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LivaNova PLC , a market-leading medical technology company, announced it received FDA 510(k) clearance and CE Mark for its Essenz In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures

BioMarin Pharmaceutical Inc. announced that an individual in Germany with severe hemophilia A was treated with Roctavian (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has been given commercially in Europe

Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history

Outlook Therapeutics, Inc. announced the FDA has issued a CRL to the Company’s BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD

Northwest Biotherapeutics a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announces that it plans to submit a Marketing Authorization Application (MAA) in the U.K., to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the FDA), for commercial approval of the Company’s DCVax -L treatment for glioblastoma.

FibroGen, Inc. announced topline data from the Phase III LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids.

Zealand Pharma A/S announced that the FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to 3 weeks of dosing. The regulatory review will be conducted in two parts under the same NDA.

Roche announced that Tecentriq SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. It will be provided by the National Health Service (NHS) England.

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1).

Neurocrine Biosciences, Inc. presented findings from a data analysis of KINECT-4 demonstrating a comparable pattern of improvement over time of clinician-rated tardive dyskinesia (TD) severity and awareness/distress as measured by the Abnormal Involuntary Movement Scale (AIMS) and patient-reported TD impact as measured by the Trajectories of Tardive Dyskinesia Impact Scale (TDIS).

Bristol Myers Squibb announced that the FDA has approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months.

Bristol Myers Squibb announced new long-term follow-up results from two Phase III studies evaluating Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Novocure announced that the phase III ENGOT-ov50 / GOG-3029 / INNOVATE-3 clinical trial of Tumor Treating Fields (TTFields) together with paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of overall survival (OS) at the final analysis. Patients randomized to receive TTFields therapy plus paclitaxel (n=280) demonstrated a median OS of 12.2 months versus a median OS of 11.9 months in patients treated with paclitaxel alone (n=278) (HR: 1.008). Consistent with previously reported studies, TTFields therapy was well-tolerated with no added systemic toxicities.

Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials.

Mallinckrodt plc announced that it has taken the next step to implement the comprehensive financial restructuring plan contemplated by a Restructuring Support Agreement ("RSA") the Company previously entered into with more than 85% of each of the Company's first and second lien debtholders and the Opioid Master Disbursement Trust II (the "Trust"), as announced on August 23, 2023.

Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as non-metastatic hormone-sensitive prostate cancer or nmHSPC) with high-risk biochemical recurrence (BCR).

Eisai’s lecanemab gained the recommendation of the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) First Committee on Drugs on August 21, setting the stage for its regulatory approval soon as Japan’s first Alzheimer’s disease (AD)-modifying therapy.

Boston Scientific Corporation announced positive 12-month results from the pivotal ADVENT clinical trial of the Farapulse Pulsed Field Ablation (PFA) System, a nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).

Bayer will support the initiation of three additional studies to extend its heart failure (HF) program with finerenone (MOONRAKER program).

American Regent/Daiichi Sankyo announced results from the phase III HEART-FID trial of Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).

Daiichi Sankyo Europe announced results from two prespecified analyses of Nexletol (bempedoic acid) from the Phase III CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking the expanded approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Amgen announced data from the final analysis of the Phase II OCEAN(a)-DOSE study of olpasiran, a small interfering RNA (siRNA) during the Late-Breaking Science Session at the European Society of Cardiology (ESC) Annual Meeting being held in Amsterdam.

Novo Nordisk announced results from the phase III STEP HFpEF trial showing that compared with placebo, once-weekly semaglutide 2.4 mg led to large reductions in heart failure-related symptoms, physical limitations and improvements in exercise function, and resulted in greater weight loss in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.

Merck Inc,. known as MSD outside of the United States and Canada, and Eisai, provided an update on the Phase III LEAP-010 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1

The Bristol Myers Squibb-Pfizer Alliance presented results from ATHENS, a retrospective real-world data study, at the European Society of Cardiology(ESC) Congress 2023 showing that switching from Eliquis (apixaban) to rivaroxaban in Non-Valvular Atrial Fibrillation (NVAF) patients was associated with a higher risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those who continued Eliquis.

Merck Inc., known as MSD outside of the United States and Canada, announced the initiation of the company’s Phase III clinical program, CORALreef, for MK 0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults with hypercholesterolemia

Medtronic plc has received CE (Conformité Européenne) Mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a closed-loop feature that senses each person's unique biological signals and adjusts stimulation moment to moment, as needed, to keep therapy in harmony with the motions of daily life.

Kyowa Kirin Co., Ltd. announces that the company has received approval from the Ministry of Health, Labour and Welfare (“MHLW”) for partial change of approved indication of Lumicef [KHK4827, generic name: brodalumab (genetical recombination)]for the treatment of palmoplantar pustulosis that respond inadequately to existing therapies.

Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment

Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics

Amneal Pharmaceuticals announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX 203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD)

GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over

Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults

Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. announce the FDA Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension

Exelixis, Inc. announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board (DSMB) unanimously recommended to unblind and stop the phase III CABINET pivotal trial early due to a dramatic improvement in efficacy that was observed at an interim analysis

Mallinckrodt plc, a global specialty pharmaceutical company, announced it has entered into a Restructuring Support Agreement ("RSA") with a substantial majority of each of the Company's first and second lien debtholders and the Opioid Master Disbursement Trust II (the "Trust") on the terms of a comprehensive financial restructuring plan that will reduce the Company's total funded debt by approximately $1.9 billion, increase free cash flow generation, extend maturity runway and better position the business for long-term success

Medtronic announced the outcome of the FDA Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral Renal Denervation (RDN) System

Soliris (eculizumab) from AstraZeneca has been approved in Japan for expanded use to include the treatment of generalised myasthenia gravis (gMG) in paediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX)

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC)

Apellis Pharmaceuticals, Inc. provided an update on injection kits supplied by Apellis and an update on the rare events of retinal vasculitis reported in real-world treatment with Synfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Geron Corporation announced that the FDA has assigned a standard review and a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS)

Roche announced that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC)

Eli Lilly and Company announced topline results from the LIBRETTO-531 study evaluating Retevmo versus physician's choice of the multikinase inhibitors (MKIs) cabozantinib (Cabometyx) or vandetanib (Caprelsa) as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC)

Amicus Therapeutics , announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted marketing authorizations for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for adults living with late-onset Pompe disease (acid ?-glucosidase [GAA] deficiency)

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection, based upon results from the CheckMate -76K trial

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted conditional marketing authorisation (CMA) of Talvey (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy

Pfizer Inc. announced that the FDA has approved Abrysvo (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD (lower respiratory tract disease) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age

Leo Pharma announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. Upon closing, this transaction will add an attractive late-stage asset to Leo Pharma’s pipeline in medical dermatology

Amgen announced the FDA Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of Lumakras (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) at a meeting on October. 5, 2023

Leo Pharma A/S announces that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE)

Astellas Pharma announced that European regulatory authorities have accepted for review a marketing authorization application for avacincaptad pegol for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Exelixis, Inc. and Ipsen announced that the global phase III CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis

Health Canada has granted approval for GSK’s Arexvy vaccine to prevent respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) in people aged 60 years and above. A recombinant, AS01E-adjuvanted RSV vaccine, Arexvy is the first to obtain approval for use in older adults in the country.

Regeneron Pharmaceuticals, Inc. announced the FDA has approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE.

Neurocrine Biosciences, Inc. announced the FDA has approved Ingrezza (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).

Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).

According to a new recommendation from NICE, Pombiliti (cipaglucosidase alfa (CIPA) plus miglustat) from Amicus Therapeutics is recommended, within its marketing authorisation, as an option for treating late-onset Pompe disease in adults.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab) in multiple myeloma, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.

Takeda has filed a new drug application for ADAMTS-13 (TAK-755) in Japan for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP). The submission, is supported by interim analysis data from a global pivotal PIII trial (281102) including Japanese cTTP patients as well as its follow-up study (TAK-755-3002).

Merck, known as MSD outside of the United States and Canada, announced topline results from LITESPARK-005, the first positive Phase III trial investigating Welireg, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2?) inhibitor.

Revance Therapeutics, Inc. announced that the FDA has approved the first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults.

Gilead Sciences, Inc.and Tentarix Biotherapeutics announced that the companies established three multi-year collaborations leveraging Tentarix’s proprietary Tentacles platform to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases

Moderna, Inc. announced that preliminary clinical trial data confirm its updated COVID-19 vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants

Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF

AbbVie announced that the European Commission has approved Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month

Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies

Innovent Biologics announces that China's National Medical Products Administration (NMPA) has approved Sintbilo (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia

Precision BioSciences, Inc. a clinical stage gene editing company developing ARCUS -based in vivo gene editing therapies, announced completion of a strategic transaction with Imugene Limited for global rights to Azercabtagene Zapreleucel (azer-cel), Precision’s lead allogeneic CAR T candidate, for cancer

The first implant in Europe of Biotroniks latest pacemaker and CRT-P generation was conducted in early August by Prof. Dr. Jan De Pooter at the University Hospital Ghent in Belgium

Boehringer Ingelheim announced it will advance survodutide, its glucagon/GLP-1 receptor dual agonist, into three registrational Phase III studies for people living with overweight or obesity.

Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Ipsen announced approval by the FDA of Sohonos (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP)

Valneva SE a specialty vaccine company, announced that the FDA has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA 1553, Valneva’s chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November

bluebird bio, Inc. announced that the FDA has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel).

Bristol Myers Squibb announced updated results from the registrational TRIDENT-1 study, demonstrating that repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor (TKI), continued to show high response rates and durable responses in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)

Harmony Biosciences Holdings, Inc. a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, announced a definitive agreement to acquire Zynerba Pharmaceuticals, Inc., a leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, including Fragile X syndrome (FXS)

CNS Pharmaceuticals, Inc. announced the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference, held August 10-12, 2023 in San Francisco, CA. The poster, titled, "A randomized, controlled trial of Berubicin, a topoisomerase II poison that appears to cross the blood-brain barrier (BBB), after first-line therapy for glioblastoma multiforme (GBM): Preliminary Results," was presented by Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals

Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that the FDA approved Hepzato Kit (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation

Sandoz, a global leader in off-patent medicines, releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need

The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Akeega (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test

Novo Nordisk A/S and Inversago Pharma announced that Novo Nordisk has agreed to acquire Inversago for up to 1.075 billion US dollars in cash if certain development and commercial milestones are achieved. Inversago Pharma is a private, Montreal-based developer of CB1 receptor-based therapies for the potential treatment of obesity, diabetes and complications associated with metabolic disorders.

Arcutis Biotherapeutics, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam).

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Bayer announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). The data reinforce sustained vision gains with unprecedented extended treatment intervals of aflibercept 8 mg reaching up to 24 weeks with efficacy and safety comparable to the current standard of care Eylea (aflibercept 2 mg) with fixed intervals of 8 weeks.

Regeneron Pharmaceuticals, Inc. and Decibel Therapeutics, Inc. a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, announced a definitive agreement for the acquisition of Decibel by Regeneron at a price of $4.00 per share of Decibel common stock payable in cash at closing, with an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods

Galera Therapeutics, Inc. announced that it has received a Complete Response Letter (CRL) from the FDA regarding the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment

Boston Scientific Corporation announced it has received FDA approval for the POLARx Cryoablation System

Bristol Myers Squibb has launched Clear Understanding, a campaign featuring patients living with moderate to severe plaque psoriasis who are sharing what it’s really like for them to live with the disease — from dealing with symptoms to navigating relationships with friends, family or co-workers to dispelling misconceptions about the condition

Novartis announced positive top-line results from the Phase III REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg b.i.d., a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines

Novo Nordisk announced the headline results from the SELECT cardiovascular outcomes trial

Vistagen announced positive top-line results from its Phase III PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH 94B) nasal spray in adults diagnosed with social anxiety disorder (SAD)

Marinus Pharmaceuticals, Inc. announced that the European Commission (EC) has granted approval of Ztamly (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age

Bavarian Nordic A/S announced positive topline results from a randomized, double-blind, placebo-controlled Phase III clinical trial (NCT05072080) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age

Gilead Sciences’ long-acting antiviral Sunlenca (lenacapavir) has secured Japanese regulatory approval for patients with multi-drug-resistant HIV and has obtained the approval for fast-track reimbursement listing, scheduled for August 9

Astellas Pharma Inc announced the FDA approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. Izervay, a new complement C5 inhibitor, is the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of ga progression at the 12-month primary endpoint across two phase iii clinical trials

The supplemental New Drug Application (NDA) for full approval of Lumakras from Amgen, for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) was accepted by the FDA for standard review, and a Prescription Drug User Fee Act (PDUFA) target action date of December 24, 2023 has been set.

The global Phase III CodeBreaK 300 study evaluating Lumakras combined with Vectibix vs current standard of care in chemo-refractory metastatic KRAS G12C mutated colorectal cancer (CRC) met its primary endpoint of progression-free survival (PFS) for both the 240 mg and 960 mg doses of Lumakras. At comparable doses, efficacy results were consistent with what was observed in CodeBreaK 101 with no new safety signals.

Abbott is initiating a US market withdrawal for the Trifecta family of valves and will be removing the limited remaining inventory from the field. On February 27, 2023, Abbott and the US FDA communicated the potential for early Structural Valve Deterioration (SVD) and provided patient management considerations for those patients implanted with the Trifecta and Trifecta GT valves. The assessment of incidence and risk associated with early SVD has not changed since the February communication.

Mesoblast Limited announced that the FDA has provided a complete response to its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more data to support marketing approval.

Galapagos revealed that it is weighing up all options for its only approved product, the JAK inhibitor Jyseleca. Galapagos has disclosed its financials for the first half 2023 which show that Jyseleca (filgotinib), approved in Europe for rheumatoid arthritis and ulcerative colitis, reached €54.3 million in sales, up by 54% on the like, year-earlier period but below consensus estimates.

Sage Therapeutics, Inc .and Biogen Inc. announced the FDA approved Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.

Eli Lilly and Company announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection (RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC) .

PharmaEssentia USA Corp announced the publication of a cost-effectiveness analysis of Besremi (ropeginterferon alfa-2b-njft) in the Journal of Comparative Effectiveness Research.

On 26 May 2023, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the conditional marketing authorization (MA) for crizanlizumab. On 3 August 2023, the European Commission endorsed the CHMP's recommendation, issuing a legally binding decision directly impacting all 27 European Union (EU) countries, as well as Iceland, Norway and Liechtenstein (as members of the European Economic Area), and Northern Ireland (which is following EU/EEA centralized procedures until January 2025).

Merck Inc announced that the FDA has approved an expanded indication for Ervebo, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. The vaccine was previously approved for use in individuals 18 years of age and older. Ervebo does not protect against other species of Ebolavirus or Marburgvirus and the duration of protection conferred by Ervebo is unknown.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease for newborns and infants below 8 months of age born during or entering their first RSV season.

Taiho Oncology and Taiho Pharmaceutical announced that the FDA has approved Lonsurf (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

Orchard Therapeutics has completed the rolling submission of its Biologics License Application (BLA) to the FDA for OTL 200 (atidarsagene autotemcel), in children with early-onset metachromatic leukodystrophy (MLD).

Vertex Pharmaceuticals Incorporated announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase II proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX 548 for acute pain following abdominoplasty and bunionectomy surgeries.

Apellis Pharmaceuticals, Inc. provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Aravive, Inc. announced that its Phase III AXLerate-OC trial evaluating the safety and efficacy of batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre-specified subset of patients naïve to prior bevacizumab treatment

Taiho Pharmaceutical announced that its partner Servier, has won European regulatory approval for Lonsurf (trifluridine + tipiracil) in combination with bevacizumab for the third-line treatment of metastatic colorectal cancer (mCRC)

The Medicines and Healthcare products Regulatory Agency (MRHA) has authorised HIPRA Human Health’s COVID-19 vaccine, Bimervax, after it met the regulator’s required safety, quality and effectiveness standards

Sumitomo Pharma Co., Ltd. and Otsuka Pharmaceutical Co., Ltd. announced that the DIAMOND (Developing Innovative Approaches for Mental Disorders) 1 clinical study and the DIAMOND 2 clinical study of ulotaront (generic name; development code: SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, dosed once-daily in acutely psychotic adults living with schizophrenia did not meet their primary endpoint

AbbVie announced that Health Canada approved Rinvoq (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]), an oral, once-daily selective and reversible JAK inhibitor, for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional, and/or biologic therapy

Health Canada has authorized the use of maralixibat oral solution (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), as recently announced by Mirum Pharmaceuticals

The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company have announced

Teleflex Incorporated a leading global provider of medical technologies announced the FDA has cleared the QuikClot Control+ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy

scPharmaceuticals Inc. a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs announced that the Company has received positive Type C meeting feedback from the FDA regarding the potential expansion of the Furoscix indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients

GSK plc announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H)

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, announced the publication of its Phase III CARES 310 study results in The Lancet