After two days of discussions yielding reaffirmed support for Tecentriq’s (atezolizumab) Accelerated Approvals, the US regulator’s scientific panel changed tack on Thursday, voting to rescind decisions for both Keytruda (pembrolizumab) and Opdivo (nivolumab). 30 April 2021
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has filed its response to the European Union (EU) roadmap/IIA on the Evaluation and revision of the general pharmaceutical legislation. 30 April 2021
London-listed Hikma Pharmaceuticals saw its share gain more than 2% to 2,415 pence by late morning, as the company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration for the emergency treatment of known or suspected opioid overdose. 30 April 2021
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo (glucagon) injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged two years and over with diabetes mellitus, said the drug’s developer, Xeris Pharmaceuticals. 30 April 2021
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a Phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro (PA21: sucroferric oxyhydroxide) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment. 30 April 2021
Complete response letters (CRLs) seem to be coming thick and fast from the US Food and Drug Administration, the latest victim being Denmark’s dermatology specialist LEO Pharma. 29 April 2021
Shares in Protalix BioTherapeutics closed 44% lower on Wednesday after the firm and its partner Chiesi Farmaceutici announced receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for Fabry disease. 29 April 2021
There was more good news for Swiss company Roche on Wednesday, as the US regulator’s scientific panel voted to maintain another Accelerated Approval for Tecentriq (atezolizumab). 29 April 2021
While the US regulator has been taking a hard look at Accelerated Approvals which lack confirmatory data, Tecentriq (atezolizumab) appears set to retain its approval in breast cancer at least. 28 April 2021
Swedish biotech Calliditas Therapeutics says that the US Food and Drug Administration has accepted its New Drug Application for Nefecon (budesonide) for priority review as a treatment for IgA nephropathy (IgAN). 28 April 2021
Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission. 28 April 2021
The US Food and Drug Administration has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788), Japan’s largest drugmaker Takeda Pharmaceutical announced today. 28 April 2021
US non-profit the Institute for Clinical and Economic Review (ICER), in collaboration with researchers from the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center, has published a new white paper. 26 April 2021
The US Food and Drug Administration’s recent guidance on new drug applications during the pandemic fails to address certain key issues, according to a former top FDA official. 26 April 2021
GlaxoSmithKline has gained European Commission conditional marketing authorization for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. 26 April 2021
Health Canada has begun the review of the rolling submission for Medicago’s plant-derived COVID-19 vaccine candidate in combination with GlaxoSmithKline’s pandemic adjuvant. 26 April 2021
The US Food and Drug Administration (FDA) has removed the clinical hold on uniQure’s hemophilia B gene therapy program after determining that Dutch gene therapy company had satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial of AMT-061. 26 April 2021
Famous as a leading Indian maker of generics, Glenmark Pharmaceuticals has taken a major step towards boosting its credentials in the innovative medicine space, with European approval for Ryaltris (olopatadine hydrochloride/mometasone furoate). 26 April 2021
Notable news last week included Australia’s Kazia Therapeutics entering a licensing deal with Germany’s Evotec for worldwide rights to cancer candidate EVT801. French vaccine specialist Valneva has started Phase III evaluation of its COVID-19 candidate VLA200 in the UK. US biotech bluebird bio gave an update on its genetic disease portfolio last Tuesday and said it was withdrawing its beta thalassemia drug Zynteglo from the German market due to failed price negotiations. GlaxoSmithKline was granted US Food and Drug Administration approval for its checkpoint blocker Jemperli. Also, on Friday the FDA lifted its pause on the use of Johnson & Johnson’s COVID-19 Vaccine Janssen. 25 April 2021
On Friday, Swiss antibody-drug conjugate specialist ADC Therapeutics saw its shares gain almost 5% to $24.40 after-hours, as it revealed that the US Food and Drug Administration has granted accelerated approval for Zynlonta (loncastuximab tesirine-lpyl). 24 April 2021
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
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