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Biogen Inc. announced that the FDA has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra

Regeneron Pharmaceuticals, Inc. announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) 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. The target action date for the FDA decision is March 31, 2024

Horizon Therapeutics plc announced new data showing that disrupting the recommended Tepezza treatment regimen by lengthening the amount of time between infusions can increase the need for a second course of treatment

Novartis announced that it has completed its divestment of ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, consisting of $1.75 billion in upfront cash plus potential additional milestone payments

Karuna Therapeutics, Inc. a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, announced the submission of a New Drug Application (NDA) to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has accepted for priority review a new Biologics License Application (BLA) for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1)

BrainStorm Cell Therapeutics Inc. announced the outcome of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS)

Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) for ages 6 months and older

ImmunoGen Inc. announced findings from two subset analyses of the Phase III confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FR alpha)-positive platinum-resistant ovarian cancer (PROC)

Ocuphire Pharma, Inc. and Viatris Inc. announced that the FDA has approved Ryzumvi (phentolamine ophthalmic solution) 0.75% (formerly Nyxol) for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents

Ionis Pharmaceuticals, Inc. announced positive topline results for the Phase III Balance study of olezarsen in people with familial chylomicronemia syndrome (FCS)

Verona Pharma plc announces the FDA has accepted for review the Company’s New Drug Application (“NDA”) seeking approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”)

Soleno Therapeutics, Inc. announced positive top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS)

Alfasigma S.p.A , one of Italy's leading pharmaceutical companies, and Intercept Pharmaceuticals, Inc., a leading biopharmaceutical company in rare and serious liver diseases, announced that they have entered into a definitive merger agreement under which Alfasigma has agreed to acquire Intercept for $19.00 per share in cash

Appili Therapeutics Inc. announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals , LLC received approval from the FDA for Metronidazole Oral Suspension 500mg/5mL (ATI 1501)

Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Phesgo combination for Subcutaneous Injection MA, IN [generic name: pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) ] (hereafter, Phesgo), antineoplastic agent / anti-HER2 humanized monoclonal antibody for the treatment of “HER2-positive breast cancer” and “Advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.”

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above

argenx SE announced that Health Canada has issued a Notice of Compliance authorizing Vyvgart (efgartigimod alfa) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. With this regulatory milestone, Vyvgart is the first- and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada

The Menarini Group and Stemline Therapeutics Inc. a wholly-owned subsidiary of the Menarini Group, announced that the European Commission has approved Orserdu (elacestrant) as a monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor

Veru Inc. announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase III clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS

Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved Epkinly (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy

Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE)

Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by Polpharma Biologics. The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Tysabri (natalizumab)

Alzheon, Inc., announced statistically significant and clinically relevant reduction in plasma biomarkers of neurodegeneration, preservation of brain volume, and positive cognitive effects in Early AD patients who are carriers of apolipoprotein e4 allele (APOE4) following 24 months of treatment with investigational agent ALZ 801 in the Phase II biomarker trial

UCB announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Rystiggo (rozanolixizumab) and for Zilbrysq (zilucoplan), for the treatment of generalized myasthenia gravis (gMG) in adult patients (only for patients who inadequately respond to steroids or other immunosuppressants)

Medtronic plc announced CE (Conformité Européenne) Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process

Arcutis Biotherapeutics, Inc. announced the launch of an educational campaign designed to elevate understanding, connection, and encouragement for those living with seborrheic dermatitis, or Seb Derm for short

Alvotech announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. has received marketing approval for AVT 04 (ustekinumab), a biosimilar to Stelara , from the Japanese Ministry of Health, Labor and Welfare

New data presented in Milan at the European Respiratory Society (ERS) International Congress demonstrated that Xenpozyme (olipudase alfa) significantly improved pulmonary function in adults with Acid Sphingomyelinase Deficiency (ASMD)- Niemann Pick disease), providing positive disease modification across four critical domains of interstitial lung disease – a group of disorders that can progressively scar lung tissue and eventually affect a person’s ability to breathe

Novartis confirmed plans for the 100% spin-off of the Sandoz business, with trading of new Sandoz Group AG shares and ADRs (American Depositary Receipts) to commence on October 4, 2023

Bayer and Hologic, Inc., announced an international partnership to deliver contrast-enhanced-mammography (CEM) solutions to improve the detection of breast cancer in multiple countries across Canada, the European and Asia Pacific regions

The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)

Novartis has announced the Phase III NETTER-2 trial with Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) met its primary endpoint

Eisai Co., Ltd. and Biogen Inc. announced that humanized anti- soluble aggregated amyloid-beta (Abeta) monoclonal antibody Leqembi Intravenous Infusion (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD)

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced the first cases with its investigational Omnypulse Catheter as part of the Omny-IRE clinical trial

An FDA advisory committee voted unanimously to reject an appeal for Intarcia Therapeutics’ Type 2 diabetes drug-device combination treatment, citing continued safety concerns

United Therapeutics Corporation announced the achievement of two milestones for its xenotransplantation programs in September: the second transplant of a UHeart xenoheart into a living person, and a 61-day study of the UThymoKidney™ xenokidney and thymus in a human pre-clinical model

Takeda announced that the FDA has accepted for review its New Drug Application (NDA) resubmission for TAK 721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus

Eisai and Merck & Co., Inc. ,known as MSD outside of the United States and Canada, provided updates on two Phase III trials, LEAP-006 and LEAP-008, evaluating Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck & Co., Inc., in patients with certain types of metastatic non-small cell lung cancer

Bristol Myers Squibb announced the Phase III CheckMate -77T trial met its primary endpoint of improved event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC)

Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression

Seagen Inc. and Astellas Pharma Inc. announced positive topline results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) for Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body

Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted marketing authorization for Enrylaze (JZP 458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase

Travere Therapeutics, Inc. announced topline two-year confirmatory secondary endpoint results from the Company’s pivotal head-to-head Phase III PROTECT Study of Filspari (sparsentan) in IgA nephropathy (IgAN) versus irbesartan

Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata

Alexion, AstraZeneca Rare Disease, has completed a definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer Inc.

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the Intracept Intraosseous Nerve Ablation System to treat vertebrogenic pain, a form of chronic low back pain.

Alvotech announced that the FDA has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT 02, a high-concentration, interchangeable biosimilar candidate to Humira (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT 02 BLA. The BsUFA goal date provided by the FDA is February 24, 2024.

ARS Pharmaceuticals, Inc. a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis for adults and children greater than 30 kg. ARS Pharma plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of this CRL.

Merck Inc., known as MSD outside of the United States and Canada, announced 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 external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer.

Japan Tobacco on September 15 filed a new drug application for tapinarof cream, a topical aryl hydrocarbon receptor agonist licensed from Swiss partner Dermavant Sciences, for the treatment of atopic dermatitis and plaque psoriasis in Japan.

Otsuka Pharmaceutical announced that European regulatory authorities have approved Inaqovi, a fixed-dose combination of decitabine and cedazuridine originated by Astex Pharmaceuticals, for the treatment of acute myeloid leukemia (AML).

Histogen Inc. has announced that its Board of Directors, after extensive consideration of potential strategic alternatives, has approved and adopted a Plan of Dissolution that would include the distribution of remaining cash to stockholders following an orderly wind down of the company’s operations, including any proceeds from the potential sale of any pipeline assets.

BeiGene, Ltd. announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab).

GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the European Commission has authorised Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention.

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for Welireg, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2alfa) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.

Allergan Aesthetics, an AbbVie company announced positive topline results from the second of three Phase III clinical studies evaluating onabotulinumtoxinA (Botox Cosmetic) for the treatment of moderate to severe platysma prominence associated with platysma muscle activity (M21-310).

POINT Biopharma Global Inc. a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and Athebio AG , an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands (“Radio-DARPins”).

Day One Biopharmaceuticals announced the recently completed submission of the rolling New Drug Application (NDA) to the FDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (LGG). The Company anticipates the FDA will file the rolling NDA by mid-November 2023.

Kite, a Gilead Company announced results from the Phase II ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The full findings from the study were published in Nature Medicine.

Orchard Therapeutics announced the FDA has accepted the filing of its Biologics License Application (BLA) for OTL 200 in metachromatic leukodystrophy (MLD) under Priority Review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of March 18, 2024.

Cassava Sciences, Inc. announced a positive interim safety review of simufilam in on-going Phase III clinical trials in patients with Alzheimer’s disease.

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma.

Orexo AB (publ.), announces the submission of the New Drug Application (NDA) to the FDA for OX 124, a high-dose rescue medication for opioid overdose with nasal delivery. OX 124, is based on Orexo´s world-class drug delivery platform amorphOX and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl.

For more than 135 years, Johnson & Johnson has provided health care products and solutions to people worldwide. Now, with its exclusive focus on healthcare innovation and tackling the toughest health challenges, the Company is updating its brand and uniting both its medtech and pharmaceutical segments under the Johnson & Johnson brand name to demonstrate its collective power in healthcare.

Abbott and Bigfoot Biomedical announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 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 Zoonotic Influenza Vaccine Seqirus, intended for the active immunisation against H5N1 subtype of Influenza A virus.

Vertex Pharmaceuticals Incorporated 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 Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor, for the treatment of children with cystic fibrosis (CF) ages 2 through 5 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

On 14 September 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 Catiolanze, intended for the reduction of elevated intraocular pressure (IOP) in adults with open angle glaucoma or ocular hypertension and in children from 4 years and adolescents with elevated IOP and paediatric glaucoma. The applicant for this medicinal product is Santen Oy.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a Paediatric Use Marketing Authorisation (PUMA) for the medicinal product Aqumeldi, intended for the treatment of heart failure in children from birth to less than 18 years.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Herwenda, intended for the treatment of HER2-positive breast and gastric cancer.

Ascendis Pharma A/S announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of TransCon PTH (palopegteriparatide)/Yorvipath as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for zilucoplan in the European Union (EU) 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.

PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

GSK plc announced that the FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

On 14 September 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 Finlee, intended for the treatment of low and high grade glioma (LGG and HGG).

BioMarin Pharmaceutical Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization to expand the indication for Voxzogo (vosoritide) for injection to treat children with achondroplasia aged 4 months and older whose epiphyses (growth plates) are not closed.

Almirall S.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy.

Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older

Iovance Biotherapeutics, Inc. announced the FDA, because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel

Altamira Therapeutics Ltd. announced further positive and statistically significant efficacy data from the randomized controlled NASAR clinical trial , which evaluated their Bentrio nasal spray in seasonal allergic rhinitis (SAR)

-Neurocrine Biosciences, Inc. announced the FDA has accepted its New Drug Application (NDA) for Ingrezza (valbenazine) oral granules, a new sprinkle formulation of Ingrezza (valbenazine) capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024

Pfizer has filed Apexxnar, its 20-valent pneumococcal conjugate vaccine in Japan for the prevention of pneumococcal infection in older adults and individuals at a high risk of contracting an infectious disease caused by pneumococcus

Astellas announced that the European Medicines Agency (EMA) has validated its Type II variation for Xtandi (enzalutamide) for the treatment of patients 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) who are unsuitable for salvage-radiotherapy

Madrigal Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced that the FDA has accepted for review its New Drug Application (NDA) for resmetirom for the treatment of adult patients with NASH with liver fibrosis

Alnylam Pharmaceuticals, Inc. announced the positive outcome of the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.

AbbVie announced top-line results from the Phase III SEQUENCE clinical trial evaluating risankizumab (Skyrizi, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (Stelara, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.

Avalo Therapeutics, Inc. announced it entered into a purchase agreement (the Purchase Agreement) with AUG Therapeutics, LLC (AUG) to sell its rights, title and interest in, assets relating to AVTX 801 (D-galactose), AVTX 802 (D-mannose) and AVTX 803 (L-fucose) (collectively, the 800 Series)

BioLineRx Ltd. a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, announced that the FDA has approved Aphexda (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma

GlaxoSmithKline has filed a new drug application in Japan for the investigational myelofibrosis treatment momelotinib, a compound acquired through its buyout of Sierra Oncology in July last year

Crinetics Pharmaceuticals, Inc. announced that paltusotine, an oral, once-daily investigational compound, achieved positive results by meeting the primary endpoint and all secondary endpoints of the Phase III PATHFNDR-1 study (NCT04837040)

Pfizer Inc. and BioNTech SE announced that the FDA approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older, and granted emergency use authorization for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine

Otsuka Pharmaceutical Co., Ltd. and ShapeTX, the programmable medicine company using AI and RNA to end genetic diseases, announce a multi-target collaboration to develop intravitreally-delivered adeno-associated viruses (AAVs) for ocular diseases, with options to add additional targets and tissue types. The companies will collaborate to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology along with Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for people living with serious eye diseases

Moderna, Inc. announced the FDA has approved the supplemental Biologics License Application(sBLA) for Spikevax for ages 12 years and above

Merck Inc., known as MSD outside of the United States and Canada, announced new analyses from studies of sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, for adults with pulmonary arterial hypertension (PAH) (WHO Group 1) at the European Respiratory Society (ERS) International Congress 2023

Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s Fasenra (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) who were receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy

Cassava Sciences, Inc. announced the publication of new research that confirms the biological activity of simufilam

Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC)

Sandoz, a global leader in generic and biosimilar medicines, announced that it has entered into a development and commercialization agreement with Samsung Bioepis

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 erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-[L]1) inhibitor

Bristol Myers Squibb announced results from a Phase II study evaluating BMS 986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist in patients with progressive pulmonary fibrosis (PPF)

Mirati Therapeutics, Inc. presented two-year follow-up data from a pooled analysis of the Phase 1/1b Cohort and Phase 2 Cohort A for the KRYSTAL-1 study evaluating adagrasib (Krazati in patients with non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation

Five abstracts evaluating several Sanofi and collaboration products and investigational treatments will be presented at the 2023 European Respiratory Society (ERS) International Congress from September 9-13 in Milan, Italy

Daiichi Sankyo announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for an omicron XBB.1.5-adapted mRNA vaccine (DS 5670) against the novel coronavirus infectious disease (COVID-19) for booster vaccination for individuals aged 12 years or older

Adamis Pharmaceuticals Corporation a commercial-stage biopharmaceutical company, announced the company changed its name to DMK Pharmaceuticals Corporation in order to better reflect its new strategic focus on advancing small molecules for the treatment of substance use disorders

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced results from the phase III clinical trials of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults

Merck Inc., announced that it has filed its PD-1 inhibitor Keytruda (pembrolizumab) in Japan for its use as a neoadjuvant therapy together with chemotherapy and continuing as a single-agent adjuvant therapy for certain non-small cell lung cancers (NSCLCs)

Actimed Therapeutics Ltd ,a UK based clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, announces that it has received approval from the FDA for its IND application for one Phase IIb/III clinical study of S-pindolol benzoate (the “IMPACT” clinical trial programme) to treat cachexia associated with colorectal cancer (IMPACT CRC) and another in patients with non-small cell lung cancer (IMPACT NSCLC)

Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, announced that it has entered into a multi-year, multi-target strategic collaboration agreement with Seagen Inc. to advance a new class of medicines called Degrader-Antibody Conjugates (DACs) for use in cancer

CymaBay Therapeutics, Inc. announced positive topline results from its Phase III pivotal RESPONSE study

Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology-based therapies, announced that it has entered into a license and collaboration agreement with Bristol Myers Squibb Company to develop and commercialize obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved an expanded indication for Ervebo for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus

Fulcrum Therapeutics, Inc., announced that it has completed enrollment in REACH, a Phase III clinical trial evaluating losmapimod in patients with FSHD (facioscapulohumeral muscular dystrophy) at sites in the United States, Canada, and Europe

Arcutis Biotherapeutics, Inc. announced interim results from the INTEGUMENT-OLE long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older with atopic dermatitis

Applied Therapeutics, Inc. announced successful completion of a recent pre-New Drug Application (“NDA”) meeting with the FDA regarding its govorestat (AT 007) Galactosemia program

BioCardia, Inc. announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP Cell Therapy for Heart Failure (CardiAMP HF, clinicaltrials.gov Identifier: NCT02438306), for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction (HFrEF)

Ascendis Pharma A/S announced new post hoc analysis showing adults with hypoparathyroidism treated with TransCon PTH demonstrated substantial improvement in estimated glomerular filtration rate (eGFR), suggesting improved kidney function

The FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+)

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients

Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (BLA) for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)

Merck Inc., known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at 9-15 years old

Nobelpharma said that UK regulatory authorities have granted approval for Hyftor (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and pediatric patients aged six years and older

Mirum has acquired Travere’s rights to Cholbam, indicated for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease, and Chenodal, indicated for the treatment of radiolucent stones in the gallbladder, which is also under Phase III clinical evaluation for cerebrotendinous xanthomatosis (CTX)

Braeburn announces that Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, is now available in the U.S.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for bimekizumab (Bimzelx, UCB) for patients with active psoriatic arthritis and adult patients with active axial spondyloarthritis

Seagen Inc. and Genmab A/S announced that the Phase III innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS)

AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy

Apellis Pharmaceuticals, Inc., a global biopharmaceutical company and leader in complement, announced a corporate restructuring to drive growth of Synfovre (pegcetacoplan injection) and Empaveli (pegcetacoplan), positioning Apellis for long-term success.

Bavarian Nordic A/S (reported additional Phase III results and provided an update on the development program for its cVLP-based COVID-19 booster vaccine candidate, ABNCoV2.

Otsuka Pharmaceutical Co., Ltd. and Mindset Pharma, Inc. announce that they have entered into a definitive arrangement agreement pursuant to which Otsuka will acquire Mindset for approximately CAD 80 million in an all-cash transaction.

New data from the BIOMAG-I first-in-human trial shed light on the vascular healing process following the implantation of DREAMS 3G, Biotronik’s third-generation resorbable magnesium scaffold (RMS).

Allergan Aesthetics, an AbbVie company announced the Journal of Cosmetic Dermatology published results from a year-long, post-hoc analysis of patient-reported outcomes (PROs) from two Phase III clinical studies evaluating the impact of onabotulinumtoxinA (BOTOX Cosmetic) on upper facial lines (UFLs) in adults new to toxin treatment.

AbbVie announced that it has submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for risankizumab (Skyrizi, 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis.

Sage Therapeutics, Inc. announced plans to reorganize its business operations and pipeline priorities to support goals for long-term business growth, including the planned commercial launch of Zurzuvae for women with postpartum depression (PPD) in late 2023

Zevra Therapeutics, Inc., a rare disease company melding science, data and patient need to create transformational therapies for diseases with limited or no treatment options, and Acer Therapeutics Inc., a pharmaceutical company focused on development and commercialization of therapies for rare and life-threatening diseases, announced the companies have entered into a definitive agreement pursuant to which Zevra would acquire Acer in a merger transaction having a total potential value for Acer stockholders of up to $91 million

Roche announced that the Phase III ALINA study evaluating Alecensa (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis

Genexine announced positive topline results from the multi-center, randomized, open-label, active-controlled pivotal phase III study (CTJ101PGHD301) being conducted in China to evaluate the efficacy and safety of eftansomatropin alfa (Genexine’s proprietary long-acting growth hormone, also known as GX-H9) in children with growth hormone deficiency

Orchard Therapeutics announced long-term results from an updated integrated analysis of 39 patients with metachromatic leukodystrophy (MLD) treated with investigational OTL 200 in the clinical development program