4

Teva Pharmaceuticals and MedinCell announced that the FDA has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone.

Astellas Pharma and Pfizer Inc. announced that Xtandi (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (mfs), in men with non-metastatic hormone-sensitive prostate cancer (nmhspc; also known as non-metastatic castration-sensitive prostate cancer or nmcspc) with high-risk biochemical recurrence (bcr).

Arcutis Biotherapeutics, Inc. announced that its next-generation topical PDE4 inhibitor therapy for plaque psoriasis, Zoryve (roflumilast) cream 0.3%, has received regulatory approval from Health Canada. In Canada, Zorvye is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in individuals 12 years of age and older.

The FDA Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca and MSD’s Lynparza (olaparib) plus abiraterone and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) based on the PROpel Phase III trial.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Vertex Pharmaceuticals announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of Orkambi(lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 to less than 2 years old who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common form of the disease

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Jaypirca, intended for the treatment of relapsed or refractory mantle cell lymphoma (MCL)

Vertex Pharmaceuticals announced the FDA approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 2 through 5 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data

Amicus Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization of miglustat, the enzyme stabilizer component of AT-GAA

Pfizer Inc. announced that the FDA has approved Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar

Shanghai Junshi Biosciences announced that the pre-specified interim analysis of the RENOTORCH study (NCT04394975) has been completed

Taiho Pharmaceutical Co., Ltd. and its European subsidiary Taiho Oncology Europe GmbH announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization (CMA) of futibatinib (Lytgobi) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma(CCA) with a fibroblast growth factor receptor 2(FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy

GSK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion by consensus recommending approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older

CHMP recommends approval for Camzyos for the treatment of symptomatic obstructive hypertrophic cardiomyopathy

Seres Therapeutics, Inc. and Nestlé Health Science announced the FDA approval of Vowst (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI)

The full results from the pediatric expansion of Novavax’s Phase III PREVENT-19 trial were published in the Journal of the American Medical Association Network Open

Novan, Inc. and MC2 Therapeutics announced that results of a recently conducted survey to assess psoriasis patients’ topical treatment experience, expectations , and preferences have been published in the Journal of Drugs in Dermatology (JDD)

Eli Lilly and Company announced that tirzepatide (10 mg and 15 mg) achieved superior weight loss compared to placebo at 72 weeks of treatment in results from SURMOUNT-2

UCB, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending granting marketing authorization for bimekizumab in the European Union (EU) for the treatment of adults with active axial spondyloarthritis (axSpA) and for adults with active psoriatic arthritis (PsA)

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Cosentyx (secukinumab) in adults with active moderate to severe hidradenitis suppurativa (HS)

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi (glofitamab), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy

Biogen Inc. announced that the FDA has approved Qalsody (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene

Novartis announced detailed results from the Phase III APPOINT-PNH trial of investigational oral monotherapy iptacopan in complement-inhibitor-naïve (including anti-C5 therapies) adults with paroxysmal nocturnal hemoglobinuria (PNH)

Assertio Holdings, Inc., a specialty pharmaceutical company offering differentiated products to patients, and Spectrum Pharmaceuticals, Inc. a commercial stage biopharmaceutical company focused on novel and targeted oncology, have announced that they have entered into a definitive agreement pursuant to which Assertio will acquire all outstanding shares of Spectrum in an all-stock and contingent value rights (“CVR”) transaction

Prilenia Therapeutics announced preliminary topline results of its Phase III PROOF-HD clinical study evaluating the safety and efficacy of pridopidine in individuals with Huntington’s disease (HD)

Virios Therapeutics, Inc. a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia announced a program summary based on initial feedback from the FDA on its Phase III FM program proposal featuring its lead development candidate IMC-1

GSK announced that the European Medicines Agency (EMA) validated the Company’s Type II Variation for a potential new indication for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer

Daiichi Sankyo announced that the FDA has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive

Global biotechnology leader CSL Behring announced the FDA approved a 50mL/10gm prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid)

Shockwave Medical, Inc. a pioneer in the development of Intravascular Lithotripsy (“IVL”) to treat severely calcified cardiovascular disease,announced the completion of its previously announced acquisition of Neovasc Inc.

Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the FDA of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD)

Applied Therapeutics, Inc. announced results from the ACTION-Galactosemia Kids study of govorestat (AT-007), a novel, oral, small molecule, central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI)

bluebird bio, Inc. announced the submission of its Biologics License Application (BLA) to the FDA for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs)

MaaT Pharma a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to improving survival outcomes for patients with cancer, reported that the FDA has lifted the clinical hold and cleared the Investigational New Drug (IND) application to initiate in the U.S. an open-label, single arm Phase III pivotal clinical trial evaluating the safety and efficacy of MaaT 013 to treat gastrointestinal acute Graft-versus-Host Disease (aGvHD) as a third line of treatment

In an effort to continue expanding the availability of Baqsimi to patients, Eli Lilly and Company and Amphastar Pharmaceuticals, Inc. have entered into a definitive agreement for Lilly to divest Baqsimi worldwide to Amphastar, a global pharmaceutical company focused on developing, manufacturing, and marketing injectable, intranasal, and inhalation products including experience with a glucagon product.

AbbVie announced positive data from its Phase III ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications.

GenSight Biologics announces that the Committee for Advanced Therapies (CAT) of the Committee Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) assessed the data presented during the oral explanation on Lumevoq European regulatory dossier.

Medtronic plc announced FDA approval of its MiniMed 780G system with the Guardian 4 sensor requiring no fingersticks while in SmartGuard technology.

CymaBay Therapeutics announced that results from the ENHANCE phase III global study evaluating MBX 8025 (seladelpar) for primary biliary cholangitis (PBC) have been published in Hepatology.

Veru Inc., a biopharmaceutical company focused on developing novel medicines for oncology and SARS-CoV-2 and other viral ARDS-related diseases, announced the sale of its Entadfi (finasteride and tadalafil) capsules business for benign prostatic hyperplasia (BPH) to Blue Water Vaccines, Inc. for $20 million and up to an additional $80 million from sales milestones

Dermata Therapeutics, Inc. announced that it has received a response from the FDA to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request

The FDA has approved IntelGenx/Gensco's rizatriptan benzoate (Rizafilm VersaFilm) oral thin film for acute migraine treatment through the 505(b)(2) new drug application (NDA) pathway

Visus Therapeutics reported positive topline results from its Phase III pivotal BRIO-I trial for the treatment of Presbyopia. BRIO-I met the pre-specified primary study endpoints agreed upon with the US-FDA and EMA/MHRA, demonstrating contribution of elements for the once-daily, fixed-dose combination, brimochol PF, over both active comparators carbachol and brimonidine monotherapies. Brimochol PF demonstrated highly statistically significant improvements in near and distance binocular visual acuity at multiple timepoints over carbachol and brimonidine

Incyte announced that the European Commission (EC) has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age

Taiho Pharmaceutical Co., Ltd. and Taiho Oncology, Inc. announced that the FDA has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (Lonsurf) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy

BeiGene announced the global RATIONALE 305 trial met its primary endpoint of overall survival, with tislelizumab in combination with chemotherapy demonstrating superior overall survival (OS) compared with chemotherapy in patients with advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status. No new safety signals were identified for tislelizumab

Genentech, a member of the Roche Group announced that the FDA has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater

Amgen announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the District of New Jersey in a patent infringement lawsuit against Sandoz Inc. and Zydus Pharmaceuticals (USA), Inc. This decision affirms the permanent injunction entered by the district court prohibiting Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until February 2028

Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability worsening events and low brain volume change versus those who started on teriflunomide and were later switched to Kesimpta

Alkermes plc announced that it has submitted a confidential draft Form 10 registration statement to the United States Securities and Exchange Commission in connection with the previously announced planned separation of the company's oncology business into an independent, publicly-traded company (Oncology Co.)

GSK plc and Bellus Health Inc announced that they have entered into an agreement under which GSK will acquire Bellus, a Canada-based, late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity value of US$2.0 billion (£1.6 billion)

Otsuka Pharmaceutical/Lundbeck’s atypical antipsychotic Rexulti (brexpiprazole) has secured the recommendation of two FDA advisory committees - the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee which at their joint meeting voted 9-1 that Otsuka and Lundbeck provided sufficient data to identify an AAD population in whom the benefits of the drug outweigh its risks for its label expansion

Gamida Cell announced that the FDA has approved Gamida Cell’s allogeneic cell therapy, Omisirge (omidubicel-onlv), for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection

AbbVie/Allergan announced that the FDA has approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine

Arcutis Biotherapeutics, Inc. announced the FDA has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older

Health Canada has granted Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) a marketing authorisation for the treatment of cystic fibrosis (CF) for children ages between one and two

Takeda announced that the FDA has approved a supplemental biologics license application (sBLA) to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years old

Merck Inc., known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire Prometheus for $200.00 per share in cash for a total equity value of approximately $10.8 billion

AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent

Merck Inc., known as MSD outside of the United States and Canada, announced results from the Phase III KEYNOTE-966 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC)

Positive results from the AEGEAN Phase III trial showed that treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery led to a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC)

Genentech, a member of the Roche Group announced new data from the Phase III IMbrave050 study that show Tecentriq (atezolizumab) plus Avastin (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent

GSK presented positive results from the pivotal EAGLE-2 and EAGLE-3 phase III trials for GSK 2140944 (gepotidacin), an investigational, first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urinary tract infections (uUTI) in female adults and adolescents.

Astellas Pharma announced that The Lancet published detailed data from the Phase III SPOTLIGHT trial evaluating first-line treatment with IMAB 362 (zolbetuximab) an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Horizon Therapeutics plc announced that the FDA has approved an update to the Indications and Usage section of the Tepezza label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.”

Soligenix, Inc. announced that the Company convened a Type A Meeting with the FDA.

Alvotech , announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira (adalimumab).

Biogen Inc. and Denali Therapeutics Inc. announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Abeta). Accumulation of Abeta plaque in the brain is a defining feature of Alzheimer’s disease (AD)

Sarepta Therapeutics, Inc. the leader in precision genetic medicine for rare diseases, announced that the date of the FDA' s Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA) is May 12, 2023

Eli Lilly and Company announced the FDA has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC)

InflaRx N.V. a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the FDA for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)

Merck Inc announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

Aldeyra Therapeutics, Inc. announced completion of enrollment in the Phase III INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis

Merck KGaA, announced the FDA has placed a partial clinical hold on the initiation of new patients on evobrutinib and patients with less than 70 days exposure to study medication in the U.S. The ongoing, fully-enrolled Phase III EVOLUTION clinical trial program of evobrutinib in relapsing multiple sclerosis (RMS) will continue as planned with all participants remaining on treatment as all are beyond 70 days exposure to study medication

Tonix Pharmaceuticals Holding Corp. announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase III RESILIENT study of TNX 102 SL for fibromyalgia and its Phase II PREVENTION study of TNX 1900 for chronic migraine

Novaliq announced that results from the second pivotal Phase III ESSENCE-2 trial for CyclASol (cyclosporine 0.05 in SFA) have been published in Journal of the American Medical Association (JAMA) Ophthalmology

Shanghai Junshi Biosciences announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical FLAMES Study (NCT04169997) investigating the poly (ADP-ribose) polymerase PARP inhibitor JS 109 (senaparib) had finished its pre-specified interim analysis

Bemnifosbuvir for COVID-19 from Atea Pharma: Poster Number: P2629; Date/Time: Monday, April 17, 2023,12:00 pm CET Title: Bemnifosbuvir (AT-527) Treatment of Non-Hospitalized Individuals with Mild to Moderate COVID-19: Results from a Truncated Phase III, Randomized, Double-Blind, Placebo-Controlled Trial (MORNINGSKY)

Pear Therapeutics, Inc. a company focused on developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), announced that the Company and its wholly owned subsidiary, Pear Therapeutics (US), Inc. (collectively, the “Debtors”) each voluntarily filed for protection under chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware and they intend to pursue a sale of the business or assets under section 363 of the Bankruptcy Code

-The Janssen Pharmaceutical Companies of Johnson & Johnson announced the availability of an additional tablet strength of Erleada (apalutamide) in the United States

Horizon Therapeutics announced positive and statistically significant topline results from its randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) evaluating Tepezza (teprotumumab) for the treatment of adults with Thyroid Eye Disease (TED) and low Clinical Activity Score (CAS), which is a measure of disease activity

Altamira Therapeutics reported highlights from a peer reviewed article showing efficacy of oral betahistine in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV) when administered along with a canal repositioning procedure, the Epley maneuver

Mallinckrodt plc announced that two scientific abstracts on the clinical and health economic outcomes of treatment with Terlivaz (terlipressin) for adult patients with hepatorenal syndrome (HRS) will be presented at the National Kidney Foundation (NKF) 2023 Spring Clinical Meeting (SCM) in Austin, TX taking place April 11 – 15, 2023

Takeda Pharmaceutical Company Limited announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of Entyvio Pens for subcutaneous (SC) injection 108 mg / Syringes for SC injection 108 mg (generic name: vedolizumab (Genetical Recombination), development code: MLN0002SC, hereinafter called “Entyvio SC”) as maintenance therapy for moderate to severe ulcerative colitis

Wegovy (semaglutide once weekly injection),from Novo Nordisk, a GLP-1 receptor agonist that contains the same API as the diabetes treatments Ozempic (injection) and Rybelsus (tablet)

Sobi announced a streamlining and simplification of the contractual economics for nirsevimab

The FDA had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment appeared on the market.

Clovis Oncology (in bankrupcy) has agreed to sell its approved cancer drug Rubraca to a privately held Austrian company as part of an auction associated with its ongoing bankruptcy proceedings.

JCR Pharmaceuticals Co., Ltd and Sumitomo Pharma Co., Ltd. announced that they have concluded a co-promotion agreement for Izcargo I.V. Infusion 10 mg (hereinafter, “the Product”) in Japan.

AbbVie announced the intent to voluntarily withdraw, in the U.S., accelerated Imbruvica (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

Merck Inc and Eisai provided updates on the Phase III LEAP-017 trial investigating Keytruda (pembrolizumab) injection, 100 mg, Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

Merck Inc and Eisai provided an update on the Phase III LEAP-003 trial investigating Keytruda (pembrolizumab) anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

Moderna, Inc , and Merck Inc., known as MSD outside of the United States and Canada, announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.

Incyte announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion (also known as 8p11 myeloproliferative syndrome)

Health Canada has approved the fixed-duration, all-oral combination of ibrutinib (Imbruvica) and venetoclax (Venclexta) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion

Pfizer Inc. announced that the FDA has accepted for review the Supplemental New Drug Applications (sNDAs) for Braftovi (encorafenib) + Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs

Two studies, published in The Lancet and The Lancet Haematology, evaluating the efficacy and safety of fitusiran, an investigational siRNA therapy for the prophylactic treatment of adults and adolescents with hemophilia A or B, reinforce the potential of this investigational therapy to transform the current standard of care and address unmet needs for all types of hemophilia, regardless of inhibitor status

GSK plc and Scynexis Inc. announced they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC)

Positive high-level results from a planned interim analysis of the DUO-O Phase III trial showed treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations

Ascendis Pharma A/S announced that the FDA has notified the Company that, as part of their ongoing review, the FDA has identified deficiencies in the Company’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in hypoparathyroidism that at this time precludes them from holding further discussions about labeling and post-marketing requirements/commitments

Baxter International Inc. announced the U.S. launch of Zosyn (piperacillin and tazobactam) Injection. Zosyn premix is indicated for the treatment of multiple infections caused by susceptible bacteria and is available in Baxter’s proprietary single-dose Galaxy containers

Amicus Therapeutics, a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, announced that the European Commission (EC) has granted approval for Pombiliti (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD)

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) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy

Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz (adalimumab)

Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced the completion of the rolling Biologics License Applications (BLAs) to the FDA for the investigational treatment exagamglogene autotemcel (exa-cel) for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)

Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+)

Medtronic plc and DaVita Inc. announced the launch of Mozarc Medical —an independent new company committed to reshaping kidney health and driving patient-centered technology solutions."Mozarc Medical's focus will be on meaningful and innovative kidney health technologies that improve the overall patient experience and increase access to care globally," said Ven Manda, CEO of Mozarc Medical.

Cytokinetics, Incorporated announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), recently convened to conduct the second planned interim analysis of this Phase III clinical trial.

The Janssen Pharmaceutical Companies of Johnson & Johnson disclosed that following a review of its portfolio to prioritize the most transformational assets for ongoing investment, and an assessment of the respiratory syncytial virus (RSV) vaccine landscape, the Company will exit its investigational RSV adult vaccine program and discontinue its Phase III EVERGREEN study.

Merck KGaA announced it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody Bavencio (avelumab) following the termination of their Alliance agreement with Pfizer.

Travere Therapeutics announced publication in The Lancet of the interim analysis of efficacy and safety data from the ongoing pivotal, Phase III PROTECT Study evaluating Filspari (sparsentan) in adults with IgA nephropathy (IgAN). The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pedmarqsi (sodium thiosulfate) from Fennec Pharmaceuticals, intended for the prevention of ototoxicity induced by cisplatin chemotherapy in children with solid tumours.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Omvoh (mirikizumab) from Eli Lilly for ulcerative colitis.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Briumvi, intended for the treatment of multiple sclerosis. The applicant for this medicinal product is Propharma Group The Netherlands B.V.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Wegovy (semaglutide once weekly injection) from Novo Nordisk for obesity.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ultomiris (ravulizumab) from Alexion Europe SAS.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tenkasi (oritavancin) from Menarini International Operations Luxembourg S.A.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epysqli (eculizumab), from Samsung Bioepis, intended for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria (PNH).

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Entresto (sacubitril/valsartan) for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in pediatric patients aged from 1 to less than 18 years.

Eisai Co.,Ltd. and Biogen Inc.announced that three additional detailed analyses from the Phase IIb clinical study