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Eisai Co., Ltd. and Biogen Japan Ltd. announce that Eisai has entered into a research collaboration agreement with the National Center of Neurology and Psychiatry (“NCNP”) to conduct apolipoprotein E (APOE) genetic testing in the dementia research and development program, “Development and Analysis of a National Clinical Registry of Disease-Modifying Therapies for Alzheimer’s Disease” (“AD-DMT Registry”).

As previously indicated Gilead Sciences Inc announced The New England Journal of Medicine (NEJM ) published the full results from the company’s pivotal Phase III PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of gender-diverse people ( (see 2nd citation) .

Roche announced that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc. a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies

Cassava Sciences, Inc  announced that the topline results from the Phase III ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints

Roche reported an update on their phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC)

GSK plc announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y

Amgen announced positive data at 52 weeks in a double-blind, dose-ranging Phase II study with MariTide (maridebart cafraglutide, formerly AMG 133), an investigational antibody peptide conjugate subcutaneously administered monthly or less frequently

BeiGene, Ltd. a global oncology company that intends to change its name to BeOne Medicines, announced that the European Commission has approved Tevimbra (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma

Applied Therapeutics, Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia

AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the FDA has granted regulatory approval for Rapiblyk (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter)

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Intera Oncology Inc., a privately held medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine – a chemotherapy drug – both of which are approved by the FDA

The business combination of two AI-powered drug discovery and development companies, Recursion and Exscientia has been completed, with Exscientia becoming a wholly owned subsidiary of Recursion creating a vertically-integrated and technology-enabled drug discovery platform

Exelixis, Inc. announced that the FDA has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx ) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025

Zimmer Biomet Holdings, Inc. announced FDA Premarket Approval Application (PMA) Supplement approval for the Oxford Cementless Partial Knee

Novartis announced that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence

Edwards Lifesciences  announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve

Eton Pharmaceuticals, Inc  announced that it has acquired the U.S. rights to Amglidia (glyburide oral suspension, known as glibenclamide in Europe) for the treatment of neonatal diabetes mellitus from AMMTeK

BridgeBio Pharma, Inc. announced that the FDA  approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization

Shorla Oncology ’ a U.S.-Ireland specialty pharmaceutical company, announced  that the FDA has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers

GSK plc  announced the FDA  has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy

China’s National Medical Products Administration (NMPA) has approved zorifertinib hydrochloride tablets (Zorifer; formerly AZD3759) for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations and central nervous system (CNS) metastases

Alnylam Pharmaceuticals, Inc.  announced that the FDA has accepted for review the Company’s supplemental New Drug Application (sNDA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Based on the Company’s use of a Priority Review Voucher, the FDA has set an action date goal of March 23, 2025, under the Prescription Drug User Fee Act (PDUFA)

Meril Life Sciences is proud to announce the launch of its next-generation Myval Octapro THV, set to debut at the upcoming GISE 2024 and London Valves 2024 conferences. The Myval Octapro THV underscores Meril's dedication to redefining TAVR technology and shaping the future of structural heart care

Merck Inc.,( known as MSD outside of the United States and Canada), announced  positive topline results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality

NICE (UK): 1.1 Elafibranor is recommended, within its marketing authorisation, as an option for treating primary biliary cholangitis in adults, when used: i) with ursodeoxycholic acid (UDCA), if the primary biliary cholangitis has not responded well enough to UDCA; or ii) alone, if UDCA cannot be tolerated

Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)

After a years-long uphill battle for Lexicon Pharmaceuticals and its insulin adjunct prospect Zynquista (sotagliflozin), the company will move forward with no commercial sales team and no further promotional efforts for its Inpefa, a heart failure version of sotagliflozin approved by the FDA in 2023.

Omeros Corporation  announced an update on its progress toward planned resubmission of its biologics license application (“BLA”) for narsoplimab, the company’s first-in-class antibody targeting MASP-2, the effector enzyme of the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”).

A biologics license application under the Accelerated Approval pathway has been filed to the FDA for vusolimogene oderparepvec (RP1) in combination with nivolumab (Opdivo) for the treatment of patients with advanced melanoma who were previously administered an anti–PD-1 regimen, according to the developer, Replimune.

Merck . known as MSD outside the United States and Canada, has been notified that TRC Capital Investment Corporation (TRC Capital) has commenced an unsolicited “mini-tender” offer, dated November 12, 2024, to purchase up to 1,000,000 shares of Merck common stock at $96.38 per share.

Royal Philips, a global leader in health technology, announced its next-generation 1.5T BlueSeal MR wide-bore scanner will be unveiled at RSNA 2024.

Bayer  announced that the  FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).  

Merck  Inc.,, (known as MSD outside of the United States and Canada),  announced that the National Medical Products Administration (NMPA) in China has approved Welireg (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Novartis has acquired Kate Therapeutics, a San Diego-based, preclinical stage biotechnology company, focused on developing adeno-associated virus (AAV)-based gene therapies to treat genetically defined neuromuscular diseases. Kate Therapeutics’ primary programs include preclinical candidates for Duchenne muscular dystrophy (DMD), facioscapulohumeral dystrophy (FSHD), and myotonic dystrophy type 1 (DM1)

Zai Lab and Pfizer  announced  a strategic collaboration for the novel antibacterial drug Xacduro (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and perform certain commercialization activities for Xacduro in mainland China

Pfizer Inc. announced  that the European Commission (EC) has granted marketing authorization for Hympavza (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors

Royal Philips , a global leader in health technology, announced a major advance in radiation oncology with 510(k) clearance from the FDA  for its new detector-based spectral computed tomography (CT) radiotherapy solution. Philips Spectral CT 7500 RT marks the next step in personalized cancer care by integrating the unique tumor visualization and tissue characterization capabilities of spectral CT into cancer treatment and planning

Jazz Pharmaceuticals plc  announced the FDA  granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test

Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing differentiated molecules addressing serious liver diseases  announced positive results from a Phase II study evaluating the safety and efficacy of once-monthly efimosfermin alfa (formerly known as BOS-580), a long-acting FGF21 analogue, in participants with stage F2/F3 fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH)

Omeros Corporation  announced an update on its progress toward planned resubmission of its biologics license application (“BLA”) for narsoplimab, the company’s first-in-class antibody targeting MASP-2, the effector enzyme of the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”)

NICE (UK) 1.1 Alectinib is recommended, within its marketing authorisation, as an option for the adjuvant treatment of stage 1B (tumours 4 cm or larger) to 3A ALK-positive non-small-cell lung cancer (NSCLC) after complete tumour resection in adults. It is only recommended if the company provides it according to the commercial arrangement

UCB and Biogen Inc. presented detailed results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE)

NICE (UK) 1.1 Teclistamab is recommended as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) when the myeloma has progressed on the last treatment

Sage Therapeutics, Inc. announced topline results from the Phase II DIMENSION Study of dalzanemdor (SAGE  718) in participants with cognitive impairment (CI) associated with Huntington’s Disease (HD)

Medtronic plc announced FDA clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera  continuous glucose monitor (CGM)

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT)

Arbutus Biopharma Corporation and Barinthus Biotherapeutics plc announced new preliminary data from the Phase IIa IM-PROVE II clinical trial (AB 729202) of people with chronic hepatitis B virus (cHBV) at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2024

CERo Therapeutics Holdings, Inc. announces that the FDA has cleared the Company’s Investigational New Drug Application (IND) for Phase I clinical trials of its lead compound, CER 1236, in acute myelogenous leukemia (AML)

UCB, announced that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A)

AbbVie announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens

Johnson & Johnson announced positive topline results from ICONIC-LEAD, a pivotal Phase III investigational study of icotrokinra (JNJ-2113), the first targeted oral peptide that selectively blocks the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO)

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two denosumab biosimilars – Obodence (60 mg pre-filled syringe) referencing Prolia (denosumab) (see separate entry) and Xbryk (120mg vial) referencing Xgeva (denosumab) – also known as SB16

Samsung Bioepis Co., Ltd.  announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two denosumab biosimilars – Obodence  (60 mg pre-filled syringe) referencing Prolia (denosumab) and Xbryk (120mg vial) referencing Xgeva (denosumab) – also known as SB16

Samsung Bioepis Co., Ltd. and Biogen Inc.   announced that the European Commission (EC) has approved Opuviz 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), developed and registered by Samsung Bioepis

Formycon AG and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB 203, a biosimilar candidate to Eylea (aflibercept)

Merck Inc., (known as MSD outside of the United States and Canada,) announced positive topline results from the pivotal Phase III MK-3475A-D77 trial

Merck Inc., ( known as MSD outside of the United States and Canada)  announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda  (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM)

InflaRx N.V., a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO))

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the Marketing Authorisation (MA)for Lazcluze (lazertinib), in combination with Rybrevant (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations

Bristol Myers Squibb  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1 -positive advanced non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted

Azurity Pharmaceuticals announced that the FDA has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib

Syndax Pharmaceuticals  announced that the FDA has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial, which were published in The New England Journal of Medicine

 Ipsen announced data at the American Association for the Study of Liver Diseases (AASLD) assessing the long-term efficacy and safety of patients treated with Bylvay from two Phase III open-label extension studies: late-breaking abstract (#5045) on PEDFIC 2 in Progressive Familial Intrahepatic Cholestasis (PFIC) and oral presentation ASSERT-EXT (#50) in Alagille syndrome (ALGS)

Gilead Sciences, Inc. announced data from a two-and-a-half-year interim analysis from the ongoing Phase III ASSURE study, which showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi  (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression. Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function

Cytokinetics, Incorporated announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase III cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.

Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the Watchman FLX Left Atrial Appendage Closure (LAAC) Device.

Cytokinetics, Incorporated announced new data relating to aficamten and hypertrophic cardiomyopathy (HCM), were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.

Eli Lilly and Company  announced detailed results from the SUMMIT Phase III trial showing tirzepatide significantly reduced the risk of worsening heart failure events in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.

Halozyme Therapeutics, Inc. confirmed it has submitted a non-binding proposal to the Management Board and Supervisory Board of Evotec SE to acquire Evotec for €11.00 per share in cash, implying a fully diluted equity value of €2.0 billion.

Eyenovia, Inc. announced that a review of the CHAPERONE data by an independent Data Review Committee (DRC) found that the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years.

Ipsen announced  late-breaking data for Iqirvo (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE study at the American Association for the Study of Liver Disease (AASLD) congress.

Pulmatrix, a clinical-stage biopharmaceutical company, announced a merger agreement with Cullgen Inc., a privately-held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE platform to discover and advance therapeutics for the treatment of cancer and other diseases

Sandoz, announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea]

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the  FDA has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025

Amgen announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheumatology (ACR) Convergence 2024 conference in Washington, D.C., Nov. 14-19, 2024

Tonix Pharmaceuticals Holding Corp.  announced the publication of a paper entitled, “Recombinant Chimeric Horsepox Virus (TNX-801) is Attenuated Relative to Vaccinia Virus Strains in Both In Vitro and In Vivo Models,” in the peer-reviewed journal mSphere

GSK plc  announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma

BioNTech SE and Biotheus announced the signing of a definitive agreement for the acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases. With the acquisition, BioNTech will obtain full global rights to the late-stage clinical asset BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A

Eisai Co., Ltd. and Biogen Inc. announced  a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology

Eli Lilly and Company announced positive topline results from the SURMOUNT-1 three-year study (176-week treatment period) evaluating the efficacy and safety of tirzepatide (Zepbound and Mounjaro) once weekly for long-term weight management and delay in progression to diabetes in adults with pre-diabetes and obesity or overweight

BeiGene, Ltd, a global oncology company,  announced its intent to change the Company’s name to BeOne Medicines Ltd., confirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible

PTC Therapeutics, Inc. announced  the FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that is directly administered to the brain

Pfizer is exploring the sale of its hospital drugs unit, as the company, which has been under pressure from activist investor Starboard Value, looks to divest non-core assets, Reuters reports

Adaptimmune Therapeutics plc, a company working to redefine the treatment of solid tumor cancers with cell therapy, announced data from the primary analysis of its pivotal Phase II IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy

Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., announced that the FDA has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women

Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, announced that the FDA  has approved the Ottava robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites

SpringWorks Therapeutics, Inc. announces that the long-term efficacy and safety data from the Phase III DeFi trial of nirogacestat in adults with progressing desmoid tumors will be presented as a late-breaking oral presentation at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting, being held November 13-16, 2024, in San Diego, CA

AbbVie announces that its two Phase II EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6

Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), showed that Koselugo (selumetinib), an oral, selective MEK inhibitor, met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR) versus placebo in these adult patients

AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy

Merck GmBH, a leading science and technology company,  announced that the Phase III MANEUVER trial of pimicotinib, an investigational medicine being developed by Abbisko Therapeutics Co., Ltd., met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001)

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped and the Bahiana Foundation of Infectiology, showing the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) achieved similar results to 3-drug therapy in viral suppression in a population of adults with advanced HIV

Treatment with regorafenib (Stivarga) led to an improvement in overall survival (OS) compared with placebo in patients with refractory advanced gastric or gastroesophageal junction (GEJ) cancer, according to data from the phase III INTEGRATE IIa trial (NCT02773524) published in the Journal of Clinical Oncology

A new drug application (NDA) has been submitted to the FDA seeking the approval of sunvozertinib (DZD9008) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy

Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced that the FDA has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates

Johnson & Johnson  announced the submission of regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of a new indication for Darzalex Faspro  (daratumumab and hyaluronidase-fihj) in the U.S. and Darzalex subcutaneous (SC) formulation in the European Union (EU)

Avapritinib is recommended, within its marketing authorisation, as an option for treating advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast cell leukaemia) in adults

$924 million merger with Revance announced

Autolus Therapeutics plc  an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the FDA has granted marketing approval for Aucatzyl   (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

In a small Phase 1 study, Viking’s once-daily oral VK 2735 led to dose-dependent reductions in weight with greatest weight loss — an average 6.8% at 28 days — achieved in the highest of the eight doses tested. The results were presented  during the ObesityWeek conference in San Antonio. Viking said   it plans to start a Phase II test of the tablet by the end of this year.

Aitia entered a fourth drug discovery collaboration with Servier on 30 October to discover and develop new drugs using Aitia’s artificial intelligence (AI)-powered Gemini Digital Twins technology.

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be forthcoming from Alteogen following a licensing deal worth up to $300 million.

Public biotechnology company AlloVir has agreed to merge with the privately held Kalaris Therapeutics, nearly one year after a clinical setback sunk its stock price and its options.

Athira Pharma, a small drugmaker focused on neuroscience, is looking into the different paths it could take to “maximizing stockholder value,” after the company’s most advanced experimental medicine failed a key study.

Sarepta announced that it is discontinuing its next generation of exon-skipping drugs for Duchenne muscular dystrophy over safety concerns. In addition to its much-debated gene therapy and other approved exon-skipping drugs for particular Duchenne mutations, Sarepta had been developing follow-on treatments designed to be more targeted toward muscle cells.

Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s Tezspire (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo

Bayer announced  510(k) clearance from the FDA for its Medrad  Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with Bayer’s portfolio of products, especially in high-volume CT suites

Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the FDA approval of the Varipulse  Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation (AFib)

NDA Submission Under Accelerated Approval for Govorestat for the Treatment of SORD Deficiency Anticipated in Early Q1 2025

Altimmune, Inc., a clinical-stage biopharmaceutical company, announced the successful completion of its End-of-Phase II Meeting with the FDA and agreement on the design of a Phase III registrational program for its product candidate, pemvidutide, in the treatment of obesity

Leon Wang, Executive Vice President International and AstraZeneca China President, is cooperating with an ongoing investigation by Chinese authorities.

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy

Merus N.V.  a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics),  announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab (Zeno) Biologics License Application (BLA) currently under priority review

Intra-Cellular Therapies, Inc. , announced positive results from Study 304 evaluating the efficacy and safety of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced  the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD)

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the 30-day primary endpoint results of DISRUPT BTK II, a post-market study to assess the continued safety, effectiveness and optimal clinical use of the Shockwave Peripheral IVL System for the treatment of calcified peripheral lesions below the knee (BTK), including some of the most challenging patients with critical limb threatening ischemia (CLTI)

Journey Medical Corporation announced that the FDA has approved Emrosi (minocycline hydrochloride extended release capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi was developed in collaboration with Dr. Reddy’s Laboratories Ltd.

Disc Medicine, Inc. announced positive feedback from its end-of-phase II meeting with the FDA  supporting the regulatory path forward for bitopertin in EPP

Matinas BioPharma Holdings, Inc. announces that negotiations under the previously disclosed non-binding term sheet regarding global rights to MAT 2203, its oral formulation of amphotericin B, have been terminated following notification from the prospective partner

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Cortex, Inc., an Ajax Health company

Shockwave Medical, Inc., part of Johnson & Johnson MedTech announces the completion of enrollment in EMPOWER CAD, the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease

Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company focused on responsible pain management and the development of novel abuse-deterrent products, announced that the FDA has approved RoxyBond (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Novartis announced that Scemblix (asciminib) was granted accelerated approval by the FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)

Shorla Oncology , a U.S.-Ireland specialty pharmaceutical company, announced that the FDA  has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA).

Eisai Co., Ltd and Biogen Inc. announced  that the latest findings for lecanemab-irmb (U.S. brand name: Leqembi), an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), were presented at the Clinical Trials for Alzheimer's Disease Conference (CTAD), held in Madrid, Spain, and virtually.

AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology.

Lexicon Pharmaceuticals, Inc. announced the outcome of the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).

ESSA Pharma Inc. announced that it has made the decision to terminate the Phase II clinical trial evaluating in a 2:1 randomization masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens.

Novo Nordisk announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase III, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).

Lundbeck announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. SUNRISE (NCT04921384) was an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled phase III trial, to confirm the efficacy and safety of Vyepti in participants with chronic migraine who were eligible for preventive treatment- that started in May 2021.

Wegovy ( semaglutide) sharply reduces pain from obesity-related knee arthritis and improves a person’s ability to engage in activities such as climbing stairs.

Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with MASH and fibrosis (scarring).

Eisai Co., Ltd.  and Biogen Inc. announced   that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.

Sobi (announced that new research showing the effect of emapalumab in patients with macrophage activation syndrome (MAS) in Still’s disease, including systemic juvenile idiopathic arthritis (sJIA) and adult-onset still’s disease (AOSD) who had an inadequate response to high-dose glucocorticoids (GCs) will be presented at the American College of Rheumatology (ACR) Convergence in Washington D.C.

NICE (UK): Danicopan (Voydeya) from Alexion/AstraZeneca, is recommended, as an add-on to ravulizumab or eculizumab as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults who have residual haemolytic anaemia, only if: they have clinically significant extravascular haemolysis while on treatment with a complement component 5 inhibitor (C5 inhibitor) and the company provides it according to the commercial arrangement.