Spesolimab in Effisayil 2 trial met its primary and key secondary endpoint, demonstrating that spesolimab, an anti-interleukin-36 receptor antibody, can prevent flares in adolescents and adults with generalized pustular psoriasis (GPP) up to 48 weeks.
Daiichi Sankyo announced that the first patient has been dosed in the global, randomized TROPION-Lung07 phase III trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 expression less than 50% (TPS<50%) and without actionable genomic alterations
The Menarini Group announced that the FDA has approved Orserdu for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
The board of directors of Shanghai Junishi Biosciences is pleased to announce that on 28 January 2023, pursuant to relevant regulations of the Drug Administration Law, the National Medical Products Administration (the NMPA) conducted urgent review and approval under Special Examination and Approval of Drugs and conditionally approved deuremidevir hydrobromide tablets (trade name: Mindewei, product code: VV116/JT001, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 Category 1 innovative drug for marketing, which was applied by Shanghai Vinnerna Biosciences Co., Ltd a subsidiary controlled by the Company, for the treatment of adult patients with mild to moderate coronavirus disease 2019
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) expanded the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab)
Roche announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis.
The preliminary results from the ongoing global phase III study STAND (NCT03814746) indicate no statistically significant difference between crizanlizumab 5mg/kg or crizanlizumab 7.5mg/kg, from Novartis, plus placebo in annualized rates of vaso-occlusive crises (pain crises) in sickle cell disease, leading to a healthcare visit over the first-year post randomization.
Loxo@Lilly, the oncology unit of Eli Lilly and Company announced that the FDA approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
Legend Biotech Corp announced that CARTITUDE-4, the Phase III study evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis.
Aridis Pharmaceuticals announced top-line results from the AR-301-002 Phase III study, which evaluated the superiority of adjunctive use of the investigational monoclonal antibody candidate AR 301 (salvecin) with standard of care (SOC) antibiotics versus SOC antibiotics alone, for the treatment of VAP caused by Gram-positive bacteria Staphylococcus aureus (S. aureus).
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a greater than 4 centimeters [cm]), II, or IIIA non-small cell lung cancer (NSCLC).
Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with anemia associated with non-transfusion-dependent (NTD) beta thalassemia.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Novavax participated in the FDA Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) meeting, which resulted in a unanimous vote recommending harmonizing vaccine strain composition of primary series and booster doses. During the meeting, Novavax shared data demonstrating that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), when used as a booster induces a broad functional immune response, including against forward drift variants.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy
Bristol Myers Squibb announced topline results from ITRANSCEND CLL 004, a Phase I/II, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Abbott has announced that the FDA has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes
The FDA has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation against
Pivotal study data published in The New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa, an investigational treatment for hemophilia A
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy
Merck Inc., ,known as MSD outside of the United States and Canada, announced positive results from the Phase III KEYNOTE-966 trial
Bayer announced that its iodine-based contrast agent Ultravist-300, -370 is now approved for contrast-enhanced mammography (CEM) in the EU
Cidara Therapeutics, Inc. and Melinta Therapeutics, LLC announced that the FDA Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options
Merck Inc., known as MSD outside of the United States and Canada, announced that it will stop the Phase III KEYNOTE-991 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with enzalutamide (Xtandi) (and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Altamira Therapeutics Ltd. provided an update on the clinical trials with Bentrio in and acute COVID-19
Summary of Results: NASAR trial: Interim Analysis Shows Superior Efficacy of Bentrio in Seasonal Allergic Rhinitis: An interim analysis based on the accumulated data from the first 53 participants in the NASAR trial showed a statistically significant reduction of nasal symptoms with Bentrio vs. saline nasal spray comparator as well as good tolerability and safety
Innate Pharma SA announced the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 with respect to the previously announced expansion of its collaboration with Sanofi. The licensing agreement is now effective
PolyPid provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs)
TheracosBio announced that the FDA has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Takeda announced that it has entered into an exclusive licensing agreement with Hutchmed (China) Limited and its subsidiary Hutchmed Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau
Cassava Sciences, Inc. announced positive top-line Phase II results for simufilam, its oral drug candidate for Alzheimer’s disease dementia
Finch Therapeutics Group, Inc. announced its decision to discontinue the PRISM4 Phase III trial of CP 101 in recurrent C. difficile infection (CDI) and focus on realizing the value of its intellectual property estate and other assets
Ultomiris (ravulizumab-cwvz) has been approved in Canada to treat adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR), the most common type of MG-causing antibody
The FDA has approved Adacel (tetanus toxoid, reduced diptheria toxoid, and acellular pertussis vaccine; Tdap) during the third trimester of pregnancy to help protect against pertussis in infants younger than 2 months of age
Luye Pharma Group announced that the FDA has approved Rykindo (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults
Blueprint Medicines Corporation announced that the FDA has accepted the company's supplemental new drug application for Ayvakit (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM)
Mallinckrodt plc announced the presentation of results from a retrospective analysis of three North American-centric, Phase III, randomized, placebo-controlled studies comparing the incidence of hepatorenal syndrome (HRS) reversal with baseline acute-on-chronic liver failure (ACLF) grade in adults with rapid reduction in kidney function treated with Terlivaz plus albumin versus those treated with placebo plus albumin
Senju Pharmaceutical and Kidswell Bio said on January 13 that their biosimilar version of the ophthalmic vascular endothelial growth factor (VEGF) inhibitor Lucentis (ranibizumab) has added a new indication of diabetic macular edema
Meiji Seika Pharma announced that its biosimilar version of Stelara (ustekinumab) being developed with South Korean partner Dong-A ST demonstrated its therapeutic equivalence to the reference product in a global Phase III study for the treatment of psoriasis. Based on these results, the companies plan to file the drug in the US, Europe, and Japan within 2023
Dr. Reddy’s Laboratories Ltd. announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions
Ipsen presented positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde (irinotecan liposome injection), a long-circulating, liposomal topoisomerase inhibitor, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”) and Concert Pharmaceuticals, Inc. announced that they have executed a definitive agreement under which Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value.
BeiGene announced that the FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced.
Phathom Pharmaceuticals, Inc. announced positive topline results from PHALCON-NERD-301, a Phase III study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults in symptomatic non-erosive gastroesophageal reflux disease (sGERD or NERD).
Phathom Pharmaceuticals, Inc. announced that the FDA has notified the Company that no action will be taken on the Company’s new drug application (NDA) for vonoprazan, a novel potassium-competitive acid blocker (PCAB), under review as a treatment for erosive esophagitis, on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
AIM ImmunoTech Inc. ,an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases – including COVID-19, the disease caused by the SARS-CoV-2 virus – announced it has entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca
Seagen Inc. announced that the FDA has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RASwild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Eli Lilly and Company announced the FDA has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted
NICE (UK): Lenvatinib with pembrolizumab is recommended as an option for untreated advanced renal cell carcinoma in adults, only if: their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and nivolumab with ipilimumab would otherwise be offered and the companies provide lenvatinib and pembrolizumab according to the commercial arrangements
BeiGene announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Brukinsa (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy
The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, announced the results of an independent, scheduled data review of the Phase III Mosaico study (also known as HPX3002/HVTN706) of Ad26.Mos4.HIV, Janssen’s investigational HIV vaccine regimen
The UK National Institute for Health and Care Excellence (NICE) has issued final guidance recommending using Takeda’s mobocertinib (Exkivity) to treat advanced lung cancer
Intercept Pharmaceuticals, Inc. announced that the FDA has accepted Intercept’s New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH)
Moderna, Inc. announced positive topline data from its ConquerRSV Phase III pivotal efficacy trial of mRNA 1345, an investigational mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs)
Genentech, a member of the Roche Group announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the pre-specified interim analysis
AbbVie announced at Health Canada has approved Qulipta (atogepant) for the prevention of episodic migraine (< 15 migraine days per month) in adults
New Amsterdam Pharma Company announced topline results from ROSE2, a Phase II clinical trial evaluating obicetrapib, the company’s oral, low-dose and once-daily cholesteryl ester transfer protein (“CETP”) inhibitor, in combination with ezetimibe as an adjunct to high-intensity statin therapy
Alkermes plc announced that nemvaleukin alfa (nemvaleukin), the company's investigational, novel engineered interleukin-2 (IL-2) variant immunotherapy, has been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the United Kingdom (UK)
Servier and Taiho Oncology announced the release of data from SUNLIGHT, a pivotal Phase III global trial evaluating the combination of Lonsurf (trifluridine/tipiracil) and Avastin (bevacizumab) in adults with refractory metastatic colorectal cancer (mCRC), demonstrating that the trial met its primary endpoint of overall survival (OS)
Shanghai Henlius Biotech announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) Hansizhuang (serplulimab injection), in combination with carboplatin and etoposide for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC), has been approved by the National Medical Products Administration (NMPA), making it the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC)
Abbott announced that the FDA has approved the company's latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery
Eisai Co and Biogen have submitted a marketing authorization application for Leqembi (lecanemab), an investigational anti-amyloid beta (alpha beta) protofibril1 antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer ’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA)
Equillium announced that an abstract was accepted for oral presentation at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy, and the Center for International Blood & Marrow Transplant Research.
Arcutis Biotherapeutics, Inc. announced new safety and efficacy durability data from its open label Phase II long-term safety study evaluating once-daily roflumilast cream (0.3%) in adults with chronic plaque psoriasis . Roflumilast cream 0.3% (Zorvye) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the FDA in July 2022.
The FDA has approved a label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg, from Novo Nordisk, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment.
AstraZeneca will permanently discontinue selling Lumoxiti, a CD22-directed antibody-drug conjugate (ADC), in the US in July 2023, advising distributors to stop all distribution of the drug in August and requesting that they return any supplies of the drug to the company.
AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.
Eyenovia, Inc.announced that the FDA has accepted for review the company’s New Drug Application (NDA) for MydCombi ophthalmic spray
Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced top-line results from its Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks
Roche has announced that the European Commission (EC) has approved Xofluza (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza.
Glaukos Corporation announced positive results for a prospective, multi-center clinical trial designed to evaluate the safety of the surgical exchange procedure for iDose TR(travoprost intraocular implant) in subjects who had previously been administered an iDose TR in the Phase IIb clinical trial (referred to as the “exchange trial”)
Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older
Eton Pharmaceuticals announced that the FDA has accepted for review the Company’s New Drug Application (NDA) response for dehydrated alcohol injection for the proposed indication of methanol poisoning
AstraZeneca and Ono Pharmaceutical have secured a label update from Japanese regulators for their SGLT2 inhibitor Forxiga (dapagliflozin), which allows the drug’s use for chronic heart failure, irrespective of left ventricular ejection fraction (LVEF)
Chiesi Farmaceutici S.p.A. an international, research-focused biopharmaceuticals and healthcare group, and Amryt Pharma Plc a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing, and commercializing novel treatments for rare diseases, announced that the companies have entered into a definitive agreement under which Chiesi will acquire Amryt (the “Transaction”)
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: Leqembi), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) to the European Medicines Agency (EMA)
Can-Fite BioPharma announced it has submitted a market registration plan to the European Medicines Agency (EMA) for its lead drug candidate CF 101 (piclidenoson) in the treatment of moderate to severe psoriasis. A submission to the FDA will follow
AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced that it has signed a multi-year research collaboration and option agreement with ReCode Therapeutics.
Neurocrine Biosciences, Inc. and Voyager Therapeutics, Inc. announced the formation of a new strategic collaboration to advance multiple gene therapies for the treatment of neurological diseases
AbbVie and Immunome, Inc., a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine
Ipsen and Albireo announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc., announce that the FDA has accepted the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing.
Statement from Eisai ( abridged): Based on hhc (human health care) concept, our corporate philosophy, Eisai is committed to improve patients health outcomes and quality of life, simplify care delivery, increase health system efficiency and spur future investments in Alzheimer's disease (AD)
CytomX Therapeutics, Inc. a leader in the field of conditionally activated oncology therapeutics and Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies utilizing Moderna’s mRNA technologies and CytomX’s Probody therapeutic platform.
Revance Therapeutics announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Daxxify (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.
H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announced that the FDA has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review.
Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the FDA supporting the conversion of the Accelerated Approval of Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval.
Madrigal Pharmaceuticals announced additional results from the pivotal Phase III MAESTRO-NASH biopsy clinical trial of MGL 3196 (resmetirom), a liver-directed selective thyroid hormone receptor agonist.
Eisai and Biogen Inc. announced that under the Accelerated Approval Pathway the FDA has approved lecanemab-irmb (Brand Name in the U.S.:Leqembi 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Abeta) for the treatment of Alzheimer’s disease (AD).
Eisai and Biogen Inc. announced that under the Accelerated Approval Pathway the FDA has approved lecanemab-irmb (Brand Name in the U.S.:Leqembi 100 mg/mL injection for intravenous use), a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Abeta) for the treatment of Alzheimer’s disease (AD).
Pfizer announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in the vaccine.
Inventiva a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis (“NASH”), mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical needs, announced that, following a consultation with the FDA, Inventiva has decided to modify the clinical development plan of lanifibranor for the treatment of NASH.
Novan, Inc. announced that the Company has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for berdazimer gel, 10.3% (SB 206) for the topical treatment of molluscum contagiosum (“molluscum”). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.
Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Zai Lab Limited and Novocure announced the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.
Takeda announced that the totality of evidence from a pre-planned interim analysis of a pivotal Phase III study supports the efficacy and safety of TAK 755 (apadamtase alfa) as enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare sub-type of thrombotic thrombocytopenic purpura (TTP), a rare, chronic and debilitating blood clotting disorder caused by a deficiency in ADAMTS13 protease.
Notified Body TÜV SÜD Product Service GmbH is happy to announce the issue of the world’s first CDx certificate in accordance with the EU Regulation on in vitro diagnostic medical devices, IVDR (EU) 2017/746.
BD (Becton, Dickinson and Company) released findings from a survey conducted by The Harris Poll, between Nov. 14-16, 2022, among 872 U.S. women ages 18 to 64 years old, that indicate a significant gap in women's knowledge about the primary causes of cervical cancer as well as the most effective means of prevention.
Amryt announces positive results from its APH-19 Phase III trial of lomitapide for the treatment of Homozygous Familial Hypercholesterolemia (HoFH) in children aged 5-17 years.
AstraZeneca’s Biologics License Application (BLA) for nirsevimab has been accepted for review by the FDA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Helsinn Group announced results from a secondary analysis of a Phase III multicenter pivotal trial in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) receiving antiemetic prophylaxis (oral or IV NEPA) have been published in The Oncologist.
Alligator Bioscience announces an expansion to its research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover and develop together new bispecific antibody cancer therapeutics.
Alligator Bioscience announces strong interim results from the ongoing OPTIMIZE-1 Phase II trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer.
Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
Bausch + Lomb Corp and Novaliq GmbH announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase III trial GOBI, which is one of two pivotal Phase III trials for NOV03 (perfluorohexyloctane).
Checkpoint Therapeutics announced the submission of a Biologics License Application to the FDA for the approval of CK 301 (cosibelimab), its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or radiation.
Gilead Sciences, Inc. and Evoq Therapeutics, Inc. announced a collaboration and licensing agreement to advance Evoq’s proprietary technology for the treatment of rheumatoid arthritis (RA) and lupus
Anthos Therapeutics announced that it has enrolled the first patient in LILAC-TIMI 76, a Phase III study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation (AF) deemed unsuitable for current anticoagulants by their physician
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of JNJ 64407564 (talquetamab) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM)
BioMarin Pharmaceutical Inc. announced that the European Medicines Agency (EMA) validated its Type II Variation application to extend the indication for Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 2. Validation confirms the submission is complete and begins the EMA's review process
NICE (UK): Pembrolizumab is recommended, within its marketing authorisation, as an option with chemotherapy for neoadjuvant treatment and then continued alone as adjuvant treatment after surgery for adults with triple-negative: i. early breast cancer at high risk of recurrence or ii. locally advanced breast cancer
Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated a Type II variation Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting
Mersana Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, announced a research collaboration and commercial license agreement with a subsidiary of Merck KGaA, Darmstadt, Germany to discover novel Immunosynthen ADCs directed against up to two targets. Immunosynthen, Mersana’s proprietary STING-agonist ADC platform, is designed to generate systemically administered ADCs that locally activate STING signaling in both tumor-resident immune cells and in antigen-expressing tumor cells, unlocking the anti-tumor potential of innate immune stimulation. The STING pathway is a fundamental means of generating innate immune responses that can lead to anti-tumor activity and immunological memory
NPMA (China) grants conditional approval for the import of Merck's COVID-19 treatment, molnupiravir
Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced that the FDA has approved its citrate-free adalimumab biosimilar Idacio for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira(adalimumab)
Polarean Imaging plc the medical imaging technology company, announces that the FDA has granted approval for its drug device combination product, Xenoview
MediWound Ltd. a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, announced that the FDA has approved NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
NICE (UK);Trifluridine–tipiracil (Lonsurf) is recommended, within its marketing authorisation, as an option for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more treatment regimens. It is only recommended if the company provides trifluridine–tipiracil according to the commercial arrangement.
TG Therapeutics, Inc. announced the FDA has approved Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Approval was granted for this indication based on data from the ULTIMATE I & II Phase III trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.
NICE (UK):Esketamine nasal spray (Spravato) with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) is not recommended, within its marketing authorisation, for treatment-resistant depression that has not responded to at least 2 different antidepressants in the current moderate to severe depressive episode in adults.
NICE(UK): Amivantamab (Rybrevant) is not recommended, within its marketing authorisation, for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) after platinum-based chemotherapy in adults whose tumours have epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
NICE (UK):Avatrombopag (Doptelet) is recommended, within its marketing authorisation, as an option for treating primary chronic immune thrombocytopenia (ITP) refractory to other treatments (for example, corticosteroids, immunoglobulins) in adults.
NICE (UK):Cabozantinib (Cabometyx) too r is recommended as an option for treating advanced hepatocellular carcinoma (HCC) in adults who have had sorafenib, only if: they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the company provides it according to the commercial arrangement.
