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Sanofi is discontinuing the global clinical development program of tusamitamab ravtansine.

Coherus BioSciences, Inc., announced that the FDA approved Udenyca Onbody, the company's on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

Boston Scientific Corporation has initiated the AVANT GUARD clinical trial to evaluate the safety and effectiveness of the Farapluse Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation (AF), the only trial to study the use of PFA as frontline therapy in patients with this form of AF

Nobelpharma Co., Ltd. announced that Hyftor (sirolimus 2mg/g) has been launched in the EU/EEA countries and the United Kingdom for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and children aged 6 years and older

Mochida Pharmaceutical Co., Ltd. announced that Mochida filed an application for approval of an additional indication for Treprost Inhalation Solution 1.74mg (generic name: treprostinil; development code: MD-711) for pulmonary hypertension (PH) associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE), to the Japanese Ministry of Health, Labour and Welfare (MHLW)

Iovance Biotherapeutics, Inc. announced a clinical program update for LN 145 TIL therapy in non-small lung cancer (NSCLC). The FDA placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen

Cytokinetics, Incorporated announced positive topline results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase III clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM)

Bristol Myers Squibb and RayzeBio, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc., a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering the AstraZeneca cell therapy ambition

Amgen announced that the FDA has completed its review of the company's supplemental New Drug Application seeking full approval of Lumakras (sotorasib)

UCB, a global biopharmaceutical company, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Bimzelx (bimekizumab) for the treatment of adults with psoriatic arthritis (PsA), non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not sufficiently responding to existing treatments

Checkpoint Therapeutics, Inc. announced that the FDA has issued a complete response letter (“CRL”) for the cosibelimab biologic license application (“BLA”) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation.

Theseus Pharmaceuticals has agreed to be acquired by Concentra Biosciences for $3.90 to $4.05 a share in cash. The acquisition price includes a base price of $3.90 a share and an additional 15 cents per share at closing, plus a non-tradeable contingent value right.

Kite, a Gilead Company announced that the FDA has approved a label update for Yescarta (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase III ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care (SOC) as second-line treatment with curative intent for V(R/R LBCL) within 12 months of completion of first-line therapy.

The World Health Organization (WHO) announced that it has prequalified the R21/Matrix-M malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas.

Clene Inc., provided an ALS regulatory update from its recent meeting with the FDA.

Zealand Pharma A/S announced that the FDA has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to 3 weeks of dosing

Bristol Myers Squibb and Karuna Therapeutics, Inc. announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.

Cidara Therapeutics, Inc. announced Rezzayo (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

AlloVir, Inc. provided an update on its three Phase III clinical trials with posoleucel, an investigational off-the-shelf multi-virus-specific T cell therapy, which targets six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV).

BeiGene, Ltd. announced the FDA has approved a label update for Brukinsa (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase III ALPINE trial comparing Brukinsa against Imbruvica (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).

Daiichi Sankyo and Merck Inc., known as MSD outside of the United States and Canada, announced today that the FDA has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

Zealand Pharma A/S announced the submission of a New Drug Application (NDA) to the FDA for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS) dependent on parenteral support.

AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN

Sanofi is discontinuing the global clinical development program of tusamitamab ravtansine

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 lazertinib, in combination with Rbrevant (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations

DMK Pharmaceuticals Corporation announced that it is reacquiring the rights to its Symjepi (epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection 0.15mg products from USWM, LLC

DMK Pharmaceuticals Corporation announces that it has regained the full rights to commercialize Zimhi (naloxone) after the termination of an exclusive commercialization and distribution with US World Meds, LLC

Highly statistically significant and clinically meaningful topline results in second positive phase III clinical trial of TNX 102 SL for the management of fibromyalgia

Atara Biotherapeutics, Inc. announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel or Ebvallo)

Calliditas Therapeutics AB announced that the FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults

argenx SE announced topline results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF)

The FDA has approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD)

Merck Inc., known as MSD outside of the United States and Canada, announced the European Commission (EC) has approved a new indication for Keytruda Merck’s anti-PD-1 therapy in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults.

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new Biologics License Application (BLA) for V 116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults

Cara Therapeutics, Inc. announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD)

Ultragenyx Pharmaceutical Inc. announced that the European Commission (EC) has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH)

The FDA has approved eflornithine (Iwilfin, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy

Veoza (Veozah in the US), also known as fezolinetant, from Astellas, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) after receiving similar approval in the US back in May 2023

Johnson & Johnson announced the first data from the Phase III PERSEUS study highlighting significant clinical improvement with a Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM)

Eisai Co., Ltd. announced that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, “tasurgratinib”) for biliary tract cancer with FGFR2 gene fusion

Santhera Pharmaceuticals announces that Agamree (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status

Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk)

The Phase III IMROZ trial evaluating the investigational use of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM)

Pfizer increased the target for its cost-cutting program, revealing the additional spending cuts alongside a sales forecast for 2024 that disappointed Wall Street analysts and sent shares down to their lowest levels in more than a decade.

The Phase III trial investigating Sarclisa (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM) .

Bristol Myers Squibb announced that the Phase III RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee.

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has approved Keytruda Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024.

Arcutis Biotherapeutics, Inc. announced the FDA has approved the new drug application (NDA) for Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older.

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Velsipity, intended for the treatment of ulcerative colitis.

Moderna, Inc. announced the publication of positive Phase III clinical study results evaluating mRNA-1345, its vaccine candidate for respiratory syncytial virus (RSV), in The New England Journal of Medicine.

Vertex Pharmaceuticals Incorporated announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia.

Merck KGaA, a leading science and technology company, and the Pediatric Praziquantel Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in children aged 3 months to 6 years.

Biogen Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older. If approved by the European Commission (EC), Skyclarys will be the first treatment authorized within the European Union for this rare, genetic, progressive neuromuscular disease.

Glaukos Corporation announced the FDA approved its New Drug Application (NDA) for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG)

Esperion announced that the FDA has approved an updated LDL-cholesterol lowering indication for Nexletol and Nexlizet to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations .

Merck Inc.,known as MSD outside of the United States and Canada, announced that the FDA has approved Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2alpha) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)

Travere Therapeutics, Inc. announced the Company has opened enrollment in the HARMONY Study, a global, randomized pivotal Phase III clinical trial of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated for the treatment of classical homocystinuria (HCU)Travere Therapeutics, Inc. announced the Company has opened enrollment in the HARMONY Study, a global, randomized pivotal Phase III clinical trial of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated for the treatment of classical homocystinuria (HCU)

Moderna, Inc. and Merck Inc., known as MSD outside of the United States and Canada, announced follow-up data from the Phase IIb randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Keytruda, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection

Amgen announced that the FDA has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab

GSK plc announced the European Commission (EC) has granted marketing authorisation for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy), for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk

Medtronic plc announced that the FDA has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF)

Pharnext SA experiences the failure of its only late-stage asset PXT 3003 less than a month after claiming that three companies were vying to partner the potential therapy for Charcot-Marie-Tooth disease

Astellas Pharma Inc. announced the European Commission (EC) on December 7 approved Veoza (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause

Octapharma USA announced the expansion of the FDA approval for wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection

United Therapeutics Corporation and Miromatrix Medical Inc.announced a definitive agreement for United Therapeutics to acquire Miromatrix

Protagonist Therapeutics, Inc. announced details from five abstracts at the American Society of Hematology 2023 Annual Meeting, including an oral presentation with two-year follow up data from the Phase II REVIVE study with rusfertide, a mimetic of the natural hormone hepcidin with potential therapeutic value in the treatment of polycythemia vera (PV) and other disease indications

Blueprint Medicines Corporation has announced the European Commission has approved Ayvakyt (avapritinib) for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment

Vertex Pharmaceuticals Incorporated announced two oral presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition from the global pivotal trials of Casgevy (exagamglogene autotemcel [exa-cel])

Kite, a Gilead Company announced data from follow-up analyses of three studies of Yescarta (axicabtagene ciloleucel) that demonstrate the long-term survival potential for patients living with several sub-types of relapsed or refractory (R/R) non-Hodgkin lymphoma, which were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition

AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc., a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.

Eli Lilly and Company announced updated clinical data from the international Phase 1/II BRUIN trial of pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with a range of B-cell malignancies.

Merck Inc., known as MSD outside of the United States and Canada, and Moderna, Inc. announced the initiation of INTerpath-002, a pivotal Phase III randomized clinical trial evaluating V 940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC).

Regeneron Pharmaceuticals, Inc. announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase II trial (ELM-2) .

Detailed results from SURMOUNT-4, which showed Zepbound (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in The Journal of the American Medical Association (JAMA).

Actinium Pharmaceuticals, Inc. a leader in the development of targeted radiotherapies, announced that results from the Phase III SIERRA trial of Iomab-B were presented in an oral presentation at the 65th Annual American Society of Hematology Meeting & Exposition (ASH) .

Roche announced that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, 9-12 December 2023.

MorphoSys AG announced comprehensive results from the Phase III MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis.

Novartis announced positive topline results from the six-month, double-blind period of the Phase III APPEAR-C3G study of iptacopan for the treatment of patients with C3 glomerulopathy (C3G).

Positive results from the 24-week and long-term extension (LTE) period of the pivotal ALPHA Phase III trial showed danicopan as add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) continued to demonstrate clinical benefit for patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience clinically significant extravascular haemolysis (EVH).

Bristol Myers Squibb announced updated results from the primary analysis of the Phase III COMMANDS trial, comparing Reblozyl) (luspatercept-aamt versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes (MDS) (Oral Presentation #193) who may require red blood cell (RBC) transfusions.

Genentech, a member of the Roche Group announced that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra (emicizumab-kxwh) in previously untreated or minimally treated infants with severe hemophilia A without factor VIII inhibitors.

Genmab and AbbVie announced new data from the ongoing phase 1/II EPCORE NHL-1 clinical trial investigating epcoritamab (DuoBody CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) follicular lymphoma (FL).

bluebird bio, announced the details of its U.S. commercial infrastructure to support timely, equitable access to Lyfgenia (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs)

bluebird bio, Inc. announced the FDA has approved Lyfgenia (pronounced as ‘lif-JEN-ee-uh’) (lovotibeglogene autotemcel), also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs).

Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises. Casgevy is the first FDA-approved therapy utilizing CRISPR/Cas9, a type of genome editing technology. Patients’ hematopoietic (blood) stem cells are modified by genome editing using CRISPR/Cas9 technology.

Novartis announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali (ribociclib) treatment completion by 78.3% of patients

Merck Inc., known as MSD outside of the United States and Canada, and Eisai announced that the Phase III LEAP-001 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.

Vanda Pharmaceuticals Inc. announced that it has acquired U.S. and Canadian rights to Ponvory (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

Medtronic the world’s leading medical technology company announced it received CE (Conformité Européenne) Mark for its Percept RC neurostimulator for deep brain stimulation (DBS)

Bristol Myers Squibb announced the Phase III CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) met the dual primary endpoint of progression-free survival (PFS)

Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3)

Merck Inc., known as MSD outside of the United States and Canada, announced full results from the non-registrational Phase II KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (Keytruda), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy

AbbVie Inc. and Cerevel Therapeutics announced a definitive agreement under which AbbVie will acquire Cerevel Therapeutics and its robust neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson's disease (PD), and mood disorders

Bristol-Myers Squibb K.K. announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody

Seagen Inc. announced data from the Phase III HER2CLIMB-02 clinical trial of Tukysa (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla)

Bristol Myers Squibb announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase III CheckMate -901 trial

Overweight or obese adults lost more weight and shed pounds faster using Mounjaro than those taking Novo Nordisk's rival weight loss drug (Wegovy/Ozempic)) according to an analysis of health records and other data

Novavax, Inc. announced that Health Canada has granted expanded authorization for Nuvaxovid XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older

Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH])

Merck KGaA, a leading science and technology company, announced that its two Phase III EVOLUTION clinical trials (evolution RMS 1 and evolution RMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (Aubagio) (0.11 vs. 0.11 in evolution RMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolution RMS 2, p=NS in both trials)

Intra-Cellular Therapies, Inc. announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting

Eli Lilly and Company announced results from the MONARCH 3 clinical trial, which will be presented in a late-breaking presentation during the 2023 San Antonio Breast Cancer Symposium (SABCS)

Vanda Pharmaceuticals Inc. announced that the FDA has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis

Genentech, a member of the Roche Group announced positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer

Exelixis, Inc. announced the initiation of STELLAR-305, a phase II/III pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Merck KGaA, a leading science and technology company, announced a license agreement with Abbisko Therapeutics Co. Ltd, Shanghai, China, for pimicotinib (ABSK 021), which is currently being evaluated in a Phase III study for the treatment of tenosynovial giant cell tumor (TGCT)

Roche announced the entry into a definitive merger agreement to acquire Carmot Therapeutics, Inc., a privately owned US company based in Berkeley, California. Carmot’s R&D portfolio includes clinical stage subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes, as well as a number of preclinical programs

UCB announced that the European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive

The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.

Pfizer Inc. announced topline data from the Phase II clinical trial (NCT04707313) investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes.

Eli Lilly and Company announced that the FDA approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Galderma announced topline results from two phase IIIb trials investigating RelabotulinumtoxinA for the treatment of glabellar lines (GL – frown lines) and lateral canthal lines (LCL – crow’s feet)

Johnson & Johnson MedTech announced the completion of the acquisition of Laminar, Inc., a privately-held medical device company focused on eliminating the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib)

AbbVie Inc.and ImmunoGen, Inc. announced a definitive agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC)

Altimmune, Inc announced topline results from its 48-week MOMENTUM Phase II obesity trial of pemvidutide

Merck In.,known as MSD outside of the United States and Canada, announced that the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC)

AstraZeneca has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate)