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The special warnings and precautions for use section of the EMA EPAR for Kesimpta indicates that it may cause injection-related reactions and injection-site reactions (including injection-site erythema, swelling, itching and pain); and infections. Adverse events reported with anti-CD20 antibodies include John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, and hepatitis B reactivation leading to fulminant hepatitis, hepatic failure and death. [Data from EMA European public assessment report for Kesimpta (ofatumumab; CD20 inhibitor)] Regulatory Agency Communication

Phase I clinical study of ifabotuzumab (EPHA3 inhibitor; 3.5 or 5.25 mg/kg) in 12 patients with glioblastoma. Treatment-related adverse events were infusion reactions (4 patients grade 1/2; 0 patients grade 3/4), headache (1; 1), seizures, cerebral edema, diarrhea (1; 0 each) and rash (0; 1). Eye disorders were observed. Congress Alert

Phase Ib study of combined lenzilumab (GM-CSF inhibitor; 600 or 1,800 mg) and axicabtagene ciloleucel (CD19-targeted CAR T-cells) in 6 patients with diffuse large B-cell lymphoma. 1 patient in the 600 mg cohort experienced grade 3 neurotoxicity. [Data from a Humanigen communication reporting positive data from a phase Ib study of lenzilumab in combination with CAR-T cell therapy in patients with diffuse large B-cell lymphoma] Company Communication

Syndax communication announcing positive interim data from the phase I portion of a phase I/II study of SNDX-5613 (menin inhibitor) in 43 patients with MLLr- and NPM1c-mutant relapsed/refractory acute leukemia. Grade ≥3 treatment-related adverse events occurring in ≥5% patients were QT prolongation, anemia and differentiation syndrome. Among the 22 patients treated at the recommended phase II dose, 2 patients (9%) experienced grade 3 QT prolongation. Company Communication

Lilly and Incyte communication announcing results from a phase II/III and a phase III trial of baricitinib (JAK1/2 inhibitor; 2 or 4 mg qd) in patients with severe alopecia areata. The most common treatment-emergent adverse events in both studies included upper respiratory tract infections, headache and acne. Company Communication

New Zealand's Medicines Adverse Reactions Committee has discussed a case report of a patient who died after developing metastatic colon cancer during treatment with adalimumab (TNF-alpha inhibitor). The causality of this adverse event was considered at least possible. Regulatory Agency Communication

New Zealand’s Medsafe has issued a safety review on adverse events (AEs) following immunization with Pfizer-BioNTech COVID-19 vaccine. The most common AEs reported to the Centre for Adverse Reactions Monitoring (CARM) were dizziness (49 reports), headache (37), nausea (36), vasovagal reaction/syncope (22), faintness (9), erythema, fatigue, fever, injection site pain and swelling (8 each). 3 serious AEs were reported to CARM, including allergic reactions (2) and a reactogenicity reaction manifested as flu-like symptoms. Regulatory Agency Communication

Nextstellis carries a black box warning for serious cardiovascular events in cigarette smoking patients treated with combined hormonal contraceptives, including Nextstellis. [Data from FDA approved drug report for Nextstellis (drospirenone/estetrol)] Regulatory Agency Communication

The FDA has updated the product information of Proscar (finasteride; steroid 5-alpha-reductase 1/2 inhibitor), adding novel information to the warning on the risk to male fetus. Based on preclinical studies and its mechanism of action, Proscar may cause abnormal development of external genitalia in male fetuses when administered to a pregnant woman. Regulatory Agency Communication

Phase I/II trial of gavocabtagene autoleucel (gavo-cel; mesothelin-targeted CAR T-cells) in 8 patients with mesothelin-positive solid tumors. Grade ≥3 hematologic adverse events (AEs) included lymphopenia (7 patients [88%]), neutropenia (6 [75%]) and thrombocytopenia (2 [25%]). Grade ≥3 cytokine release syndrome (2 [25%]) was an AE of special interest considered on-target and on-tumor. Other AEs of special interest included pneumonitis and sepsis (1 [13%] each). [Data from TCR2 Therapeutics Corporate Presentation, April 2021] Company Communication

Case report of 2 patients who received a second dose of the Moderna COVID-19 vaccine after experiencing immediate hypersensitivity reactions to the first dose. The first patient had generalized pruritus, urticaria and tachycardia, and the other experienced urticaria and facial angioedema. Before the second administration, a skin prick test was conducted for polyethylene glycol, polysorbate and the Moderna vaccine. The test was negative for the components but positive for the vaccine. After the second administration, via a graded dosing protocol, patient 1 had no symptoms and patient 2 reported pruritus (which resolved without medical intervention).

The Australian Therapeutic Goods Administration (TGA) has identified the third case of thrombosis with thrombocytopenia following AstraZeneca COVID-19 vaccine administration in Australia. The patient was a 48-year-old woman who developed the event 4 days after the vaccination and died after admission to the hospital. The event was considered likely related to vaccination. To date, 885,000 doses of the AstraZeneca COVID-19 vaccine have been administered in Australia, and 3 cases of thrombosis with thrombocytopenia have been reported (1 per 295,000 doses). Regulatory Agency Communication

The FDA has updated the product information of Xiaflex (collagenase clostridium histolyticum) to include the risk of acute post-injection back pain reactions (sometimes accompanied by radiation of pain to the extremities, chest pain, headache, dyspnea, muscle spasms, paresthesia, gait instability and/or inability to ambulate) in the “Warnings and Precautions” and “Adverse Reactions” sections. Regulatory Agency Communication

The CHMP is reviewing clinical data to assess whether extremity pain, abdominal pain, urticaria and influenza-like symptoms are side effects of Vaxzevria (AstraZeneca COVID-19 vaccine). [Data from the COVID-19 vaccine safety update for Vaxzevria (April 2021)] Regulatory Agency Communication

The PRAC has started an assessment of embolic and thrombotic events following the report of serious and unusual types of thrombosis together with thrombocytopenia in patients receiving the Janssen COVID-19 vaccine. Based on clinical data, venous thromboembolism was identified as a potential risk. [Data from the COVID-19 vaccine safety update for Janssen COVID-19 vaccine (April 2021)] Regulatory Agency Communication

First-in-human study evaluating the safety and tolerability of BLU-263 (KIT/PDGFRalpha inhibitor; 15-200 mg) in healthy volunteers. Treatment-related adverse events (TRAEs) reported in subjects receiving BLU-263 200 mg in the single-ascending dose part were upper abdominal pain and decreased appetite (1 each). TRAEs observed in the 25 mg dose cohort of the multiple-ascending dose part were upper abdominal pain, fatigue, chapped lips, nausea and headache (1 each). Congress Alert

The FDA has updated the product information of Trulance (plecanatide; guanylate cyclase activator), adding hypersensitivity reactions (including skin itching, hives and rash) and vomiting as adverse reactions reported postmarketing. Regulatory Agency Communication

Phase I study of ZN-c3 (Wee1 inhibitor; 20-450 mg qd) in 55 patients with advanced or metastatic solid cancer. The most common treatment-related adverse events (TRAEs) were nausea (42% of patients; 5.4% grade ≥3), diarrhea (32.7%; 3.6%) and fatigue (29%; 5.4%). Other AEs, including those leading to ZN-c3 dose reduction and those reported in clinical trials of adavosertib (AZD1775), are listed. [Data from a Zentalis corporate presentation, April 2021] Company Communication

The CHMP has recommended to update the product information of PecFent (fentanyl; opioid mu receptor agonist) to include Cheynes-Stokes respiration in a context of overdose. 2 spontaneous reports had a close temporal relationship and a positive dechallenge. The PRAC considers that a causal relationship is at least a reasonable possibility with a transmucosal route of administration. [Data from the conclusions from a Periodic Safety Update Report of PecFent] Regulatory Agency Communication

The ANSM has decided to restrict the indication of Estracyt (estramustine; DNA alkylating agent/estrogen receptor-beta modulator) and to modify its prescription and dispensing conditions. The product information will be updated to include jaundice, cholestasis and cytolytic hepatic impairment. Regulatory Agency Communication

Conclusions from a Periodic Safety Update Report of octreotide (somatostatin receptor agonist). The CMDh has recommended updating the product information of octreotide to include a warning on atrioventricular block (including complete atrioventricular block) when is administered by IV infusion at high doses. The PRAC considers that a causal relationship is at least a reasonable possibility. Regulatory Agency Communication

The EMA has updated the product information of Comirnaty (Pfizer-BioNTech COVID-19 vaccine) to include diarrhea and vomiting to the “Undesirable effects” section with frequencies very common and common respectively. The adverse drug reaction “hypersensitivity reactions” was further detailed to include rash, pruritus, urticaria and angioedema. Regulatory Agency Communication

The special warnings and precautions for use section of the EMA EPAR for Sogroya (somapacitan) indicates that somapacitan and/or growth hormone (GH) may cause adrenocortical insufficiency (including reduction in serum cortisol concentrations); hyperglycemia in subjects with inadequate insulin secretory capacity; slight increase in second neoplasms in childhood cancer survivors, with the most frequent being intracranial tumors; hypothyroidism; lipohypertrophy; and increased risk of mortality in patients with acute critical illness. Other warnings and precautions of somapacitan and/or GH are listed. [Data from EMA European public assessment report for Sogroya (somapacitan; growth hormone receptor agonist)] Regulatory Agency Communication

Case report of a 70-year-old woman who developed chilblains after receiving a first dose of the mRNA-1273 vaccine (SARS-CoV-2 protein-directed immunity inducer). Similar lesions were also observed after she received a second dose.

The FDA has updated the product information of Ozempic (semaglutide; GLP-1 receptor agonist). The warning about hypoglycemia with concomitant use of insulin secretagogues or insulin has been updated to include severe hypoglycemia. Hypersensitivity including anaphylaxis, angioedema, rash and urticaria have been included as adverse reactions reported postmarketing. Regulatory Agency Communication

The FDA has updated the product information of Trodelvy (sacituzumab govitecan; tumor-associated calcium signal transducer 2/DNA topoisomerase 1 inhibitor) to include novel adverse reactions (listed) reported in a clinical trial evaluating Trodelvy for metastatic triple-negative breast cancer. Anemia has also been added to the list of adverse reactions occurring more frequently in patients with reduced UGT1A1 activity. Regulatory Agency Communication

First-in-human phase I study of ASP4132 (AMPK activator; 5-10 mg qd or intermittent 10/15 mg) in 39 patients with cancer. The most common drug-related adverse events (AEs) were nausea (24 patients [62%]), vomiting (16 [41%]), increased blood lactic acid (13 [33%]), fatigue (12 [31%]), decreased appetite (6 [15%]) and dizziness (5 [13%]). Dose-limiting toxicities included grade 4 mental status change and grade 3 fatigue (1 patient each) at 10 mg qd; lactic acidosis, dizziness and grade 3 fatigue (1 each) at 7.5 mg qd; grade 3 enteritis (1) at intermittent 10 mg; and posterior reversible encephalopathy syndrome and grade 3 mental status change (1 each) at intermittent 15 mg. Other AEs are listed.

Results from preclinical studies evaluating the safety and antitumor efficacy of IL12-Fc fusion protein. Mice receiving wild-type IL12-Fc at 0.01, 0.1 or 1 mg/kg exhibit decreased body weight and body temperature and increased spleen weights compared to mice exposed to a potency-reduced IL2-Fc. Congress Alert

Population-based study assessing the association between antihypertensive medications and a risk of keratinocyte carcinoma and melanoma in subjects aged ≥66 years. Increased thiazide exposure was associated with increased rates of keratinocyte carcinoma (adjusted hazard ratio 1.08 [95% CI :1.03-1.14]) and melanoma (1.34 [1.01-1.78]). Compared with 0-0.5 defined annual dose (DAD) units, patients exposed to >7.5 DAD units had an increased risk of keratinocyte carcinoma (1.44 [1.35-1.54]), advanced keratinocyte carcinoma (1.52 [1.29-1.79]) and melanoma (1.60 [1.10-2.32).

Phase II study of berzosertib (ATR inhibitor; 210 mg/m2) plus topotecan (DNA topoisomerase 1 inhibitor; 1.25 mg/m2) in 26 patients with relapsed small cell neuroendocrine cancers. The most common treatment-related adverse events (TRAEs) were lymphopenia (25 patients [96.2%]; 18 [69.2%] grade ≥3), anemia (25 [96.2%]; 14 [53.8%]), thrombocytopenia (24 [76.9%]; 15 [57.7%]), neutropenia (13 [50%]; 4 [15.4%]) and nausea (13 [50%]; 1 [3.8%]). Other TRAEs are listed.

Study using human cardiac progenitor cells reporting that imatinib mesylate (BCR/ABL inhibitor) significantly reduced cell viability after 24 hours by impairing mitochondrial membrane potential and autophagic flux and inducing necroptosis.

The special warnings and precautions for use section of the EMA EPAR for Seffalair Spiromax indicates that it may cause serious asthma-related events and exacerbations (including sudden and progressive deterioration); cardiac arrhythmias (including supraventricular tachycardia and atrial fibrillation); hypokalemia and hyperglycemia; paradoxical bronchospasm; adrenal suppression and acute adrenal crisis due to fluticasone propionate administration; drug interactions with other potent CYP3A inhibitors (ketoconazole); and oral infections due to the fluticasone propionate component. Other warnings and precautions of Seffalair Spiromax and corticosteroids or beta-adrenoceptor agonists are listed. [Data from EMA European public assessment report for Seffalair Spiromax (fluticasone propionate/salmeterol)] Regulatory Agency Communication

The special warnings and precautions for use section of the EMA EPAR for Vazkepa indicates that it may cause atrial fibrillation or flutter requiring hospitalization; and bleeding. Patients receiving anticoagulants and/or antiplatelet agents such as acetylsalicylic acid may be at increased risk of bleeding. It is not known if patients with allergies to fish and/or shellfish have an increased risk of allergic reactions to icosapent ethyl. [Data from EMA European public assessment report for Vazkepa (icosapent ethyl)] Regulatory Agency Communication

In vitro study in human embryonic stem cells characterizing the mechanisms of retinitis pigmentosa associated with MERTK deficiency.

First-in-human phase I study of ABBV-085 (antibody drug conjugate targeting LRRC15 and tubulin; 0.3-6.0 mg/kg q14d IV), alone or in combination with nivolumab or gemcitabine with or without nab-paclitaxel, in 85 patients with sarcomas and other advanced solid tumors. The most common drug-related adverse events (AEs) with ABBV-085 monotherapy were fatigue (23 [30%] patients; grade ≥3 in 3 [4%]), nausea (15 [19%]; 1 [1%]) and decreased appetite (13 [17%]). Dose-limiting toxicities were grade 3 anemia (at 3.6 mg/kg), grade 3 hypertriglyceridemia (at 4.2 mg/kg), grade 3 nausea and grade 2 ileus (each at 4.8 mg/kg). 2 cases of treatment-related diarrhea were reported with ABBV-085 plus nivolumab. Other AEs are listed.

Phase III study comparing tebentafusp (melanocyte protein PMEL/CD3 interacting agent; 20, 30 or 68 mcg) with investigator’s choice in 378 patients with untreated metastatic uveal melanoma. Treatment-related adverse events (TRAEs) with tebentafusp included cytokine release syndrome (217 patients [89%]; 2 [1%] grade 3-4), pyrexia (185 [76%]; 9 [4%]), chills (114 [47%]; 1 [0.4%]) and nausea (105 [43%]; 2 [1%]). Other TRAEs are listed. [Data from an Immunocore corporate presentation] Company Communication

Case report of a 48-year-old woman who suffered vaccine-induced immune thrombotic thrombocytopenia presenting as extensive thrombosis, severe thrombocytopenia and disseminated intravascular coagulation after Ad26.COV2.S vaccination. Thrombotic events included splanchnic vein thrombosis, cerebral venous sinus thrombosis with hemorrhagic stroke, and hepatic and splenic vein thrombosis. Other findings are listed.

The special warnings and precautions for use section of the EMA EPAR for Ontozry indicates that it may cause drug reaction with eosinophilia and systemic symptoms (which may be life-threatening or fatal) manifesting as fever, rash associated with other organ system involvement, lymphadenopathy, liver function test abnormalities, eosinophilia and hypersensitivity; and shortening of the QTcF interval. Suicidal ideation and behavior have been reported with anti-epileptic drugs, and the possibility of an increased risk with Ontozry cannot be excluded. [Data from EMA European public assessment report for Ontozry (cenobamate; sodium channel blocker)] Regulatory Agency Communication

The EMA's PRAC is evaluating very rare cases of unusual blood clots (cerebral venous sinus thrombosis) that occurred in the United States following the use of Janssen’s COVID-19 vaccine. Most cases of cerebral venous sinus thrombosis were accompained by low levels of blood platelets (thrombocytopenia). The EMA is investigating all the cases reported and will decide whether regulatory action is necessary. While its review is ongoing, the EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. Regulatory Agency Communication

Phase Ib study of pegcetacoplan (complement C3 inhibitor; 15 mg/0.1 mL qm) in 13 patients with bilateral geographic atrophy. 2 patients (16%) developed new-onset ocular exudation. [Data from an Apellis communication announcing updated data from the APL2-103 study] Company Communication

Safety data from 4 clinical trials of CoronaVac (SARS-CoV-2 proteins-directed immunity inducer). Very common and common injection-site reactions were pain, swelling, pruritus, erythema and induration. Very common and common systemic adverse reactions (ARs) included headache, fatigue, myalgia, nausea, diarrhea, arthralgia and cough. Grade ≥3 ARs included injection-site pain, fever, headache, fatigue and hypersensitivity. Other ARs are listed. [Data from a Sinovac Biotech communication summarizing clinical results of CoronaVac] Company Communication

The FDA has updated the product information of Definity (perflutren) to add the risk of anaphylaxis (which may be fatal) to the “Warnings and Precautions” section for hypersensitivity reactions. Definity contains polyethylene glycol, which may be involved in the reaction. Regulatory Agency Communication

Study identifying novel off-target proteins of finasteride (steroid 5-alpha-reductase 1/2 inhibitor). Results suggested that finasteride inhibits phenylethanolamine N-methyltransferase (PNMT) activity, which may be linked to the drug’s sexual and psychological side effects (listed). PNMT inhibition may also be associated with the microbiota alterations observed in finasteride users. Other adverse events are listed.

In a press conference held by Peter Arlett, the European Medicines Agency’s head of pharmacovigilance, on April 7th, the cases of blood clots reported worldwide were discussed. There have been 35 cases of serious thrombosis with the Pfizer/BioNTech vaccine among 54 million doses given, 5 cases with the Moderna vaccine among 4 million Europeans dosed, and 6 cases of thrombosis with low platelet counts among 6.8 million worldwide doses with the Johnson & Johnson vaccine. Additionally, 2 papers have been published which described 16 cases of cerebral venous sinus thrombosis with the AstraZeneca vaccine, all of which were seen in subjects with high levels of antibodies to platelet factor 4.

First-in-human study of etrolizumab autoinjector (integrin alpha4beta7 antagonist; 105 mg SC) in 30 healthy volunteers. Adverse events were injection site erythema (10 patients [33.3%]) and pain (2 [6.7%]), and hives (1).

2 first-in-human phase I studies of SUVN-D4010 (5-HT4 receptor partial agonist; 5-45 mg single dose or 10, 20 and 40 mg qd) in healthy volunteers. In study 1, the only treatment-emergent adverse event (TEAE) deemed possibly drug-related and reported more frequently with SUVN-D4010 than with placebo was headache (1/6 patients [16.7%] with both SUVN-D4010 10 mg and 20 mg vs 1/6 [16.7%] with placebo). In study 2, TEAEs considered possibly drug-related were headache (4/28 [14.3%]), nausea (2 [7.1%]), vomiting and photophobia (1 [3.6%] each).

The FDA has recommended a pause in the vaccination with the Janssen COVID-19 vaccine to review 6 cases of a rare and severe type of blood clot (cerebral venous sinus thrombosis) in combination with low levels of blood platelets (thrombocytopenia). All cases occurred among women aged between 18 and 48 years, and symptoms occurred 6 to 13 days after vaccination. Regulatory Agency Communication

First-in-human phase I study evaluating the safety and immunogenicity of the SARS-CoV-2 vaccine MVC-COV1901 with adjuvant aluminum hydroxide and CpG 1018 in 45 healthy participants. Local injection-site reactions were mild across all dose groups. 1 patient in the high-dose group experienced malaise and fatigue.

Descriptive analysis evaluating the association between diclofenac (COX-1/2 inhibitor) and rhabdomyolysis using data from the WHO Global Pharmacovigilance Database (VigiBase). 70 reports of rhabdomyolysis were identified, including 7 cases assessed as probably related to diclofenac. Diclofenac was considered to be a probably indirect cause in 5 cases of rhabdomyolysis due to injection-site necrosis. 8 fatalities were reported. Disproportionality analysis did not find a significant association between the adverse drug reaction and diclofenac (IC025=-1.4). Features of rhabdomyolysis and concomitant drugs are listed.

Several vaccination sites at the USA have temporarily paused Janssen COVID-19 vaccine administration after adverse reactions such as immediate reactions, nausea, dizziness, fainting, light headedness and rapid breathing were observed. The vaccination will resume after CDC evaluation.

First-in-human phase I study of TAS0728 (HER2 inhibitor; 50-200 mg bid) in 19 patients with advanced solid tumors with HER2 or HER3 aberrations. The study was stopped due to unacceptable toxicity during the dose-escalation phase. The most common grade 3 treatment-related adverse event (AE) was diarrhea (1/3 [33.3%] patients at 50 mg; 2/6 [33.3%] at 150 mg; 3/7 [42.9%] at 200 mg), dose-limiting in 2 patients at 200 mg. AEs leading to discontinuation included decreased blood albumin, myalgia, abdominal pain (1 each at 100 mg), grade 3 acute kidney injury and weight decrease (1 each at 200 mg). 1 patient died from treatment-related cardiac arrest. Other treatment-related AEs are listed.

Phase II/III clinical study of mavrilimumab (GM-CSF receptor, alpha subunit antagonist; 6 or 10 mg/kg IV) in patients with severe COVID-19. In the phase II portion of the trial, 116 non-mechanically ventilated patients were enrolled. Infections were reported in all groups, including placebo. [Data from a Kiniksa communication announcing positive results in the phase II portion of a phase II/III clinical study of mavrilimumab for the treatment of COVID-19] Company Communication

Phase Ib study of AMG0103 (NF-kappa B decoy oligo DNA; 0.3, 3.0 and 10.0 mg) in 25 patients with chronic discogenic low back pain. One drug-related adverse event of mild nausea was reported in a patient from the low-dose cohort. [Data from an AnGes communication announcing topline results from a phase I study of AMG0103 for the treatment of discogenic low back pain] Company Communication

The Australian Therapeutic Goods Administration (TGA) has identified the second case of thrombosis with thrombocytopenia following AstraZeneca COVID-19 vaccine administration in Australia. The event was considered likely related to vaccination. Regulatory Agency Communication

Bausch + Lomb communication announcing topline results from the first phase III study of NOV03 (perfluorohexyloctane) ophthalmic solution in patients with dry eye disease associated with meibomian gland dysfunction. Instillation-site reactions were reported in <0.5% patients. Rates of ocular treatment-emergent adverse events were similar between the NOV03 and placebo arms (9.6% vs 7.5%, respectively). Company Communication

The EMA’s PRAC has started a review on thromboembolic events in people who received the Janssen COVID-19 vaccine. To date, 4 serious cases (1 fatal) of blood clots with low blood platelets have been reported (1 during a clinical trial and 3 during vaccine rollout in the USA). [Data from the PRAC 6-9 April 2021 meeting highlights] Regulatory Agency Communication

The EMA’s PRAC has started a review on the risk of capillary leak syndrome in people who were vaccinated with Vaxzevria (AstraZeneca COVID-19 vaccine). To date, 5 cases have been reported to EudraVigilance. [Data from the PRAC 6-9 April 2021 meeting highlights] Regulatory Agency Communication

Sage Therapeutics and Biogen communication announcing topline results from a phase II study of SAGE-324 (GABAA positive allosteric modulator; 60 mg qd) in 67 patients with essential tremor. The most common treatment-emergent adverse events (≥10% patients and ≥2 times more frequent than with placebo) were somnolence (68%), dizziness (38%), balance disorder (15%), diplopia, dysarthria and gait disturbance (12% each). Company Communication

Study evaluating pre-treatment predictors of tolerability and clinical outcome of lenvatinib therapy in 80 patients with hepatocellular carcinoma. Patients with a level of Mac-2-binding protein glycosylation isomer ≥ 1.5 had a higher incidence of adverse events (such as fatigue and anorexia) during treatment with lenvatinib.

The EMA has updated the product information of Lynparza (olaparib; PARP-1/2 inhibitor) to include myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) as adverse drug reactions with frequency “uncommon”. The existing warning on MDS/AML was also modified accordingly. Regulatory Agency Communication

Phase III study of combined casirivimab and imdevimab (1,200 mg) in 1,505 individuals without SARS-CoV-2 antibodies or any COVID-19 symptom, and in 204 infected patients. Injection-site reactions occurred in 55 (4%) non-infected individuals treated with casirivimab/imdevimab vs 19 (2%) with placebo, and in 6 (4%) infected patients treated with the combination vs 1 (1%) with placebo. [Data from a Roche communication announcing positive phase III results of combined casirivimab and imdevimab] Company Communication

Health Canada has issued a safety review evaluating the potential association between Veklury (remdesivir; viral RNA polymerase inhibitor) and the risk of acute kidney injury and acute renal failure. 64 case reports of acute kidney injury/acute renal failure were considered possibly associated with Veklury. The agency concluded that there is not enough evidence to stablish a direct relationship between Veklury and acute kidney injury/acute renal failure. Regulatory Agency Communication