nod for its checkpoint blocker, Keytruda (pembrolizumab), into regular approval. 30 March 2023
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
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
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
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
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
Germany’s Merck KGaA has regained exclusive worldwide rights to develop, manufacture, and commercialize its checkpoint blocker Bavencio (avelumab). 27 March 2023
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
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024